Clinical trial NCT01463202: Timing of Postpartum Depot Medroxyprogesterone Acetate Administration on Breastfeeding, Contraceptive Continuation, and Depression
Official title: Effect of Timing of Postpartum Depot Medroxyprogesterone Acetate Administration on Breastfeeding Continuation, Contraceptive Continuation, and Postpartum Depression: a Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Contraception
Postpartum Depression
Lactation
Keywords: Postpartum contraception
Contraceptive continuation
Breastfeeding
Postpartum depression
Progestins
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: Society of Family Planning
First posted: 2011-11-01
Enrollment: 184
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Duration of Breastfeeding Among Women Who Plan to Breastfeed Their Infants After Postpartum or Delayed (4-6 Weeks Postpartum) Initiation of DMPA
timeFrame: 2, 4, 6, 8 12, 16, 20, 24, and 28 weeks postpartum
Secondary outcomes:
measure: Rates of Use of Highly Effective Contraception (Defined as DMPA, IUD, Implant, Sterilization, or Lactational Amenorrhea) After Postpartum or Delayed Initiation of DMPA
timeFrame: 6 months
measure: Rates of Postpartum Depression After Postpartum or Delayed Initiation of DMPA
timeFrame: 8 weeks postpartum
measure: Exclusivity of Breastfeeding Among Women Who Plan to Breastfeed Their Infants After Postpartum or Delayed (4-6 Weeks Postpartum) Initiation of DMPA
timeFrame: 2, 4, 6, 8, 12, 16, 20,24 and 28 weeks postpartum
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: Center for Family Planning Research, Magee-Womens Hospital
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Study Coordinator
role: PRINCIPAL_INVESTIGATOR
References: