NCT03538106

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
153

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2016

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2016

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

October 25, 2017

Completed
7 months until next milestone

First Posted

Study publicly available on registry

May 25, 2018

Completed
Last Updated

May 25, 2018

Status Verified

October 1, 2017

Enrollment Period

1 month

First QC Date

October 25, 2017

Last Update Submit

May 15, 2018

Conditions

Pregnant WomenDiabetes Type 1Cesrean Delivery

Keywords

Cesrean deliveryRisks factorsDiabetes Type 1

Outcome Measures

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.

    6 years

Secondary Outcomes (2)

  • Risk factors associated with a planned cesarean delivery in patients with diabetes type 1

    6 years

  • Risk factors associated with an emergency cesarean delivery in patients with diabetes type 1

    6 years

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All pregnant women with diabetes type 1

You may qualify if:

  • Pregnant women with diabetes type 1
  • Pregnancy initiated between 2009 and 2015
  • Pregnancy followed up in the universitary hospital center of Montpellier

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uhmontpellier

Montpellier, 34295, France

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 25, 2017

First Posted

May 25, 2018

Study Start

November 1, 2016

Primary Completion

December 1, 2016

Study Completion

October 1, 2017

Last Updated

May 25, 2018

Record last verified: 2017-10

Locations

FR(1)