Contraception 94 (2016) 253 – 261

Review article

Safety of the progesterone-releasing vaginal ring (PVR) among lactating
women: A systematic review☆
Shannon L. Carr a,⁎, Mary E. Gaffield b , Monica V. Dragoman b , Sharon Phillips b
a
Department of Obstetrics and Gynecology, University of New Mexico School of Medicine, Albuquerque, NM 87131, USA
b
Department of Reproductive Health and Research, World Health Organization, 1211 Geneva 27, Switzerland
Received 6 March 2015; revised 30 March 2015; accepted 3 April 2015

Abstract

Context: Lactation causes a delay in ovulation in the postpartum period, and therefore a delay in the resumption of menses. However, return
to fertility is variable in the postpartum period and is contingent upon numerous factors. The postpartum period is therefore a critical time to
initiate effective contraception in order to support the numerous beneficial health outcomes of optimal pregnancy spacing. Breastfeeding
women have an unmet need for highly effective birth control methods that do not interfere with lactation and that are safe for their infants.
The progesterone-releasing vaginal ring (PVR) releases a natural progesterone that suppresses ovulation and is specifically designed for
breastfeeding women in the first postpartum year.
Objective: To review the published peer-reviewed literature regarding the safety and effectiveness of the PVR used for contraception among
lactating women, as well as the safety for their infants. Results of this review informed the decisions of the Guideline Development Group to
include recommendations on contraceptive eligibility for the PVR within the World Health Organization Medical Eligibility Criteria for
Contraceptive Use, 5th Edition.
Methods: We searched the PubMed, Popline, and LILACS bibliographic databases for articles published in any language from database
inception through October 1, 2014. We reviewed the literature for evidence regarding the safety of the PVR among breastfeeding women using
the method, as well as for their infants. The US Preventive Services Task Force system was applied to assess the quality of the evidence.
Results: Seven articles met our criteria for inclusion in this review. All studies were of a prospective cohort design. All studies consistently
showed that use of the PVR among breastfeeding women compares favorably to other methods of contraception with regard to effectiveness,
does not compromise a woman’s breastfeeding performance, and does not adversely affect infant growth during the first year postpartum.
Conclusion: The PVR is a safe and highly effective method of contraception for use among breastfeeding women. It should be offered to
women who plan to breastfeed in the context of postpartum contraceptive counseling.
© 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: Progesterone vaginal ring; Lactation; Breastfeeding; Contraception

1. Introduction and their families. Recognizing the imperative to reach
women in the postpartum period, the 2012 London Summit
Worldwide, postpartum women represent a large propor- on Family Planning included a prioritization on expanding
tion of women who have an unmet need for family planning services and methods to this vulnerable population [1,2].
services. Failure to meet the contraceptive needs of these Lactational amenorrhea (LAM) is one method of
women results in adverse outcomes for women, their infants, contraception available to those women who choose to
breastfeed. In addition to a host of well-documented
maternal and child health benefits, LAM is approximately
98% effective in preventing pregnancy, provided that

women adhere to three criteria: (1) menstruation has not
Disclaimer: The findings and conclusions in this report are those of
resumed, (2) the infant is fully or nearly fully breastfeeding,
the authors and do not necessarily represent the official position of the World
Health Organization. and (3) the infant is less than 6 months of age [3]. While this
⁎ Corresponding author. Tel.: +1-505-925-0688; fax: +1-505-925-0689. method is safe and effective, LAM offers only short-term
E-mail address: scarrgo66@gmail.com (S.L. Carr). protection against unplanned pregnancy. At any time a
http://dx.doi.org/10.1016/j.contraception.2015.04.001
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 critical P threshold required to inhibit ceptive methods. and LILACS biblio- using a contraceptive method [6]. with infrequent 2. as well as key review released at an average rate of 10 mg/day over a 90-day period. In addition. we lactational amenorrhea [7. extent of loss tional family planning and HIV. which is similar breastfeeding women and their infants. reproductive biologists.12].1. sample size and represen- participants from 25 countries including experts in interna. Study quality assessment during March 9–12. supplementation). duration of mean P levels decreased from 17±1 to 14±1 nmol/L (mean± lactation. tativeness. Study selection removal approved for 2 h maximum. vaginal rings. Reference lists 58 mm. to follow-up. rapidly degraded after ingestion and has a very short half-life of review articles. current 3-month PVR labeling instructions were