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Accepted Manuscript

Etonogestrel-releasing contraceptive implant for postpartum adolescents: a


randomized controlled trial

Amy G. Bryant, MD, MSCR, Anna E. Bauer, MPH, Gretchen S. Stuart, MD, MPHTM,
Erika E. Levi, MD, MPH, Matthew L. Zerden, MD, MPH, Antoinette Danvers, MD,
MSCR, Joanne M. Garrett, PhD
PII: S1083-3188(16)30135-8
DOI: 10.1016/j.jpag.2016.08.003
Reference: PEDADO 2025

To appear in: Journal of Pediatric and Adolescent Gynecology

Received Date: 18 April 2016


Revised Date: 27 July 2016

Accepted Date: 6 August 2016

Please cite this article as: Bryant AG, Bauer AE, Stuart GS, Levi EE, Zerden ML, Danvers A, Garrett JM,
Etonogestrel-releasing contraceptive implant for postpartum adolescents: a randomized controlled trial,
Journal of Pediatric and Adolescent Gynecology (2016), doi: 10.1016/j.jpag.2016.08.003.

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ACCEPTED MANUSCRIPT

Etonogestrel-releasing contraceptive implant for postpartum adolescents: a randomized controlled


trial

Authors:

Amy G Bryant, MD, MSCRa*


Anna E. Bauer, MPHb
Gretchen S. Stuart, MD, MPHTMa
Erika E. Levi, MD, MPHa,c
Matthew L. Zerden, MD, MPHa,d
Antoinette Danvers, MD, MSCRa,e
Joanne M. Garrett, PhDa,b

*Corresponding Author: Dr. Amy G. Bryant


Department of Obstetrics and Gynecology University of North Carolina at Chapel Hill
4002 Old Clinic Building, CB 7570 Chapel Hill, NC 27514
Email: amy_bryant@med.unc.edu Phone: 919-962-4889 Fax: 919-843-6691

a
Department of Obstetrics and Gynecology
University of North Carolina at Chapel Hill
Chapel Hill, NC
b
Department of Epidemiology
Gillings School of Global Public Health
University of North Carolina at Chapel Hill
Chapel Hill, NC

c
Present address for Dr. Levi:
Department of Obstetrics and Gynecology, Albert Einstein College of Medicine, Bronx, NY
d
Present address for Dr. Zerden:
Department of Obstetrics and Gynecology, WakeMed Health and Hospitals, Raleigh, NC
e
Present address for Dr. Danvers
Department of Obstetrics and Gynecology, Columbia University School of Medicine
New York, NY

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Abstract: (word count 245)

Study Objective: To compare immediate postpartum insertion of the contraceptive implant to


placement at the 6-week postpartum visit among adolescent and young women. Design: Non-
blinded, randomized controlled trial.
Setting and participants: Postpartum adolescents and young women ages 14-24 years delivering
at an academic tertiary care hospital serving both rural and urban populations in North Carolina.

Interventions: Placement of an etonogestrel-releasing contraceptive implant prior to leaving the


hospital postpartum, or at the 4-6 week postpartum visit.
Main Outcome Measure: Contraceptive implant use at 12 months postpartum.
Results: Ninety-six participants were randomized into the trial. Data regarding use at 12 months
were available for 64 participants, 37 in the immediate group and 27 in the 6-week group. There
was no difference in use at 12 months between the immediate group and the 6-week group (81%
vs. 78%; p=0.75). At 3 months, the immediate group was more likely to have the implant in place
(92% vs. 70%; p=0.02).
Conclusions: Placing the contraceptive implant in the immediate postpartum period results in
higher use at 3 months postpartum and appears to have similar use rates at 12 months
compared to 6-week postpartum placement. Providing contraceptive implants to adolescents
prior to hospital discharge takes advantage of access to care, increases the likelihood of
effective contraception in the early postpartum period, appears to have no adverse effects on
breastfeeding, and may lead to increased utilization at one year postpartum.

