An observational study in Induction of Labor Affected Fetus / Newborn and Obese, sponsored by Centre Hospitalier Universitaire de Besancon. Completed at 2 sites in France. Open to female participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2021-05-03.
Sponsored by Centre Hospitalier Universitaire de Besancon · Observational
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.
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.
Centre Hospitalier Universitaire de Besancon is the lead sponsor of 439 studies on the registry; 97 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients of the level III maternity of university hospital center of Besançon and level IIB maternity of regional hospital of Trevenans, France.
Exclusion Criteria:
Induction of labor by 10mg of vaginal dinoprostone
Drug: Dinoprostone 10mg
Induction of labor by single balloon Foley catheter
Device: single balloon Foley catheter
Vaginal delivery system containing 10mg of dinoprostone placed at the bottom of the vagina
A single balloon Foley catheter is being inserted on transcervical and inflated above the internal cervical os
Cesarean sections
Rate of cesarean sections in each group
Time frame: 1 year
Entry into active phase (dilation to 5-6 cm)
Rate of entry into active phase (dilation to 5-6 cm)
Time frame: 1 year
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)
Time frame: 1 year
This study is completed, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.
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Centre Hospitalier Universitaire de Besancon