Contraception 94 (2016) 262 – 274

Review article

Combined hormonal contraceptive use among breastfeeding women: an
updated systematic review☆,☆☆
Naomi K. Tepper a,⁎, Sharon J. Phillips b , Nathalie Kapp b, c ,
Mary E. Gaffield b , Kathryn M. Curtis a
a
Division of Reproductive Health, US Centers for Disease Control and Prevention, Atlanta, GA 30341
b
Department of Reproductive Health and Research, World Health Organization, Geneva, Switzerland (prior affiliation for Dr. Phillips and Dr. Kapp)
c
Current affiliation: Independent reproductive health consultant, Paris, France
Received 27 March 2015; revised 13 May 2015; accepted 13 May 2015

Abstract

Background: Contraception is important for women who are postpartum, including those who are breastfeeding. Use of combined hormonal
contraceptives (CHCs) may affect breastfeeding performance and infant health outcomes.
Objective: The objective was to identify evidence examining clinical outcomes for breastfeeding and infant health among breastfeeding
women using CHCs compared to nonusers.
Search strategy: We searched the PubMed database for all articles published from database inception through September 30, 2014.
Selection criteria: We included primary research studies that compared breastfeeding women using CHCs with breastfeeding women using
nonhormonal or no contraception, or compared breastfeeding women initiating combined hormonal contraception at early versus later times
postpartum. Breastfeeding outcomes of interest included duration, rate of exclusive breastfeeding and timing of supplementation. Infant
outcomes of interest included growth, health and development.
Results: Fifteen articles describing 13 studies met inclusion criteria for this review. Studies ranged from poor to fair methodological quality
and demonstrated inconsistent effects of combined oral contraceptives (COCs) on breastfeeding performance with COC initiation before or
after 6 weeks postpartum; some studies demonstrated greater supplementation and decreased breastfeeding continuation among COC users
compared with nonusers, and others demonstrated no effect. For infant outcomes, some studies found decreases in infant weight gain for
COC users compared with nonusers when COCs were initiated at b 6 weeks postpartum, while other studies found no effect. None of the
studies found an effect on infant weight gain when COCs were started after 6 weeks postpartum, and no studies found an effect on other
infant health outcomes regardless of time of COC initiation.
Conclusion: Limited evidence of poor to fair quality demonstrates an inconsistent impact of COCs on breastfeeding duration and success.
The evidence also demonstrated conflicting results on whether early initiation of COCs affects infant outcomes but generally found no
negative impact on infant outcomes with later initiation of COCs. The body of evidence is limited by older studies using different
formulations and doses of estrogen and poor methodologic quality. Given the significant limitations of this body of evidence, the importance
of contraception for postpartum women and the theoretical concerns that have been raised about the use of combined hormonal contraception
by women who are breastfeeding, rigorous studies examining these issues are needed. In addition, postpartum women should be counseled
about the full range of safe alternative contraceptive methods, particularly during the first 6 weeks postpartum when the risk of venous
thromboembolism is highest and use of estrogen may exacerbate this risk.
© 2016 Published by Elsevier Inc. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).

Keywords: Combined hormonal contraceptives; Combined oral contraceptives; Breastfeeding; Lactation; Systematic review


Disclaimer: The findings and conclusions in this report are those of the authors and do not necessarily represent the official position of the World Health
Organization or US Centers for Disease Control and Prevention.
☆☆
Disclosure: Dr. Kapp is currently employed by HRA Pharma which makes emergency contraception.
⁎ Corresponding author at: US Centers for Disease Control and Prevention, 4770 Buford Hwy, MS K-34, Atlanta, GA 30341. Tel.: + 1 770 488 6506;
fax: + 1 770 488 6391.
E-mail address: ntepper@cdc.gov (N.K. Tepper).

http://dx.doi.org/10.1016/j.contraception.2015.05.006
0010-7824/© 2016 Published by Elsevier Inc. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).