Key words: adolescent, LARC, contraceptive implant, postpartum, long-acting reversible


contraception, rapid repeat pregnancy

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1. Introduction

Each year almost 750,000 adolescents in the United States become pregnant, and 82% of these
pregnancies are unplanned.1 Young adult women, ages 18-24, experience the highest rates of
unintended pregnancy.2 Rapid repeat pregnancy within 24 months of a previous delivery occurs
at a rate of up to 50% in this population,3, 4 and is associated with adverse outcomes, including
lower educational achievement and higher poverty for adolescent mothers.5-7 Providing long-
acting reversible contraception (LARC) immediately postpartum could be an important factor for
decreasing rapid repeat pregnancy.3, 8-11 This is particularly important in the adolescent
population as up 47% of adolescents and 40% of young women will resume sexual intercourse
within 6 weeks of a birth.10, 11 (Sok 2016)

The etonogestrel-releasing contraceptive implant is one of the most effective reversible


contraceptives available, with failure rates of less than 1%.12 The contraceptive implant appeals
to adolescents and young women, and in several studies was chosen more often than other forms
of LARC.13-15 Continuation of the contraceptive implant at 12-months among adults and
adolescents ranges from 83%-100%10, 16, 17 and is much higher than that seen with oral
contraceptives or depot medroxyprogesterone. 17-19

Many women who intend to use a LARC method for postpartum contraception never return for
their postpartum visit, and subsequently never receive the method.20, 21 These women often face
barriers such as low social support, lack of transportation, lack of stable housing, and difficulty
communicating with their healthcare providers.22 Providing LARC at convenient time frames such
as immediately postpartum can lead to higher uptake of LARC and avoid rapid repeat
pregnancy.23-26 The contraceptive implant has been shown to be safe and acceptable in the
postpartum period,16, 27-29 and does not appear to negatively affect breastfeeding.30, 31
The objective of this study was to investigate immediate postpartum placement of the
contraceptive implant compared to placement at the 6-week postpartum visit among adolescent
and young women ages 14-24. The primary outcome was contraceptive implant use at one year
postpartum.

2. Materials and methods

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We conducted a parallel, 1:1, non-blinded, randomized controlled trial among adolescent and
young women to compare receiving the contraceptive implant immediately postpartum to
receiving the contraceptive implant at the traditional 6-week postpartum visit. Enrollment occurred
at the University of North Carolina Womens Hospital between August 2012 and April 2014, with
follow-up concluding in April 2015. The study was approved by the University of North Carolina,
Chapel Hill Institutional Review Board and was registered with the Clinical Trials Registry.
(ClinicalTrials.gov Identifier NCT01666912). All study activities adhered to the CONSORT
guidelines.32

Adolescents and young women were eligible to enroll if they were aged 14-24 years, gave birth to
a healthy infant, spoke English or Spanish, and desired to use the contraceptive implant.
Exclusion criteria included the following: 1) current or past history of thrombosis or
thromboembolic disorders; 2) hepatic tumors; 3) active liver disease; 4) undiagnosed abnormal
genital bleeding; 5) known, suspected or history of carcinoma of the breast; 6) hypersensitivity to
the implant; 7) use of hepatic enzyme inducers; 8) maternal ICU admission after delivery; 9)
postpartum hemorrhage requiring blood transfusion; 10) hospital stay >7 days postpartum; 11)
coagulopathy; or 12) HELLP syndrome. We initially excluded women with severe pregnancy-
induced hypertension and postpartum fever; but amended the protocol in October 2013 because
these criteria were not clear contraindications. Participants 14-17 years were required to have
parental consent, in addition to their assent, to participate.

Screening and recruitment took place during prenatal care or in the hospital postpartum. All
adolescents and young women who expressed an interest in the implant or were undecided
during postpartum contraceptive counseling were approached. Informed consent, enrollment, and
randomization occurred postpartum. A research assistant not involved in the trial prepared
envelopes using computer-generated random allocation in randomly permutated blocks of 4 and
6. After delivery, the investigator opened the next sequentially numbered, opaque, sealed
envelope containing the allocation. Participants allocated to the immediate group received the
implant prior to hospital discharge. Participants allocated to the 6-week group received the implant
at the scheduled routine postpartum visit. Standard insertion technique was used. Follow-up data
were collected in person or by telephone at 3, 6, 9, and 12 months postpartum. The data collected
at the follow-up visits included satisfaction, bleeding patterns, breastfeeding, and whether the
implant was still in place. All women enrolled could receive the implant free-of-

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charge if they had no insurance coverage for the implant. Each participant was reimbursed a
nominal amount for each study visit.

Sample size was based on the assumption that a 30% difference in contraceptive implant use at
one year postpartum would be clinically meaningful. We estimated that 30% of subjects in the
control group would not return for implant placement and that 10% of all subjects would request
removal within one year17. We anticipated 60% of women in the 6-week group and 90% of
women in the immediate group would be using the implant at 12 months postpartum. Using a two-
sided alpha of 0.05% and a beta of 0.20 (power of 80%) we calculated a sample size of 76
women (38 in each group). We anticipated a 15-20% loss to follow up, and planned to enroll 96
women total.

