CClinicalTrials.gg
CompletedNCT03538106Updated May 25, 2018

Factors Associated With Cesarean Delivery in Women With Type 1 Diabetes

An observational study in Pregnant Women, Diabetes Type 1 and Cesrean Delivery, sponsored by University Hospital, Montpellier. Completed at 1 site in France. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-05-25.

Sponsored by University Hospital, Montpellier · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
153
Ages
18 Years and older
Sex
Female
01

Study 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.

02

Conditions studied

  • Pregnant Women
  • Diabetes Type 1
  • Cesrean Delivery

Keywords

  • Cesrean delivery
  • Risks factors
  • Diabetes Type 1
03

In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's enrollment of 153 is below the median of 233 across 2,220 observational studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

University Hospital, Montpellier is the lead sponsor of 1,244 studies on the registry; 225 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

All pregnant women with diabetes type 1

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

Exclusion Criteria:

  • Women who deliver in an other center
  • women with intraperitoneal injections of insulin
  • twin gestation
  • termination of pregnancy
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
153 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 6 years

Secondary outcomes

  1. 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.

    Time frame: 6 years

  2. 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.

    Time frame: 6 years

07

Study locations

1 site
  • Uhmontpellier
    Montpellier, 34295, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 25, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03538106
Lead sponsor
University Hospital, Montpellier
Responsible party
Sponsor
First posted
May 25, 2018
Start date
Nov 2016
Primary completion
Dec 2016
Completion
Oct 2017
Last update
May 25, 2018

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion