Breastfeeding Etonogestrel Implant Study

NCT ID: NCT03978598

Last Updated: 2025-11-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-03
• Study Completion Date: 2024-09-19

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.

Detailed Description

Counseling and provision of postpartum contraception is an integral component of comprehensive reproductive healthcare. A woman's preference for contraception is paramount; early initiation of postpartum contraception may assist in optimal birth spacing promoting the wellbeing of mother and baby. Equally important is the provision of appropriate support for breastfeeding. Exclusive breastfeeding for six months with continuation beyond one year of age is recommended by the American Academy of Pediatrics (AAP), American Academy of Family Physicians, American College of Obstetricians and Gynecologists (ACOG), and the World Health Organization (WHO).

The utilization of Long Acting Reversible Contraception (LARC's) has increased in the last decade. The etonogestrel (ENG) implant is one of the most effective LARC's and has become one of the methods used by many women in the postpartum period to prevent an unplanned pregnancy. The major advantage of immediate ENG implant insertion is the prompt initiation of a highly effective contraceptive method at a time that does not interfere with breastfeeding and the life changes and demands of motherhood.

Our long-term goal is to understand the impact of the ENG implant hormonal contraceptive, initiated early in the postpartum period, on breastfeeding. The central hypothesis is that breastfeeding continuation at eight weeks postpartum is not inferior in women in the immediate insertion group of the ENG implant than in those with standard insertion and that time to lactogenesis stage II is not more than 8 hours difference between the immediate insertion and standard insertion groups.

Primary:

Aim #1: To determine breastfeeding continuation rates at 8 weeks in both groups.

Aim #2: To determine the timing of lactogenesis in both groups

Secondary:

Aim #1: To assess breastfeeding continuation and exclusivity between the immediate versus the standard group. Aim #2: To compare postpartum factors associated with discontinuing breastfeeding between the immediate versus the standard group. Aim #3: To compare participant satisfaction with postpartum contraception counseling in women enrolled in the study and in those women who opted not to enroll in the study between the immediate versus the standard group. Aim #4: To compare postpartum mood as measured by EPDS score between the immediate versus the standard group. Aim #5: To compare postpartum sexual function as measured by Female Sexual Function Index (FSFI) score between the immediate versus the standard group. Aim #6: To compare the total number of days of postpartum bleeding in the immediate versus standard. Aim #7: To compare participant satisfaction with the timing of ENG implant insertion between the immediate versus the standard group

This proposal will support a non-inferiority RCT where participants will be randomly assigned to immediate insertion (first 24 hours after delivery) or delayed postpartum insertion (4-6 weeks postpartum). This project will provide needed evidence on breastfeeding impact of early postpartum initiation of the ENG implant.

Conditions

Contraception

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Immediate insertion group

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

Group Type: EXPERIMENTAL

Etonogestrel

Intervention Type: DRUG

Immediate v. Standard insertion.

Nexplanon

Intervention Type: DEVICE

Implant.

Standard Postpartum Insertion Group

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

Group Type: ACTIVE_COMPARATOR

Etonogestrel

Intervention Type: DRUG

Immediate v. Standard insertion.

Nexplanon

Intervention Type: DEVICE

Implant.

Interventions

Etonogestrel

Immediate v. Standard insertion.

Intervention Type: DRUG

Nexplanon

Implant.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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)

Exclusion Criteria

• 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

• Minimum Eligible Age: 13 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Society of Family Planning

OTHER

Sponsor Role: collaborator

University of New Mexico

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jamie Krashin@salud.unm.edu

Role: PRINCIPAL_INVESTIGATOR

University of New Mexico

Locations

University of New Mexico

Albuquerque, New Mexico, United States

University of Utah

Salt Lake City, Utah, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 26410174 (View on PubMed)

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.

Reference Type: 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.

Reference Type: BACKGROUND

PMID: 22371471 (View on PubMed)

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

Reference Type: BACKGROUND

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.

Reference Type: BACKGROUND

PMID: 30247365 (View on PubMed)

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/

Reference Type: BACKGROUND

PMID: 23905206 (View on PubMed)

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

Reference Type: BACKGROUND

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.

Reference Type: BACKGROUND

PMID: 11110856 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 27467196 (View on PubMed)

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].

Reference Type: 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.

Reference Type: BACKGROUND

PMID: 28842126 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 28432791 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21508750 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 27561981 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22143258 (View on PubMed)

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].

Reference Type: 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.

Reference Type: BACKGROUND

PMID: 24973904 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 7847530 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26545933 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 29599988 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 28867443 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 27695725 (View on PubMed)

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

Reference Type: 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.

Reference Type: BACKGROUND

PMID: 27741195 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 11898697 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 30131221 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 18829834 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23420922 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

19-049

Identifier Type: -

Identifier Source: org_study_id