Primary analysis used data from participants who had 12-month outcomes available. Intention-to-
treat analysis was also performed, based on originally randomized groups. We also performed
sensitivity analyses on the primary outcome to assess the potential impact of loss to follow-up. We
used descriptive statistics for secondary analyses of demographic and reproductive health
characteristics for both intervention groups. We used Students t- test for continuous variables,
and Pearsons chi-square for categorical variables. Statistical analysis was performed using Stata
13. (College Station, TX)

3. Results

A total of 187 adolescent and young women were screened for eligibility. Of those, 91 were
ineligible, declined to participate, or were not able to enroll. Ninety-six women were
randomized: 48 participants to the immediate group, and 48 to the 6-week group. (Figure 1)
Baseline characteristics were similar between the groups (Table 1).

For our primary outcome of contraceptive implant use at 12 months postpartum, we included only
the participants for whom we had 12-month follow-up data (n=64). In the immediate group, 30/37
(81%) and 21/27 (78%) in the 6-week group had an implant in place at 12 months (p=0.74)
(Table 2). Using intention-to-treat analysis, use at 12 months was higher in the immediate group,
30/48 (63%) versus the 6-week group, 21/48 (44%) (p=0.07); however this assumes that all
women lost to follow up did not have an implant placed at any point in the postpartum period.
There was no crossover between the treatment groups.

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Of the women allocated to the immediate group 48 (100%) received their implant during their
hospital stay. Of the 48 participants allocated to 6-week implant insertion, 32 (67%) were known
to have an implant successfully placed at the 6-week visit (p<0.0001). Among the participants
with 12-month follow-up data, those who received the implant immediately postpartum were
significantly more likely to have the implant in place at 3 months postpartum (92% vs 70%;
p=0.02). Seven participants declined an implant during their follow-up visit; two received other
methods and the remaining 5 were not started on any method. Ten participants never returned
for any study or postpartum visit after enrollment; whether they received an implant is unknown.

The overall loss to follow-up was high (32/96, 33%), and the loss to follow-up in the 6-week
group (21/48, 44%) was higher than in the immediate group (11/48, 23%) (p=0.03) Baseline
characteristics among those who were lost to follow up were similar to those not lost, except for
age. The participants lost to follow-up were younger than those who remained in the study (20.3
years vs. 21.4 years; p=0.04). (Data not shown).

Because of the loss to follow-up, we performed sensitivity analyses to evaluate the primary
outcome using several possible scenarios (Table 3). When we assumed that all participants lost
to follow-up in the immediate group still had the implant in place at 12 months (41/48) and no one
lost to follow-up in the 6-week group had the implant (21/48), having the implant placed
immediately postpartum was associated with a higher likelihood of having the implant in place at
12 months (p<0.001). When we assumed that the same proportion of implants in the immediate
group (81%) were in place among the women who were lost as in the cohort for whom data were
available, the proportion of implants continued was 39/48 (81%) in the immediate group and
38/48 (79%) in the 6-week group (p=0.8).

In the immediate group, 7 of the 37 participants had their implants removed prior to 12 months
postpartum. One participant had the implant removed due to pain at the insertion site; two due to
migraines, one due to dizziness, and three due to continuous or excessive bleeding. All of these
participants had the implant for at least 6 months. In the 6-week insertion group, one of the 27
participants desired pregnancy and had the implant removed. No serious adverse events were
reported for participants in either group.

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Overall, participants in both groups were satisfied with their implants (Table 4). At one year
postpartum, 89% (33/37) in the immediate group and 78% (21/26) of the participants in the 6-
week group stated that they would recommend an implant to a friend (p=0.2). There were no
differences between the two groups in heavy bleeding, irregular bleeding, severe cramping,
lighter periods, or other symptoms at one-year follow-up.

Among the participants for whom we had 12-month follow-up data, breastfeeding at 3 months
postpartum was higher in participants in the immediate group (15/37, 40.5% versus the 6-week
group (5/27, 18.5%, p=0.06) and at 6 months postpartum (11/37, 30% vs 4/27, 15%, p=0.16),
though these were not statistically significant differences. Among the participants for whom we
had 3 and 6 month follow-up, breastfeeding was also higher in the immediate group among those
with an implant in place at both 3 months (18/38; 47% vs. 8/26; 31%, p=0.18) and in the 6 month
group (14/35; 40% vs. 4/24; 17% (p=0.06). (Data not shown)

Seven unplanned pregnancies occurred among study participants during the study follow-up
period, five in the 6-week group, and two in the immediate group. This difference was not
statistically significant. All of the pregnancies occurred in participants who had not had the
implant placed, or had had it removed.

