Timing of Postpartum Depot Medroxyprogesterone Acetate Administration on Breastfeeding, Contraceptive Continuation, and Depression

NCT ID: NCT01463202

Last Updated: 2018-08-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 184 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-11-30
• Study Completion Date: 2017-10-16

Brief Summary

The investigators plan to enroll 184 women who are planning to breastfeed and use DMPA after delivery to find out whether the timing of postpartum administration of DMPA (prior to hospital discharge or 4-6 weeks after delivery) affects the duration or exclusivity of breastfeeding among women who plan to breastfeed their infants.

Detailed Description

In the United States, depot medroxyprogesterone acetate (DMPA) is given to women after delivery and before hospital discharge with the belief that women who delay starting DMPA may be more likely to become pregnant when they are not yet ready to be pregnant and that giving DMPA before discharge has little to no negative effect on breastfeeding. Administering DMPA to breastfeeding women has not been widely questioned because the limited existing studies do not show any adverse impact of DMPA on breastfeeding. However, these studies used inappropriate control groups and did not control for prior lactation experience.

The investigators plan to enroll 184 women who are planning to breastfeed and use DMPA after delivery to find out whether the timing of postpartum administration of DMPA (prior to hospital discharge or 4-6 weeks after delivery) affects the duration or exclusivity of breastfeeding among women who plan to breastfeed their infants. The investigators will also look at rates of use of highly effective contraception (defined as DMPA, intrauterine device, implant, sterilization, or lactational amenorrhea) and postpartum depression.

Conditions

Contraception; Postpartum Depression; Lactation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

DMPA postpartum

Depot medroxyprogesterone acetate postpartum

Group Type: ACTIVE_COMPARATOR

Depot medroxyprogesterone acetate

Intervention Type: DRUG

Postpartum administration of DMPA (prior to hospital discharge)

DMPA at 4-6 weeks after delivery

Depot medroxyprogesterone acetate at 4-6 weeks after delivery

Group Type: ACTIVE_COMPARATOR

Depot medroxyprogesterone acetate

Intervention Type: DRUG

Delayed administration of DMPA (4-6 weeks postpartum)

Interventions

Depot medroxyprogesterone acetate

Postpartum administration of DMPA (prior to hospital discharge)

Intervention Type: DRUG

Depot medroxyprogesterone acetate

Delayed administration of DMPA (4-6 weeks postpartum)

Intervention Type: DRUG

Other Intervention Names

DMPA; Depo Provera; DMPA; Depo Provera

Eligibility Criteria

Inclusion Criteria

• Age > 18 years old and > 24 0/7 weeks pregnant at time of enrollment
• Planning to deliver at Magee-Womens Hospital and to breastfeed
• Plans to use DMPA for postpartum contraception for at least 6 months
• Willing and able to provide informed consent in English and to comply with study protocol

Exclusion Criteria

• Intolerance of irregular vaginal bleeding
• Severe coagulation disorder
• Severe liver disease (LFTs >2x upper limits of normal at time of randomization)
• Contraindications to breastfeeding: maternal HIV infection; active herpes simplex with breast lesions; active varicella; active, untreated tuberculosis; antineoplastic, thyrotoxic, or immunosuppressive medications; concern that the infant may have galactosemia
• History of breast cancer, reduction or augmentation surgery
• History of severe clinical depression
• Multiple gestation

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Society of Family Planning

OTHER

Sponsor Role: collaborator

Beatrice Chen

OTHER

Sponsor Role: lead

Responsible Party

Beatrice Chen

Associate Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Study Coordinator

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

Center for Family Planning Research, Magee-Womens Hospital

Pittsburgh, Pennsylvania, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

SFP5-1

Identifier Type: -

Identifier Source: org_study_id