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

NCT03355040 | Completed

• 1 other identifier: RECHMPL17_0261
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Macrosomia; Induction of Labour; Non-insulin-dependent Diabetes

Keywords

shoulder dystocia; maternal and neonatal morbidity

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (8)

• Number of Cord blood pH< 7,10 for the newborn

  1 day (after delivery)

• 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

  1 day (after delivery)

• Number of highest bilirubin concentration for the newborn

  1 day (after delivery)

• Number of Caesarean for the patient

  1 day (after delivery)

Interventions

induction of labour OTHER

induction of labour

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

Uhmontpellier

Montpellier, 34295, France

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Shoulder Dystocia

Interventions

Labor, Induced

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Dystocia; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Delivery, Obstetric; Obstetric Surgical Procedures; Surgical Procedures, Operative

Study Officials

• florent FUCHS

  University Hospital, Montpellier

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2017
• First Posted: November 28, 2017
• Study Start: April 1, 2016
• Primary Completion: January 1, 2019
• Study Completion: January 1, 2019
• Last Updated: April 18, 2019

Record last verified: 2019-04

Locations

FR (1)