4. Discussion
Placing contraceptive implants in the immediate postpartum period appears to have some
benefits. All of the women in the immediate group had the implant at the time of leaving the
hospital, and significantly more of them had the implant in place at 3 months postpartum. The
large loss to follow-up in this study makes it difficult to conclude that placing a contraceptive
implant in adolescent and young women in the immediate postpartum period leads to higher use
of the contraceptive implant at one year postpartum. However, this large loss to follow-up
suggests that young women may be most effectively reached for implant insertion during their
hospital stay after birth.

To our knowledge, this is the first randomized controlled trial to evaluate immediate vs. 6-week
postpartum contraceptive implant use among adolescents and young women, populations at
significant risk for rapid repeat pregnancy. This study took place in the clinical setting of a large,
tertiary care center serving both urban and rural populations. A large proportion of women who

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deliver at our center come from all over the state and do not necessarily return for postpartum
care.

This study contributes to the growing body of research suggesting that immediate postpartum
placement of contraceptive implants is acceptable and effective for adolescents. In one
retrospective study, women who had the contraceptive implant placed immediately postpartum
had high continuation rates at 1, 2 and 3 years postpartum.33 Another retrospective review
showed that women who received the implant immediately postpartum were no more likely to
have it removed for irregular bleeding than women who had 6-week placement.34 A cost-
effectiveness analysis indicated that placing the contraceptive implant immediately postpartum in
adolescents results in significant cost savings due to averted births.35 Additionally, it appears that
adolescent mothers who initiate a LARC method within 8 weeks of delivery are far less likely to
experience a rapid repeat pregnancy in the subsequent 2 years than those who do not.3, 8

Interestingly, this study found that women who received the implant immediately postpartum were
more likely to be breastfeeding their infant at three and six months postpartum. This was a
secondary outcome of our study; however, it suggests that the implant does not adversely affect
breastfeeding if placed immediately postpartum. This finding is compatible with findings from other
studies investigating breast milk production after immediate postpartum implant insertion.30, 31

The biggest limitation of this study is the large loss to follow-up, particularly in the group
randomized to receive the implant at 6 weeks postpartum. In designing our study we assumed
that more women in the 6-week group would not have the implant placed, but we did not
anticipate that more of them would not follow-up. We used rigorous methods to locate
participants, including obtaining multiple contacts and cell phone numbers at each encounter. The
women who remained in the study were slightly older than those lost to follow-up. Adolescents
can be notoriously difficult to follow during longitudinal studies, due to frequent changes in life
situations and barriers to care.36 Reaching women in the hospital immediately postpartum, prior to
their 6-week follow-up visit, may be important precisely because they are less likely to follow-up.

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We addressed the lack of follow-up by performing intention-to-treat analyses and sensitivity


analyses. Assuming that women who did not follow-up did not receive an implant postpartum,
women who received an implant in the hospital were much more likely to be using an implant at all
points postpartum than women who did not. While our loss to follow-up limits our conclusions
significantly, these analyses suggest that receiving an implant while in the hospital is beneficial to
women who do not return for follow-up.

Providing the implant in the immediate postpartum period is becoming more feasible as Medicaid
reimbursement becomes more widespread. Therefore a large, multi-center cohort trial might
provide more conclusive findings regarding use at 12 months, breastfeeding, and other outcomes
related to immediate postpartum implant placement.

Providing the contraceptive implant to adolescents and young women prior to hospital discharge
takes advantage of access to care, increases the likelihood that they will have effective
contraception in the early postpartum period, appears to have no adverse effects on
breastfeeding, and may lead to increased utilization and decreased rapid repeat pregnancy at one
year postpartum.

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Acknowledgements
This study was supported by a small grant from the Society of Family Planning and the
American College of Obstetricians and Gynecologists/ Bayer HealthCare Pharmaceuticals
Research Fellowship in Long Term Contraception

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Table 1. Baseline characteristics of women allocated to immediate contraceptive implant


placement or placement 6 weeks postpartum

Immediate 6 week postpartum


*M postpartum implant implant placement
placement (n=48) (n=48)
ean
Age (years) 21 (2.35)* 21 (2.58)

(S Parity at Admission
0 10 17
D) or
1 44 35

n( %)
2+ 46 48
Race/Ethnicity
White 29 31
African-American 29 25
Hispanic/Latino 40 40
Other 2 4
Educational Status
High school or less 58 60
Some college 17 25
College or more 6 2
Marital Status
Married or Living with Partner 65 60
Single 35 40
Monthly Household Income
<1000 23 23
1001-3000 58 50
Over 3000 2 4
Refuse to answer/missing 17 23
Delivery Type (% Vaginal) 77 73
Birthweight of fetus (g) 3043 (585.4) 3194 (719.3)
Living with parents (vs. Not living with
63 79
parents)
In school 67 79
Worked in the last 12 months (% yes) 71 63
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Table 2. Primary outcomes related to contraceptive implant use at each follow-up point postpartum
for participants allocated to immediate vs 6-week placement

Primary Outcome: Postpartum Implant Use Immediate 6-week p value


Group Group

3 month follow-up (n=74) 38/40 26/34 0.02


(95%) (77%)

6 month follow-up (n=68) 35/40 24/28 0.8


(88%) (86%)

9 month follow-up (n=64)* 33/38 22/26 0.8


(87%) (85%)

12 month follow-up (n=64) 30/37 21/27


0.7
(81%) (78%)
Analyzed by intention-to-treat at 12 months (n=96) 30/48 21/48
0.07
(63%) (44%)
*Four participants lost at 6 and 9 months contributed 12 month follow-up data.
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Table 3. Sensitivity Analyses: Primary outcomes related to assumptions about contraceptive


implant use at 12 months postpartum in the women lost to follow-up (LTFU)

Primary Outcome: Postpartum Implant Use Immediate 6-week p value


Group Group
Immediate group: 100% LTFU had implant
41/48 (85%) 21/48 (44%) <0.001
6 week group: 0% LTFU had implant
Immediate group: 0% LTFU had implant
30/48 (63%) 42/48 (88%) 0.005
6 week group: 100% LTFU had implant
Immediate group: 81% LTFU had implant
39/48 (81%) 38/48 (79%) 0.80
6 week group: 81% LTFU had implant
Immediate group: 63% LTFU had implant
37/48 (77%) 34/48 (71%) 0.48
6 week group: 63% LTFU had implant
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Table 4. Secondary outcomes related to contraceptive implant use for women who were
allocated to immediate vs interval implant placement and were followed to 12 months

Immediate 6-week
Secondary Outcomes* Group (n=37) Group (n=27) p value

Liked using implant (yes) 29 (78) 21 (78) 0.95


Satisfaction with implant,0-10 (10 =
8.3 (2.1) 8.7 (1.4) 0.5
satisfied)
Would recommend placement to a friend 33 (89) 21 (78) 0.2
Plan to continue implant for another year 29 (78) 22 (81.5) 0.8
Lighter bleeding at 12 months 15 (40.5) 16 (59) 0.2
Heavy, irregular bleeding, or severe
25 (68) 18 (67) 0.9
cramping at 12 months
Breastfeeding at 3 months 15 (40.5) 5 (18.5) 0.06
Breastfeeding at 6 months 11 (30) 4 (15) 0.16
Breastfeeding at 9 months 7 (19) 4 (15) 0.7
Breastfeeding at 12 months 4 (11) 1 (4) 0.3
Rapid repeat pregnancy 5 (13.5) 2 (7) 0.4
*Including only participants with 12 month outcome data. Mean (SD) or n(%)
ACCEPTED MANUSCRIPT

Figure 1. Adolescent Postpartum Implant Study Flow Diagram

Enrollment Assessed for eligibility (n=187) Excluded (n=91)


Ineligible
Not English or Spanish
speaking (n=2)
Preeclampsia/HELLP (n=12)
Postpartum fever (n= 2)
Enrolled (n=96) Infant in NICU (n=6)

Declined participation (n= 21)


Wanted implant at 6 weeks (n=21)
Wanted other contraceptive (n=20)
No implants available (n=2)
Delivered at another facility (n=2)
Randomized (n=96) Delivery missed by study team (n=2)
Other (n=1)
Allocation

Allocated to immediate implant insertion (n=48) Allocated to 6 week implant insertion (n=48)
Received allocated intervention (n=48 ) Received allocated intervention (n=30)

Did not receive allocated intervention (n=0) Did not receive allocated intervention (n=6)

Unknown (n=12)

Follow-Up

Implant in place at 12 months (n= 30) Implant in place at 12 months (n= 21)

Lost to follow-up Lost to follow-up


By 3 months (n= 8) By 3 months (n= 14)
By 6 months (n=8) By 6 months (n= 20)
By 9 months (n=10) By 9 months (n=23)
By 12 months (n=11) By 12 months (n=21)
Discontinued intervention by 12 months (n=7) Discontinued intervention by 12 months (n=1)

Analysis

Analyzed using Intention-to-Treat analysis Analyzed using Intention-to-Treat analysis


(n=48) (n=48)
Outcome analysis including only women for Outcome analysis including only women for
whom we have 12 month data (n=37) whom we have 12 month data (n=27)