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

Contraception Clinical Trial

— DEPO-ABCD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01463202
• Other study ID #: SFP5-1
• Status: Completed
• Phase: Phase 4
• Start date: November 2011
• Est. completion date: October 16, 2017

Study information

• Verified date: August 2018
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 184
• Est. completion date: October 16, 2017
• Est. primary completion date: February 13, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Contraception
• Depression
• Depression, Postpartum
• Depressive Disorder
• Lactation
• Postpartum Depression

Intervention

Drug:
• Depot medroxyprogesterone acetate
Postpartum administration of DMPA (prior to hospital discharge)
• Depot medroxyprogesterone acetate
Delayed administration of DMPA (4-6 weeks postpartum)

Locations

Country	Name	City	State
United States	Center for Family Planning Research, Magee-Womens Hospital	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Beatrice Chen	Society of Family Planning

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration of Breastfeeding Among Women Who Plan to Breastfeed Their Infants After Postpartum or Delayed (4-6 Weeks Postpartum) Initiation of DMPA	Any breastfeeding at specific time intervals postpartum	2, 4, 6, 8 12, 16, 20, 24, and 28 weeks postpartum
Secondary	Rates of Use of Highly Effective Contraception (Defined as DMPA, IUD, Implant, Sterilization, or Lactational Amenorrhea) After Postpartum or Delayed Initiation of DMPA	Use of DMPA, IUD, implant, or sterilization	6 months
Secondary	Rates of Postpartum Depression After Postpartum or Delayed Initiation of DMPA	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	8 weeks postpartum
Secondary	Exclusivity of Breastfeeding Among Women Who Plan to Breastfeed Their Infants After Postpartum or Delayed (4-6 Weeks Postpartum) Initiation of DMPA	Exclusive breastfeeding at specific time intervals postpartum	2, 4, 6, 8, 12, 16, 20,24 and 28 weeks postpartum