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

This study is not yet open for participant recruitment.
Verified October 2011 by University of Pittsburgh
Sponsor:
Collaborator:
Society of Family Planning
Information provided by (Responsible Party):
Beatrice Chen, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT01463202
First received: October 27, 2011
Last updated: October 31, 2011
Last verified: October 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Contraception
Postpartum Depression
Lactation
 Drug: Depot medroxyprogesterone acetate
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effect of Timing of Postpartum Depot Medroxyprogesterone Acetate Administration on Breastfeeding Continuation, Contraceptive Continuation, and Postpartum Depression: a Randomized Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • Duration of breastfeeding among women who plan to breastfeed their infants after postpartum or delayed (4-6 weeks postpartum) initiation of DMPA [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Rates of postpartum depression after postpartum or delayed initiation of DMPA [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Exclusivity of breastfeeding among women who plan to breastfeed their infants after postpartum or delayed (4-6 weeks postpartum) initiation of DMPA [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 184
Study Start Date: November 2011
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: DMPA postpartum
Depot medroxyprogesterone acetate postpartum
 Drug: Depot medroxyprogesterone acetate
Postpartum administration of DMPA (prior to hospital discharge)
Other Names:
  • Depot medroxyprogesterone acetate
  • DMPA
  • Depo Provera
Active Comparator: DMPA at 4-6 weeks after delivery
Depot medroxyprogesterone acetate at 4-6 weeks after delivery
 Drug: Depot medroxyprogesterone acetate
Delayed administration of DMPA (4-6 weeks postpartum)
Other Names:
  • Depot medroxyprogesterone acetate
  • DMPA
  • Depo Provera

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01463202

Contacts
Contact: Beatrice Chen, MD MPH 412-641-5496

Locations
United States, Pennsylvania
Center for Family Planning Research, Magee-Womens Hospital Not yet recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact     412-641-5496        
Sponsors and Collaborators
University of Pittsburgh
Society of Family Planning
Investigators
Principal Investigator: Beatrice Chen, MD MPH University of Pittsburgh
  More Information

No publications provided

Responsible Party: Beatrice Chen, Assistant Professor, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01463202     History of Changes
Other Study ID Numbers: SFP5-1
Study First Received: October 27, 2011
Last Updated: October 31, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pittsburgh:
Postpartum contraception
Contraceptive continuation
Breastfeeding
Postpartum depression
Progestins

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depression, Postpartum
Behavioral Symptoms
Mood Disorders
Mental Disorders
Puerperal Disorders
Pregnancy Complications
Contraceptive Agents
Medroxyprogesterone
Medroxyprogesterone Acetate
 Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents, Male
Antineoplastic Agents, Hormonal
Antineoplastic Agents

ClinicalTrials.gov processed this record on May 22, 2013