Labor and Delivery Implant Insertion: A Randomized Controlled Trial

NCT02866643 | Completed Phase 3 Results FDA Drug

• 1 other identifier: IRB-38505
• Study Type: interventional
• Target: 95
• Locations: 1 country
• Sites: 1

Brief Summary

A barrier to initiating progestin contraceptives in the early postpartum period is the concern of interference with breastfeeding, specifically lactogenesis. In this trial, the investigators aim to describe the effects of immediate insertion of the contraceptive implant on breastfeeding. The investigators seek to examine the time to lactogenesis with immediate post-delivery insertion in delivery room versus insertion of a contraceptive implant in the postpartum ward prior to medical discharge. For this study, 82 consenting women will be randomized to immediate implant insertion (0-2 hours following delivery) in the delivery room or insertion of the implant following delivery in postpartum room and prior to medical discharge (24-48 hours following delivery). Participants complete a questionnaire that asks questions about breastfeeding continuation, supplementation, duration, and exclusivity. This questionnaire also includes questions about contraceptive continuation, patient satisfaction with implant, pregnancy, and postpartum care visits.

Conditions

Postpartum Contraception; Family Planning

Keywords

contraceptive implant; postpartum contraception; breastfeeding and contraception

Outcome Measures

Primary Outcomes (1)

• Time to Lactogenesis Stage II [Questionnaire]

  Lactogenesis Stage II: The initiation of copious milk secretion as documented by maternal perception. To obtain measurement of time to lactogenesis, we will document time at which participants perceive initiation of copious milk secretion using a set of specific validated questions and subtract this by the documented time of delivery.

  Participants will be monitored daily by the research staff, in the first seven days postpartum, or until lactogenesis reported, beginning at 24-hours following delivery, to determine time to lactogenesis stage II.

Secondary Outcomes (5)

• Number of of Participants Actively Breastfeeding

  2 weeks, 4 weeks, 3 months, 6 months, and 12 months after delivery

• Number of Participants Still With the Contraceptive Implant at Month 12.

  month 12

• Number of Participants Satisfied or Very Satisfied With Implant Contraceptive

  month 12

• Number of Participants Reporting a Pregnancy Within 12 Months

  12 months

• Number of Participants Attending a Postpartum Care Visit by Month 3

  month 3

Study Arms (2)

Delivery Room Insertion

EXPERIMENTAL

Participants who randomize to this arm will receive the contraceptive implant in the Labor and Delivery room (0-2 hours following delivery).

Drug: Etonogestrel-Immediate

Postpartum Insertion

ACTIVE COMPARATOR

Participants who randomize to this arm will receive the contraceptive implant in the postpartum ward room before discharge (24-48 hours following delivery).

Drug: Etonogestrel-Delayed

Interventions

Etonogestrel-Immediate DRUG

The investigational intervention will be to insert the contraceptive implant immediately postpartum in the delivery room insertion (0-2 hours following delivery).

Also known as: Nexplanon, Contraceptive Implant

Delivery Room Insertion

Etonogestrel-Delayed DRUG

The investigational intervention will be to insert the contraceptive implant 24-48 hours following delivery.

Also known as: Nexplanon, Contraceptive Implant

Postpartum Insertion

Eligibility Criteria

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

You may qualify if:

• Pregnant women who are patients of the Stanford University Obstetrics service
• Pregnant women who delivery a healthy infant, regardless of gestational age.
• Intend to breastfeed
• Desire the contraceptive implant as their method of contraception
• Agree to be randomized to delivery room vs. postpartum ward insertion

You may not qualify if:

• Not English or Spanish speaking
• Allergy or Contraindication to contraceptive implant.

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Obstetrics--Lucile Packard Children's Hospital

Stanford, California, 94305, United States

Location

Related Publications (20)

• Finer LB, Zolna MR. Declines in Unintended Pregnancy in the United States, 2008-2011. N Engl J Med. 2016 Mar 3;374(9):843-52. doi: 10.1056/NEJMsa1506575.

  PMID: 26962904 BACKGROUND

• Zhu BP. Effect of interpregnancy interval on birth outcomes: findings from three recent US studies. Int J Gynaecol Obstet. 2005 Apr;89 Suppl 1:S25-33. doi: 10.1016/j.ijgo.2004.08.002.

  PMID: 15820365 BACKGROUND

• Zhu BP, Rolfs RT, Nangle BE, Horan JM. Effect of the interval between pregnancies on perinatal outcomes. N Engl J Med. 1999 Feb 25;340(8):589-94. doi: 10.1056/NEJM199902253400801.

  PMID: 10029642 BACKGROUND

• Mayer JP. Unintended childbearing, maternal beliefs, and delay of prenatal care. Birth. 1997 Dec;24(4):247-52. doi: 10.1111/j.1523-536x.1997.tb00598.x.

  PMID: 9460316 BACKGROUND

• Heller R, Cameron S, Briggs R, Forson N, Glasier A. Postpartum contraception: a missed opportunity to prevent unintended pregnancy and short inter-pregnancy intervals. J Fam Plann Reprod Health Care. 2016 Apr;42(2):93-8. doi: 10.1136/jfprhc-2014-101165. Epub 2015 Dec 8.