excluded. program managers. has an overall diameter of of PVRs for women who are breastfeeding. risk for rapid repeat pregnancy [4]. multinational survey data 2. In addition. does the use of the to that detected in the average luteal phase among normally PVR. as well as to infant exposure to P via the breast milk of mothers who use contraceptive effectiveness were selected for inclusion in this the PVR. and anillo population. Safety and efficacy trials have been carried out in vaginal.2 mcg of P [11. breastfeeding ovulation during breastfeeding is 10 nmol/L [9]. infant health (e. Articles addressing combined estrogen–progesto- exposure to exogenous hormones for infants whose mothers use gen vaginal rings or dosing patterns that differed from the the PVR [13].L. Methods from developing countries reveal that breastfeeding and/or postpartum amenorrhea are cited as a primary reasons for not We searched the PubMed. commentaries. 2014.g. With regard growth. thus conferring additional reassurance of lack of excluded. Progestina. policymakers. ingestion of 600 mL of breast milk per day will expose review. maintenance of comparable groups. The ring is designed for 6 months continuous use for women breastfeeding at least four times per day.2. affect maternal health. a search of the International Clinical Trials Registry countries [7]. still within the range to inhibit ovulation [10]. Carr et al. . and contains micronized progesterone (P) that is from articles identified by the search. and researchers. completeness of outcome measurement. 2014 and September 24–25. and dissertations were 3–90 min. The World Health Organization (WHO) convened meetings of its Guideline Development Group (GDG) 2.g. it is critical to graphic databases for articles published in peer-reviewed provide women with options for early initiation of journals in any language from database inception through contraception in the postpartum period to prevent unplanned October 1. clinicians. 2014 for evidence reporting data addressing the and rapid repeat pregnancies.4 mm. safety of PVR use among breastfeeding women. or adverse health events). even though the majority of women do not wish to conceive again during their first postpartum year [5]. safety for Popline. In order to consider eligibility for inclusion of the PVR methods is key to preventing unintended pregnancy during in the fifth edition of the MEC guidelines.int/trialsearch/) was performed to trade name “Progering®”. Female”[Mesh] for PubMed.254 S.E. breastfeeding women in order to expand the method mix for this Progesterone. revise specific evidence-based recommenda. transition to other effective gists. The GDG consisted of 62 following: type of study design. articles.8]. conference presentations. S. The silicone-elastomer ring has a identify completed and ongoing trials investigating the safety cross-sectional diameter of 8. This amount is among women using the PVR with medical conditions or well below the recommended maximum intake of 150 mcg/day characteristics currently included in the MEC were of as per the European Medicines Agency [13]. Specifically. and pharmacolo- on LAM for contraception. we conducted this the postpartum period. assessed using the United States Prevention Task Force tions included in the WHO Medical Eligibility Criteria grading system [14]. The The progesterone-releasing vaginal ring (PVR) is a contra. The purpose of these meetings was to review and. Popline. related to safety.).who. In Latin America where it is approved and currently in use in nine addition. compared with non-use of progestogen-only contra- ovulating women. studies reporting on these outcomes infants to approximately 4. where The quality of each individual piece of evidence was appropriate. and infant health? Articles reporting outcomes clinical trial that assessed extending use of the PVR to 4 months. following search terms were applied: “Progesterone”[Mesh] ceptive device that was specifically designed for use among AND “Contraceptive Devices. Evaluation criteria included the (MEC) for Contraceptive Use. an average sought to answer the following key question: Among plasma concentration of 20 nmol/L is achieved. development. During proper use. The device is manufactured in Chile under the Platform (http://apps. Many women discontinue fully systematic review of the evidence regarding the safety and breastfeeding before 6 weeks postpartum and will be at efficacy of the PVR for use among breastfeeding women. continuation. guideline adjustment for confounders. The non-oral delivery We reviewed titles as well as abstracts to identify primary system of the PVR allows for a sustained release of micronized P reports of studies investigating the safety of PVR use among at levels sufficient to inhibit ovulation and extend the period of breastfeeding women of any age or parity. P is interest. In addition. and Progesterona for LILACS. Therefore. / Contraception 94 (2016) 253–261 woman no longer meets criteria or no longer wishes to rely methodologists. breastfeeding performance (e. were hand-searched to identify additional articles. In a phase 2 performance. Unpublished studies. epidemiologists.

