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

A Comparative Study about Maternal and Neonatal Outcomes of Using Extra-Amniotic Saline Infusion and vaginal Misoprostol for Cervical Ripening and Labor Induction in Pregnant Women with Unfavorable Cervix

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
IRCT
Registry ID
IRCT20201024049128N1
Enrollment
144
Registered
2020-12-01
Start date
2020-11-10
Completion date
Unknown
Last updated
2021-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Unfavorable cervix.

Interventions

Intervention 1: Intervention group: Vaginal Misoprostol. Misoprostol is a prostaglandin E1 analog known to stimulate uterine contractions. In this study 100-microgram tablets were used. In this interv

Sponsors

Karaj University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactBita Badehnoosh

Karaj University of Medical Sciences

b_badehnoosh@yahoo.com+98 26 3222 2021

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026