Labor Complications, Obesity
Conditions
Keywords
Obesity, Labor complications, Induction of labor, Mechanical cervical ripening
Brief summary
The purpose of this study is to investigate whether mechanical cervical ripening (using the Cook double balloon catheter) is superior or inferior to pharmacological agents (PGE1) in overweight and obese women undergoing labor induction.
Interventions
DRUGPGE1 tablet
Sponsors
Hillel Yaffe Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* Age 18 years of age or older. * Diagnosed to be pregnant (al least 37 weeks of gestation) with a medical indication for labor induction, including: postdate pregnancy, preeclampsia, gestational or chronic hypertension, Gestational Diabetes Mellitus at term, Oligohydramnios, Polyhydramnios, fetal growth restriction, maternal background disease necessitating delivery, Isoimmunisation, maternal Thrombophilia, intrahepatic cholestasis of pregnancy. * Having a Bishop score of 4 points or less. * Diagnosed as having singleton pregnancy at term (37 weeks at least) in a vertex presentation, with intact membranes, and absence of significant regular uterine contraction. * Willingness to comply with the protocol for the duration of the study. * Has agreed and signed an informed consent after given oral and written explanation.
Exclusion criteria
* Anay contraindication for a vaginal delivery (i.e. placenta previa, non vertex presentation, estimated fetal weight of less than 4500 gr). * Ruptured membranes. * Previous cesarian section or presence of any uterine scar. * Documented labor with four or more spontanous uterine contractions per hour. * Suspected fetal distress necessitating immediate intervention. * Proven malignancy of the cervix. * Active vaginal bleeding. * Active inflammatory or purulent condition of the lower genital tract. * Active asthma.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cesarian section rate | 24 hours |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of excessive uterine activity Incidence of excessive uterine activity | 24 hours | At least 6 uterine contractions per 10- minutes period, or hyperstimulation, if combined with fetal heart rate abnormalities, or hypertonus defined as single contraction of 2-minute duration. |
| Active labor onset | 24 hours | — |
| Treatment failure | 12-24 hours | Proportion of subjects with unfavorable/unchanged Bishop score 12-24 hours after ripening |
| The ripening-to-delivery time interval | 24 hours | — |
| Need for oxytocin induction and/or augmentation of labor | 24 hours | — |
| Proportion of vaginal delivery | 24 hours | — |
| Intra-partum or postpartum fever | 48 hours | — |
| Incidence of meconium staining | 24 hours | — |
| The proportion of neonates with 5-minute Apgar scores of less than 7 | 48 hours | — |
| The number of neonates who were admitted to the neonatal intensive care unit | 48 hours | — |
| morbidity and mortality | 48 hours | Number of cases of serious maternal and/or neonatal morbidity or death (including uterine rupture, maternal admission to the intensive care unit, maternal septicemia, placental abruption, hemorrhage at required blood transfusion, hysterectomy, neonatal seizures, birth asphyxia, meconium aspiration syndrome, or neonatal sepsis). |
| Mode of delivery | 24 hours | NVD vs. instrumental |
Countries
Israel
Contacts
Primary ContactSaja Murra Anabosy, MD
Backup ContactAsnat Walfisch, MD
Outcome results
None listed