Timing of Postpartum Depot Medroxyprogesterone Acetate Administration on Breastfeeding, Contraceptive Continuation, and Depression (DEPO-ABCD)

Beatrice Chen

Status and phase: Completed; Phase 4

Conditions: Contraception; Lactation; Postpartum Depression

Treatments: Drug: Depot medroxyprogesterone acetate

Study type: Interventional

Funder types: Other

Identifiers

NCT01463202

SFP5-1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 184 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

184 participants in 2 patient groups

DMPA postpartum

Active Comparator group

Description:

Depot medroxyprogesterone acetate postpartum

Treatment:

Drug: Depot medroxyprogesterone acetate

Drug: Depot medroxyprogesterone acetate

DMPA at 4-6 weeks after delivery

Active Comparator group

Description:

Depot medroxyprogesterone acetate at 4-6 weeks after delivery

Treatment:

Drug: Depot medroxyprogesterone acetate

Drug: Depot medroxyprogesterone acetate