Factors Associated With Cesarean Delivery in Women With Type 1 Diabetes

Pregnant Women Clinical Trial

Official title:

Factors Associated With Cesarean Delivery in Women With Type 1 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03538106
• Other study ID #: RECHMPL17_0332
• Status: Completed
• Start date: November 2016
• Est. completion date: October 2017

Study information

• Verified date: October 2017
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 153
• Est. completion date: October 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cesrean Delivery
• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Diabetes Type 1
• Pregnant Women

Locations

Country	Name	City	State
France	Uhmontpellier	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Risk factors associated with a cesarean delivery in patients with diabetes type 1	he statistical analysis was made with multiple logistic regression using SAS V9.1 and R V3.1.1 programs.	6 years
Secondary	Risk factors associated with a planned cesarean delivery in patients with diabetes type 1	the statistical analysis was made with multiple logistic regression using SAS V9.1 and R V3.1.1 programs.	6 years
Secondary	Risk factors associated with an emergency cesarean delivery in patients with diabetes type 1	the statistical analysis was made with multiple logistic regression using SAS V9.1 and R V3.1.1 programs.	6 years