The Impact of Contraception on Postpartum Weight Loss

Weight Clinical Trial

— PPWL  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02144259
• Other study ID #: 813000
• Status: Completed
• Phase: N/A
• First received: May 19, 2014
• Last updated: June 3, 2014
• Start date: April 2011
• Est. completion date: October 2012

Study information

• Verified date: June 2014
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Weight

Intervention

Drug:
• DMPA immediately postpartum
DMPA is an intramuscular injection of 150mg of depot medroxyprogesterone acetate.
• Implanon immediately postpartum
Implanon ® is a subdermal implant that contains 68mg of etonogesterel.

Locations

Country	Name	City	State
United States	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Contraceptive satisfaction	Satisfaction will be measured by the occurrence of unscheduled clinical visits to other facilities and responses to a series of questions to assess contraceptive continuation rates, contraceptive satisfaction, and bleeding patterns.	1 year	No
Primary	Weight change	Weight will be measured at 3, 6 and 12 months postpartum. Percent weight change will be compared amongst the groups	6 months postpartum	No
Secondary	Pregnancy rate	The secondary outcome variables is pregnancy rate. Pregnancy testing will occur at 3, 6 and 12 months postpartum.	1 year	No