Clinical trial NCT03355040: Induction of Labour for LGA fœtus in Women Without Insulin-treated Diabetes.
Official title: Induction of Labour for LGA fœtus in Women Without Insulin-treated Diabetes.. Application of DAME Study in Montpellier University Hospital.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Macrosomia
Induction of Labour
Non-insulin-dependent Diabetes
Keywords: shoulder dystocia
maternal and neonatal morbidity
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2017-11-28
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Pregnant patients non diabetic or diabetic without insulin-treatment with large for date fœtus.

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.

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.

Primary outcomes:
measure: number of shoulder dystocia
timeFrame: 1 day (after delivery)
measure: number of Clavicle fracture
timeFrame: 1 day (after delivery)
measure: number of Brachial plexus injury
timeFrame: 1 day (after delivery)
measure: number of Intracranial heamorrhage
timeFrame: 1 day (after delivery)
measure: number of Neonatal death
timeFrame: 1 day (after delivery)
Secondary outcomes:
measure: Number of Cord blood pH< 7,10 for the newborn
timeFrame: 1 day (after delivery)
measure: Number of apgar < 7 at 5 min for the newborn
timeFrame: 1 day (after delivery)
measure: Number of admission to neonatal intensive care unit for the newborn
timeFrame: 1 day (after delivery)
measure: Number of highest bilirubin concentration for the newborn
timeFrame: 1 day (after delivery)
measure: Number of Caesarean for the patient
timeFrame: 1 day (after delivery)
measure: Number of Forceps or vacuum for the patient
timeFrame: 1 day (after delivery)
measure: Number of Haemorrage and blood transfusion for the patient
timeFrame: 1 day (after delivery)
measure: Number of Anal sphincter tear for the patient
timeFrame: 1 day (after delivery)
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Uhmontpellier
Study officials:
affiliation: University Hospital, Montpellier
name: florent FUCHS
role: PRINCIPAL_INVESTIGATOR
References: