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

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ClinicalTrials.gov Identifier: NCT01463202
Recruitment Status : Completed
First Posted : November 1, 2011
Results First Posted : March 13, 2018
Last Update Posted : June 14, 2018
Sponsor:
Collaborator:
Society of Family Planning
Information provided by (Responsible Party):
Beatrice Chen, University of Pittsburgh

October 27, 2011
November 1, 2011
February 14, 2018
March 13, 2018
June 14, 2018
November 2011
February 13, 2017   (Final data collection date for primary outcome measure)
Duration of Breastfeeding Among Women Who Plan to Breastfeed Their Infants After Postpartum or Delayed (4-6 Weeks Postpartum) Initiation of DMPA [ Time Frame: 2, 4, 6, 8 12, 16, 20, 24, and 28 weeks postpartum ]
Any breastfeeding at specific time intervals postpartum
Duration of Breastfeeding Among Women Who Plan to Breastfeed Their Infants After Postpartum or Delayed (4-6 Weeks Postpartum) Initiation of DMPA [ Time Frame: 6 months ]
Complete list of historical versions of study NCT01463202 on ClinicalTrials.gov Archive Site
  • Rates of Use of Highly Effective Contraception (Defined as DMPA, IUD, Implant, Sterilization, or Lactational Amenorrhea) After Postpartum or Delayed Initiation of DMPA [ Time Frame: 6 months ]
    Use of DMPA, IUD, implant, or sterilization
  • Rates of Postpartum Depression After Postpartum or Delayed Initiation of DMPA [ Time Frame: 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
  • Exclusivity of Breastfeeding Among Women Who Plan to Breastfeed Their Infants After Postpartum or Delayed (4-6 Weeks Postpartum) Initiation of DMPA [ Time Frame: 2, 4, 6, 8, 12, 16, 20,24 and 28 weeks postpartum ]
    Exclusive breastfeeding at specific time intervals postpartum
  • Rates of Use of Highly Effective Contraception (Defined as DMPA, IUD, Implant, Sterilization, or Lactational Amenorrhea) After Postpartum or Delayed Initiation of DMPA [ Time Frame: 6 months ]
  • Rates of Postpartum Depression After Postpartum or Delayed Initiation of DMPA [ Time Frame: 6 months ]
  • Exclusivity of Breastfeeding Among Women Who Plan to Breastfeed Their Infants After Postpartum or Delayed (4-6 Weeks Postpartum) Initiation of DMPA [ Time Frame: 6 months ]
Not Provided
Not Provided
 
Timing of Postpartum Depot Medroxyprogesterone Acetate Administration on Breastfeeding, Contraceptive Continuation, and Depression
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.

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.

Interventional
Phase 4
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Contraception
  • Postpartum Depression
  • Lactation
  • Drug: Depot medroxyprogesterone acetate
    Postpartum administration of DMPA (prior to hospital discharge)
    Other Names:
    • DMPA
    • Depo Provera
  • Drug: Depot medroxyprogesterone acetate
    Delayed administration of DMPA (4-6 weeks postpartum)
    Other Names:
    • DMPA
    • Depo Provera
  • Active Comparator: DMPA postpartum
    Depot medroxyprogesterone acetate postpartum
    Intervention: Drug: Depot medroxyprogesterone acetate
  • Active Comparator: DMPA at 4-6 weeks after delivery
    Depot medroxyprogesterone acetate at 4-6 weeks after delivery
    Intervention: Drug: Depot medroxyprogesterone acetate
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
184
Same as current
October 16, 2017
February 13, 2017   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
18 Years and older   (Adult, Older Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01463202
SFP5-1
No
Not Provided
Plan to Share IPD: Undecided
Beatrice Chen, University of Pittsburgh
Beatrice Chen
Society of Family Planning
Principal Investigator: Study Coordinator University of Pittsburgh
University of Pittsburgh
June 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP