Labor and Delivery Implant Insertion: A Randomized Controlled Trial

Family Planning Clinical Trial

— LADII  

Official title:

Labor and Delivery Implant Insertion: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02866643
• Other study ID #: IRB-38505
• Status: Completed
• Phase: Phase 3
• Start date: October 28, 2016
• Est. completion date: July 31, 2021

Study information

• Verified date: June 2022
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 95
• Est. completion date: July 31, 2021
• Est. primary completion date: September 6, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• Not English or Spanish speaking

• Allergy or Contraindication to contraceptive implant.

Related Conditions & MeSH terms

• Family Planning
• Postpartum Contraception

Intervention

Drug:
• Etonogestrel-Immediate
The investigational intervention will be to insert the contraceptive implant immediately postpartum in the delivery room insertion (0-2 hours following delivery).
• Etonogestrel-Delayed
The investigational intervention will be to insert the contraceptive implant 24-48 hours following delivery.

Locations

Country	Name	City	State
United States	Obstetrics--Lucile Packard Children's Hospital	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

References & Publications (20)

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. — View Citation

Brito MB, Ferriani RA, Quintana SM, Yazlle ME, Silva de Sá 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Chapman DJ, Pérez-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. — View Citation

Dewey KG. Maternal and fetal stress are associated with impaired lactogenesis in humans. J Nutr. 2001 Nov;131(11):3012S-5S. Review. — View Citation

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. — View Citation

Duvan CI, Gözdemir E, Kaygusuz I, Kamalak Z, Turhan NÖ. 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. — View Citation

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. — View Citation

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. — 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

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. — View Citation

Mayer JP. Unintended childbearing, maternal beliefs, and delay of prenatal care. Birth. 1997 Dec;24(4):247-52. — View Citation

Medical Eligibility Criteria for Contraceptive Use. 5th edition. Geneva: World Health Organization; 2015. — View Citation

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. — View Citation

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. — View Citation

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. Epub 2005 Dec 27. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 20 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of of Participants Actively Breastfeeding	Exclusive breastfeeding means feedling with breast milk only. Any breast feeding means feeding with breast milk, with water and/or formula.	2 weeks, 4 weeks, 3 months, 6 months, and 12 months after delivery
Secondary	Number of Participants Still With the Contraceptive Implant at Month 12.		month 12
Secondary	Number of Participants Satisfied or Very Satisfied With Implant Contraceptive	Participant-rated as very satisfied, satisfied, neither satisfied or dissatisfied, dissatisfied, or very dissatisfied.	month 12
Secondary	Number of Participants Reporting a Pregnancy Within 12 Months		12 months
Secondary	Number of Participants Attending a Postpartum Care Visit by Month 3		month 3