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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 DMPA

Rates 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

Page last updated: August 23, 2015

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