Postpartum Family Planning

NCT03844633 | Terminated Phase 4 Results DMC FDA Drug

• 1 other identifier: 2017H0445
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Delay in Time to Lactogenesis Stage II

Keywords

lactation; Depo Provera; contraception

Outcome Measures

Primary Outcomes (2)

• Time to Lactogenesis Stage 2

  Self-reported time to lactogenesis stage 2 (i.e., milk "let-down")

  within 7 days postpartum

• 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

Study Arms (3)

Intervention arm

EXPERIMENTAL

Intramuscular injectable depot medroxyprogesterone acetate (1 mL of medroxyprogesterone acetate sterile aqueous suspension 150 mg/mL) provided within 48 hours of childbirth

Drug: Depo-Provera Injectable Product

Placebo arm

PLACEBO COMPARATOR

0.9% sodium chloride injection provided within 48 hours of childbirth

Drug: Placebos

Open arm

NO INTERVENTION

No intervention provided

Interventions

Depo-Provera Injectable Product DRUG

Depo-Provera Injectable Product -- Shot administered within 48 hours of childbirth

Intervention arm

Placebos DRUG

Placebos -- Shot administered within 48 hours of childbirth

Placebo arm

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Intend to deliver in the Labor and Delivery Unit at Ohio State University Wexner Medical Center, Grady Memorial Hospital or Emory University Midtown;
• 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 or no hormonal contraception immediately postpartum; AND
• Intend to reside in Ohio or Georgia for the first 12 months after delivery.

You may not qualify if:

• 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, Grady Memorial Hospital or Emory University Midtown Hospital; AND
• Have delivered a term, singleton infant of ≥2500 grams without any apparent health concerns.

Sponsors & Collaborators

• Ohio State University: lead
• Nationwide Children's Hospital: collaborator
• Emory University: collaborator

Study Sites (1)

Ohio State University Wexner Medical Center

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Results Point of Contact

• Title: Maria Gallo
• Organization: Ohio State University

gallo.86@osu.edu

6146882145

Study Officials

• Maria Gallo, PhD

  The Ohio State University, College of Public Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The intervention and control injection arms will be blinded. The no injection arm will be unblinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 14, 2019
• First Posted: February 18, 2019
• Study Start: March 21, 2019
• Primary Completion: May 26, 2021
• Study Completion: April 18, 2022
• Last Updated: May 7, 2024
• Results First Posted: May 7, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: Once the primary results are accepted for publication in a peer-reviewed journal, we will make full, de-identified datasets available to individual investigators formally requesting this access.
• Access Criteria: The request should specify the data variables needed, the plan for their analysis, the individuals who will have access to the data, and the plan for destroying the data once the planned analysis is completed. To protect the integrity of the data, the requestor must submit proof of IRB approval or exemption from their institution before we will release the data. The shared data will not contain any individual participant identifiers. The data will be sent in a secured encrypted data file, and the requestors will be responsible for notifying the project PIs upon completion of analysis and specifying the manner in which the data were destroyed. Any presentations, abstracts, or publications will be required to include an acknowledgement of the trial funding source.

Locations

US (1)