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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.

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03355040
Enrollment
150
Registered
2017-11-28
Start date
2016-04-01
Completion date
2019-01-01
Last updated
2019-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

shoulder dystocia, maternal and neonatal morbidity

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.

Interventions

OTHERinduction of labour

induction of labour

Sponsors

University Hospital, Montpellier
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
number of shoulder dystocia1 day (after delivery)number of shoulder dystocia
number of Clavicle fracture1 day (after delivery)number of Clavicle fracture
number of Brachial plexus injury1 day (after delivery)number of Brachial plexus injury
number of Intracranial heamorrhage1 day (after delivery)number of Intracranial heamorrhage
number of Neonatal death1 day (after delivery)number of Neonatal death

Secondary

MeasureTime frameDescription
Number of Forceps or vacuum for the patient1 day (after delivery)Number of Forceps or vacuum for the patient
Number of Caesarean for the patient1 day (after delivery)Number of Caesarean for the patient
Number of Anal sphincter tear for the patient1 day (after delivery)Number of Anal sphincter tear for the patient
Number of Haemorrage and blood transfusion for the patient1 day (after delivery)Number of Haemorrage and blood transfusion for the patient
Number of apgar < 7 at 5 min for the newborn1 day (after delivery)Number of apgar \< 7 at 5 min for the newborn
Number of admission to neonatal intensive care unit for the newborn1 day (after delivery)Number of admission to neonatal intensive care unit for the newborn
Number of highest bilirubin concentration for the newborn1 day (after delivery)Number of highest bilirubin concentration for the newborn
Number of Cord blood pH< 7,10 for the newborn1 day (after delivery)Number of Cord blood pH\< 7,10 for the newborn

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026