- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01463202
Timing of Postpartum Depot Medroxyprogesterone Acetate Administration on Breastfeeding, Contraceptive Continuation, and Depression (DEPO-ABCD)
Effect of Timing of Postpartum Depot Medroxyprogesterone Acetate Administration on Breastfeeding Continuation, Contraceptive Continuation, and Postpartum Depression: a Randomized Trial
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
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Pennsylvania
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Pittsburgh, Pennsylvania, United States, 15213
- Center for Family Planning Research, Magee-Womens Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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:
Delayed administration of DMPA (4-6 weeks postpartum)
Other Names:
|
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:
Delayed administration of DMPA (4-6 weeks postpartum)
Other Names:
|
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
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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
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8 weeks postpartum
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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
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Exclusive breastfeeding at specific time intervals postpartum
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2, 4, 6, 8, 12, 16, 20,24 and 28 weeks postpartum
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Study Coordinator, University of Pittsburgh
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Behavioral Symptoms
- Mental Disorders
- Mood Disorders
- Pregnancy Complications
- Puerperal Disorders
- Depression
- Depressive Disorder
- Depression, Postpartum
- Physiological Effects of Drugs
- Antineoplastic Agents
- Antineoplastic Agents, Hormonal
- Contraceptive Agents, Hormonal
- Contraceptive Agents
- Reproductive Control Agents
- Contraceptives, Oral
- Contraceptive Agents, Female
- Contraceptives, Oral, Synthetic
- Contraceptives, Oral, Hormonal
- Contraceptive Agents, Male
- Medroxyprogesterone Acetate
- Medroxyprogesterone
Other Study ID Numbers
- SFP5-1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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