The effect of oral and sublingual and buccal Misoprostol on induction of preterm premature rupture of membrane
Phase 3
- Conditions
- Preterm premature rupture of the membranes.Premature rupture of membranes
- Registration Number
- IRCT20190410043237N1
- Lead Sponsor
- Mashhad University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Female
- Target Recruitment
- 120
Inclusion Criteria
women with single pregnancy
preterm premature rupture of membrane
gestational age of 37-42 weeks
cephalic presentation
informed consent of the individual to enter the study
low risk pregnancy (no complications such as preeclampsia and gestational diabetes and heart diseases)
satisfactory fetal heart rate patterns
absence of contraindication to natural childbirth and no history of uterine scar
bishop score of less than 6
Exclusion Criteria
onset of uterine contractions
symptoms of chorioamnionitis
fetal macrosomia
use of other methods of initiating induction within the last 7 days
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The interval between initiation of induction and delivery. Timepoint: after the intervention. Method of measurement: patient's file.
- Secondary Outcome Measures
Name Time Method atural delivery or cesarean section. Timepoint: after the intervention. Method of measurement: based on file.;Investigation of Misoprostol side-effects. Timepoint: after medication use. Method of measurement: based on clinical observations.;Investigation of maternal complications such as postpartum hemorrhage. Timepoint: after delivery. Method of measurement: based on clinical observations.;Investigation of neonatal complications such as Apgar Score, dystocia, ICU hospitalization , Sepsis and bacteremia. Timepoint: Immediately after the birth of the infant. Method of measurement: based on clinical observations.