9.2. supplementary foods were observed among women using the Four studies investigated bleeding patterns. outcome among either Cu-IUD users [16. Results of exposure in another study [17]. [18]. Lastly.5/100 [22]. implant users [22] or 14 months post-recruitment among and one study followed them through 12 months after PVR and Cu-IUD users [21]. included in this review are presented in Table 1. Two studies examined whether weaning [22]. the six-rod levonorgestrel subdermal implant (LNG however. differences in lactation duration were recorded in any of tum.5/100 [18] and 3. various measures of breastfeeding performance in compar- ing women were not included in the study populations or the ison with women using nonhormonal contraception or other investigations focused on progestogen-only contraceptive types of progestogen-only contraception (depending upon methods but did not address PVRs. did not differ among infants whose study provided evidence on measures of bone health for the mothers used the PVR compared with infants whose mothers age subcategory of 18–35 years. Two studies recorded pregnancy rates at 12 months the studies. Results from the seven articles POP users and 48 among users who initially elected LAM. two studies found no difference in studies followed them through 12 months post-initiation of the proportion of women who were fully breastfeeding at the chosen contraceptive method [18. Similarly. another study reported no pregnancies among PVR or Cu-IUD users at 12 months. POPs. Three studies examined duration of lactation randomized controlled trials were identified. One pregnancy was observed during 739 woman-months of exposure in one of the studies [16] and 1007 woman-months 3. or LNG implant [22].22]. Among six studies evaluating the effect of PVR use on Studies were excluded primarily because either breastfeed. The remaining four studies observed one compute summary measures of associations due to hetero.21. We did not respectively) [19]. Data synthesis Cu-IUD [20. and method discontinuation/continuation. or LNG followed them through 12 months postpartum [16. no significant differences (Cu-IUD) [16. or progestogen-only pills (POPs) breastfeeding episodes per day compared with Cu-IUD users [17. PVR users reported a slightly higher number of implant). Four studies presented comparisons on differences in the number of breastfeeding episodes occurred outcomes between women who self-selected to use either among PVR users compared with women using other the PVR or the copper-containing intrauterine device contraceptive methods. used nonhormonal contraceptives or other progestogen-only 3. pregnancy in the PVR group compared with none observed geneity across study designs. One study PVR or Cu-IUD in a study conducted in Egypt [17].18. S. Breastfeeding performance review of titles and abstracts.21]. Carr et al.3 vs. Moreover. Weight gain. The remaining three studies were noted at 12 months follow-up between PVR and compared PVR users with women who elected to use the Cu-IUD users enrolled in a large multicountry study.21].20.L. LAM [18].22]. no statistically significant Two studies reported no pregnancies during 12 months of differences in infant weight gain were observed among PVR follow-up among women who chose to use either the PVR or users compared with women using a Cu-IUD [17. and one absolute or average.19.3. PVR. and attrition rates within groups across [22]. / Contraception 94 (2016) 253–261 255 2.1. Each study among Chilean women using the following: the PVR.05) public sector clinics in Latin America [16. Cu-IUD. or a full article when necessary. Four of the seven studies were conducted in at 183 days postpartum (8. study populations. With respect to the various conditions or All seven studies included in this review monitored infant characteristics published within the MEC. Following a 3. no significant differences were All seven studies applied a prospective cohort design. all seven studies weight gain during study follow-up. three studies either 6 months postpartum among PVR. specifically assessed measures of bone metabolism and bone density during breastfeeding and 6–12 months after 3.18. “breastfeeding”. seven articles satisfied the review inclusion criteria [16–22]. no reported. pb. among PVR volunteers of 1. Six differences between PVR and Cu-IUD users at 14 months studies examined lactation performance and occurrence of postpartum [21]. In general. respectively. infant breastfeeding episodes did not show any significant weight gain. LAM.17. three these studies. enrolled healthy. The other study that assessed the number of All seven studies reported on pregnancy outcomes.3. the particular study design). Infant health weaning.19. no differences on the introduction of side effects and/or adverse events such as device expulsion. and PVR and Cu-IUD [16]. fully breastfeeding volunteers between the Cu-IUD.19. either reported evidence for the condition. Similarly. Cu-IUD.22]. an .20].21]. Two authors (MG and SC) participated in summarizing however. 50 pregnancies occurred among women in this and systematically assessing the evidence through the use of study who elected other contraceptive methods (2 among standard abstract forms [15].20.22] or LNG implant users measures collected. Follow-up of women and their infants varied. Contraceptive effectiveness methods across three studies conducted in Chilean health centers [16. and ages of 18 and 38 years who delivered healthy singletons.19]. No significant Contraception initiation ranged from 5 to 9 weeks postpar. 7.21. Cu-IUD. Our search strategy identified 679 articles.

