An interventional study of Misoprostol and Oxytocin in Prelabor Rupture of Membranes and Premature Rupture of Membrane, sponsored by sammour.rami. Status unknown at 1 site in Israel. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-01-29.
Sponsored by sammour.rami · Not applicable, Interventional, and Treatment
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.
2,554 studies on the registry are indexed under Premature Birth; 498 are open to participants now.
This study's planned enrollment of 200 is above the median of 84 across 1,689 interventional studies indexed under Premature Birth.
Browse Premature Birth studies →This is the only study on the registry with sammour.rami as lead sponsor.
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Exclusion Criteria:
misoprostol 50 mcg tablet by mouth every four hours for maximum dosage of six
Drug: Misoprostol
Oxytocin 10 IU in 1000 mL Standard solution. Starting with 10 mL/hr infusion rate and increasing by 10mL/hr every 20 minutes until achieving 3-5 regular uterine contractions every 10 minutes (as recorded by cardiotocography)
Drug: Oxytocin
Oral administration of cytotec every 4 hours until a maximum of 6 doses
Also known as: Cytotec, PGE1
Intravenous infusion of Pitocin through an IVAC until delivery
Also known as: Pitocin
Vaginal 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
Plan to share: No
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This study is status unknown, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.
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