Factors Associated With Cesarean Delivery in Women With Type 1 Diabetes

May 15, 2018 updated by: University Hospital, Montpellier

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

153

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Montpellier, France, 34295
        • Uhmontpellier

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

All pregnant women with diabetes type 1

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Montpellier

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2016

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

October 1, 2017

Study Registration Dates

First Submitted

October 25, 2017

First Submitted That Met QC Criteria

May 15, 2018

First Posted (Actual)

May 25, 2018

Study Record Updates

Last Update Posted (Actual)

May 25, 2018

Last Update Submitted That Met QC Criteria

May 15, 2018

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RECHMPL17_0332

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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