cervical intraepithelial neoplasia stage 1 (HPV) in 3 PVR users.047). nondifferential by method Cu-IUD (N= 262) Infant health: weight No differences between groups for % Weaknesses: Initiated 5–9 weeks postpartum Adverse events: colposcopic fully breastfeeding or number of Timing of initiation of method varied Follow-up at 1. 6. methods at postweaning bone density implant. pharmacokinetic Pregnancy No pregnancies observed over 2320 Strengths: II-2. Minor vaginal alterations in 8/45 PVR users and 2/54 Cu-IUD users. 6.L. 256 Table 1 Evidence for the progesterone-releasing vaginal ring. measures collected Cu-IUD (N=57) Bone density (dual-energy X-ray Significant differences in mean months Weaknesses: Initiated 57±3 days postpartum absorptiometry) of LAM between PVR and LNG Few measures of infant health Lactating. one women . Cu-IUD at 6 months. location Diaz S. Author year.01). Bone metabolism did not differ between groups. until weaning. / Contraception 94 (2016) 253–261 lumbar spine significantly lower at 1 month postpartum in all groups vs. PVR users compared with Cu-IUD users urinary infections higher in PVR group (62. Massai R. 12 (LNG breastfeeding at 6 months. 12 months months 1. normal vaginal Biochemical measures of endocrine implant vs. 2183 Low loss to follow-up (3%). 60. Carr et al. S. 3. 18–35 years. fair Population Council LNG implant (N=36) Lactation performance: duration no pregnancies in Cu-IUD (0/48). PVR: vaginal abrasions (n=2). low abdominal pain and menstrual problems higher in Cu-IUD group (pb.005). except alkaline phosphatases were lower in PVR vs. PVR and Cu-IUD (p=. 6. Cu-IUD (12. Differential continuation rates. Biochemical values similar across three groups.6±9 kg vs. 12 months vaginal epithelium evaluation: breastfeeding episodes at 14 months. Chile PVR (N= 285) frequency women-months exposure (Cu-IUD). fair USAID study and clinical trial Lactation performance: nursing women-months exposure (PVR). source of Study design Outcome measures Results Strengths/weaknesses Quality support. and 7 Limited information on method use delivery of healthy singleton 38–40 function and nutritional status months. or Detailed clinical and biochemical Chile PVR (N=36) Infant health: weight LNG implant (0/24) groups. PVR=45. 16% loss to follow-up weeks No difference in mean infant weight at Small sample size Bone evaluation at 1. and 12 months. Cu-IUD) months after weaning No difference in any bone density measurement. nonbreastfeeding women (pb.2±8 kg) (p=. respectively). 1999 Prospective cohort study Pregnancy One pregnancy in PVR group (1/28). LAM mean duration: PVR=361±9 days Self-reported bleeding. among volunteers postmethod initiation. 18–38 years. measures after contraceptive initiation. Strengths: II-2. Cu-IUD=198±8 days (pb. nursing outcomes or use of 4 rings Method continuation vs. 1999 Prospective cohort. Mean weight significantly higher among Vaginal complaints. no difference after weaning. Cu-IUD=54. 9. normal No significant differences in monthly differential loss to follow-up within vaginal delivery of healthy singleton infant weight or mean weight increases groups 38–40 weeks between groups. urinary discomfort. borderline significant difference in parathyroid hormone between LNG implant vs.05).01). % fully PVR group 78% (N=22) using other postpartum and 6 (PVR). 12. Lactating.

