Induction of Labour for LGA fœtus in Women Without Insulin-treated Diabetes.

NCT ID: NCT03355040

Last Updated: 2019-04-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-04-01

Study Completion Date

2019-01-01

Brief Summary

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A french study published in 2015 (DAME) showed a decrease of shoulder dystocia and an increase of spontaneous vaginal delivery when the non insulin-treated diabetes patients with large-for-date fetus were induced.

This new protocole was introduced in Montpellier University Hospital delivery room.

The aim of this study is to evaluate the protocole in Montpellier hospital and to compare our results with the DAME results.

Detailed Description

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Currently, large for date fœtus need an induction of labour just if the mother is an insulin diabetic.

The DAME's protocol included the large for date feotus witch have a estimate weight \>3500g at 36 GA, \>3700g at 37 GA, \>3900g at 38 GA.

Conditions

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Macrosomia Induction of Labour Non-insulin-dependent Diabetes

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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induction of labour

induction of labour

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

Age \>18 years old Single pregnancy Cephalic presentation no contraindications to planned vaginal delivery no fœtal pathology

Large-for-date foetus (estimated weight \> 95%) :

* Clinically suspeted or estilated weight \>90% at the 3 trimester ultrasound
* Estimated fœtal weight :

\> 3500g at 36 GA \> 3700g at 37 GA \> 3900g at 38 GA

Exclusion Criteria

Age \<18 yeaurs old contraindications to vaginal delivery insulin-trated diabetics or imbalance diabetics. neonatal trauma or shoulder dystocia, severe urinary or faecal incontinence.
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Montpellier

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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florent FUCHS

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Montpellier

Locations

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Uhmontpellier

Montpellier, , France

Site Status

Countries

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France

Other Identifiers

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RECHMPL17_0261

Identifier Type: -

Identifier Source: org_study_id

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