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

Study Overview
=================
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.

Official Title
-----------------
Induction of Labour for LGA fœtus in Women Without Insulin-treated Diabetes.. Application of DAME Study in Montpellier University Hospital.

Conditions
-----------------
Macrosomia, Induction of Labour, Non-insulin-dependent Diabetes

Intervention / Treatment
-----------------
* Other: induction of labour


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: induction of labour|induction of labour|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of shoulder dystocia | number of shoulder dystocia | 1 day (after delivery) | 
| number of Clavicle fracture | number of Clavicle fracture | 1 day (after delivery) | 
| number of Brachial plexus injury | number of Brachial plexus injury | 1 day (after delivery) | 
| number of Intracranial heamorrhage | number of Intracranial heamorrhage | 1 day (after delivery) | 
| number of Neonatal death | number of Neonatal death | 1 day (after delivery) | 

Secondary Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
shoulder dystocia, maternal and neonatal morbidity