the combined vaginal ring and combined body of evidence was very limited given the poor methodo. Studies reported a variety of breastfeeding clinical outcomes including percent fully breastfeeding at certain times 2. We also included articles that included a logic quality. This systematic review examines the safety of CHC use Articles were included in this review if they were primary among breastfeeding women and updates the previous review reports on studies of breastfeeding women using CHCs conducted for the World Health Organization (WHO). For women who are breastfeeding. However. concern has been raised over (((((((((("Contraceptives. We also searched Cochrane systematic review that attempted to determine reference lists of identified articles and relevant review the effect of hormonal contraceptives on breastfeeding articles for additional citations of interest. A Articles in all languages were accepted. Introduction or N 6 weeks postpartum have negative effects on breast- feeding outcomes or infant outcomes compared with no Initiation of contraception during the postpartum period is contraception or nonhormonal contraception? (b) Do CHCs important to prevent unintended pregnancy and short birth initiated by breastfeeding women at b 6 weeks postpartum intervals. Concept] OR ortho evra OR "contraceptive patch" OR Breastfeeding has important well-established health "transdermal patch")) OR ("NuvaRing"[Supplementary Concept] benefits for both mother and infant. have demonstrated that levels of hormones absorbed by the infant are fairly low [7]. using the following search strategy: immediate return to fertility when discontinued and effectiveness [4]. the review also concluded that the hormonal patch. N. total duration of breastfeeding (without We assessed two specific questions for this review: specifying whether full or partial breastfeeding). abstracts of conference (RCTs) do not sufficiently establish an effect of hormonal presentations or dissertations. percent continuing to breastfeeding at certain times postpartum. . Oral"[Mesh]) OR "oral contracep- possible effects of CHCs on breastfeeding performance and tives")) OR oral contracept*))) OR ("Ortho Evra"[Supplementary infant health. the review nonhormonal comparison group.12]. mix. it is still unclear what effect 2. Therefore. as part compared with breastfeeding women using nonhormonal of the process of updating the Medical Eligibility Criteria for contraception or no contraception. However. as many women prefer their familiarity and ease of use.K. Study designs without a comparison group were evidence largely did not show negative effects on infant growth excluded.2. Literature search repeat pregnancy. which can lead to negative health outcomes for have negative effects on breastfeeding outcomes or infant mother and infant [1. Selection criteria exogenous hormones have on infant growth and development.1. and these benefits can OR nuvaring OR "vaginal ring")) OR (((once a month OR be maximized with at least 6 months of exclusive monthly) AND inject*) AND contracept* OR cyclofem OR lunelle breastfeeding [5]. use of contraception even among breastfeeding women is critical to prevent early 2. and examines outcomes by timing of CHC initiation. We considered clinical breastfeeding performance feeding. exclusivity and ment. Tepper et al. Therefore. outcomes such as duration of breastfeeding. CHCs of interest included COCs. Specifically. frequency. We did not concluded that the existing randomized controlled trials consider unpublished studies. Two important [Mesh] or breast feeding or breastfeeding)) OR ("Lactation" [Mesh] or lactation)) Filter: limit to human. Articles were also Contraceptive Use (MEC) [8]. or Reporting Items for Systematic Reviews and Meta-Analyses less if menstrual bleeding resumes or supplemental feedings guidelines [10]. Materials and methods postpartum. Combined hormonal contraceptives We searched the PubMed database for all relevant articles (CHCs) play an important role in the contraceptive method published from database inception through September 30. percent (a) Do CHCs initiated by breastfeeding women at b 6 weeks using supplementation and age at infant supplementation. areas of consideration for potential impact of medications include effects on breastfeeding and effects on the infant. timing of initiation of supplemental feedings.2]. outcomes compared with initiation at N 6 weeks postpartum? the lactational amenorrhea method can be an effective We conducted this systematic review according to Preferred contraceptive method but is only effective for six months. however. Some studies author of one study to clarify study methodology [11. are introduced [3]. initiation of supplemental outcomes. Outcomes of interest examines the effects of CHC use on clinical outcomes such included breastfeeding performance and infant health as breastfeeding duration. Therefore. we have updated the previous review comparison group of women using progestin-only contra- with additional evidence in preparation for the forthcoming ceptives but considered this indirect evidence if there was no update of the WHO MEC [9]. We previously contacted the contraception on milk quality or quantity [6]. The previous review concluded included if they compared women who initiated CHCs that the evidence was inconsistent on whether COCs negatively early with women who initiated CHCs at a later time impacted breastfeeding duration and success and that the postpartum. anything that potentially OR mesigyna OR cycloprovera))) AND ((("Breast Feeding" interferes with breastfeeding is of concern. / Contraception 94 (2016) 262–274 263 1. 2014. and health and develop. the combined and development. injectables. weaning and infant growth.

USA (women who to breastfeed at least mestranol+1 mg performance More supplemental calories Small numbers poor . US military hospital. aged 17–44 regimens)=83 duration 54% of COC users and 59% Various COC formulations poor N. Study design Population Interventions (CHC and Outcomes Results Strengths/weaknesses Quality support comparison groups only) grading COCs initiated b6 weeks postpartum Kaern [20]. Egypt clinical trial women ages 20–37. Tepper et al.05) Extent of blinding Syntex Pharmaceuticals) day 1 Infant weight: difficult to assess No significant weight change Method of randomization between groups from unclear days 2 to 8 Gambrell [18]. 264 Table 1 Evidence table for studies of clinical outcomes among breastfeeding women using CHCs.1 mg group and estrogen-only Assignment to groups (newly identified) ethinyl estradiol)=10 group than control not described Placebo=10 group through 14 days Patient selection and POP=10 (results not (no p value reported) inclusion/exclusion reported here) criteria not described Initiated on postpartum Small numbers day 2 Short follow-up (14 days) p value for comparison of interest not reported Miller [24]. follow-up among breastfeeding women not noted Kamal [21].K. Author. women. 1970 Nonrandomized N=40 breastfeeding COC (0.08 mg Breastfeeding Breastfeeding performance: Weaknesses: Level I. location. parity and past lactation duration High loss to follow-up (~40%) over 6 weeks among all study women. 1970 Partially RCT N=100 women planning COC (0.1 mg Infant growth Infant growth: Strengths: Level II-1. 1967 RCT N=451 breastfeeding COC (0.3% (26/212) Weaknesses: not stated Placebo=218 Placebo group: 3. Denmark women after healthy mestranol+1 mg performance Supplemental feeding on day 8: Randomized treatment poor Source of support delivery norethisterone)=233 Infant weight COC group: 12. year. 1970 Prospective cohort N=174 breastfeeding COC (various Breastfeeding Breastfeeding performance: Weaknesses: Level II-2.4% (7/206) Short follow-up (8 days) (COCs supplied by Initiated on postpartum (pb. mestranol+1 mg Percent changes in infant Double-blinded poor Source of support delivered by cesarean lynestrenol)=10 weight higher in COC Weaknesses: not stated section Estrogen-only (0. / Contraception 94 (2016) 262–274 Germany Controls (“other control group were used Source of support method of family breastfeeding at 6 weeks Short follow-up (6 weeks) not stated planning”)=91 (authors state not significant) Control group may have Initiated on postpartum included users of day 5 progestin-only methods Self-selected intervention No assessment of time of breastfeeding initiation postpartum No adjustment for potential confounders including age.05 mg Breastfeeding Breastfeeding performance: Strengths: Level I.

