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

Primary Purpose

Contraception, Postpartum Depression, Lactation

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Depot medroxyprogesterone acetate
Depot medroxyprogesterone acetate
Sponsored by
Beatrice Chen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Contraception focused on measuring Postpartum contraception, Contraceptive continuation, Breastfeeding, Postpartum depression, Progestins

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Center for Family Planning Research, Magee-Womens Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

DMPA postpartum

DMPA at 4-6 weeks after delivery

Arm Description

Depot medroxyprogesterone acetate postpartum

Depot medroxyprogesterone acetate at 4-6 weeks after delivery

Outcomes

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
Any breastfeeding at specific time intervals postpartum

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
Use of DMPA, IUD, implant, or sterilization
Rates of Postpartum Depression After Postpartum or Delayed Initiation of DMPA
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
Exclusivity of Breastfeeding Among Women Who Plan to Breastfeed Their Infants After Postpartum or Delayed (4-6 Weeks Postpartum) Initiation of DMPA
Exclusive breastfeeding at specific time intervals postpartum

Full Information

First Posted
October 27, 2011
Last Updated
August 2, 2018
Sponsor
Beatrice Chen
Collaborators
Society of Family Planning
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1. Study Identification

Unique Protocol Identification Number
NCT01463202
Brief Title
Timing of Postpartum Depot Medroxyprogesterone Acetate Administration on Breastfeeding, Contraceptive Continuation, and Depression
Acronym
DEPO-ABCD
Official Title
Effect of Timing of Postpartum Depot Medroxyprogesterone Acetate Administration on Breastfeeding Continuation, Contraceptive Continuation, and Postpartum Depression: a Randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
November 2011 (undefined)
Primary Completion Date
February 13, 2017 (Actual)
Study Completion Date
October 16, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Beatrice Chen
Collaborators
Society of Family Planning

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Contraception, Postpartum Depression, Lactation
Keywords
Postpartum contraception, Contraceptive continuation, Breastfeeding, Postpartum depression, Progestins

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
184 (Actual)

8. Arms, Groups, and Interventions

Arm Title
DMPA postpartum
Arm Type
Active Comparator
Arm Description
Depot medroxyprogesterone acetate postpartum
Arm Title
DMPA at 4-6 weeks after delivery
Arm Type
Active Comparator
Arm Description
Depot medroxyprogesterone acetate at 4-6 weeks after delivery
Intervention Type
Drug
Intervention Name(s)
Depot medroxyprogesterone acetate
Other Intervention Name(s)
DMPA, Depo Provera
Intervention Description
Postpartum administration of DMPA (prior to hospital discharge)
Intervention Type
Drug
Intervention Name(s)
Depot medroxyprogesterone acetate
Other Intervention Name(s)
DMPA, Depo Provera
Intervention Description
Delayed administration of DMPA (4-6 weeks postpartum)
Primary Outcome Measure Information:
Title
Duration of Breastfeeding Among Women Who Plan to Breastfeed Their Infants After Postpartum or Delayed (4-6 Weeks Postpartum) Initiation of DMPA
Description
Any breastfeeding at specific time intervals postpartum
Time Frame
2, 4, 6, 8 12, 16, 20, 24, and 28 weeks postpartum
Secondary Outcome Measure Information:
Title
Rates of Use of Highly Effective Contraception (Defined as DMPA, IUD, Implant, Sterilization, or Lactational Amenorrhea) After Postpartum or Delayed Initiation of DMPA
Description
Use of DMPA, IUD, implant, or sterilization
Time Frame
6 months
Title
Rates of Postpartum Depression After Postpartum or Delayed Initiation of DMPA
Description
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
Time Frame
8 weeks postpartum
Title
Exclusivity of Breastfeeding Among Women Who Plan to Breastfeed Their Infants After Postpartum or Delayed (4-6 Weeks Postpartum) Initiation of DMPA
Description
Exclusive breastfeeding at specific time intervals postpartum
Time Frame
2, 4, 6, 8, 12, 16, 20,24 and 28 weeks postpartum

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center for Family Planning Research, Magee-Womens Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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