This study compares the rate of vaginal delivery after induction of labor with misoprostol versus oxytocin in women with prelabor rupture of membranes. Participants will be randomized to receive either oral misoprotsol every four hours until going into labor, or intravenous oxytocin in increasing dose.
Misoprostol is a synthetic prostaglandin analogue commonly used for labor induction. It causes uterine contractions and ripening of the cervix. Oxytocin sold under the brand name Pitocin among others, is a medication made from the peptide oxytocin and is used to cause contraction of the uterus to start labor. This randomized controlled trial will compare induction of labor in women with term premature rupture of the membranes and unripe cervix using misoprostol versus oxytocin. The primary outcome is the rate of vaginal delivery. Secondary outcomes will include cesarean section rate, time interval from induction of labor to delivery, neonatal morbidity, patient satisfaction and side effects, as well as chorioamnionitis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
200
Oral administration of cytotec every 4 hours until a maximum of 6 doses
Intravenous infusion of Pitocin through an IVAC until delivery
Bnai Zion Medical Center
Haifa, Israel
RECRUITINGVaginal delivery rate
Time frame: During delivery
Operative delivery rate, Cesarean section rate, time interval from induction of labor to delivery
Time frame: During delivery
chorioamnionitis rate
intra-amniotic infection during or after delivery representing in possible combination of maternal fever, fetal tachycardia, maternal leukocytosis, Histopathologic evidence of infection or inflammation or both in the placenta, fetal membranes, or the umbilical cord vessels
Time frame: During or after delivery up to 7 days
Uterine tachysystole
Time frame: During delivery
Neonatal morbidity
Apgar score, , ,
Time frame: After delivery until discharge
Neonatal morbidity
Umbilical Cord Blood Gases
Time frame: immediately after delivery
Neonatal morbidity
NICU admission
Time frame: up to 7 days after delivery
Neonatal morbidity
Antibiotic administration
Time frame: up to 7 days after delivery
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.