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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04219852
Other study ID # PO19121*
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 10, 2019
Est. completion date December 31, 2020

Study information

Verified date March 2021
Source CHU de Reims
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Description:

The purpose of this study is to describe contraception in obese women who have undergone bariatric surgery in Champagne-Ardenne.


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date December 31, 2020
Est. primary completion date April 14, 2020
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 50 Years
Eligibility Inclusion Criteria: - Women between 18 and 50 years old - Followed at Reims University Hospital after bariatric surgery - Pre-menopausal status - Accepting to participate in the study Exclusion Criteria: - Women less than 18 or more than 50 years old - Women with postmenopausal status - Women refusing to participate

Study Design


Related Conditions & MeSH terms


Intervention

Other:
data collection
data collection

Locations

Country Name City State
France Chu Reims Reims

Sponsors (1)

Lead Sponsor Collaborator
CHU de Reims

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary contraception method Presence of contraception during the postoperative 3 months consultation Day 0
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