[19]. 16–40 quinestrol+5 mg breastfeeding Mean length of lactation: Retrospective information poor Population council. Ortho Research requested OCs 3 months. Thailand breastfeeding women mestranol+1 mg Average weight gain per Included only women poor Source of support ages 20–39.84 g (n=13) with birth weight Control (no hormonals)=20 Control: 202.5 mg Group 3: 4.1 mg Infant growth Infant growth: Weaknesses: Level II-2. results ethinodiol-diacetate)=20 week from weeks 6 with previous not stated reported for 60 women COC group 2 (0.24 g (n=20) 2500–3999 g Initiated within 6 weeks (authors state significant Small numbers postpartum (implied) but p value not reported) Assignment to contraceptive groups not described Exact timing of contraceptive initiation not stated 36% (34/94) lost to follow-up Infant growth not reported for all women in COC groups p value for comparison of interest not reported Guiloff. / Contraception 94 (2016) 262–274 gain than those using COCs at weeks 4 and 5 (p values not reported) Koetsawang [23]. information Control measures of quingestanol acetate)=194 Group 1: 2. 1972 Prospective cohort N=94 healthy COC group 1 (0.25 g (n=16) Included only male infants of study chlormadinone acetate)=20 Group 2: 179.6 months participants was used as women with past quingestanol acetate)=81 Group 4: 3.01 when compared contraceptive groups mechanical contraceptive norethindrone)=40 with controls Assignment or choice of use who were still COC group 4 (0. 1974 Cohort study with N=696 COC group 1 (2 mg Length of Breastfeeding performance: Weaknesses: Level II-2. placebo) None=48 and 5 (p values not reported) allocation and blinding Initiated on postpartum At 12 weeks postpartum.K.5 mg chlormadinone)=52 POC (various regimens)=168 265 (continued on next page) .3 months comparison between no hormonal or ethinyl estradiol+1 mg *p=. 52% of COC initiators at 6 weeks and 21% of COC initiators at 2 weeks were still breastfeeding (p values not reported) Infant weight: Infants with mothers in the placebo group had significantly greater weight N. 95 included norethindrone)=24 Infant weight required for infants in the Values and statistical Foundation randomized to in analyses Placebo (until 6 weeks. not specified day 14 or at postpartum 73% in the nonhormonal No power calculation week 6 group.5 months* from past lactation Warner-Lambert duration of lactation COC group 2 (2 mg Group 2: 2.08 mg to 16 postpartum: Group 1: breastfeeding experience (newly identified) who completed 16 weeks mestranol+2 mg 147. COC group compared to tests not stated COC or oral then COCs)=23 placebo group at weeks 4 Method of randomization.7 months* historical control rather than lactation history and COC group 3 (0. Chile historic comparison Multiparous women.05 mg Controls: 5.5 months* durations of current study Research Institute came from study quinestrol+2. Tepper et al.08 mg contraceptive method unclear lactating at 30 days mestranol+1.

Diaz [12]. 1983 (randomized for healthy women with estradiol+0. days 30–35 Percent weaned at 6 months: COC: 16.6% vs.025) but no difference Initiated on postpartum at 12 months. from 61 to 183 days PP. 4. Tepper et al. Study design Population Interventions (CHC and Outcomes Results Strengths/weaknesses Quality support comparison groups only) grading (results not reported here) Historical controls=346 Initiated on postpartum day 30 Croxatto [11]. pb.025 No physical abnormalities at 1 year of age . to pill or injectable The Population Council to COC or used nonhormonal Also significantly lower rates No determination of reason oral placebo) methods at 4–10 months postpartum for weaning N.01 for COC versus IUD) Percent weaned at 8 months: COC: 33.7% (pb.05).3% Placebo: 9% Copper IUD: 4.05) Average infant weight at 366 days: COC: 9938±592 g Placebo: 10746±729 g pb.05 Average weight significantly lower for COC users. / Contraception 94 (2016) 262–274 Copper IUD= 118 (pb. 10 and 12 months Infant health: Total infant weight increase at 6 months: COC: 4636±765 g Placebo: 4971±669 g pb. location. Development Research who requested and pill)=188 gain.3% Placebo: 19. 1983 and Partially RCT N= 330 breastfeeding.05) Percent weaned not different between groups at 2. 109 abnormalities) (80.15 mg performance COC group had significantly Long follow-up fair Chile first part of study.K. normal delivery and LNG)=103 Infant health lower rates of exclusive Weaknesses: International also women postpartum course Placebo (injectable (weight. and at 366 days PP from the nonhormonal users (pb.03 mg ethinyl Breastfeeding Breastfeeding performance: Strengths: Level II-1. weight breastfeeding at postpartum Although placebos used. OCs randomized After 91 days. year.5% (pb. 266 Table 1 (continued) Author. physical day 91 than placebo group women chose their allocation Center of Canada. 92%.8% Copper IUD: 16. COC (0.

