Timing of Postpartum Depot Medroxyprogesterone Acetate Administration on Breastfeeding, Contraceptive Continuation, and Depression
Information source: University of Pittsburgh
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Contraception; Postpartum Depression; Lactation
Intervention: Depot medroxyprogesterone acetate (Drug); Depot medroxyprogesterone acetate (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: University of Pittsburgh Official(s) and/or principal investigator(s): Beatrice Chen, MD MPH, Principal Investigator, Affiliation: University of Pittsburgh
Overall contact: Beatrice Chen, MD MPH, Phone: 412-641-5496
Summary
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.
Clinical Details
Official title: Effect of Timing of Postpartum Depot Medroxyprogesterone Acetate Administration on Breastfeeding Continuation, Contraceptive Continuation, and Postpartum Depression: a Randomized Trial
Study design: Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Duration of breastfeeding among women who plan to breastfeed their infants after postpartum or delayed (4-6 weeks postpartum) initiation of DMPA
Secondary outcome: Rates of use of highly effective contraception (defined as DMPA, IUD, implant, sterilization, or lactational amenorrhea) after postpartum or delayed initiation of DMPARates of postpartum depression after postpartum or delayed initiation of DMPA Exclusivity of breastfeeding among women who plan to breastfeed their infants after postpartum or delayed (4-6 weeks postpartum) initiation of DMPA
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Female.
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
Locations and Contacts
Beatrice Chen, MD MPH, Phone: 412-641-5496
Center for Family Planning Research, Magee-Womens Hospital, Pittsburgh, Pennsylvania 15213, United States; Recruiting Phone: 412-641-5496
Additional Information
Starting date: November 2011
Last updated: December 1, 2014
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