001. CONRAD. one women had extended area abrasion that regressed with ring removal and normal after 3 months.3%).8% PVR vs. LNG implant= Chile PVR (N=187) Method continuation PVR 0/1339 1%. 6 months (86. unpleasant ring use N= 13. 3. 18–35 years. Mean B/S episodes and B/S days: significantly lower for PVR vs.2% PVR vs.01). significantly higher than Cu-IUD at all visits (p≤. N= 54. NS at 9 months. discontinuation (PVR=54%.3/ Significant differences in baseline Lactating. one woman with petechiae at study discontinuation Continuation significantly lower in PVR group at 3. p=. Cu-IUD: one woman with hyperemia at 6 months. 2. More than 75% PVR reporting amenorrhea during study period. Diaz S. 3. Cu-IUD for all follow-up periods (p≤. Irregular bleeding significantly lower for PVR vs. Clear definition and analysis of China Cu-IUD (N=97) Method continuation No difference in infant weight gain bleeding and spotting patterns Initiated 29–64 days postpartum Adverse events between groups. 2. 6. Reasons for characteristics between methods: of healthy singleton 38–40 weeks discontinuation PVR: menstrual PVR users slightly more educated. Carr et al. 95%. personal (10.1% PVR vs. poor WHO. 6 women had minor abrasions. 6 months. visits among PVR vs. Cu-IUD=2. with small asymptomatic abrasion.3% Cu-IUD). vaginal problems more PVR users had cesarean section.5%). 16.001). Limited 12 months Complaints higher at all follow-up data/limited explanation: PVR=31%. problems N= 3. Weaknesses: Follow-up at 1. 1998 Prospective cohort study Pregnancy Pregnancy: none in Cu-IUD or PVR Strengths: II-2. Cu-IUD=2. 78.2% Cu-IUD). Cu-IUD = 10%. p= .7% vs.004) S. Cu-IUD=60% significantly higher at 1.L. poor Population Council PVR (N=100) Infant health: weight groups at 12 months. NS for later periods. loss to follow-up (5. Cu-IUD at 1. 12 months Discontinuation: PVR=65. expulsion N=7. p=. “treated” Lactation performance: duration months of exposure Relatively low loss to follow-up: Population Council LNG implant (N= 120) Infant health: weight POP 2/1023 PVR=7%. / Contraception 94 (2016) 253–261 Chen JH. ring out ≥48 h High and differential method N= 12.2% Cu-IUD). N=2.4/100 Self-reported bleeding postmethod initiation (clinic or home) women/years.0004. 66. 9. LAM=0% (same protocol as POP (N=117) Adverse events Cu-IUD 0/1410 Weaknesses: Sivin 1997) Cu-IUD (N=122) LNG implant 0/1410 Self-reported bleeding 257 (continued on next page) .001. Cu-IUD users. other medical reasons N=5. normal delivery 100 women-years. Reasons for discontinuation: method use problems (26. (p=. 3 months. 1997 Prospective cohort study Pregnancy Pregnancies: number of pregnancies/ Strengths: II-2.8% vs. POP=9%. (increased discharge or vaginitis) N= Few measures of infant health 10.

91. LNG implant PVR use problems resulted in compared with Cu-IUD and discontinuation (N=23). Diaz 1999). Large interstudy center differences Cu-IUD=74. 12 months weight at 61. PVR groups: methods=0% protocol stipulated stopping at Bleeding. for other groups. UNFPA.02) higher maternal weight (pb. 6. LAM significantly reported.01).7% Egypt. spotting greater in “treated” weaning vs. Bleeding: significantly higher amenorrhea in PVR group at 1.6/100 termination rate. 274 and 365 days. 5. Cu-IUD.1/100 termination rate. 8. USA. Slightly Cu-IUD=5. location LAM “untreated” (N= 236) LAM “untreated” 48/1363 (1 before Several significant differences in Initiated 57±3 days postpartum first episode of bleeding) baseline characteristics between Lactating. Carr et al. vaginal discharge. 34.001) Abnormal vaginal findings: (i. (9 clinics) Follow-up 1. 9.05) and Discontinuation: significantly higher higher percentage of vaginal for bleeding in PVR group at 6. Vaginal complaints (i. Expulsion: PVR=6%. Multiple study locations Population Council Cu-IUD (N= 734) episodes Mean number breastfeeding Large sample size Multicenter study Initiation 4–9 weeks postpartum Infant health: episodes: NS between method groups Low loss to follow-up: PVR=4. Cu-IUD Diaz 1997) 12 months in Cu-IUD group (p=. Difficult to determine if some of the postpartum. Chile. fair USAID.8% at 6 months. 