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Effect of Isosorbide with Misoprostol on the cervical ripening

Comparison of the combined effect of Isosorbide with Misoprostol and Misoprostol alone on the cervical ripening in post-term pregnancy

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20180922041083N1
Enrollment
150
Registered
2018-12-27
Start date
2017-09-23
Completion date
Unknown
Last updated
2021-02-22

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

Conditions

Vaginal Delivery. Spontaneous Vertex Delivery

Interventions

Intervention 1: In the Intervention group, Isosorbide tablets (Isocor Tablet, 40 m, Aria Pharmacy) are used vaginally. Then 24 hours later, after re-establishing a bishop: 25 microgram vaginal misopr

Sponsors

Babol University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 40 Years

Inclusion criteria

Inclusion criteria: Pregnant mothers from 18 to 40 years old Bishop Score 6 and less with a range score of 0 to 13 Body mass in the first trimester of pregnancy in the normal range (26 - 19.8 kg . m2) 41 weeks pregnancy based on ultrasonography of the first trimester of pregnancy Singleton and cephalic pregnancy Having a normal fetal heart rate or proper biophysical in 48 hours before entering the study

Exclusion criteria

Exclusion criteria: Pregnant women with a history of headache Misoprostol contraindications Alcohol consumption Preeclampsia and eclampsia Uncontrolled diabetes Intrauterine growth restriction Polyhydramnios and oligohydramnios Placenta previa or any other factor that prevents the induction of labor Interaction medicine with Isosorbide

Design outcomes

Primary

MeasureTime frame
The time interval between administration of the first dose of Isosorbide until the cervix is fully ripened and dilated (hours). Timepoint: the time interval between administration of the first dose of Isosorbide until the cervix is fully ripened and dilated (hours). Method of measurement: ?Vaginal examinatin by Hours.

Secondary

MeasureTime frame
The time interval between administration of the first dose of Isosorbide until delivery of the neonate. Timepoint: ?From administration of the first dose of Isosorbide until delivery of the neonate. Method of measurement: Hours.;The effect of Isosorbide on the Bishop score 24 hours after administration of Isosorbide. Timepoint: 24 hours after administration of Isosorbide To delivery. Method of measurement: Bishop Score Scale.;The effect of Isosorbide on the number of Misoprostol used during labor. Timepoint: 24 hours after intervention to delivery. Method of measurement: Number Of misoprostol suppository.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Shahnaz Barat

Babol University of Medical Sciences

shahnaz-barat200@yahoo.com+98 11 3222 7667

Outcome results

None listed

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