Immediate Postpartum Contraceptive Implant Placement and Breastfeeding Success in Women at Risk for Low Milk Supply: A Non-inferiority Trial
Status: | Recruiting |
---|---|
Conditions: | Contraception, Contraception, Healthy Studies |
Therapuetic Areas: | Other, Reproductive |
Healthy: | No |
Age Range: | 17 - 45 |
Updated: | 3/9/2019 |
Start Date: | November 2016 |
End Date: | October 2019 |
Contact: | Erika Levi, MD, MPH |
Email: | elevi@montefiore.org |
Phone: | 718-405-8260 |
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
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
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.
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.
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
We found this trial at
1
site
3550 Jerome Avenue
Bronx, New York 10467
Bronx, New York 10467
(718) 920-4321
Phone: 718-405-8260
Montefiore Medical Center As the academic medical center and University Hospital for Albert Einstein College...
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