30 across groups. PVR (N= 802) Lactation performance: number of PVR vs. China. 12 months (pb.5.001. . vs.5/100 Strengths: II-2.e. feeling the ring): higher in PVR (pb. monthly through 12 Weaning: POP=64%. respectively. 6. “untreated” group within first 30 Few measures of infant health days of initiation. lower weight. Follow-up days 7–10. 1997 Prospective cohort study Pregnancy Pregnancy rate at 12 months: 1. vaginal delivery of healthy singleton groups. lactation users lower parity. Sivin I. 30 after Reasons for discontinuation: stu dy po pu l a t i on i s re p or t e d initiation. normal Duration of lactation: mean NS across methods: Cu-IUD users older.8.05). 0.e. parity) and PVR significantly greater than POP.001). PVR=80% elsewhere (i.5. 23. 3.5/100 Cu-IUD. Cu-IUD=0. 12 months pb. PVR (same protocol as year. LNG implant. 18–35 years. 258 Table 1 (continued) Author year. months postpartum Bleeding: LNG implant=2%. S. days 15.5. postmethod initiation Method continuation higher for PVR group at 183 days Weaknesses: Singapore. 20. but significantly higher at significantly lower parity. source of Study design Outcome measures Results Strengths/weaknesses Quality support.e. / Contraception 94 (2016) 253–261 longer in POP. other High attrition in POP. 9. deliveries (pb. LNG implant. nonspecific vaginitis. 3. lower 38–40 weeks Infant weight increase: NS differences BMI. yeast) higher in Cu-IUD group (pb. Adverse events (pb. Overall rates at 6 Difference in continuation rates and 12 months: PVR=52.L.7% at 12 months. not an issue “untreated” (controlled for age.4%.01). Most baseline characteristics were Sri Lanka No difference in infant weight during similar between groups. PVR.

Cu-IUD= 11 B/S=bleeding/spotting. Method continuation health Cu-IUD=0%. normal exclusively breastfeeding at 6 placebo group Foundation UNFPA vaginal delivery of healthy singleton months=57% vs. HPV=human papilloma virus. fair WHO. 1985 Prospective cohort study Baseline characteristics No significant differences in baseline Strengths: II-2. Population Council. 1991 Prospective cohort study Pregnancy Pregnancy: 1/1007 woman-months in Weaknesses: II-2. Cu-IUD=85. 18–35 years. Shaaban M. 20%. Cu-IUD= 10. USAID. respectively. / Contraception 94 (2016) 253–261 J Hecht Funds. population not presented Egypt Initiated 5–7 weeks postpartum of supplementary foods No difference between groups. The Ford Lactating. PVR (N=103) Lactation performance: PVR group.6%. Weaknesses: Mellon Foundation. at 12 Chile 38–40 weeks months=11% vs. Loss to follow-up: PVR=5. 0/958 woman-months in Baseline characteristics of study Rockefeller Foundation Cu-IUD T380A (N= 83) Time to introduction Cu-IUD group. placebo=19/677. Limited information on additional S. PVR (N=128) Pregnancy characteristics. Differential continuation rates Follow-up at 12 months postpartum Infant health: weight No differences in infant weight or Low loss to follow-up: PVR=4%. 51% in PVR group (pb.5% described No data on population characteristics Diaz S. every 2 months Infant weight: No significant up to 12 months) differences in absolute or average infant weight gain. Continuation rates at one year: PVR= Study methodology not adequately 66. for PVR and Follow-up at 12 months postpartum Cu-IUD groups. Carr et al. George Initiated 60±5 days postpartum Method continuation No significant differences. 259 . 58%. Andrew W Placebo injection (N= unknown) Infant health: weight 1/739. Cu-IUD=0. poor WHO. Population Council. NS=not significant.L. Loss to follow-up: PVR=4%. Study termination for weaning/infant health higher in Cu-IUD group: 58% vs. Rockefeller Cu-IUD (N= 127) Lactation performance: duration Pregnancies (woman-months): PVR= Cu-IUD=9% Foundation.05). Discontinuation: PVR = 23. (monthly visits to 6.

