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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
624
Hillel Yaffe Medical Center
Hadera, Israel
Cesarian section rate
Time frame: 24 hours
Incidence of excessive uterine activity Incidence of excessive uterine activity
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.
Time frame: 24 hours
Active labor onset
Time frame: 24 hours
Proportion of vaginal delivery
Time frame: 24 hours
Treatment failure
Proportion of subjects with unfavorable/unchanged Bishop score 12-24 hours after ripening
Time frame: 12-24 hours
The ripening-to-delivery time interval
Time frame: 24 hours
Need for oxytocin induction and/or augmentation of labor
Time frame: 24 hours
Mode of delivery
NVD vs. instrumental
Time frame: 24 hours
Intra-partum or postpartum fever
Time frame: 48 hours
Incidence of meconium staining
Time frame: 24 hours
The proportion of neonates with 5-minute Apgar scores of less than 7
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Time frame: 48 hours
The number of neonates who were admitted to the neonatal intensive care unit
Time frame: 48 hours
morbidity and mortality
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).
Time frame: 48 hours