K. genitals) in COC group Espey [17]. reported here) Authors state no Numbers in each group differences in growth not specified curves (exact numbers Initiated 6–10 weeks and p values not reported).03 mg ethinyl Breastfeeding Breastfeeding performance: Strengths: Level II-2.6 weeks not described lynestrenol) Placebo: 15. nonhormonal group at 4. (64% in COC group.15 mg performance COC group had lower rates Long follow-up fair International healthy women LNG)=59 Infant weight of exclusive BF than Low loss to follow-up Development Research with healthy Nonhormonal (spermicides.35 mg (weight. 2012 RCT N=127 women COC (0. acetophenide) (results not compared with placebo. postpartum Peralta [26]. infants IUD)=82 8. 1983 Prospective cohort N=141 fully COC (0. 6.5 mg performance Average age of infant at Double-blinded poor Source of support lynestrenol) Infant weight supplementation: Weaknesses: not stated COC group 2 (0. USA ages 15–45. Egypt clinical trial mestranol+2.5% Double-blinded of New Mexico norethindrone)=63 head circumference) in POP group) Minimal amount of method (newly identified) Initiated at 2 weeks No difference in supplementation switching among women postpartum at 8 weeks (percents not continuing to breastfeed reported) at 8 weeks No difference in breastfeeding Loss to follow-up similar continuation through 6 months between groups Infant growth: Weaknesses: No difference in growth Small numbers parameters through 8 weeks Short follow-up of infant outcomes (8 weeks) N20% loss to follow-up in N. 10 and 12 months Treatment chosen The Population Council Initiated at postpartum postpartum (pb.075 mg Breastfeeding Breastfeeding performance: Strengths: Level II-1. (breasts. 1969 Nonrandomized N=120 women COC group 1 (0. 63.05) by participants day 90 No difference between groups Included only healthy in rates of weaning through infants 12 months (p values not Small numbers reported reported) for infant outcomes (continued on next page) 267 . / Contraception 94 (2016) 262–274 both groups COCs initiated N6 weeks postpartum Kamal [22]. estradiol+0. length.035 mg ethinyl Breastfeeding Breastfeeding performance: Strengths: Level I.0 weeks Numbers of women in IUD+placebo (no p value reported) each group and retained in POC (results not Infant weight: study not reported reported here) Mean infant weight at p value for comparisons of Deladroxate (10 mg 32 weeks postpartum interest not reported estradiol enanthate+150 mg lower in group 1 dihydroxyprogesterone and higher in group 2. Tepper et al. Weaknesses: Center of Canada. Chile breastfeeding. planning estradiol+1 mg performance No difference in breastfeeding Randomization procedure fair ACOG Contraceptive to breastfeed and to use norethindrone)=64 Infant growth continuation at 8 weeks described Indirect grant and University oral contraceptives POP (0.1 mg Group 1: 13.8 weeks Assignment to groups (newly identified) mestranol+1 mg Group 2: 11.

6 months Small numbers user controls and postpartum (pb. and Non-OC users=48 COC: 3.15 mg performance No differences in breastfeeding Multiple countries fair Hungary. non-OC Initiated at 2 months Controls: 4. No other significant differences between groups through 6 months. performance breastfeeding information in school up to age 8 Study group may have contained progestin-only OC users. N. measurements through 58% follow-up at 24 weeks 24 weeks in COC and nonhormonal No differences in episodes groups of infant illness between groups Nilsson [25]. of supplementation through for changes in infant weight Initiated at 6 weeks head circumference) 24 weeks (p values not Weaknesses: postpartum and morbidity reported) Included only women with Infant growth: prior breastfeeding No differences in mean weight experience and with or rate of growth between healthy infants contraceptive groups through No details of method 24 weeks. Thailand who chose OCs prior experience LNG)=86 Infant growth continuation between Examined several infant WHO/HRP randomized to COC breastfeeding. ambidirectional N=96 women using COC (most containing Breastfeeding Breastfeeding duration: Strengths: Level II-2. (weight.27].K. Nonhormonal (barriers. Tepper et al. not reported) infant illness chose methods) healthy term delivery POC=144 (results not arm circumference. 268 Table 1 (continued) Author. contraceptive groups (rates measurements and or POP.03 mg ethinyl Breastfeeding Breastfeeding performance: Strengths: Level II-1. after sterilization. estradiol+0. female switching/discontinuation infants smaller in the control Did not assess supplementation group. WHO [15. year. length. No difference in prevalence Power calculation reported reported here) skinfold thickness.001). Sweden Sweden COCs while 0. compared to COC No adjustment for potential group (16–24 weeks) at confounders one site Follow up variable among No differences in other infant study groups and study sites. 1986 Cohort. IUD)=111 ponderal index.7 months Weaknesses: breastfeeding. control group . / Contraception 94 (2016) 262–274 and 1988 clinical trial (women ages 20–35. COC group infants had lower mean weight increase than nonhormonal group (pb. Study design Population Interventions (CHC and Outcomes Results Strengths/weaknesses Quality support comparison groups only) grading Infant weight: by 12 months No difference in mean infant No adjustment for weight between groups potential confounders through postpartum day 366 At 4 months. 1984 Partially randomized N=341 women COC (0.05) 19 used COCs for b 1 month their infants Infant health: and 21 used for 1–3 months No differences in occurrence Retrospective collection of of serious illness.05 mg ethinyl duration Mean length of breastfeeding Long follow-up time (8 years) fair Source of support breastfeeding and estradiol)=48 Infant health (from postpartum records): Low loss to follow-up not stated their infants. location. other groups parity 2–4.