02) [18]. With the excep. At 1 month postpartum.21.18.260 S. or LAM [19] in studies 4. Although no measures of bone health among a small sample (N= 129) significant adverse effects were noted in any studies with of Chilean breastfeeding women. this outcome measure was poorly defined. phosphorus. values and circumstances.4. use of the PVR did not affect breastfeeding performance or an observational study of Egyptian women reported no infant weight gain. a variety of safe and effective discontinuation among women who elected to use the contraceptive methods are necessary so that breastfeeding PVR compared with women who chose the Cu-IUD women are able to choose a method that meets their own [16–18. vary depending upon earlier initiation of PVR use. Results from these studies consistently showed that difference was statistically significant (p=. or LNG implant.19. and the America. however. breastfeeding participants small sample size [22].5. Carr et al. Reasons for discontinuation varied across personal preferences. The reasons cited by the participants in these who used the PVR. lumbar spine. Bone health self-reported/subjective accounts of breastfeeding and bleed- ing episodes. there was a notable difference in continu- compared with an external nonbreastfeeding comparison ation rates between contraception methods in several studies cohort (these women were not enrolled in the study). as well as studies included complaints such as unscheduled vaginal the nonbreastfeeding comparison cohort. The participants underwent evalua. Moreover. PVR users and 12 months for Cu-IUD and LNG implant and Cu-IUD on maternal bone turnover and density had a users).22]. breastfeeding performance or infant health measures would and right trochanter). In general. 9307 g (PVR)]. / Contraception 94 (2016) 253–261 LNG implant [19]. compared with the Cu-IUD and LNG implant both of which . however. and that the PVR was as effective at significant differences in “infant health” between PVR and preventing pregnancy during 12 months postpartum or Cu-IUD users during a 12-month period.20]. these outcome measures remain appropriate in One study included in this review examined several the context of the desired assessments. The collected to define infant health. no differences in bone density measures were of PVR discontinuation compared with other methods observed after weaning between breastfeeding women [19.L.20. the timing of PVR initiation postpartum within the studies alkaline phosphatases. Discussion conducted in Egypt. however. This infant health were collected and there was limited informa- observational study assessed differences between markers tion on the specific measures that were collected. Four of the seven infants whose mothers used a Cu-IUD weighed more [mean studies were conducted in public sector settings in Latin weight: 9528 g (Cu-IUD) vs. right femoral neck. more studies reported higher rates of advantages are maximized. few measures of other aspects of to use the PVR. and hydroxyproline/creatinine) and varied from 29 to 270 days. magnesium. the postmethod initiation (depending upon the study design) as investigator failed to describe the health outcomes that were both the highly effective Cu-IUD and LNG implant.18. studies suggested limited evidence that overall infant health was not affected by PVR use. and Chile. While all of the studies relied upon 3. POPs [19]. LNG implant. of bone metabolism (calcium. particularly when metabolism were noted during the study [22]. Cu-IUD. To ensure that these variable. patterns of infant weight were similar The seven studies included in this review were assessed to among women using a PVR or the Cu-IUD through be of poor (three studies [17. bleeding. 12-month study period and after weaning (6 months for The study examining the effect of the PVR. in particular. According to a large multicountry study. increased vaginal discharge. 3. described difficulties using the method compared with it is important to recognize several limitations to this small women using other methods.21]. The women self-selected regard to infant weight gain. the studies. Finally. at 12 months follow-up. or other personal results. [17. In tion of lower levels of alkaline phosphatases at 6 months addition. Two tion of the above described parameters during the studies experienced high rates of loss to follow-up [20. [16. and ring expulsion. contraceptive methods or to other progestogen-mediated methods. Significantly higher proportions of PVR users Despite the reassuring findings derived from this review. two studies reported higher rates However. Difficulties cited included body of evidence that may limit the generalizability of the vaginal problems. which may also partially explain higher users. exhibited lower bone density levels at the lumbar spine Additionally. No serious adverse events occurred or contributed to controlled trials comparing the PVR to nonhormonal the discontinuation rates observed in all studies. the LNG implant. or the Cu-IUD.20.21]. None of the included studies were randomized reasons.20]) to fair (four studies 12 months of observation. Discontinuation/continuation Expanding the use of modern contraceptive methods Discontinuation of self-selected methods prior to the among women who breastfeed is a vitally important completion of the included studies was common and individual and public health issue. bleeding irregularities. it is not known whether bone density (total body. no other significant differences in markers of bone discontinuation rates among these women. participants in all of the studies selected their contraceptive method. participants were instructed to discontinue the PVR follow-up among PVR users compared with Cu-IUD with weaning.22]) methodological quality. China.

