Status:
COMPLETED
Timing of Postpartum Depot Medroxyprogesterone Acetate Administration on Breastfeeding, Contraceptive Continuation, and Depression
Lead Sponsor:
Beatrice Chen
Collaborating Sponsors:
Society of Family Planning
Conditions:
Contraception
Postpartum Depression
Eligibility:
FEMALE
18+ years
Phase:
PHASE4
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 o...
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 b...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 16 2017
Estimated Enrollment :
184 Patients enrolled
Trial Details
Trial ID
NCT01463202
Start Date
November 1 2011
End Date
October 16 2017
Last Update
August 31 2018
Active Locations (1)
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1
Center for Family Planning Research, Magee-Womens Hospital
Pittsburgh, Pennsylvania, United States, 15213