Breastfeeding Etonogestrel Implant Study

NCT03978598 | Completed Phase 4 Results DMC FDA Drug FDA Device

• 1 other identifier: 19-049
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 2

Brief Summary

The investigators are studying the effect of placing the etonogestrel implant (Nexplanon) in the first 24 hours after birth on breastfeeding. Women who wish to have an etonogestrel implant placed after their birth, wish to breastfeed, and are willing to participate in the study will be randomly assigned to either get the implant placed in the first 24 hours after delivery of the baby and placenta or 4-6 weeks later. The investigators do not believe there will be a difference in breastfeeding 8 weeks after delivery or time to lactogenesis between those who get the implant placed early or later.

Conditions

Contraception

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Continuation of Breastfeeding at 8 Weeks Postpartum

  Using a questionnaire the investigators seek to compare continuation of lactation between women in the immediate versus standard group. This will be assessed by answering a question with a dichotomous scale of yes or no in the follow-up questionnaire administer at 2,4,8,12 and 24 weeks postpartum.

  For the primary outcome will be the first eight weeks after delivery.

Secondary Outcomes (8)

• Exclusive Breastfeeding

  Up to 24 weeks postpartum.

• Factors Associated With Breastfeeding Discontinuation.

  Up to 24 weeks postpartum.

• Satisfaction With Postpartum Contraception Counseling

  At enrollment.

• Postpartum Mood

  At 2, 4, and 8 weeks postpartum.

• Sexual Function

  At 4, 8, and 12 weeks postpartum

Study Arms (2)

Immediate insertion group

EXPERIMENTAL

Immediate insertion in the first 24 hours after delivery ENG implant insertion Intervention.

Drug: Etonogestrel; Device: Nexplanon

Standard Postpartum Insertion Group

ACTIVE COMPARATOR

Insertion of the Etonogestrel implant 4-6 weeks postpartum Intervention.

Drug: Etonogestrel; Device: Nexplanon

Interventions

Etonogestrel DRUG

Immediate v. Standard insertion.

Immediate insertion group; Standard Postpartum Insertion Group

Nexplanon DEVICE

Implant.

Immediate insertion group; Standard Postpartum Insertion Group

Eligibility Criteria

• Age: 13 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Pregnant women or women who have delivered vaginally and by cesarean section within 22 hours (2-hour window will allow for implant insertion by 24 hours postpartum)
• Aged 13 and older
• English or Spanish speakers
• Deliver an infant at UNM Hospital at \> 37 weeks gestational age
• Intend to breastfeed
• Desire the implant as a method for contraception
• Agree to randomization
• Must have a working phone (study questions to be answered through phone calls or accessed electronically by a link sent through email or text message)

You may not qualify if:

• Under age 13
• History of breast cancer (screen by past medical history)
• History of undiagnosed vaginal bleeding (screen by past medical history)
• Head trauma that affected pituitary function (screen by past medical history)
• Prolactin insufficiency (screen by past medical history)
• Previous lactation failure (defined as no lactation within 5 days postpartum)
• Any contraindication to lactation/implant use including diseases transmittable by breast milk (screen by past medical history)
• Liver dysfunction (screen by past medical history)
• Use of drugs that inhibit lactation (screen by medical history)
• Sensitivity to the components of the ENG implant (screen by past medical history)
• Contraindications to use the implant by the (US MEC) (screen by past medical history)
• Active labor
• Delivery at \< 37 weeks gestational age

Sponsors & Collaborators

• University of New Mexico: lead
• Society of Family Planning: collaborator

Study Sites (2)

University of New Mexico

Albuquerque, New Mexico, 87131, United States

Location

University of Utah

Salt Lake City, Utah, 84132, United States

Location

Related Publications (28)

• American College of Obstetricians and Gynecologists. ACOG committee opinion 736, Optimizing Postpartum Care. Washington, DC: American College of Obstetricians and Gynecologists. 2018 May; 131(5):140-150.

  BACKGROUND

• Section on Breastfeeding. Breastfeeding and the use of human milk. Pediatrics. 2012 Mar;129(3):e827-41. doi: 10.1542/peds.2011-3552. Epub 2012 Feb 27.

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• AAFP Releases Position Paper on Breastfeeding Am Fam Physician. 2015 Jan 1;91(1):56-57.

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• ACOG Committee Opinion No. 756: Optimizing Support for Breastfeeding as Part of Obstetric Practice. Obstet Gynecol. 2018 Oct;132(4):e187-e196. doi: 10.1097/AOG.0000000000002890.

