Timing of Postpartum Depot Medroxyprogesterone Acetate Administration on Breastfeeding, Contraceptive Continuation, and Depression

Phase 4

Completed

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 or 4-6 weeks after delivery) affects the duration or exclusivity of breastfeeding among women who plan to breastfeed their infants.

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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
DMPA at 4-6 weeks after delivery	Depot medroxyprogesterone acetate	Depot medroxyprogesterone acetate at 4-6 weeks after delivery
DMPA postpartum	Depot medroxyprogesterone acetate	Depot medroxyprogesterone acetate postpartum

Primary Outcome Measures

Name	Time	Method
Duration of Breastfeeding Among Women Who Plan to Breastfeed Their Infants After Postpartum or Delayed (4-6 Weeks Postpartum) Initiation of DMPA	2, 4, 6, 8 12, 16, 20, 24, and 28 weeks postpartum	Any breastfeeding at specific time intervals postpartum

Secondary Outcome Measures

Name	Time	Method
Rates of Use of Highly Effective Contraception (Defined as DMPA, IUD, Implant, Sterilization, or Lactational Amenorrhea) After Postpartum or Delayed Initiation of DMPA	6 months	Use of DMPA, IUD, implant, or sterilization
Exclusivity of Breastfeeding Among Women Who Plan to Breastfeed Their Infants After Postpartum or Delayed (4-6 Weeks Postpartum) Initiation of DMPA	2, 4, 6, 8, 12, 16, 20,24 and 28 weeks postpartum	Exclusive breastfeeding at specific time intervals postpartum
Rates of Postpartum Depression After Postpartum or Delayed Initiation of DMPA	8 weeks postpartum	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