NCT04219852

Brief Summary

Obesity is a public health phenomenon affecting more than 17% of women in France, and more than 20% of men and women in Champagne-Ardenne. Obese women are more likely to have an unplanned pregnancy, whereas these pregnancies are more at risk than women of normal weight and should be planned or considered after weight loss. These women are also often less well followed in terms of gynecology and especially on contraception. More and more patients are opting for bariatric surgery. However, bariatric surgery is not trivial. Indeed, the important loss of weight expected is at risk of nutritional deficiencies. In addition, a large number of patients are still obese during the months following surgery. This is why pregnancy is theoretically contraindicated within 12 or 18 months postoperatively. Women with bariatric surgery must have been properly informed of these risks so that they can choose a contraceptive method, and that can be adapted to both their risk factors and the surgical technique performed.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 10, 2019

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 3, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 7, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 14, 2020

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

March 3, 2021

Status Verified

March 1, 2021

Enrollment Period

7 months

First QC Date

January 3, 2020

Last Update Submit

March 2, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • contraception method

    Presence of contraception during the postoperative 3 months consultation

    Day 0

Study Arms (1)

"bariatric surgery" group

Women between 18 and 50 years, who undergone bariatric surgery at the University Hospital of Reims.

Other: data collection

Interventions

data collection

"bariatric surgery" group

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Women between 18 and 50 years, pre-menopausal, who undergone bariatric surgery at Reims University Hospital

You may qualify if:

  • Women between 18 and 50 years old
  • Followed at Reims University Hospital after bariatric surgery
  • Pre-menopausal status
  • Accepting to participate in the study

You may not qualify if:

  • Women less than 18 or more than 50 years old
  • Women with postmenopausal status
  • Women refusing to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chu Reims

Reims, 51092, France

Location

MeSH Terms

Interventions

Data Collection

Intervention Hierarchy (Ancestors)

Epidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 3, 2020

First Posted

January 7, 2020

Study Start

September 10, 2019

Primary Completion

April 14, 2020

Study Completion

December 31, 2020

Last Updated

March 3, 2021

Record last verified: 2021-03

Locations