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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03355040
Other study ID # RECHMPL17_0261
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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.

Study Design


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)
See also
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