Postpartum Family Planning

  • STATUS
    Recruiting
  • End date
    May 31, 2023
  • participants needed
    800
  • sponsor
    Ohio State University
Updated on 5 March 2022
Accepts healthy volunteers

Summary

Investigators will conduct a randomized controlled trial (RCT) to evaluate the effects of immediate postpartum initiation of DMPA on breastfeeding and long-term contraceptive use. Investigators will randomize approximately 429 adult women who have delivered a healthy, full-term infant at The Ohio State University Wexner Medical Center (OSUWMC), who intend to breastfeed for 6 months, and who want to use DMPA (Depo-Provera; Pfizer Corp.) Note that because of anticipated screening failures, investigators will enroll more than the number randomized (i.e., up to 800 women). Investigators will randomize women to receive within 48 hours of delivery: 1) DMPA ("intervention" arm), 2) placebo injection ("placebo" arm) or 3) no injection ("open control" arm). The first two arms will be blinded while the open control arm will be unblinded. Note that postpartum patients at the study site do not receive DMPA before discharge as standard care. At enrollment, women will receive condom counseling and provision and referral for contraception at 12 weeks (intervention and placebo arms) or at 6 weeks postpartum (open control arm). Investigators will collect data on lactogenesis, infant feeding and growth, and contraception use during 12 follow-up months. Investigators conducted a pilot study (N=100) in the target population, which supports the feasibility of the current trial.

Description

Postpartum women often are inadequately protected against rapid repeat pregnancy. Ensuring adequate inter- birth intervals could prevent an estimated 9% of deaths worldwide among children less than 5 years of age. Intramuscular injectable depot medroxyprogesterone acetate (DMPA) is rapidly becoming the method of choice in some settings, including regions where high maternal and child mortality make birth spacing critical. DMPA possesses many advantages for postpartum contraception as compared to other methods. However, the World Health Organization (WHO) advises against use of progestin-only injectables during the first six weeks postpartum among breastfeeding women. In contrast, the Centers for Disease Control and Prevention (CDC) recommends that progestin-only injectables generally can be started immediately postpartum on the grounds that their known advantages, as a whole, outweigh their unknown risks. This inconsistency in guidance reflects the lack of high-quality data for making evidence-based decisions. Studies conducted, to date, have important limitations: short follow-up intervals, low power, lack of consistency in using sensitive and standardized assessments, and lack of randomized trials evaluating DMPA administration specifically in the immediate postpartum period. Investigators propose to evaluate the effects of immediate postpartum initiation of DMPA on breastfeeding and on child development. We will conduct a randomized controlled trial of 429 adult women who have delivered a healthy, full-term infant, intend to breastfeed for 6 months, and want to use DMPA. Women will be randomized to receive within 48 hours of delivery: 1) DMPA ("intervention" arm), 2) placebo injection ("placebo" arm) or 3) no injection ("open control" arm). The first two arms will be blinded while the open control arm will be unblinded. Investigators will determine the effect of immediate postpartum initiation of DMPA on breastfeeding (Aim 1) and on contraception use (Aim 2). The proposed trial is innovative in use of 1) a randomized, partially-blinded design with sufficient power and follow up; 2) standardized, validated measures on lactation as well as breastfeeding and contraception behaviors; and 3) whole-body air displacement plethysmography to identify differences between arms in infant body composition. The findings of a pilot study in the target population support the feasibility of the proposed trial. Investigators expect the trial findings will permit the harmonization of the WHO and CDC guidance on the timing of DMPA initiation among breastfeeding women. This would have important implications for shaping global policy and practice worldwide, especially in settings where inadequate birth spacing contributes to high maternal and infant morbidity and mortality.

Details
Condition Delay in Time to Lactogenesis Stage II
Treatment placebos, Depo-Provera Injectable Product
Clinical Study IdentifierNCT03844633
SponsorOhio State University
Last Modified on5 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Intend to deliver in the Labor and Delivery Unit at Ohio State University Wexner Medical Center
Are 18 years of age
Speak English
Intend to breastfeed, or express milk for their infant, for 6 months
Do not want to become pregnant within the first 12 months after delivery
Want to start use of DMPA immediately after delivery before discharge; AND
Intend to reside in Ohio for the first 12 months after delivery

Exclusion Criteria

\. Undiagnosed vaginal bleeding
\. Known or suspected malignancy of breast
\. Active thrombophlebitis, or current or past history of thromboembolic
disorders, or cerebral vascular disease
\. Liver dysfunction or disease; OR
\. Known hypersensitivity to Depo-Provera
Women who enroll prenatally will need to rescreen following delivery to
confirm their eligibility. Women enrolling after delivery or who are
rescreening will need to meet criteria 2-12 above as well as the following
eligibility criteria
Are a postpartum patient in the Labor and Delivery Unit at OSUWMC; AND
Have delivered a term, singleton infant of 2500 grams without any apparent health concerns
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