Mulrow CD. New York: Guttmacher Institute.uk/government/news/family. editors. & Kiesel L. [18] Sivin I.27:991–4. and bleeding patterns during use of progesterone vaginal rings. Lavin P. [10] Massai R. Contraceptive efficacy of lactational amenorrhea in urban postpartum breastfeeding women in the WHO MEC for Chilean women. Contraception 1997. Acceptors of the PVR should also be analysis of findings from seventeen countries. et al. Juez G. Valdes P. The place of progesterone in human category 1).27:20–7. Maturana X. duration of lactation. Afr J Reprod Health counseled about transitioning to another effective method of 2010. Peterson HB. Curtis KM. Contraception 1999. Sayad EH. This review was supported by resources from the WHO. . Miranda P. issued the following recommendation for use of the PVR: [11] Diaz S. et al. Zepeda A. Summary of evidence: direct. Development and [7] Nath A. Quinteros E. The comparative trial of TCu 380A IUD and summit. VI. Ball H. Current methods of the US Preventive Services Task Force: a review of 5. Development. Reyes MV. women who breastfeed compares favorably to other highly Fertility regulation in nursing women: VIII. Casado [1] Department for International Development. Jackanicz TM. contraception during the weaning process as the effective. Herreros C. et al. the [9] Croxatto HB. Miranda P. Progesterone: at least four breastfeeding episodes per day) to maintain the Summary Report. Lohr KN. Zepeda A. Casado ME. whether PVR use can be safely initiated prior to 4 weeks Female contraception and male fertility regulation. Acknowledgments Contraceptives for lactating women: a comparative trial of a progesterone-releasing vaginal ring and the copper T 380A IUD. et al. Peralta O. WHO nursing women: a phase II clinical trial. Fertility regulation in nursing women. et al. Contraception 1998. level II-2.40:705–10. infant growth.55:225–32. Fertility regulation in nursing women. et al. Peralta O. 135–42.20:21–35. 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[13] EMEA Committee for Veterinary Medicinal Products.europa. women who use the PVR must be actively breastfeeding (e. Zepeda A. Teutsch S. Aravena R. Progesterone plasma levels effective methods of contraception and does not compromise and contraceptive efficacy of a progesterone-releasing vaginal ring. Progesterone vaginal ring for contraceptive Evaluation profile that summarized the strength of the use during lactation. Contraception 1991. Reyes MV. Casado ME. Carr et al. Statement for [21] Massai R. Contraceptive effectiveness of Women who breastfeed and are four or more weeks a subdermal progesterone implant. 5th Edition. Family planning: a global Hum Reprod 1999. Contraceptive technologies: responding evidence presented in this systematic review. Contraceptive Use. Miranda P. J Steroid Biochem 1987. and an anonymous donor. Maturana X. Return to sexual activity and use and expectations for irregular bleeding patterns and other modern family planning use in the extended postpartum period: an minor side effects. collective action for postpartum family planning. et al. Int Fam Plan Perspect 2001. 1st ed. Gaffield ML. [4] Borda MR. Baltimore and Geneva: should thus be counseled appropriately with regard to proper CCP and WHO. and Research (WHO/RHR). The Guideline Development Group advised that contraception. Conclusion the process. et al.g.scribd.14:2499–505. Family planning: London ME. In: Runnebaum B. Reyes MV. Helfand M.L. Casado ME. progestin-only pills. document_library/Maximum_Residue_Limits_-_Report/2011/07/ WC500108427. [5] Ross JA. Contraception 2005. Norplant implants. Diaz S.gov. [15] Mohllajee AP. Croxatto HB. Valdes P. Zepeda A. need during the extended postpartum period. intention to use and unmet ness of the PVR in nonbreastfeeding women is not known. J Steroid Biochem Mol Biol 1991. http://www. 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Herreros C. maternal bone turnover and density during lactation and after weaning. Winfrey W. Progesterone vaginal rings for contraception Group noted that additional studies are needed to examine during breastfeeding.43:335–52.14:72–9. progesterone-releasing vaginal ring in Chilean nursing women.72:352–7.57:371–9. Miranda P. Johns Hopkins Bloomberg School of Norplant((R)) implants and progesterone vaginal rings do not affect Public Health/Center for Communications Programs (CCP). Rinehart W. Contraception 1997. / Contraception 94 (2016) 253–261 261 are long-acting reversible devices. Salvatierra AM. Diaz S.pdf 1999 [accessed 24 March 2015].56:223–32. Contraception with progestogens and progesterone during lactation. 2011. Montero After consideration of the evidence provided by this JC. Assessment. as well as a to womens’ needs. and References Copper T 380-A intrauterine devices. Caviedes R. 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