NCT02144259

Brief Summary

This is a prospective mixed methods study to assess weight changes in women randomized to receive Implanon ® or Depo Provera® (DMPA) immediately postpartum compared to women who choose non-hormonal contraception or no contraception immediately postpartum. After enrollment, subjects return for a visit at 3, 6 and 12 months postpartum to be asked a series of questions, take a pregnancy test, and be weighed. Total length of participation for each subject is 1 year or until pregnancy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2011

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

Study Start

First participant enrolled

April 1, 2011

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

May 19, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 21, 2014

Completed
2.7 years until next milestone

Results Posted

Study results publicly available

February 17, 2017

Completed
Last Updated

February 17, 2017

Status Verified

December 1, 2016

Enrollment Period

1.5 years

First QC Date

May 19, 2014

Results QC Date

December 19, 2014

Last Update Submit

December 23, 2016

Conditions

Weight

Outcome Measures

Primary Outcomes (1)

  • Weight

    Weight will be measured at 6 months postpartum. Percent weight change will be compared amongst the groups

    6 months from postpartum (baseline)

Secondary Outcomes (1)

  • Pregnancy Rate

    1 year

Other Outcomes (1)

  • Contraceptive Satisfaction

    1 year

Study Arms (3)

DMPA group

ACTIVE COMPARATOR

Subjects randomized to receive DepoProvera(DMPA) immediately post-partum.

Drug: DMPA immediately postpartum

Implanon group

ACTIVE COMPARATOR

Subjects randomized to receive Implanon immediately post-partum.

Drug: Implanon immediately postpartum

Control group

NO INTERVENTION

Subjects selecting their own method of contraception or no contraception.

Interventions

DMPA immediately postpartumDRUG

DMPA is an intramuscular injection of 150mg of depot medroxyprogesterone acetate.

Also known as: DepoProvera, depot medroxyprogesterone acetate (DMPA)
DMPA group
Implanon immediately postpartumDRUG

Implanon ® is a subdermal implant that contains 68mg of etonogestrel.

Also known as: etonogestrel implant
Implanon group

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • English speaking
  • Aged 18-45 at enrollment (inclusive)
  • Immediately postpartum of a live singleton infant, 37 weeks gestation, at HUP
  • Desiring to delay another pregnancy for 6 months
  • Willing and able to follow the study protocol

You may not qualify if:

  • Breastfeeding during study participation
  • Plans for relocation outside of Philadelphia in the next six months
  • Plans for use of weight loss medication or diet pills in the next six months
  • Women who wish to start Implanon ® or DMPA prior to discharge but who do not want to be randomized. 5. Issues or concerns in the judgment of the investigator that may compromise the safety of the subject or confound the reliability of compliance and information acquired in this study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Body Weight

Interventions

Medroxyprogesterone Acetateetonogestrel

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

MedroxyprogesteroneHydroxyprogesteronesProgesteronePregnenedionesPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Limitations and Caveats

First, we chose to exclude nursing women. Second, we had a small sample with power to detect one standard deviation difference in weight loss. Third, all data were collected prospectively,thus we did not have each participant's pre-pregnancy weight.

Results Point of Contact

Title
Dr. Courtney Schreiber
Organization
University of Pennsylvania
courtney.schreiber@uphs.upenn.edu
215-615-5234

Study Officials

  • Courtney A Schreiber, MD

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 19, 2014

First Posted

May 21, 2014

Study Start

April 1, 2011

Primary Completion

October 1, 2012

Study Completion

October 1, 2012

Last Updated

February 17, 2017

Results First Posted

February 17, 2017

Record last verified: 2016-12

Locations

US(1)