Clinical trial NCT02866279: Immediate Postpartum Contraceptive Implant Placement and Breastfeeding Success in Women at Risk for Low Milk Supply: A Non-inferiority Trial
Official title: Immediate Postpartum Contraceptive Implant Placement and Breastfeeding Success in Women at Risk for Low Milk Supply: A Non-inferiority Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Contraception
Breastfeeding
Postpartum Contraception
Lead sponsor: Montefiore Medical Center
Sponsor class: OTHER
Collaborators: name: Society of Family Planning
First posted: 2016-08-15
Enrollment: 155
Sex: FEMALE
Minimum age (years): 17
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 Stage 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.

Eligibility 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

Primary outcomes:
measure: Number of Participants Breastfeeding at 6 Months
timeFrame: 6 months postpartum
measure: Time to Lactogenesis Stage II
timeFrame: 1-5 days postpartum
Secondary outcomes:
measure: Vaginal Bleeding
timeFrame: 0-6 months postpartum
measure: Satisfaction With Contraceptive Implant
timeFrame: 0-6 months postpartum
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
Study officials:
affiliation: Montefiore Medical Center
name: Erika Levi, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: Sothornwit J, Kaewrudee S, Lumbiganon P, Pattanittum P, Averbach SH. Immediate versus delayed postpartum insertion of contraceptive implant and IUD for contraception. Cochrane Database Syst Rev. 2022 Oct 27;10(10):CD011913. doi: 10.1002/14651858.CD011913.pub3.