K. Breastfeeding performance FAPEP and CNPq (newly identified) We identified seven articles describing six studies that examined women who initiated COCs at b 6 weeks postpartum and reported on breastfeeding performance Brazil (Table 1) [11.P. POC. Several additional articles were excluded planning to breastfeed women ages 18–44.1. FAPEP. 2013 3.24]. Of these articles. One LNG)=10 article provided indirect evidence only. Results performance Our search identified 925 articles.18–20. or the methods did not provide enough information to determine if inclusion criteria were met [29–37]. All included LNG-IUD=10 (results estradiol+0.15.12. health (as measured Duration of exclusive by illness and mortality) and development. 3. and 2 were ENG implant=10 (results Initiated on postpartum COC (0. from which 15 primary tibia length) Breastfeeding Infant growth height and research articles describing 13 studies met our inclusion (weight.17–20. Fundacao de Apoio a Pesquisa do Level II-2.24–27] were described in a previous review [8]. oral contraceptive. may have included contraceptive users nonoral hormonal Small numbers not reported 2.17. criteria for this review (Fig. length. Study quality assessment and data synthesis Weaknesses: confounders 6 months (duration not reported) experience Strengths: We summarized the evidence using standard abstraction forms. as the comparison day 42 group was women using progestin-only pills (POPs) [17]. / Contraception 94 (2016) 262–274 269 ACOG. 1 and Table 1) [11. Articles that only investigated milk quality and composition or milk quantity. Summary odds ratios were not calculated No significant differences in tibia length between COC in COC group vs Copper infant weight. 3 were newly identified for this Estago de Sao Paulo. CNPq. Two authors (N. the results of which were already included in this review [15. timing of initiation of contraception or measurement of outcomes was not stated. four partially randomized trials or cohort studies and one .12. height and and Copper IUD groups given the heterogeneity of contraceptive initiation. results breastfeeding similar IUD group on 7 out Duration of exclusive of 21 days (pb. head circumference. No articles were Copper IUD=10 identified that reported on women using other CHCs. Studies included one RCT. Tepper et al. as measured by volume of pumped milk or No loss to follow-up by day 63 fair infant weight before and after feedings. We considered infant health outcomes such as growth (as breastfeeding at 6 months measured by weight. were excluded. Conselho Nacional de Pesquisa.15–28]. no comparison group was included.15 mg not reported here) not reported here) articles reported on women using COCs. etonogestrel.3.26] of the same study. and S. Results were between groups at summarized and reported by timing of contraception Infant growth: initiation (b 6 weeks postpartum and N 6 weeks postpartum) at day 63 and outcome (breastfeeding and infant health). 3. review but originally published before 1973. levonorgestrel. combined injectable contraceptive.21–23].03 mg ethinyl published since the last review [16. arm Included only women with No adjustment for potential previous breastfeeding circumference or skin-fold thickness).05) and nonquantifiable outcomes reported. study contraceptives N=40 healthy parous because the type of oral contraceptive (combined or and to use one of progestogen-only) was not specified.27].T. OC. N.14]. LNG. CIC.1. Excluded articles most frequently reported only outcomes of milk composition or volume without including clinically relevant outcomes. American College of Obstetricians and Gynecologists. 10 [11. COCs initiated at b 6 weeks postpartum Bahamondes [16]. One article was excluded [38] because it was a duplicate of two more comprehensive Prospective cohort English-language publications [12.1. progestin-only contraceptive. ENG.) independently assessed the quality of each piece of evidence using the system developed by the United States Preventive Services Task Mean number of breastfeeding episodes significantly higher Breastfeeding performance: Force [13. Another article was excluded [28] because it was a subgroup report from the WHO study.12.

08 mg mestranol. pb. there was a significantly significantly more women in the COC group initiated higher percent weaned in the COC group compared with the supplemental feeding for their infants than those in the placebo and copper IUD groups. Randomization was partial because women choosing postpartum day 5 were followed for 6 weeks [18]. there was no device (IUD) was initiated in 103. One new article of fair quality was identified. which A fair-quality partially randomized trial. At 6 weeks postpartum. 1. breastfeeding was lower in the COC group than in the placebo tions of COCs [18–20. Four of the studies preference.035 mg ethinyl estradiol) (n= 64) or POPs (n= 63) initiated nonhormonal methods were started) or the copper intrauterine at 2 weeks postpartum. These differences did not placebo group (12. Systematic review of breastfeeding and CHCs. other hormonal contraceptives [17]. By postpartum day 8.05). In this RCT from the Thirty to 35 days postpartum. persist at 10 and 12 months [11]. the percent exclusively were conducted prior to 1973 and evaluated older formula. COCs (containing 0. women were randomized to use either COCs ethinyl estradiol). in which random. women on placebo cohort study in Chile investigated COC use among women switched to COCs. 188 and 118 women. there was a significantly higher placebo initiated on postpartum day 1 in 451 breastfeeding percent weaned in the COC group compared with the copper mothers of healthy infants [20]. / Contraception 94 (2016) 262–274 RCT that provides indirect evidence. All of the studies were included group (81% versus 92%. 0. There COCs were randomized to initiate use of COCs (containing were no significant differences between the groups in the 0. The COCs used higher supplemental calories given to their infants at 4 and contained 2 mg quinestrol (n= 275). outcomes because the comparison group was women using examined 291 women after a normal delivery in Chile [11. n= 25) or placebo (n= 25) at 2 weeks percent of women still breastfeeding at 6 weeks. This study additionally provided progestin components. placebo (until 90 days postpartum when (0. with the exception of the RCT that breastfeeding was also lower in the COC group than the provides indirect evidence. . Tepper et al. At 8 months postpartum. placebo and IUD groups from 4 to 10 months postpartum A poor-quality RCT conducted in Denmark investigated (specific percents not reported. COCs at 2 weeks (p values not reported). found to be significantly shorter for the COC group than By 12 weeks.08 mg mestranol (n= 52).3% versus 3. Women who initiated COCs at 2 weeks had who initiated at 30 days postpartum [19]. provided indirect evidence on breastfeeding performance ization was performed for the first portion of the study. US-based. initiating various COC regimens (n= 83) or some “other tion (n= 50) with women who chose to initiate COCs (n= 50) method of family planning” (not further specified) (n= 91) on [24].05) [12]. statistically significant difference in breastfeeding continua- respectively.270 N. with various (p values not reported). Duration of breastfeeding was some information on early compared with later COC initiation.12].24]. partially randomized trial A poor-quality prospective cohort study of 174 women compared women who chose not to use hormonal contracep.K. pb. IUD group. but not in the COC initiating COCs at 6 weeks and 21% among those initiating formulations with 0.05 mg mestranol) versus [11].4%. At postpartum day 91.03 mg United States. At 6 months postpartum. A poor-quality.025) but not at 12 months the use of COCs (containing 0. The percent exclusively in the previous review. either randomly or according to the women's tion or supplementation between the COC group and the POP Fig.05 mg ethinyl estradiol 5 weeks postpartum compared with the placebo group (n= 40) and 0. pb. 52% among those using mestranol or quinestrol.05 mg of ethinyl estradiol. the percentages of women still breastfeeding the nonhormonal historical control group for preparations were 73% in the nonhormonal group. Another postpartum. At 8 weeks postpartum.

