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Completed

NCT Number: NCT03355040

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

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.

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Key information

Conditions

Macrosomia Diabetes Mellitus Diabetes Mellitus, Type 2 Dystocia Endocrine System Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Induction of Labour Metabolic Diseases Non-insulin-dependent Diabetes Nutritional and Metabolic Diseases Obstetric Labor Complications Pregnancy Complications Shoulder Dystocia Urogenital Diseases

Age range

18 year–50 year

Sex eligibility

Female

Study type

Observational

Primary location

Uhmontpellier

Montpellier, 34295, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

induction of labour

Other

induction of labour

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Official study title

Induction of Labour for LGA fœtus in Women Without Insulin-treated Diabetes.. Application of DAME Study in Montpellier University Hospital.

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Nov 28, 2017
Registry last updated
Apr 18, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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