Timing of Postpartum Depot Medroxyprogesterone Acetate Administration on Breastfeeding, Contraceptive Continuation, and Depression
| Status: | Completed |
|---|---|
| Conditions: | Contraception, Contraception, Depression, Women's Studies, Women's Studies |
| Therapuetic Areas: | Psychiatry / Psychology, Reproductive |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 9/2/2018 |
| Start Date: | November 2011 |
| End Date: | October 16, 2017 |
Effect of Timing of Postpartum Depot Medroxyprogesterone Acetate Administration on Breastfeeding Continuation, Contraceptive Continuation, and Postpartum Depression: a Randomized Trial
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.
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.
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.
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.
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
We found this trial at
1
site
Pittsburgh, Pennsylvania 15213
Phone: 412-641-5496
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