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NCT Number: NCT04299854

Modality of Induction of Labor in Obese Women at Term (MODOBAT)

In normal-weight patients, numerous studies show an equivalence of efficacy between dinoprostone and balloon to induce labor. In obese patients, this efficacy is not known, although inductions of labor are more frequent. MODOBAT aims to describe the ability to obtain a vaginal delivery of two modality of induction of labor (vaginal dinoprostone and single balloon Foley catheter) in obese women at term.

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Key information

Conditions

Induction of Labor Affected Fetus / Newborn Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obese Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–60 year

Sex eligibility

Female

Study type

Observational

Primary location

CHU Besançon, Besançon, France

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About this study

Obesity has for several decades become a global epidemic in developed countries. In case of pregnancy, obesity leads to an increased risk of obstetric complications, the indications of induction of labor are then more frequent. Unfortunately the rate of failed induction is also higher and therefore the risk of caesarean section is increased in obese women compared to normal-weight patients when induction of labor is indicated. However, in this context effectiveness of each mode of induction is not known. Some retrospective studies would suggest that the balloon would be more effective because it would not be affected by the increase in fat mass but this result are not , but the to confirm this hypothesis.

The aim of this study is to describe the caesarean section rate in induction of labor by vaginal dinoprostone and single balloon Foley catheter in obese women. Patients in the vaginal dinoprostone arm will be included retrospectively and patients in the single balloon Foley catheter arm will be included prospectively.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age ≥ 18 years
  • Medical indication of induction of labor
  • BMI ≥ 30 kg / m2
  • Bishop < 6
  • Singleton
  • Gestational age > 36 SA + 6j
  • Cephalic presentation

Exclusion criteria

  • Adults under guardianship or curatorship
  • Scarred uterus
  • Placenta praevia

Treatment and study plan

Dinoprostone 10mg

Drug

Vaginal delivery system containing 10mg of dinoprostone placed at the bottom of the vagina

Single balloon foley catheter

Device

A single balloon Foley catheter is being inserted on transcervical and inflated above the internal cervical os

Primary outcomes

  1. Cesarean sections

    Time frame: 1 year

    Rate of cesarean sections in each group

Secondary outcomes

  1. Entry into active phase (dilation to 5-6 cm)

    Time frame: 1 year

    Rate of entry into active phase (dilation to 5-6 cm)

  2. Complication

    Time frame: 1 year

    Complication rate = composite criteria including :

    • Hypercinesia / hypertonia rate
    • Rate of fetal heart rate anomalies
    • Fever rate during work
    • Rate of uterine ruptures
    • Postpartum hemorrhage rate
    • Rate of infectious complications in immediate postpartum (fever> 38.5 ° or wall abscess or endometritis defined by a fever greater than 38 ° with pain in uterine mobilization and foul or foul-smelling lochia)

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Besancon

Other

Collaborators

  • Hopital Nord Franche-Comte

Registry information

Official study title

Modalités de Déclenchement Des Patientes Obèses à Terme (MODOBAT)

Acronym: MODOBAT

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Mar 9, 2020
Registry last updated
May 3, 2021

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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