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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

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

Condition or disease Intervention/treatment Phase
Contraception Breastfeeding Postpartum Contraception Device: Etonogestrel Contraceptive Implant Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 375 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Immediate Postpartum Contraceptive Implant Placement and Breastfeeding Success in Women at Risk for Low Milk Supply: A Non-inferiority Trial
Study Start Date : November 2016
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : October 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Postplacental
contraceptive implant placed within 30 minutes of placental delivery
Device: Etonogestrel Contraceptive Implant
Women will be randomized to the TIMING of implant placement
Other Name: Nexplanon

Experimental: Immediate Postpartum
Contraceptive Implant placed 1-3 days postpartum
Device: Etonogestrel Contraceptive Implant
Women will be randomized to the TIMING of implant placement
Other Name: Nexplanon

Active Comparator: Delayed
Contraceptive Implant placed 6 or more weeks postpartum
Device: Etonogestrel Contraceptive Implant
Women will be randomized to the TIMING of implant placement
Other Name: Nexplanon




Primary Outcome Measures :
  1. Duration of breastfeeding [ Time Frame: 6 months postpartum ]
  2. Time to lactogenesis II [ Time Frame: 1-5 days postpartum ]

Secondary Outcome Measures :
  1. 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

  2. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   17 Years to 45 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02866279


Contacts
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Contact: Erika Levi, MD, MPH 718-405-8260 elevi@montefiore.org

Locations
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United States, New York
Montefiore Medical Center Recruiting
Bronx, New York, United States, 10034
Contact: Erika Levi, MD, MPH    718-405-8260    elevi@montefiore.org   
Sponsors and Collaborators
Montefiore Medical Center
Society of Family Planning

Publications of Results:
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Responsible Party: Erika Levi, Assistant Professor, Montefiore Medical Center
ClinicalTrials.gov Identifier: NCT02866279     History of Changes
Other Study ID Numbers: 2016-6852
First Posted: August 15, 2016    Key Record Dates
Last Update Posted: March 7, 2019
Last Verified: March 2019

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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
Additional relevant MeSH terms:
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Contraceptive Agents
Etonogestrel
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptive Agents, Female