Breastfeeding after immediate vs delayed postpartum contraceptive implant placement: a noninferiority randomized controlled trial - 22/04/25
, Maritza Rivera-Montalvo, MD, MPH a, b, Lawrence Leeman, MD, MPH c, Victoria Y. Trujillo, BA a, Timothy R. Petersen, PhD a, d, Dominique Sanchez, MD c, e, Emily Bender, MD c, f, Smita Carroll, MD, MBA, MPH a, g, Erin Bulleit, MD b, h, Jasmin Alcantara, BS i, David K. Turok, MD, MPH i, Patricia Black, MD a, j, Eve Espey, MD, MPH aCet article a été publié dans un numéro de la revue, cliquez ici pour y accéder
Abstract |
Background |
Breastfeeding and access to contraception are important to patient and public health. The etonogestrel contraceptive implant is a popular and highly effective long-acting progestin contraceptive with few medical contraindications. Despite theoretical concern about early exogenous progestin exposure inhibiting lactogenesis, previous studies showed reassuring lactogenesis and long-term breastfeeding with immediate placement. However, no studies compare placement within 24 hours postpartum to delayed placement at a postpartum visit.
Objective |
We studied the association between etonogestrel contraceptive implant placement within 24 hours vs at least 2 weeks postpartum and breastfeeding continuation at 8 weeks postpartum.
Study design |
We conducted a noninferiority randomized controlled trial of postpartum participants who planned to breastfeed and use the etonogestrel implant at 2 university hospitals in the Mountain West. Participants were at least 13 years old, fluent in English or Spanish, had term deliveries, and lacked contraindications to implant use. They were randomized 1:1 to implant placement within 24 hours or at least 2 weeks postpartum. We collected baseline participant characteristics from chart review and questionnaires. Participants reported breastfeeding status and implant use via electronic questionnaires at 2, 4, 8, 12, and 24 weeks postpartum. The study was powered to assess a 15% noninferiority margin between groups of the primary outcome, any breastfeeding at 8 weeks in the per protocol population.
Results |
We enrolled 150 participants (n=78 immediate, n=72 delayed). After removing participants who declined implant placement, withdrew, or were ineligible (n=8) or lacked primary outcome data (n=16), the modified intention-to-treat analysis included 126 participants (n=69 immediate, n=57 delayed). The per protocol analysis included 115 participants (n=62 immediate, n=53 delayed) after excluding additional participants who received the implant outside of the placement timing windows (n=11). Participants were similar in age, race, and ethnicity, as well as previous breastfeeding experience, delivery mode, and epidural use; the delayed group reported prior implant use less frequently (29% vs 43%). In the per protocol analysis, 77.4% (48/62) of participants in the immediate group and 81.1% (43/53) in the delayed group reported any breastfeeding at 8 weeks; the lower limit of the one-sided 95% confidence interval around this −3.7% difference was −16%, exceeding our predefined noninferiority margin. The difference between groups in the modified intention-to-treat group was smaller (−0.6%) and within the noninferiority margin (−12.8% lower limit of the 1-sided 95% confidence interval): 78.3% (54/69) immediate and 78.9% (45/57) delayed. Implant continuation at 24 weeks trended toward favoring immediate placement (96%, 52/54) compared to in those assigned to delayed placement, (85%, 39/46, P=.08). Exclusive or any breastfeeding and implant continuation through 24 weeks were similar between groups.
Conclusion |
The results demonstrated no clinically important differences in breastfeeding and implant continuation outcomes though our primary outcome exceeded our predefined noninferiority margin. These reassuring data add to the evidence base for supporting etonogestrel implant initiation for breastfeeding people whenever they desire it postpartum.
Le texte complet de cet article est disponible en PDF.Key words : breastfeeding continuation, etonogestrel contraceptive implant, immediate postpartum contraception, lactation, progestin-only contraception, subdermal contraceptive implant
Plan
| D.K.T. serves as a consultant for Sebela Pharmaceuticals. J.W.K., M.R.-M., L.L., V.Y.T., T.R.P., D.S., E. Bender, S.C., E. Bulleit, J.A., P.B., E.E. report no conflict of interest. |
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| This work was supported by the Society of Family Planning Research Fund #19-28. At the time of the study, J.W.K. was supported by a grant from the Society of Family Planning Research Fund (FSS19-06) and through the University of New Mexico (UNM) Center for Translational Science Center's KL2 program under grant numbers UL1TR001448 and KL2TR001448 from the National Center for Advancing Translational Sciences, National Institutes of Health. P.B. received a University of New Mexico Department of Obstetrics & Gynecology Seligman Grant to cover the cost of clinic implant placements for insured patients. The LARC Mentoring Program and the Ryan LARC Program provided free implants for uninsured participants. The Division of Family Planning in the University of Utah's Department of Obstetrics and Gynecology receives research funding from Bayer Women's Health Care, Organon & Co, Inc, Cooper Surgical, Sebela Pharmaceuticals, Femasys, and Medicines 360. |
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| Cite this article as: Krashin JW, Rivera-Montalvo M; Leeman L, et al. Breastfeeding after immediate vs delayed postpartum contraceptive implant placement: a noninferiority randomized controlled trial. Am J Obstet Gynecol 2025;XXX:XX–XX. |
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| Date of clinical trial registration: June 6, 2019. |
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| Date of initial participant enrollment: June 17, 2019. |
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| Clinical trial identification number: NCT03978598 (URL of the registration site: NCT03978598). |
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