Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Factors Associated With Cesarean Delivery in Women With Type 1 Diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03538106
Recruitment Status : Completed
First Posted : May 25, 2018
Last Update Posted : May 25, 2018
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease
Pregnant Women Diabetes Type 1 Cesrean Delivery

Layout table for study information
Study Type : Observational
Actual Enrollment : 153 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Factors Associated With Cesarean Delivery in Women With Type 1 Diabetes
Study Start Date : November 2016
Actual Primary Completion Date : December 2016
Actual Study Completion Date : October 2017

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
All pregnant women with diabetes type 1
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03538106


Locations
Layout table for location information
France
Uhmontpellier
Montpellier, France, 34295
Sponsors and Collaborators
University Hospital, Montpellier

Layout table for additonal information
Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT03538106     History of Changes
Other Study ID Numbers: RECHMPL17_0332
First Posted: May 25, 2018    Key Record Dates
Last Update Posted: May 25, 2018
Last Verified: October 2017

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Hospital, Montpellier:
Cesrean delivery
Risks factors
Diabetes Type 1

Additional relevant MeSH terms:
Layout table for MeSH terms
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases