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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03355040
Recruitment Status : Completed
First Posted : November 28, 2017
Last Update Posted : April 18, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Montpellier

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.


Condition or disease Intervention/treatment
Macrosomia Induction of Labour Non-insulin-dependent Diabetes 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.

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Study Type : Observational
Actual Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Induction of Labour for LGA fœtus in Women Without Insulin-treated Diabetes.. Application of DAME Study in Montpellier University Hospital.
Actual Study Start Date : April 1, 2016
Actual Primary Completion Date : January 1, 2019
Actual Study Completion Date : January 1, 2019

Resource links provided by the National Library of Medicine



Intervention Details:
  • Other: induction of labour
    induction of labour


Primary Outcome Measures :
  1. number of shoulder dystocia [ Time Frame: 1 day (after delivery) ]
    number of shoulder dystocia

  2. number of Clavicle fracture [ Time Frame: 1 day (after delivery) ]
    number of Clavicle fracture

  3. number of Brachial plexus injury [ Time Frame: 1 day (after delivery) ]
    number of Brachial plexus injury

  4. number of Intracranial heamorrhage [ Time Frame: 1 day (after delivery) ]
    number of Intracranial heamorrhage

  5. number of Neonatal death [ Time Frame: 1 day (after delivery) ]
    number of Neonatal death


Secondary Outcome Measures :
  1. Number of Cord blood pH< 7,10 for the newborn [ Time Frame: 1 day (after delivery) ]
    Number of Cord blood pH< 7,10 for the newborn

  2. Number of apgar < 7 at 5 min for the newborn [ Time Frame: 1 day (after delivery) ]
    Number of apgar < 7 at 5 min for the newborn

  3. Number of admission to neonatal intensive care unit for the newborn [ Time Frame: 1 day (after delivery) ]
    Number of admission to neonatal intensive care unit for the newborn

  4. Number of highest bilirubin concentration for the newborn [ Time Frame: 1 day (after delivery) ]
    Number of highest bilirubin concentration for the newborn

  5. Number of Caesarean for the patient [ Time Frame: 1 day (after delivery) ]
    Number of Caesarean for the patient

  6. Number of Forceps or vacuum for the patient [ Time Frame: 1 day (after delivery) ]
    Number of Forceps or vacuum for the patient

  7. Number of Haemorrage and blood transfusion for the patient [ Time Frame: 1 day (after delivery) ]
    Number of Haemorrage and blood transfusion for the patient

  8. Number of Anal sphincter tear for the patient [ Time Frame: 1 day (after delivery) ]
    Number of Anal sphincter tear for the patient



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Pregnant patients non diabetic or diabetic without insulin-treatment with large for date fœtus.
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03355040


Locations
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France
Uhmontpellier
Montpellier, France, 34295
Sponsors and Collaborators
University Hospital, Montpellier
Investigators
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Principal Investigator: florent FUCHS University Hospital, Montpellier
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Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT03355040    
Other Study ID Numbers: RECHMPL17_0261
First Posted: November 28, 2017    Key Record Dates
Last Update Posted: April 18, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: NC

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Montpellier:
shoulder dystocia
maternal and neonatal morbidity
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases