Timing of Postpartum Depot Medroxyprogesterone Acetate Administration on Breastfeeding, Contraceptive Continuation, and Depression (DEPO-ABCD)

August 2, 2018 updated by: Beatrice Chen

Effect of Timing of Postpartum Depot Medroxyprogesterone Acetate Administration on Breastfeeding Continuation, Contraceptive Continuation, and Postpartum Depression: a Randomized Trial

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.

Study Overview

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.

Study Type

Interventional

Enrollment (Actual)

184

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • Center for Family Planning Research, Magee-Womens Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: DMPA postpartum
Depot medroxyprogesterone acetate postpartum
Postpartum administration of DMPA (prior to hospital discharge)
Other Names:
  • Depo Provera
  • DMPA
Delayed administration of DMPA (4-6 weeks postpartum)
Other Names:
  • Depo Provera
  • DMPA
Active Comparator: DMPA at 4-6 weeks after delivery
Depot medroxyprogesterone acetate at 4-6 weeks after delivery
Postpartum administration of DMPA (prior to hospital discharge)
Other Names:
  • Depo Provera
  • DMPA
Delayed administration of DMPA (4-6 weeks postpartum)
Other Names:
  • Depo Provera
  • DMPA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of Breastfeeding Among Women Who Plan to Breastfeed Their Infants After Postpartum or Delayed (4-6 Weeks Postpartum) Initiation of DMPA
Time Frame: 2, 4, 6, 8 12, 16, 20, 24, and 28 weeks postpartum
Any breastfeeding at specific time intervals postpartum
2, 4, 6, 8 12, 16, 20, 24, and 28 weeks postpartum

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rates of Use of Highly Effective Contraception (Defined as DMPA, IUD, Implant, Sterilization, or Lactational Amenorrhea) After Postpartum or Delayed Initiation of DMPA
Time Frame: 6 months
Use of DMPA, IUD, implant, or sterilization
6 months
Rates of Postpartum Depression After Postpartum or Delayed Initiation of DMPA
Time Frame: 8 weeks postpartum
Edinburgh Postnatal Depression Scale (EPDS) score after postpartum or delayed initiation of DMPA: minimum possible score 0, maximum possible score 30; score of 12 or greater is a positive screen for postpartum depression
8 weeks postpartum
Exclusivity of Breastfeeding Among Women Who Plan to Breastfeed Their Infants After Postpartum or Delayed (4-6 Weeks Postpartum) Initiation of DMPA
Time Frame: 2, 4, 6, 8, 12, 16, 20,24 and 28 weeks postpartum
Exclusive breastfeeding at specific time intervals postpartum
2, 4, 6, 8, 12, 16, 20,24 and 28 weeks postpartum

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Principal Investigator: Study Coordinator, University of Pittsburgh

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2011

Primary Completion (Actual)

February 13, 2017

Study Completion (Actual)

October 16, 2017

Study Registration Dates

First Submitted

October 27, 2011

First Submitted That Met QC Criteria

October 31, 2011

First Posted (Estimate)

November 1, 2011

Study Record Updates

Last Update Posted (Actual)

August 31, 2018

Last Update Submitted That Met QC Criteria

August 2, 2018

Last Verified

August 1, 2018

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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