NCT01463202

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
184

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Nov 2011

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 27, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 1, 2011

Completed
Same day until next milestone

Study Start

First participant enrolled

November 1, 2011

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 13, 2017

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 16, 2017

Completed
5 months until next milestone

Results Posted

Study results publicly available

March 13, 2018

Completed
Last Updated

August 31, 2018

Status Verified

August 1, 2018

Enrollment Period

5.3 years

First QC Date

October 27, 2011

Results QC Date

February 14, 2018

Last Update Submit

August 2, 2018

Conditions

ContraceptionPostpartum DepressionLactation

Keywords

Postpartum contraceptionContraceptive continuationBreastfeedingPostpartum depressionProgestins

Outcome Measures

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

    Any breastfeeding at specific time intervals postpartum

    2, 4, 6, 8 12, 16, 20, 24, and 28 weeks postpartum

Secondary Outcomes (3)

  • Rates of Use of Highly Effective Contraception (Defined as DMPA, IUD, Implant, Sterilization, or Lactational Amenorrhea) After Postpartum or Delayed Initiation of DMPA

    6 months

  • Rates of Postpartum Depression After Postpartum or Delayed Initiation of DMPA

    8 weeks postpartum

  • Exclusivity of Breastfeeding Among Women Who Plan to Breastfeed Their Infants After Postpartum or Delayed (4-6 Weeks Postpartum) Initiation of DMPA

    2, 4, 6, 8, 12, 16, 20,24 and 28 weeks postpartum

Study Arms (2)

DMPA postpartum

ACTIVE COMPARATOR

Depot medroxyprogesterone acetate postpartum

Drug: Depot medroxyprogesterone acetate

DMPA at 4-6 weeks after delivery

ACTIVE COMPARATOR

Depot medroxyprogesterone acetate at 4-6 weeks after delivery

Drug: Depot medroxyprogesterone acetate

Interventions

Depot medroxyprogesterone acetateDRUG

Postpartum administration of DMPA (prior to hospital discharge)

Also known as: DMPA, Depo Provera
DMPA postpartum

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for Family Planning Research, Magee-Womens Hospital

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Depression, PostpartumBreast Feeding

Interventions

N,N-dimethyl-4-anisidineMedroxyprogesterone Acetate

Condition Hierarchy (Ancestors)

Puerperal DisordersPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDepressive DisorderMood DisordersMental DisordersFeeding BehaviorBehavior

Intervention Hierarchy (Ancestors)

MedroxyprogesteroneHydroxyprogesteronesProgesteronePregnenedionesPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Results Point of Contact

Title
Principal Investigator
Organization
Center for Family Planning Research
fpr@upmc.edu
412-641-5496

Study Officials

  • Study Coordinator

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

October 27, 2011

First Posted

November 1, 2011

Study Start

November 1, 2011

Primary Completion

February 13, 2017

Study Completion

October 16, 2017

Last Updated

August 31, 2018

Results First Posted

March 13, 2018

Record last verified: 2018-08

Locations

US(1)