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

Obese Clinical Trial

— MODOBAT  

Official title:

Modalités de Déclenchement Des Patientes Obèses à Terme (MODOBAT)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04299854
• Other study ID #: P/2019/469
• Status: Completed
• Start date: June 11, 2020
• Est. completion date: December 12, 2020

Study information

• Verified date: March 2021
• Source: Centre Hospitalier Universitaire de Besancon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 77
• Est. completion date: December 12, 2020
• Est. primary completion date: December 12, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Induction of Labor Affected Fetus / Newborn
• Obese

Intervention

Drug:
• Dinoprostone 10mg
Vaginal delivery system containing 10mg of dinoprostone placed at the bottom of the vagina

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

Locations

Country	Name	City	State
France	CHU Besançon	Besançon
France	Hopital Nord Franche-Comté	Trévenans

Sponsors (2)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Besancon	Hopital Nord Franche-Comte

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cesarean sections	Rate of cesarean sections in each group	1 year
Secondary	Entry into active phase (dilation to 5-6 cm)	Rate of entry into active phase (dilation to 5-6 cm)	1 year
Secondary	Complication	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)	1 year