The purpose of this study is to specifically investigate whether oxytocin and mechanical dilation decreases the rate of cesarean section compared to misoprostol and mechanical dilation for pregnancies at risk of fetal compromise
This is a single center randomized control trial of two arms. Singleton, cephalic, high risk pregnancies will be randomized to either oxytocin with mechanical dilation versus misoprostol with mechanical dilation. In group A, receiving misoprostol with mechanical dilation, will serve as the control group. Group B, oxytocin with mechanical dilation, will serve as the experimental group. The expected duration of participation begins at induction of labor and concludes at time of delivery.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
150
Intervention
Control
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States
Rate of Cesarean Delivery
Total rate of cesarean delivery
Time frame: 48 hours
The time interval from induction-to-delivey for vaginal deliveries
Maternal outcome
Time frame: 48 hours
The number of vaginal births within 24 hours
Maternal outcome
Time frame: 24 hours
The number of misoprostol doses received by each participant
Maternal outcome
Time frame: 24 hours
The incidence of uterine tachysystole
Defined as greater than 5 contractions in a ten minute window, averaged over 30 minutes
Time frame: 24 hours
The rate of each indication for the cesarean delivery
Indications include non-reassuring fetal hear tones, arrest of dilation, arrest in the 2nd stage of labor etc.
Time frame: 48 hours
The rate of operative vaginal delivery
Maternal outcome - includes forceps or vacuum assisted deliveries
Time frame: 48 hours
The rate of intra-amniotic infection
Maternal outcome
Time frame: 48 hours
The rate of postpartum hemorrhage
Maternal outcome
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 24 hours
The rate of Fetal heart rate abnormaliies
recurrent late decelerations, bradycardia, or prolonged deceleration
Time frame: 48 hours
The number of patients that received betamethasone for fetal lung maturity and/or magnesium sulfate for fetal neuroprotection
Maternal outcome
Time frame: 24 hours
The rate of stillbirth
Fetal/Neonatal outcome
Time frame: 48 hours
The total rate of Neonatal Apgar scores less than 7 at 5 minutes
Neonatal outcome
Time frame: 5 minutes
The total rate of Neonatal RDS
Neonatal outcome
Time frame: 96 hours
The total rate of Neonatal admission to the NICU
Neonatal outcome
Time frame: 96 hours
The total rate of neonatal arterial umbilical blood pH < 7.1
Neonatal outcome
Time frame: 96 hours
The rate of neonatal Sepsis
Neonatal outcome
Time frame: 96 hours
The rate of Neonatal Death
Neonatal outcome
Time frame: 96 hours