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

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

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.

Study Overview

• Status: Completed
• Conditions: Induction of Labour; Macrosomia; Non-insulin-dependent Diabetes
• Intervention / Treatment: Other: induction of labour

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 Type: Observational
• Enrollment (Actual): 150

Contacts and Locations

Study Locations

• France
  • Montpellier, France, 34295
    • UHMontpellier

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

Pregnant patients non diabetic or diabetic without insulin-treatment with large for date fœtus.

Description

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.

Study Plan

How is the study designed?

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)

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier
• Investigators: Principal Investigator: florent FUCHS, University Hospital, Montpellier

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2016
• Primary Completion (Actual): January 1, 2019
• Study Completion (Actual): January 1, 2019

Study Registration Dates

• First Submitted: October 12, 2017
• First Submitted That Met QC Criteria: November 27, 2017
• First Posted (Actual): November 28, 2017

Study Record Updates

• Last Update Posted (Actual): April 18, 2019
• Last Update Submitted That Met QC Criteria: April 17, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: shoulder dystocia; maternal and neonatal morbidity
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: RECHMPL17_0261

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: NC

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No