Depo-Provera Injectable Product for Delayed Onset of Lactation

Phase-Based Progress Estimates
3
Effectiveness
3
Safety
Delayed Onset of LactationDepo-Provera Injectable Product - Drug
Eligibility
18+
Female
What conditions do you have?
Select

Study Summary

This trial will test whether giving DMPA to women immediately postpartum, while they are still in the hospital, will increase breastfeeding and long-term contraceptive use compared to no injection or placebo.

Treatment Effectiveness

Effectiveness Progress

3 of 3
This is further along than 93% of similar trials

Study Objectives

2 Primary · 0 Secondary · Reporting Duration: At 12 months postpartum

At 12 months postpartum
Use of highly-effective contraception
within 7 days postpartum
Time to lactogenesis stage 2

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Trial Design

3 Treatment Groups

Open arm
1 of 3
Intervention arm
1 of 3
Placebo arm
1 of 3

Active Control

Experimental Treatment

Non-Treatment Group

800 Total Participants · 3 Treatment Groups

Primary Treatment: Depo-Provera Injectable Product · Has Placebo Group · Phase 4

Intervention arm
Drug
Experimental Group · 1 Intervention: Depo-Provera Injectable Product · Intervention Types: Drug
Placebo arm
Drug
PlaceboComparator Group · 1 Intervention: Placebos · Intervention Types: Drug
Open armNoIntervention Group · 1 Intervention: Open arm · Intervention Types:

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: at 12 months postpartum

Who is running the clinical trial?

Nationwide Children's HospitalOTHER
311 Previous Clinical Trials
5,215,637 Total Patients Enrolled
Ohio State UniversityLead Sponsor
716 Previous Clinical Trials
463,740 Total Patients Enrolled
Maria Gallo, PhDPrincipal InvestigatorThe Ohio State University, College of Public Health
1 Previous Clinical Trials
500 Total Patients Enrolled

Eligibility Criteria

Age 18+ · Female Participants · 7 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are at least 18 years of age.
You are going to deliver babies in the labor and delivery unit at Ohio State University Wexner Medical Center.
You intend to breastfeed, or express milk for your infant, for at least 6 months.
Do not want to become pregnant within the first 12 months after delivery.
You intend to reside in Ohio for the first 12 months after delivery.