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OpenTrials
Completed

NCT Number: NCT03538106

Factors Associated With Cesarean Delivery in Women With Type 1 Diabetes

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Uhmontpellier

Montpellier, 34295, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Important dates

Study start
2016
Primary completion
2016
Study completion
2017
First posted
May 25, 2018
Registry last updated
May 25, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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