COCs initiated at N 6 weeks postpartum There were seven articles describing six studies which examined women who initiated COCs at b 6 weeks postpartum 3. study was a partially randomized trial. sterilization or days and at 366 days postpartum (pb. such as or prevalence of supplementation between groups (p values genital or breast changes. however.03 mg ethinyl estradiol. p values were not reported. The average age of the pill (0. no significant nonrandomized trial. four of these studies were newly identified: one was an older study.075 mg mestranol.05).1. 10 women used an estrogen-only IUD (type not specified) plus placebo.24]. Compared with 10 women using copper initiated COCs within 6 weeks postpartum [23]. Infant outcomes 3.03 mg group at 4 and 5 weeks postpartum.25–27]. The COC group had lower rates of exclusive but no p values were reported. / Contraception 94 (2016) 262–274 271 group. initiated at 6 weeks postpartum [15. women using COCs had a higher mean number of included 20 women using a COC with 0. group 2=180 g) than in the control group nonhormonal contraception (n= 82) at 90 days postpartum (202 g). At 14 days postpartum.08 mg days 42–63 (pb. [26]. control group.1 mg of mestranol.05) [11]. and three were cohort studies. breastfeeding episodes were not mestranol. Group 1 IUDs. The average infant weight gain per week from postpartum women exclusively breastfeeding chose to weeks 6 to 16 postpartum was lower in the COC groups initiate either COCs (0. group up to 1 year postpartum [11]. Six articles reporting on five studies examined women Three of these studies were newly identified: two were older initiating COCs at N 6 weeks postpartum and reported on studies.17. The COC group also had higher provided indirect evidence. the Women choosing oral contraceptives were randomly assigned average infant weight of exclusively breastfed infants was to either progestin-only or combined pills (n= 86 for COCs). 3.8 weeks. As with the breastfeeding outcomes. Two differences in infant weight among infants exclusively studies evaluated higher-dose pills [22. differences in breastfeeding continuation (rates not reported) No physical manifestations of exogenous estrogen.12]. group 1 and 13 women in group 2 versus all 20 women in the In a fair-quality prospective cohort study from Chile.03-mg ethinyl estradiol pills.2.24].16. and group 2 used a COC with specify whether women were randomized. study from Brazil examined 10 postpartum women who One newly identified poor-quality prospective cohort initiated COCs (0. however. n= 59) or (group 1=147 g. weight gain per week was only reported for 16 women in although the exact duration and p values were not reported.05) [11. Tepper et al. One newly identified poor quality nonrandomized clinical One newly identified poor-quality clinical trial from Egypt trial from Egypt divided women into five groups of hormonal provided women after cesarean delivery with oral hormonal and nonhormonal contraceptives initiated at 6–10 weeks contraceptives or placebo pills initiated on postpartum day 2 postpartum [22].1 mg mestranol. The total no contraception were included as nonhormonal controls infant weight increase at 6 months was lower in the COC group (n= 111). The comparison group was women using an COCs (0. N. whose mothers were using COCs compared with POPs [17].22]. pb.27]. 10 In the newly published RCT described above which and 12 months (pb. Survival analysis demonstrated no difference in infant growth parameters. while the other breastfed were noted by postpartum day 8 between women three studies examined 0. and 10 women used placebo infant at supplementation was lower in the COC groups (group pills. and one was published since the previous review breastfeeding performance [15. lower in the COC group than the placebo group from 61 to 183 Women who chose IUDs. In the partially randomized study from Chile. breastfeeding than the nonhormonal group at 4. as measured by weight. 6. both progestin-only and combined (0. At 24 weeks postpartum. and studies were conducted before 1973 and examined older. using COCs and those using placebo [20]. barrier methods. but the authors did not a COC with 0. compared with the placebo group.25]. The outcome of average infant breastfeeding was similar between groups at 6 months.6 weeks) than in the placebo group weight were higher in the COC and estrogen-only groups (15 weeks). one was a In the RCT from Denmark described above.21.20.05). The control group included 20 women using no different on the remaining days. reported [24]. although p values were not ethinyl estradiol). In the US WHO conducted a fair-quality partially randomized clinical partially-randomized trial described above.1 mg ethinyl estradiol).22. one was published since the previous review [16.23. Breastfeeding performance and reported on infant outcomes [11.21.K.21. were noted in the infants in the COC not reported) [27].2. exact percents and One newly published fair-quality prospective cohort p values were not reported. group 2=11. Two of these [17.23]. at 8 weeks postpartum among those not reported). Two of the groups used COCs: group 1 used [21].1 mg mestranol).23. the authors state that this difference was significant. breastfeeding episodes on 7 out of 21 days from postpartum and group 2 included 20 women using a COC with 0. length and breastfeeding continuation at 6 months postpartum (percents head circumference. The study was double-blinded. The duration of exclusive hormonal contraceptive.1. One higher-dose COC formulations [20. there were no significant than in the placebo group (4636 g versus 4971 g. 8.12. Ten women used 0. infants in the trial at three centers in two countries on the effect of oral placebo group gained more weight than infants in the COC contraception. there were no differences in proportions initiating supplementation at the same time .03 mg ethinyl estradiol) at 42 days study from Thailand reported on postpartum women who postpartum [16].2. the percent increases in infant 1=13.

