WeightPPWLNCT02144259

The Impact of Contraception on Postpartum Weight Loss

A study testing DMPA immediately postpartum and Implanon immediately postpartum in people with Weight, run by University of Pennsylvania at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 45 years, women onlyHealthy volunteers can take part
Conditions the study is for: Weight
What is being tested?: DMPA immediately postpartum and Implanon immediately postpartum
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 100 participants
Where: 1 siteUnited States
Study dates: Apr 2011to Oct 2012
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 45 years
Women only
Healthy volunteers accepted
Adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Pennsylvania
Philadelphia, Pennsylvania, 19104

Other trials in United States

About this study

Official title: 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.

Conditions: Weight
Being tested: DMPA immediately postpartum, Implanon immediately postpartum
Medical subject headings: Body Weight

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

DMPA immediately postpartumDrug
Also called DepoProvera, depot medroxyprogesterone acetate (DMPA)
DMPA is an intramuscular injection of 150mg of depot medroxyprogesterone acetate.
Implanon immediately postpartumDrug
Also called etonogestrel implant
Implanon ® is a subdermal implant that contains 68mg of etonogestrel.

Study groups in NCT02144259
Study group	Role	What they receive
DMPA group	Active comparator	Subjects randomized to receive DepoProvera(DMPA) immediately post-partum. Receives: Drug: DMPA immediately postpartum
Implanon group	Active comparator	Subjects randomized to receive Implanon immediately post-partum. Receives: Drug: Implanon immediately postpartum
Control group	No intervention	Subjects selecting their own method of contraception or no contraception.

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (1)

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.
Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2011Oct 2012

First posted21 May 2014 (estimated)
Study startApr 2011
Primary completionOct 2012
Study completionOct 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for WeightStudies of the same condition, open and under way.
More trials run by University of PennsylvaniaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 100 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02144259
Sponsor's protocol ID: 813000
Acronym: PPWL
Status last verified: Dec 2016
First submitted: 19 May 2014
Last updated: 17 Feb 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 17 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Impact of Contraception on Postpartum Weight Loss: a Prospective Study
ClinicalTrials.gov ID: NCT02144259
Acronym / sponsor ID: PPWL / 813000
Conditions: Weight
Study type: Interventional
Recruitment status: Completed
Enrolment: 100 participants (actual)
Lead sponsor: University of PennsylvaniaUniversity, hospital or other
Study start: Apr 2011
Primary completion: Oct 2012 (actual)
Study completion: Oct 2012 (actual)
First posted: 21 May 2014 (estimated)
Results: Posted 17 Feb 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
DMPA group	Active comparator	Drug: DMPA immediately postpartumSubjects randomized to receive DepoProvera(DMPA) immediately post-partum.
Implanon group	Active comparator	Drug: Implanon immediately postpartumSubjects randomized to receive Implanon immediately post-partum.
Control group	No intervention	–Subjects selecting their own method of contraception or no contraception.

Who may qualify

Ages: 18 to 45 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (4 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
DMPA immediately postpartumAlso: DepoProvera, depot medroxyprogesterone acetate (DMPA)DMPA is an intramuscular injection of 150mg of depot medroxyprogesterone acetate.	Drug	DMPA group
Implanon immediately postpartumAlso: etonogestrel implantImplanon ® is a subdermal implant that contains 68mg of etonogestrel.	Drug	Implanon group

Primary outcome

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

1 secondary outcome

Pregnancy Rate
Time frame: 1 year

Results and safety

Results posted to the registry on 17 Feb 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
DMPA Group	33	23
Implanon Group	33	28
Control Group	34	16

Primary outcome: Weight

Time frame: 6 months from postpartum (baseline). Mean (Standard Deviation). Unit: percent weight lost

Measure	DMPA Group n = 23	Implanon Group n = 28	Control Group n = 16
Value	3.2 (9.1)	6.8 (8.1)	7.0 (10.2)

DMPA Group vs Implanon Group vs Control Group: p <0.05, GEE

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
DMPA Group	0 of 33 (0%)	0 of 33 (0%)	Not reported
Implanon Group	0 of 33 (0%)	0 of 33 (0%)	Not reported
Control Group	0 of 34 (0%)	0 of 34 (0%)	Not reported

Limitations and caveats (from the sponsor): First, we chose to exclude nursing women. Second, we had a small sample with power to detect one standard deviation difference in weight loss. Third, all data were collected prospectively,thus we did not have each participant's pre-pregnancy weight.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Weight

RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
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Obesity & Overweight, Vitamin D
Recruiting
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Active, not recruiting
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Obesity & Overweight, Gestational Diabetes Mellitus (GDM)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Courtney A Schreiber, MD principal investigator

University of Pennsylvania

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing DMPA immediately postpartum and Implanon immediately postpartum in people with Weight, run by University of Pennsylvania at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Feb 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Weight (time frame: 6 months from postpartum (baseline)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02144259.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2017.