  PMID: 30247365 BACKGROUND

• Infant and Young Child Feeding: Model Chapter for Textbooks for Medical Students and Allied Health Professionals. Geneva: World Health Organization; 2009. Available from http://www.ncbi.nlm.nih.gov/books/NBK148965/

  PMID: 23905206 BACKGROUND

• CDC. 2018 Breastfeeding Report Card [Internet]. Centers for Disease Control and Prevention. 2018 [cited 2018 Nov 10]. Available from: https://www.cdc.gov/breastfeeding/data/reportcard.htm

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• Chapman DJ, Perez-Escamilla R. Maternal perception of the onset of lactation is a valid, public health indicator of lactogenesis stage II. J Nutr. 2000 Dec;130(12):2972-80. doi: 10.1093/jn/130.12.2972.

  PMID: 11110856 BACKGROUND

• Curtis KM, Tepper NK, Jatlaoui TC, Berry-Bibee E, Horton LG, Zapata LB, Simmons KB, Pagano HP, Jamieson DJ, Whiteman MK. U.S. Medical Eligibility Criteria for Contraceptive Use, 2016. MMWR Recomm Rep. 2016 Jul 29;65(3):1-103. doi: 10.15585/mmwr.rr6503a1.

  PMID: 27467196 BACKGROUND

• Cunningham FG, Leveno KJ, Bloom SL, Dashe JS, Hoffman BL, Casey BM, et al. Contraception. In: Williams Obstetrics, 25e [Internet]. New York, NY: McGraw-Hill Education; 2018 [cited 2018 Nov 10].

  BACKGROUND

• Turok DK, Leeman L, Sanders JN, Thaxton L, Eggebroten JL, Yonke N, Bullock H, Singh R, Gawron LM, Espey E. Immediate postpartum levonorgestrel intrauterine device insertion and breast-feeding outcomes: a noninferiority randomized controlled trial. Am J Obstet Gynecol. 2017 Dec;217(6):665.e1-665.e8. doi: 10.1016/j.ajog.2017.08.003. Epub 2017 Aug 23.

  PMID: 28842126 BACKGROUND

• Sothornwit J, Werawatakul Y, Kaewrudee S, Lumbiganon P, Laopaiboon M. Immediate versus delayed postpartum insertion of contraceptive implant for contraception. Cochrane Database Syst Rev. 2017 Apr 22;4(4):CD011913. doi: 10.1002/14651858.CD011913.pub2.

  PMID: 28432791 BACKGROUND

• Gurtcheff SE, Turok DK, Stoddard G, Murphy PA, Gibson M, Jones KP. Lactogenesis after early postpartum use of the contraceptive implant: a randomized controlled trial. Obstet Gynecol. 2011 May;117(5):1114-1121. doi: 10.1097/AOG.0b013e3182165ee8.

  PMID: 21508750 BACKGROUND

• Phillips SJ, Tepper NK, Kapp N, Nanda K, Temmerman M, Curtis KM. Progestogen-only contraceptive use among breastfeeding women: a systematic review. Contraception. 2016 Sep;94(3):226-52. doi: 10.1016/j.contraception.2015.09.010. Epub 2015 Sep 26.

  PMID: 26410174 BACKGROUND

• 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. J Pediatr Adolesc Gynecol. 2017 Jun;30(3):389-394. doi: 10.1016/j.jpag.2016.08.003. Epub 2016 Aug 22.

  PMID: 27561981 BACKGROUND

• Espey E, Ogburn T, Leeman L, Singh R, Ostrom K, Schrader R. Effect of progestin compared with combined oral contraceptive pills on lactation: a randomized controlled trial. Obstet Gynecol. 2012 Jan;119(1):5-13. doi: 10.1097/AOG.0b013e31823dc015.

  PMID: 22143258 BACKGROUND

• Acog.org. (2018). Medicaid Reimbursement for Postpartum LARC by State - ACOG. [online] Available at: https://www.acog.org/About-ACOG/ACOG-Departments/Long-Acting-Reversible-Contraception/Immediate-Postpartum-LARC-Medicaid-Reimbursement?IsMobileSet=false [Accessed 12 Jan. 2019].

  BACKGROUND

• Ireland LD, Goyal V, Raker CA, Murray A, Allen RH. The effect of immediate postpartum compared to delayed postpartum and interval etonogestrel contraceptive implant insertion on removal rates for bleeding. Contraception. 2014 Sep;90(3):253-8. doi: 10.1016/j.contraception.2014.05.010. Epub 2014 May 24.

