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Immediate Postpartum Contraceptive Implant Placement and Breastfeeding Success in Women at Risk for Low Milk Supply: A Non-inferiority Trial

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ClinicalTrials.gov Identifier: NCT02866279
Recruitment Status : Recruiting
First Posted : August 15, 2016
Last Update Posted : March 7, 2019
Sponsor:
Collaborator:
Society of Family Planning
Information provided by (Responsible Party):
Erika Levi, Montefiore Medical Center

Tracking Information
First Submitted Date  ICMJE August 7, 2016
First Posted Date  ICMJE August 15, 2016
Last Update Posted Date March 7, 2019
Study Start Date  ICMJE November 2016
Estimated Primary Completion Date October 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 10, 2016)
  • Duration of breastfeeding [ Time Frame: 6 months postpartum ]
  • Time to lactogenesis II [ Time Frame: 1-5 days postpartum ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02866279 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 10, 2016)
  • Vaginal Bleeding [ Time Frame: 0-6 months postpartum ]
    Vaginal Bleeding will be assessed via a weekly questionnaire regarding total days of bleeding in the last week
  • Satisfaction with contraceptive implant [ Time Frame: 0-6 months postpartum ]
    Satisfaction will be assessed via a questionnaire at 6 weeks, 3 months, and 6 months postpartum
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Immediate Postpartum Contraceptive Implant Placement and Breastfeeding Success in Women at Risk for Low Milk Supply: A Non-inferiority Trial
Official Title  ICMJE Immediate Postpartum Contraceptive Implant Placement and Breastfeeding Success in Women at Risk for Low Milk Supply: A Non-inferiority Trial
Brief Summary The investigators goal is to measure the impact of timing of postpartum contraceptive implant insertion on breastfeeding success and duration and to explore women's experiences with and attitudes towards contraceptive and breastfeeding counseling in the peripartum time period
Detailed Description

Immediate postpartum initiation of the etonogestrel contraceptive implant has been proven to decrease rates of rapid, repeat pregnancies. Evidence supports that in healthy women with term infants initiation of the contraceptive implant 1-3 days postpartum does not appear to have any adverse effects on lactogenesis or breastfeeding continuation. However, no high quality study to date has examined the effects of progestin-only contraception in women known to be at risk for low milk supply, including women with a premature delivery, obesity, polycystic ovarian syndrome, diabetes, or a prior history of low milk supply.

The investigators goal is to measure the impact of timing of postpartum contraceptive implant insertion on breastfeeding success and duration. This will be a three-armed randomized non-inferiority study of women who plan to breastfeed, have known risk factors for low milk supply, and who intend to use the contraceptive implant postpartum. Women will be randomized to one of three groups for the timing of contraceptive implant placement: within 30 minutes of placental delivery, 24-72 hours postpartum, or 6 or more weeks postpartum. Women will be assessed at 6 weeks, 3 months and 6 months postpartum. Outcomes will include time to lactogenesis II, duration and exclusivity of breastfeeding, continuation of and satisfaction with the contraceptive implant, and side effects, including bleeding patterns, associated with the implant.

Findings from this trial will be used by clinicians, hospital systems, and policy makers working to expand access to immediate postpartum implants while supporting women in meeting their breastfeeding goals.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Contraception
  • Breastfeeding
  • Postpartum Contraception
Intervention  ICMJE Device: Etonogestrel Contraceptive Implant
Women will be randomized to the TIMING of implant placement
Other Name: Nexplanon
Study Arms  ICMJE
  • Experimental: Postplacental
    contraceptive implant placed within 30 minutes of placental delivery
    Intervention: Device: Etonogestrel Contraceptive Implant
  • Experimental: Immediate Postpartum
    Contraceptive Implant placed 1-3 days postpartum
    Intervention: Device: Etonogestrel Contraceptive Implant
  • Active Comparator: Delayed
    Contraceptive Implant placed 6 or more weeks postpartum
    Intervention: Device: Etonogestrel Contraceptive Implant
Publications * 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):1114-21. doi: 10.1097/AOG.0b013e3182165ee8.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 10, 2016)
375
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 2019
Estimated Primary Completion Date October 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Live pregnancy of at least 24 weeks gestation
  • Intention to use a contraceptive implant postpartum
  • 17 years of age or older
  • English or Spanish speaking
  • Admission to Labor and Delivery with a plan for delivery (women in both latent and active labor will be eligible)
  • The presence of at least one of the following conditions known to be a risk factor for low milk supply:

    • Expected delivery prior to 34 weeks
    • Obesity (pre-pregnancy BMI >35)
    • Polycystic Ovarian Syndrome
    • Diabetes (gestational or pre-gestational)
    • Self-reported difficulty with low milk supply in past

Exclusion Criteria:

  • Not English or Spanish speaking
  • Allergy or Contraindication to contraceptive implant
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 17 Years to 45 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Erika Levi, MD, MPH 718-405-8260 elevi@montefiore.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02866279
Other Study ID Numbers  ICMJE 2016-6852
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Erika Levi, Montefiore Medical Center
Study Sponsor  ICMJE Montefiore Medical Center
Collaborators  ICMJE Society of Family Planning
Investigators  ICMJE Not Provided
PRS Account Montefiore Medical Center
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP