Prelabor Rupture of Membranes, Premature Rupture of Membrane
Conditions
Keywords
PROM
Brief summary
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.
Detailed description
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.
Interventions
DRUGMisoprostol
Oral administration of cytotec every 4 hours until a maximum of 6 doses
DRUGOxytocin
Intravenous infusion of Pitocin through an IVAC until delivery
Sponsors
sammour.rami
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Women in their 1st - 4th delivery * Term prelabor rupture of membranes (37+0 to 42+0 gestational age) * Vertex presentation * Singleton pregnancy
Exclusion criteria
* Multiple pregnancy * Previous cesarean section * Chorioamnionitis on admission * \>2 symptomatic uterine contractions in 10 minutes * Prostaglandins hypersensitivity * Contraindication for vaginal delivery
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Vaginal delivery rate | During delivery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Operative delivery rate, Cesarean section rate, time interval from induction of labor to delivery | During delivery | — |
| chorioamnionitis rate | During or after delivery up to 7 days | 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 |
| Uterine tachysystole | During delivery | — |
| Neonatal morbidity | After delivery until discharge | Apgar score, , , |
Countries
Israel
Outcome results
None listed