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Phase 4 N=157 Randomized Treatment

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

Contraception · Postpartum Depression · Lactation

Bottom Line

View on ClinicalTrials.gov: NCT01463202 ↗
Enrolled (actual)
157
Serious AEs
0.0%
Results posted
Mar 2018
Primary outcome: Primary: Duration of Breastfeeding Among Women Who Plan to Breastfeed Their Infants After Postpartum or Delayed (4-6 Weeks Postpartum) Initiation of DMPA — 71; 70; 4; 4 Participants

Study Design & Population

Study type
Interventional
Phase
Phase 4
Interventions
Depot medroxyprogesterone acetate (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
Female
Sponsor
Beatrice Chen
Primary completion
Feb 2017

Outcome Measures

OutcomeResultp-value
PRIMARY
Duration of Breastfeeding Among Women Who Plan to Breastfeed Their Infants After Postpartum or Delayed (4-6 Weeks Postpartum) Initiation of DMPA		 71; 70; 4; 4; 4; 3 —
SECONDARY
Rates of Use of Highly Effective Contraception (Defined as DMPA, IUD, Implant, Sterilization, or Lactational Amenorrhea) After Postpartum or Delayed Initiation of DMPA		 43; 44; 25; 21; 11; 13 —
SECONDARY
Rates of Postpartum Depression After Postpartum or Delayed Initiation of DMPA		 1.0; 0 —
SECONDARY
Exclusivity of Breastfeeding Among Women Who Plan to Breastfeed Their Infants After Postpartum or Delayed (4-6 Weeks Postpartum) Initiation of DMPA		 38; 37; 37; 37; 4; 3 —

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.

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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01463202). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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