The Impact of Contraception on Postpartum Weight Loss

Not Applicable

Completed

• Conditions: Weight
• Interventions: Drug: DMPA immediately postpartum; Drug: Implanon immediately postpartum

• Registration Number: NCT02144259
• Lead Sponsor: University of Pennsylvania

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-04
• Primary Completion: 2012-10
• Study Completion: 2012-10
• Study First Submitted: 2014-05-19
• Study First Submitted QC: 2014-05-20
• Study First Posted: 2014-05-21
• Results First Submitted: 2014-12-19
• Status Verified: 2016-12
• Results First Submitted QC: 2016-12-23
• Last Update Submitted: 2016-12-23
• Results First Posted: 2017-02-17
• Last Update Posted: 2017-02-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 100

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DMPA group	DMPA immediately postpartum	Subjects randomized to receive DepoProvera(DMPA) immediately post-partum.
Implanon group	Implanon immediately postpartum	Subjects randomized to receive Implanon immediately post-partum.

Primary Outcome Measures

Name	Time	Method
Weight	6 months from postpartum (baseline)	Weight will be measured at 6 months postpartum. Percent weight change will be compared amongst the groups

Secondary Outcome Measures

Name	Time	Method
Pregnancy Rate	1 year	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.

Trial Locations

Locations (1)

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States