and one was fair-quality. both of poor quality.12. there were no differences at any There are several limitations to this body of evidence. at 63 days postpartum [16]. and one poor-quality Six articles reporting on five studies examined women study found no effect on weight gain [20]. although p values proportions continuing to breastfeed [11. 5 of which current formulations and delivery systems of modern CHCs. however. estrogen diminished breastfeeding outcomes among COC users. Discussion between studies difficult.2. hormones.25–27]. breastfeeding success and corresponding infant health and limiting the generalizablity of this body of evidence to growth include 13 studies. published since the last review [16. therefore making comparison 4. Lactation is postpartum. Several poor-quality studies included study with longest child follow-up.6 months (pb.25–27]. height articles. and two fair-quality published study from Brazil. growth hormone and cortisol [39]. In the newly performance among COC users [25. mean weight reporting infant outcomes [16. insulin. randomization procedures [20. there were no significant studies showed no effect [15.16. one fair-quality study and one poor-quality study found less weight gain in infants of COC 3. Two of these studies on weight gain [23]. school performance between the COC and control groups Many of the studies did not conduct statistical tests for through 8 years of follow-up [25]. Studies used a variety of outcomes to define “successful” breastfeeding. control group. Newly identified articles through postpartum day 366.24]. height increase. In the high loss to follow-up. other time points through 6 months [26]. one poor-quality study found some effect infant outcomes [15. The mean length of Among studies examining COCs initiated at b 6 weeks breastfeeding was shorter in the COC group than in the postpartum. breastfeeding among COC users [22]. results Overall.26].40]. mean infant weight did to infant outcomes.19. arm circumference. and in weight gain. Of the previously identified studies. 10 and 12 months. Infant outcomes users compared with nonusers [11.17]. ponderal index. with no articles finding differences in not significantly differ between COC and nonhormonal groups either infant growth or health. indirect study found no effect [21.2. Of the previously identified articles. published in 15 articles. there were no differences only women with previous breastfeeding experience. results were inconsistent regarding breastfeeding triggered by progesterone withdrawal after delivery of the performance. Tepper et al. triceps skinfold studies were of poor quality and included small numbers of thickness and head circumference). results were consistent with regard the study from Chile described above.K. infant illness episodes or women. results were inconsistent on breastfeeding there were no differences between groups in infant growth performance.24]. indirect women who initiated OCs (most used COCs with 0.27]. but exact fair-quality studies showed some diminished breastfeeding numbers and p values not reported) [22]. including estrogen. one poor-quality study showed some diminished and tibia length. which leads to prolactin secretion [39. The authors state that there were no differences in the ing increased proportions using supplementation and decreased percent weaning at 6. comparisons of interest and did not control for other potential confounders. and one fair-quality The remaining studies were included in the previous review study did not [16].272 N. Of the newly identified differences in infant growth. results were also inconsistent on infant outcomes. are newly identified for this updated review. The WHO study There were only two direct-evidence randomized or partially described above found no differences between the COC and randomized trials.20.22]. Most of the observational length. Among studies examining COCs initiated at N 6 weeks In the newly identified study from Egypt described above. and neither described nonhormonal groups in infant growth (including weight. In at N 6 weeks postpartum.05 mg study of fair quality found no effect on supplementation or ethinyl estradiol) at 2 months postpartum compared with 48 breastfeeding continuation when compared with POPs [17]. Among studies examining COCs initiated and also did not demonstrate any effects on infant outcomes. occurrence of serious illness or others did not control for previous breastfeeding experience. while were not reported. the evidence identified by this systematic review from the new studies added to this review are consistent with found inconsistent effects on clinical breastfeeding measures. includ.22. as measured by weight.27]. withdrawal also accompanies secretory activation. prolactin. but one poor-quality study and one were newly identified: one was an older study. group (pb. Of the newly initiating COCs at N 6 weeks postpartum and reported on identified studies.24]. one poor-quality study found no effect on breastfeeding One fair-quality cohort study in Sweden examined 48 continuation at 6 weeks [18]. In general. 8. At 4 months of age. One newly identified. Some studies . progesterone. three placenta. previous findings on breastfeeding performance and infant The physiology of breastfeeding is mediated by several outcomes among CHC users compared with nonusers.22] were consistent with those increase in the COC group was lower than the nonhormonal previously identified [15. Of the previously identified studies. While this poor-quality studies and one fair-quality study found some drop in progesterone appears to be the key trigger. two curves at 32 weeks postpartum (stated by authors. / Contraception 94 (2016) 262–274 points.12. The vast majority of articles were published in the 1960s–1980s using higher doses and Studies addressing possible effects of COC use on different formulations of estrogen than currently available. postpartum. controls who did not use OCs [25]. 3.001). Among studies examining COCs initiated at b 6 weeks thyroxin.7 months versus 4.05). had short follow-up times (less than 6 weeks) or had number of days of sickness through 24 weeks [15.

