search
Back to results

The Impact of Contraception on Postpartum Weight Loss (PPWL)

Primary Purpose

Weight

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
DMPA immediately postpartum
Implanon immediately postpartum
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Weight

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • University of Pennsylvania

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

No Intervention

Arm Label

DMPA group

Implanon group

Control group

Arm Description

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

Subjects randomized to receive Implanon immediately post-partum.

Subjects selecting their own method of contraception or no contraception.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Pregnancy Rate
The secondary outcome variable is pregnancy rate. Pregnancy testing will occur at 3, 6 and 12 months postpartum or at any time that a participant felt that she might be pregnant.

Full Information

First Posted
May 19, 2014
Last Updated
December 23, 2016
Sponsor
University of Pennsylvania
search

1. Study Identification

Unique Protocol Identification Number
NCT02144259
Brief Title
The Impact of Contraception on Postpartum Weight Loss
Acronym
PPWL
Official Title
The Impact of Contraception on Postpartum Weight Loss: a Prospective Study
Study Type
Interventional

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
April 2011 (undefined)
Primary Completion Date
October 2012 (Actual)
Study Completion Date
October 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pennsylvania

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Weight

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
DMPA group
Arm Type
Active Comparator
Arm Description
Subjects randomized to receive DepoProvera(DMPA) immediately post-partum.
Arm Title
Implanon group
Arm Type
Active Comparator
Arm Description
Subjects randomized to receive Implanon immediately post-partum.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Subjects selecting their own method of contraception or no contraception.
Intervention Type
Drug
Intervention Name(s)
DMPA immediately postpartum
Other Intervention Name(s)
DepoProvera, depot medroxyprogesterone acetate (DMPA)
Intervention Description
DMPA is an intramuscular injection of 150mg of depot medroxyprogesterone acetate.
Intervention Type
Drug
Intervention Name(s)
Implanon immediately postpartum
Other Intervention Name(s)
etonogestrel implant
Intervention Description
Implanon ® is a subdermal implant that contains 68mg of etonogestrel.
Primary Outcome Measure Information:
Title
Weight
Description
Weight will be measured at 6 months postpartum. Percent weight change will be compared amongst the groups
Time Frame
6 months from postpartum (baseline)
Secondary Outcome Measure Information:
Title
Pregnancy Rate
Description
The secondary outcome variable is pregnancy rate. Pregnancy testing will occur at 3, 6 and 12 months postpartum or at any time that a participant felt that she might be pregnant.
Time Frame
1 year
Other Pre-specified Outcome Measures:
Title
Contraceptive Satisfaction
Description
Satisfaction will be measured in response to the question, "How satisfied are you with your current birth control method?" This question will be asked to the participant at the 6 month follow-up visit. Answer choices that participants could choose from range from "Very Good" to "Very Poor". "Good" or "Very Good" responses will be analyzed as having been satisfied with the method.
Time Frame
1 year

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Courtney A Schreiber, MD
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

Learn more about this trial

The Impact of Contraception on Postpartum Weight Loss

We'll reach out to this number within 24 hrs