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Completed

NCT Number: NCT01463202

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

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Center for Family Planning Research, Magee-Womens Hospital

Pittsburgh, Pennsylvania, 15213, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Depot medroxyprogesterone acetate

Drug

Postpartum administration of DMPA (prior to hospital discharge)

Other names: DMPA, Depo Provera

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Beatrice Chen

Other

Collaborators

  • Society of Family Planning

Registry information

Official study title

Effect of Timing of Postpartum Depot Medroxyprogesterone Acetate Administration on Breastfeeding Continuation, Contraceptive Continuation, and Postpartum Depression: a Randomized Trial

Acronym: DEPO-ABCD

Important dates

Study start
2011
Primary completion
2017
Study completion
2017
First posted
Nov 1, 2011
Registry last updated
Aug 31, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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