Postpartum Family Planning

Delay in Time to Lactogenesis Stage II Clinical Trial

Official title:

Initiation of Injectable Contraception Immediately Postpartum Among Breastfeeding Women

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03844633
• Other study ID #: 2017H0445
• Status: Terminated
• Phase: Phase 4
• Start date: March 21, 2019
• Est. completion date: April 18, 2022

Study information

• Verified date: April 2024
• Source: Ohio State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 49
• Est. completion date: April 18, 2022
• Est. primary completion date: May 26, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Intend to deliver in the Labor and Delivery Unit at Ohio State University Wexner Medical Center, Grady Memorial Hospital or Emory University Midtown;

2. Are =18 years of age;

3. Speak English;

4. Intend to breastfeed, or express milk for their infant, for =6 months;

5. Do not want to become pregnant within the first 12 months after delivery;

6. Want to start use of DMPA immediately after delivery before discharge or no hormonal contraception immediately postpartum; AND

7. Intend to reside in Ohio or Georgia for the first 12 months after delivery.

Exclusion Criteria:

8. Undiagnosed vaginal bleeding;

9. Known or suspected malignancy of breast;

10. Active thrombophlebitis, or current or past history of thromboembolic disorders, or cerebral vascular disease;

11. Liver dysfunction or disease; OR

12. 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:

1. Are a postpartum patient in the Labor and Delivery Unit at OSUWMC, Grady Memorial Hospital or Emory University Midtown Hospital; AND

2. Have delivered a term, singleton infant of =2500 grams without any apparent health concerns.

Related Conditions & MeSH terms

• Delay in Time to Lactogenesis Stage II

Intervention

Drug:
• Depo-Provera Injectable Product
Depo-Provera Injectable Product -- Shot administered within 48 hours of childbirth
• Placebos
Placebos -- Shot administered within 48 hours of childbirth

Locations

Country	Name	City	State
United States	Ohio State University Wexner Medical Center	Columbus	Ohio

Sponsors (3)

Lead Sponsor	Collaborator
Ohio State University	Emory University, Nationwide Children's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to Lactogenesis Stage 2	Self-reported time to lactogenesis stage 2 (i.e., milk "let-down")	within 7 days postpartum
Primary	Use of Highly-effective Contraception	Rates of use of a highly-effective method of contraception (defined here as DMPA, implant, IUD, sterilization, pill, patch, or ring) at 12 months post-delivery among women in the intervention or placebo arm versus those in the open control arm	At 12 months postpartum