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Comparison of the Effectiveness of Intravaginal Misoprostol with Extra-Amniotic Saline Infusion in Labor Inductio

Phase 4
Recruiting
Conditions
nfavorable cervix.
Registration Number
IRCT20201024049128N1
Lead Sponsor
Karaj University of Medical Sciences
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
Female
Target Recruitment
144
Inclusion Criteria

Singleton gestation
Alive fetus
Cephalic presentation
Intact membranes
Unfavorable cervix (Bishopscore =6)
Reassuring fetal heart rate
Gestational age=28

Exclusion Criteria

Non-cephalic presentation
Adequate uterine contractions (3 contractions Lasting for 30sec/10 min)
Ruptured membranes
Cephalopelvic disproportion
Multiple pregnancy
Polyhydramnios
Estimated fetal weight =4000g or =1800g
Placental abruption, Placenta previa
Unexplained vaginal bleeding
Prior lower segment cesarean section/Scarred uterus
Non-reassuring fetal status
Clinically detected vaginal infections(exp:genital herpes) or chorioamnionitis
Latex or Prostaglandins allergy or any contraindications receiving Prostaglandins, including a history of asthma, glaucoma, or cardiovascular disease
Intrauterine fetal death
Renal or hepatic failure

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
The mean time interval from start of induction to delivery. Timepoint: Time of birth. Method of measurement: Clock.;Duration of latent phase. Timepoint: At the end of latent phase. Method of measurement: Clock.;Duration of active phase. Timepoint: At the end of active phase. Method of measurement: clock.;Rate of delivery within 12 hours. Timepoint: At the end of study. Method of measurement: Patient's file.;Rate of delivery within 24 hours. Timepoint: At the end of study. Method of measurement: Patient's file.
Secondary Outcome Measures
NameTimeMethod
Cesarean rate. Timepoint: At the end of study. Method of measurement: Patient's file.;Incidence of tachysystole. Timepoint: Continuously. Method of measurement: Cardiotocography.;Incidence of hypertonus. Timepoint: Continuously. Method of measurement: Cardiotocography.;Apgar score. Timepoint: 1 minute and 5 minutes after birth. Method of measurement: Examination of the newborn.;Incidence of meconium passage. Timepoint: At birth. Method of measurement: Examination of the newborn.;Incidence of chorioamnionitis. Timepoint: Every 3 hours. Method of measurement: Physical examination.
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