  PMID: 24973904 BACKGROUND

• Phemister DA, Laurent S, Harrison FN Jr. Use of Norplant contraceptive implants in the immediate postpartum period: safety and tolerance. Am J Obstet Gynecol. 1995 Jan;172(1 Pt 1):175-9. doi: 10.1016/0002-9378(95)90109-4.

  PMID: 7847530 BACKGROUND

• Dobromilsky KC, Allen PL, Raymond SH, Maindiratta B. A prospective cohort study of early postpartum etonogestrel implant (Implanon(R)) use and its effect on duration of lochia. J Fam Plann Reprod Health Care. 2016 Jul;42(3):187-93. doi: 10.1136/jfprhc-2014-101081. Epub 2015 Nov 6.

  PMID: 26545933 BACKGROUND

• Horibe M, Hane Y, Abe J, Matsui T, Kato Y, Ueda N, Sasaoka S, Motooka Y, Hatahira H, Hasegawa S, Kinosada Y, Hara H, Nakamura M. Contraceptives as possible risk factors for postpartum depression: A retrospective study of the food and drug administration adverse event reporting system, 2004-2015. Nurs Open. 2018 Jan 17;5(2):131-138. doi: 10.1002/nop2.121. eCollection 2018 Apr.

  PMID: 29599988 BACKGROUND

• Roberts TA, Hansen S. Association of Hormonal Contraception with depression in the postpartum period. Contraception. 2017 Dec;96(6):446-452. doi: 10.1016/j.contraception.2017.08.010. Epub 2017 Sep 1.

  PMID: 28867443 BACKGROUND

• Flore M, Chen XL, Bonney A, Mullan J, Dijkmans-Hadley B, Hodgkins A, Evans G, Frew H, Lloyd G. Patients' perspectives about why they have their contraceptive Implanon NXT device removed early. Aust Fam Physician. 2016 Oct;45(10):740-744.

  PMID: 27695725 BACKGROUND

• SAFE-T Pocket Card: Suicide Assessment Five-Step Evaluation and Triage for Clinicians. SAMHSA

  BACKGROUND

• Higgins JA, Sanders JN, Palta M, Turok DK. Women's Sexual Function, Satisfaction, and Perceptions After Starting Long-Acting Reversible Contraceptives. Obstet Gynecol. 2016 Nov;128(5):1143-1151. doi: 10.1097/AOG.0000000000001655.

  PMID: 27741195 BACKGROUND

• Meston CM, Derogatis LR. Validated instruments for assessing female sexual function. J Sex Marital Ther. 2002;28 Suppl 1:155-64. doi: 10.1080/00926230252851276.

  PMID: 11898697 BACKGROUND

• Sanders JN, Higgins JA, Adkins DE, Stoddard GJ, Gawron LM, Turok DK. The Impact of Sexual Satisfaction, Functioning, and Perceived Contraceptive Effects on Sex Life on IUD and Implant Continuation at 1 Year. Womens Health Issues. 2018 Sep-Oct;28(5):401-407. doi: 10.1016/j.whi.2018.06.003. Epub 2018 Aug 18.

  PMID: 30131221 BACKGROUND

• Li R, Fein SB, Chen J, Grummer-Strawn LM. Why mothers stop breastfeeding: mothers' self-reported reasons for stopping during the first year. Pediatrics. 2008 Oct;122 Suppl 2:S69-76. doi: 10.1542/peds.2008-1315i.

  PMID: 18829834 BACKGROUND

• Odom EC, Li R, Scanlon KS, Perrine CG, Grummer-Strawn L. Reasons for earlier than desired cessation of breastfeeding. Pediatrics. 2013 Mar;131(3):e726-32. doi: 10.1542/peds.2012-1295. Epub 2013 Feb 18.

  PMID: 23420922 BACKGROUND

MeSH Terms

Interventions

etonogestrel

Results Point of Contact

• Title: Family Planning Research Team
• Organization: UNM Obstetrics & Gynecology

HSC-FamilyPlanningResearch@salud.unm.edu

505-205-4118

Study Officials

• Jamie Krashin@salud.unm.edu

  University of New Mexico

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2019
• First Posted: June 7, 2019
• Study Start: June 3, 2019
• Primary Completion: June 4, 2024
• Study Completion: September 19, 2024
• Last Updated: November 28, 2025
• Results First Posted: September 8, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)