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Trial record 97 of 264 for:    Postpartum Depression AND Postpartum Depression | "Depression" AND "Depression"

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 : August 31, 2018
Sponsor:
Collaborator:
Society of Family Planning
Information provided by (Responsible Party):
Beatrice Chen, University of Pittsburgh

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.

Condition or disease Intervention/treatment Phase
Contraception Postpartum Depression Lactation Drug: Depot medroxyprogesterone acetate Phase 4

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 184 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Timing of Postpartum Depot Medroxyprogesterone Acetate Administration on Breastfeeding Continuation, Contraceptive Continuation, and Postpartum Depression: a Randomized Trial
Study Start Date : November 2011
Actual Primary Completion Date : February 13, 2017
Actual Study Completion Date : October 16, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: DMPA postpartum
Depot medroxyprogesterone acetate postpartum
Drug: Depot medroxyprogesterone acetate
Postpartum administration of DMPA (prior to hospital discharge)
Other Names:
  • DMPA
  • Depo Provera

Active Comparator: DMPA at 4-6 weeks after delivery
Depot medroxyprogesterone acetate at 4-6 weeks after delivery
Drug: Depot medroxyprogesterone acetate
Delayed administration of DMPA (4-6 weeks postpartum)
Other Names:
  • DMPA
  • Depo Provera




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01463202


Locations
United States, Pennsylvania
Center for Family Planning Research, Magee-Womens Hospital
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
Beatrice Chen
Society of Family Planning
Investigators
Principal Investigator: Study Coordinator University of Pittsburgh
  Study Documents (Full-Text)

Documents provided by Beatrice Chen, University of Pittsburgh:

Responsible Party: Beatrice Chen, Associate Professor, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01463202     History of Changes
Other Study ID Numbers: SFP5-1
First Posted: November 1, 2011    Key Record Dates
Results First Posted: March 13, 2018
Last Update Posted: August 31, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Beatrice Chen, University of Pittsburgh:
Postpartum contraception
Contraceptive continuation
Breastfeeding
Postpartum depression
Progestins

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depression, Postpartum
Puerperal Disorders
Behavioral Symptoms
Mood Disorders
Mental Disorders
Pregnancy Complications
Contraceptive Agents
Medroxyprogesterone
Medroxyprogesterone Acetate
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents, Male
Antineoplastic Agents, Hormonal
Antineoplastic Agents