The Impact of Contraception on Postpartum Weight Loss (PPWL)

The Impact of Contraception on Postpartum Weight Loss: a Prospective Study

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.

Study Overview

• Status: Completed
• Conditions: Weight
• Intervention / Treatment: Drug: DMPA immediately postpartum; Drug: Implanon immediately postpartum

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: DMPA group; Subjects randomized to receive DepoProvera(DMPA) immediately post-partum.	Drug: DMPA immediately postpartum; DMPA is an intramuscular injection of 150mg of depot medroxyprogesterone acetate.; Other Names: DepoProvera, depot medroxyprogesterone acetate (DMPA)
Active Comparator: Implanon group; Subjects randomized to receive Implanon immediately post-partum.	Drug: Implanon immediately postpartum; Implanon ® is a subdermal implant that contains 68mg of etonogestrel.; Other Names: etonogestrel implant
No Intervention: Control group; Subjects selecting their own method of contraception or no contraception.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight	Weight will be measured at 6 months postpartum. Percent weight change will be compared amongst the groups	6 months from postpartum (baseline)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 year

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Contraceptive Satisfaction	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.	1 year

Collaborators and Investigators

• Sponsor: University of Pennsylvania
• Investigators: Principal Investigator: Courtney A Schreiber, MD, University of Pennsylvania

Study record dates

Study Major Dates

• Study Start: April 1, 2011
• Primary Completion (Actual): October 1, 2012
• Study Completion (Actual): October 1, 2012

Study Registration Dates

• First Submitted: May 19, 2014
• First Submitted That Met QC Criteria: May 20, 2014
• First Posted (Estimate): May 21, 2014

Study Record Updates

• Last Update Posted (Actual): February 17, 2017
• Last Update Submitted That Met QC Criteria: December 23, 2016
• Last Verified: December 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Weight Changes; Weight Loss; Body Weight; Physiological Effects of Drugs; Antineoplastic Agents; Antineoplastic Agents, Hormonal; Contraceptive Agents, Hormonal; Contraceptive Agents; Reproductive Control Agents; Contraceptives, Oral; Contraceptive Agents, Female; Contraceptives, Oral, Synthetic; Contraceptives, Oral, Hormonal; Contraceptive Agents, Male; Medroxyprogesterone Acetate; Medroxyprogesterone; Etonogestrel
• Other Study ID Numbers: 813000