  PMID: 26645197 BACKGROUND

• Speroff L, Mishell DR Jr. The postpartum visit: it's time for a change in order to optimally initiate contraception. Contraception. 2008 Aug;78(2):90-8. doi: 10.1016/j.contraception.2008.04.005. Epub 2008 Jun 12. No abstract available.

  PMID: 18672108 BACKGROUND

• Centers for Disease Control and Prevention (CDC). Postpartum care visits--11 states and New York City, 2004. MMWR Morb Mortal Wkly Rep. 2007 Dec 21;56(50):1312-6.

  PMID: 18097343 BACKGROUND

• Gariepy AM, Duffy JY, Xu X. Cost-Effectiveness of Immediate Compared With Delayed Postpartum Etonogestrel Implant Insertion. Obstet Gynecol. 2015 Jul;126(1):47-55. doi: 10.1097/AOG.0000000000000907.

  PMID: 26241255 BACKGROUND

• Centers for Disease Control and Prevention (CDC). Contraceptive use among postpartum women - 12 states and New York City, 2004-2006. MMWR Morb Mortal Wkly Rep. 2009 Aug 7;58(30):821-6.

  PMID: 19661855 BACKGROUND

• Centers for Disease Control and Prevention (CDC). Update to CDC's U.S. Medical Eligibility Criteria for Contraceptive Use, 2010: revised recommendations for the use of contraceptive methods during the postpartum period. MMWR Morb Mortal Wkly Rep. 2011 Jul 8;60(26):878-83.

  PMID: 21734635 BACKGROUND

• Medical Eligibility Criteria for Contraceptive Use. 5th edition. Geneva: World Health Organization; 2015. Available from http://www.ncbi.nlm.nih.gov/books/NBK321151/

  PMID: 26447268 BACKGROUND

• Dunn K, Bayer LL, Mody SK. Postpartum contraception: An exploratory study of lactation consultants' knowledge and practices. Contraception. 2016 Jul;94(1):87-92. doi: 10.1016/j.contraception.2016.03.007. Epub 2016 Mar 17.

  PMID: 26996737 BACKGROUND

• Duvan CI, Gozdemir E, Kaygusuz I, Kamalak Z, Turhan NO. Etonogestrel contraceptive implant (Implanon): analysis of patient compliance and adverse effects in the breastfeeding period. J Turk Ger Gynecol Assoc. 2010 Sep 1;11(3):141-4. doi: 10.5152/jtgga.2010.21. eCollection 2010.

  PMID: 24591920 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

• Taneepanichskul S, Reinprayoon D, Thaithumyanon P, Praisuwanna P, Tosukhowong P, Dieben T. Effects of the etonogestrel-releasing implant Implanon and a nonmedicated intrauterine device on the growth of breast-fed infants. Contraception. 2006 Apr;73(4):368-71. doi: 10.1016/j.contraception.2005.10.010. Epub 2005 Dec 27.

  PMID: 16531169 BACKGROUND

• Brito MB, Ferriani RA, Quintana SM, Yazlle ME, Silva de Sa MF, Vieira CS. Safety of the etonogestrel-releasing implant during the immediate postpartum period: a pilot study. Contraception. 2009 Dec;80(6):519-26. doi: 10.1016/j.contraception.2009.05.124. Epub 2009 Jul 10.

  PMID: 19913145 BACKGROUND

• Braga GC, Ferriolli E, Quintana SM, Ferriani RA, Pfrimer K, Vieira CS. Immediate postpartum initiation of etonogestrel-releasing implant: A randomized controlled trial on breastfeeding impact. Contraception. 2015 Dec;92(6):536-42. doi: 10.1016/j.contraception.2015.07.009. Epub 2015 Jul 23.

  PMID: 26209863 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.

  PMID: 11110856 BACKGROUND

• Sievers E, Haase S, Oldigs HD, Schaub J. The impact of peripartum factors on the onset and duration of lactation. Biol Neonate. 2003;83(4):246-52. doi: 10.1159/000069485.

  PMID: 12743453 BACKGROUND

• Dewey KG. Maternal and fetal stress are associated with impaired lactogenesis in humans. J Nutr. 2001 Nov;131(11):3012S-5S. doi: 10.1093/jn/131.11.3012S.

  PMID: 11694638 BACKGROUND

MeSH Terms

Conditions

Breast Feeding

Interventions

etonogestrel; Contraceptive Agents

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Intervention Hierarchy (Ancestors)

Reproductive Control Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Therapeutic Uses

Results Point of Contact

• Title: Clinical Research Manager
• Organization: Stanford University

gynresearch@stanford.edu

6507247826

Study Officials

• Kate A Shaw, MD, MS

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor

Study Record Dates

• First Submitted: August 5, 2016
• First Posted: August 15, 2016
• Study Start: October 28, 2016
• Primary Completion: September 6, 2019
• Study Completion: July 31, 2021
• Last Updated: July 25, 2022
• Results First Posted: September 29, 2020

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)