Trial Outcomes & Findings for The Impact of Contraception on Postpartum Weight Loss (NCT NCT02144259)

NCT ID: NCT02144259

Last Updated: 2017-02-17

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 100 participants
• Primary outcome timeframe: 6 months from postpartum (baseline)
• Results posted on: 2017-02-17

Participant Flow

Participant milestones

Measure	DMPA Group Subjects randomized to receive DepoProvera(DMPA) immediately post-partum. DMPA immediately postpartum: DMPA is an intramuscular injection of 150mg of depot medroxyprogesterone acetate.	Implanon Group Subjects randomized to receive Implanon immediately post-partum. Implanon immediately postpartum: Implanon ® is a subdermal implant that contains 68mg of etonogestrel.	Control Group Subjects selecting their own method of contraception or no contraception.
Overall Study STARTED	33	33	34
Overall Study COMPLETED	23	28	16
Overall Study NOT COMPLETED	10	5	18

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Impact of Contraception on Postpartum Weight Loss

Baseline characteristics by cohort

Measure	DMPA Group n=33 Participants Subjects randomized to receive DepoProvera(DMPA) immediately post-partum. DMPA immediately postpartum: DMPA is an intramuscular injection of 150mg of depot medroxyprogesterone acetate.	Implanon Group n=33 Participants Subjects randomized to receive Implanon immediately post-partum. Implanon immediately postpartum: Implanon ® is a subdermal implant that contains 68mg of etonogestrel.	Control Group n=34 Participants Subjects selecting their own method of contraception or no contraception.	Total n=100 Participants Total of all reporting groups
Age, Continuous	23.06 years STANDARD_DEVIATION 4.68 • n=5 Participants	22.42 years STANDARD_DEVIATION 3.81 • n=7 Participants	26.59 years STANDARD_DEVIATION 5.42 • n=5 Participants	24.02 years STANDARD_DEVIATION 4.63 • n=4 Participants
Gender Female	33 Participants n=5 Participants	33 Participants n=7 Participants	34 Participants n=5 Participants	100 Participants n=4 Participants
Gender Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Region of Enrollment United States	33 participants n=5 Participants	33 participants n=7 Participants	34 participants n=5 Participants	100 participants n=4 Participants

PRIMARY outcome

Timeframe: 6 months from postpartum (baseline)

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

Outcome measures

Measure	DMPA Group n=23 Participants Subjects randomized to receive DepoProvera(DMPA) immediately post-partum. DMPA immediately postpartum: DMPA is an intramuscular injection of 150mg of depot medroxyprogesterone acetate.	Implanon Group n=28 Participants Subjects randomized to receive Implanon immediately post-partum. Implanon immediately postpartum: Implanon ® is a subdermal implant that contains 68mg of etonogestrel.	Control Group n=16 Participants Subjects selecting their own method of contraception or no contraception.
Weight	3.2 percent weight lost Standard Deviation 9.1	6.8 percent weight lost Standard Deviation 8.1	7.0 percent weight lost Standard Deviation 10.2

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	DMPA Group n=23 Participants Subjects randomized to receive DepoProvera(DMPA) immediately post-partum. DMPA immediately postpartum: DMPA is an intramuscular injection of 150mg of depot medroxyprogesterone acetate.	Implanon Group n=28 Participants Subjects randomized to receive Implanon immediately post-partum. Implanon immediately postpartum: Implanon ® is a subdermal implant that contains 68mg of etonogestrel.	Control Group n=16 Participants Subjects selecting their own method of contraception or no contraception.
Pregnancy Rate	1 number of pregnancies	1 number of pregnancies	4 number of pregnancies

OTHER_PRE_SPECIFIED outcome

Timeframe: 1 year

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.

Outcome measures

Measure	DMPA Group n=23 Participants Subjects randomized to receive DepoProvera(DMPA) immediately post-partum. DMPA immediately postpartum: DMPA is an intramuscular injection of 150mg of depot medroxyprogesterone acetate.	Implanon Group n=28 Participants Subjects randomized to receive Implanon immediately post-partum. Implanon immediately postpartum: Implanon ® is a subdermal implant that contains 68mg of etonogestrel.	Control Group n=16 Participants Subjects selecting their own method of contraception or no contraception.
Contraceptive Satisfaction	74 percentage of women satisfied w. method	89 percentage of women satisfied w. method	75 percentage of women satisfied w. method

Adverse Events

DMPA Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Implanon Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Courtney Schreiber

University of Pennsylvania

Phone: 215-615-5234

Email: courtney.schreiber@uphs.upenn.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place