Breastfeeding Etonogestrel Implant Study

Contraception Clinical Trial

— LACTO-Rod  

Official title:

Effect of Immediate Versus Standard Postpartum Insertion of the Contraceptive Implant on Breastfeeding Outcomes

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03978598
• Other study ID #: 19-049
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: June 3, 2019
• Est. completion date: July 31, 2024

Study information

• Verified date: June 2024
• Source: University of New Mexico
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 150
• Est. completion date: July 31, 2024
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 13 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Contraception

Intervention

Drug:
• Etonogestrel
Immediate v. Standard insertion.

Device:
• Nexplanon
Implant.

Locations

Country	Name	City	State
United States	University of New Mexico	Albuquerque	New Mexico
United States	University of Utah	Salt Lake City	Utah

Sponsors (2)

Lead Sponsor	Collaborator
University of New Mexico	Society of Family Planning

Country where clinical trial is conducted

United States, 

References & Publications (28)

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

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. — View Citation

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].

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.

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. — View Citation

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

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. — View Citation

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].

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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/ — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 28 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Continuation of breastfeeding.	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.
Primary	Time to lactogenesis.	To compare time to lactogenesis stage II between women in the immediate versus standard group.	First 7 days.
Secondary	Exclusive breastfeeding.	Using a questionnaire the investigators seek to compare exclusive breastfeeding through 6 months postpartum between the immediate versus the standard group. This will be assessed by answering a trichotomous question with the following statement: If you are currently breastfeeding, are you: Exclusively breastfeeding; Breastfeeding and supplementing breastfeeding with bottles of breast milk; Breastfeeding and supplementing breastfeeding with bottles of formula This question is part of the follow-up questionnaire administer at 2,4,8,12 and 24 weeks postpartum.	Up to 24 weeks postpartum.
Secondary	Factors associated with breastfeeding discontinuation.	Using a questionnaire the investigators seek to compare factors associated with discontinuing breastfeeding between the immediate versus the standard group. To asses this outcome a four-point Likert scale will be used with the following anchors: not at all important, not very important, somewhat important and very important.; This question is part of the follow-up questionnaire administer at 2,4,8,12 and 24 weeks postpartum	Up to 24 weeks postpartum.
Secondary	Satisfaction with postpartum contraception counseling	Using a questionnaire the investigators seek to compare participant satisfaction with postpartum contraception counseling. This will be assessed by a questionnaire of six questions using a Likert rating scale including poor, fair, good, very good and excellent. T	Up to 24 weeks postpartum.
Secondary	Postpartum mood.	To compare postpartum mood as measured by Edinburgh Postnatal Depression Scale (EPDS) score at 2, 4, 8, 12 and 24 weeks postpartum. Results reported as a total score ranging from 0-30, no subscale scores. A higher scale represents a worse outcome, ie. is more predictive of a depressive disorder including postpartum depression.	Up to 24 weeks postpartum.
Secondary	Sexual Function.	To compare postpartum sexual function as measured by Female Sexual Function Index (FSFI) score. Minimum score 2, Maximum score 36. Subscales are combined by first totaling the scores for the individual questions in that domain (ex. for Desire, the sum of scores for questions 1 and 2). That total is then multiplied by the factor for that domain, which is listed in the table above. The output is the final score for that domain, and will fall within the minimum and maximum scores listed in the table above.; For every domain, a lower score indicates either no sexual activity or negative outcomes in that domain, while a higher score indicates positive outcomes in that domain.	Up to 24 weeks postpartum.
Secondary	Postpartum bleeding days.	To compare the total number of days of postpartum bleeding in the immediate versus standard group during the study period.	Up to 24 weeks postpartum.
Secondary	Satisfaction with timing of implant insertion: questionnaire	Using a questionnaire the investigators seek to compare participant satisfaction with the timing of ENG implant insertion between the immediate versus the standard group. This will be assessed by a questionnaire using a four-point Likert scale including very unsatisfied, unsatisfied, satisfied and very satisfied.	Up to 24 weeks postpartum.