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

Induction of Labour Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03355040
• Other study ID #: RECHMPL17_0261
• Status: Completed
• Start date: April 1, 2016
• Est. completion date: January 1, 2019

Study information

• Verified date: April 2019
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: January 1, 2019
• Est. primary completion date: January 1, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Induction of Labour
• Macrosomia
• Non-insulin-dependent Diabetes

Intervention

Other:
• induction of labour
induction of labour

Locations

Country	Name	City	State
France	Uhmontpellier	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of shoulder dystocia	number of shoulder dystocia	1 day (after delivery)
Primary	number of Clavicle fracture	number of Clavicle fracture	1 day (after delivery)
Primary	number of Brachial plexus injury	number of Brachial plexus injury	1 day (after delivery)
Primary	number of Intracranial heamorrhage	number of Intracranial heamorrhage	1 day (after delivery)
Primary	number of Neonatal death	number of Neonatal death	1 day (after delivery)
Secondary	Number of Cord blood pH< 7,10 for the newborn	Number of Cord blood pH< 7,10 for the newborn	1 day (after delivery)
Secondary	Number of apgar < 7 at 5 min for the newborn	Number of apgar < 7 at 5 min for the newborn	1 day (after delivery)
Secondary	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)
Secondary	Number of highest bilirubin concentration for the newborn	Number of highest bilirubin concentration for the newborn	1 day (after delivery)
Secondary	Number of Caesarean for the patient	Number of Caesarean for the patient	1 day (after delivery)
Secondary	Number of Forceps or vacuum for the patient	Number of Forceps or vacuum for the patient	1 day (after delivery)
Secondary	Number of Haemorrage and blood transfusion for the patient	Number of Haemorrage and blood transfusion for the patient	1 day (after delivery)
Secondary	Number of Anal sphincter tear for the patient	Number of Anal sphincter tear for the patient	1 day (after delivery)