Purpose

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

Conditions

Eligibility

Eligible Ages
Between 17 Years and 45 Years
Eligible Genders
Female
Accepts Healthy Volunteers
Yes

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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Prevention
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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 names:
    • 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 names:
    • 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 names:
    • Nexplanon

Recruiting Locations

Montefiore Medical Center
Bronx, New York 10034
Contact:
Erika Levi, MD, MPH
718-405-8260
elevi@montefiore.org

More Details

NCT ID
NCT02866279
Status
Recruiting
Sponsor
Montefiore Medical Center

Study Contact

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

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.