Factors Associated With Cesarean Delivery in Women With Type 1 Diabetes

Completed

• Conditions: Pregnant Women; Cesrean Delivery; Diabetes Type 1

• Registration Number: NCT03538106
• Lead Sponsor: University Hospital, Montpellier

Brief Summary

Introduction : Cesarean rate varies from 45% to 73% in the literature in patient with diabetes type 1. Having a prior C-section is the most important risk factor. The aim of this study was to identify risk factor of cesarean in this population.

Methods: This study is an observational, retrospective and single-center study from the hospital of Montpellier. All the pregnancies, planned or not, with subcutaneous insulin infusion or multiple daily injections of insulin, in patients with diabetes type 1 between 2009 and 2015, after 24 weeks of gestation were included. All the data were retrospectively collected by the principal investigator with computer and paper files.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-11
• Primary Completion: 2016-12
• Status Verified: 2017-10
• Study Completion: 2017-10
• Study First Submitted: 2017-10-25
• Study First Submitted QC: 2018-05-15
• Last Update Submitted: 2018-05-15
• Study First Posted: 2018-05-25
• Last Update Posted: 2018-05-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 153

Inclusion Criteria

• Pregnant women with diabetes type 1
• Pregnancy initiated between 2009 and 2015
• Pregnancy followed up in the universitary hospital center of Montpellier

Exclusion Criteria

• Women who deliver in an other center
• women with intraperitoneal injections of insulin
• twin gestation
• termination of pregnancy

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Risk factors associated with a cesarean delivery in patients with diabetes type 1	6 years	he statistical analysis was made with multiple logistic regression using SAS V9.1 and R V3.1.1 programs.

Secondary Outcome Measures

Name	Time	Method
Risk factors associated with an emergency cesarean delivery in patients with diabetes type 1	6 years	the statistical analysis was made with multiple logistic regression using SAS V9.1 and R V3.1.1 programs.
Risk factors associated with a planned cesarean delivery in patients with diabetes type 1	6 years	the statistical analysis was made with multiple logistic regression using SAS V9.1 and R V3.1.1 programs.

Trial Locations

Locations (1)

Uhmontpellier; 🇫🇷 Montpellier, France