Effect of Isosorbide with Misoprostol on the cervical ripening

Phase 2

Conditions: Vaginal Delivery.
Spontaneous Vertex Delivery
O80.0

Registration Number: IRCT20180922041083N1

Lead Sponsor: Babol University of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Complete

Sex: Female

Target Recruitment: 150

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

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

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.