coupled with the increased risk of VTE with use of CHCs. 2007. Attempt should be made to maximize generalizability of [3] World Health Organization Department of Reproductive Health and results by considering characteristics of women who partici. implants. Gallo MF. For breastfeeding women. The effects of unintended of exact timing of contraceptive initiation and control for pregnancy on infant. longer-term follow-up of infants during lactation.26:26–30. / Contraception 94 (2016) 262–274 273 have found that estrogen alone is effective in suppressing may increase the risk of VTE in postpartum women to an lactation. consensus is needed among researchers for International Development.to poor-quality evidence showed mechanism through which estrogen may inhibit lactation is conflicting results on whether use of COCs affects not well understood but may involve direct suppression in breast breastfeeding performance. Impact of early postpartum administration potential impacts on breastfeeding and infant health. the kidneys WHO. conflicting results on whether early initiation of COCs Studies have generally found that very low levels of affects infant outcomes but generally no negative impact on hormones transfer to the infant during breastfeeding [7]. Grimes DA. 2009.who. Studies should be undertaken among breastfeeding supported by resources from the Department of Reproductive women using modern low-dose COCs as well as the combined Health and Research at the World Health Organization. The body of While evidence is limited. Optimal duration of exclusive breastfeeding. Geneva: WHO. Contraception 2003. [2] Gipson JD. N. literature. evidence identified by this systematic review generally did not support negative clinical consequences for infants exposed to CHCs. exposed to hormones through breast milk is needed in order to [5] Kramer MS. The findings of this systematic review will be may be inefficient at excretion and plasma-binding capacity incorporated into the forthcoming update of the WHO MEC. infant outcomes with later initiation of COCs. including study design (i.K. 2015]. Alternative methods of contra- different types of estrogen at different doses and time frames ception. Study design should include careful maternal_child_adolescent/documents/birth_spacing. Paradoxically. Roger Chou and the other combined hormonal contraception by women who are members of the WHO Guidelines Development Group for the breastfeeding. may be low [7]. including more effective methods such as IUDs and than those given for contraceptive purposes [41].186:1250–6 [discussion 1256–8]. However. Faysel El-Kak. consideration of intervention and comparison groups. the hormonal patch. combined vaginal ring and combined Centers for Disease Control and Prevention. child. Cochrane Database Syst Rev 2012. The evidence also demonstrated tissue [42]. Fraser AB. be counseled about the full range of contraceptive options [9]. Stud Fam Plann 2008. Koenig MA. reporting Accessed March 18. are safe for postpartum women. and development of standard definitions on birth spacing.68:233–8. women: a systematic review. Acknowledgements Given the significant limitations of this body of evidence. the importance of contraception for postpartum women and the The authors would like to acknowledge the contributions of theoretical concerns that have been raised about the use of Suneeta Mittal. Kakuma R. In addition. Hindin MJ. rigorous studies examining these issues are Medical Eligibility for Contraceptive Use. [9] World Health Organization. [6] Truitt ST. However. and alternatives. studies have demonstrated that evidence is limited by older studies using different low levels of estrogen and progestins are present in breast formulations and doses of estrogen and poor methodologic milk [7. 4th ed. breastfeeding and infant outcomes (i. This review was needed.39:18–38. which questions are best suited for observational studies and which might References only be able to be answered with RCTs)..82:10–6. Report of a WHO technical consultation recommendations). Am J Obstet Gynecol 2002. it is contraception during lactation.e. there of progestin-only hormonal contraceptives compared with nonhor- are additional considerations due to their postpartum status. systematic review of randomized important to consider the full context of the risks and benefits controlled trials. which are most important to guide [1] World Health Organization. however. and women should although a drop in estrogen correlates with lactation initiation. Combined oral contraceptive use among breastfeeding among postpartum women particularly in the first 6 weeks. in addition to [7] Halderman LD. Baltimore and Geneva: CCP and Studies should follow women for at least the first few months WHO. Curtis K. Tepper et al. monal contraceptives on short-term breast-feeding patterns. 2006 [Available at: http://www. Johns Hopkins Bloomberg School of Public pate in such studies and by inclusion of ill or preterm infants. new studies.43. more fully understand any impacts on child development. Health/Center for Communication Programs (CCP). Hormonal When considering choice of contraceptive methods. Nelson AL. .. the US Agency injectables. estrogen actually stimulates prolactin release [42]. The increased risk of venous thromboembolism (VTE) [8] Kapp N.e. Fam Plann Perspect 1994. To use or not use combined hormonal oral contraceptives performance. these studies involved administration of unacceptable level [45–47]. Contraception 2010. fair. Research (WHO/RHR).int/ and measurements. The information in this review was presented to an hormone levels may be higher in the infant because the expert review panel in March 2014 at a meeting convened by immature liver may not metabolize effectively. there is theoretical concern that quality.44]. and the National Institute of on several critical issues for the design and interpretation of Child Health and Human Development. and parental health: a review of the important factors such as prior breastfeeding experience. postpartum to truly assess any impact on breastfeeding [4] Erwin PC. Family planning: a global handbook for providers.8:CD003517. Schulz KF.pdf?ua=1. Medical eligibility criteria for contracep- suggests that estrogen-containing contraceptive methods tive use. Nonetheless. The In conclusion.

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