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

Completed

• Conditions: Macrosomia; Non-insulin-dependent Diabetes; Induction of Labour

• Registration Number: NCT03355040
• Lead Sponsor: University Hospital, Montpellier

Brief Summary

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

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.

Study Timeline

• Study Start: 2016-04-01
• Study First Submitted: 2017-10-12
• Study First Submitted QC: 2017-11-27
• Study First Posted: 2017-11-28
• Primary Completion: 2019-01-01
• Study Completion: 2019-01-01
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-17
• Last Update Posted: 2019-04-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 150

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
number of Brachial plexus injury	1 day (after delivery)	number of Brachial plexus injury
number of Intracranial heamorrhage	1 day (after delivery)	number of Intracranial heamorrhage
number of shoulder dystocia	1 day (after delivery)	number of shoulder dystocia
number of Clavicle fracture	1 day (after delivery)	number of Clavicle fracture
number of Neonatal death	1 day (after delivery)	number of Neonatal death

Secondary Outcome Measures

Name	Time	Method
Number of Cord blood pH< 7,10 for the newborn	1 day (after delivery)	Number of Cord blood pH\< 7,10 for the newborn
Number of admission to neonatal intensive care unit for the newborn	1 day (after delivery)	Number of admission to neonatal intensive care unit for the newborn
Number of Forceps or vacuum for the patient	1 day (after delivery)	Number of Forceps or vacuum for the patient
Number of Caesarean for the patient	1 day (after delivery)	Number of Caesarean for the patient
Number of highest bilirubin concentration for the newborn	1 day (after delivery)	Number of highest bilirubin concentration for the newborn
Number of apgar < 7 at 5 min for the newborn	1 day (after delivery)	Number of apgar \< 7 at 5 min for the newborn
Number of Haemorrage and blood transfusion for the patient	1 day (after delivery)	Number of Haemorrage and blood transfusion for the patient
Number of Anal sphincter tear for the patient	1 day (after delivery)	Number of Anal sphincter tear for the patient

Trial Locations

Locations (1)

Uhmontpellier; 🇫🇷 Montpellier, France