The effect of Isosorbide Mononitrate on induction success

The effect of Isosorbide Mononitrate (vs. placebo) on induction success in pregnant women

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

IRCT

Registry ID

IRCT138803311946N3

Enrollment

Registered

2010-12-08

Start date

2009-08-27

Completion date

Unknown

Last updated

2018-02-22

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

Conditions

Other assisted single delivery. Other assisted single delivery

Interventions

Intervention 1: Isosorbide Mononitrate, 40mg, vaginal for the caces. Intervention 2: Placebo for the control group.

Treatment - Drugs

Placebo

Isosorbide Mononitrate, 40mg, vaginal for the caces

Placebo for the control group

Eligibility

Sex/Gender

Female

Age

15 Years to 45 Years

Inclusion criteria

Inclusion criteria: The inclusion criteria: 1-single pregnancy, 2- cephalic presentation, 3- Bishop Score =6, 4-normal AFI>5, 5- regular FHR, 6- intact membrane, 7- gestational age =37 weeks. Exclusion criteria are: Uterine contraction (=3 contraction 45’’ in 10 minutes) previous mymomectomy, history of headache, intolerance IMN, cardiopulmonary disease, vaso previa or placenta previa, cord prolepses, classic incision or previous myomectomy, irregular FHR, multiple pregnancy, macrosomia, polyhydramious, severe preeclampsia, maternal short stature.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Labor course. Timepoint: Hospitalization to delivery. Method of measurement: Based on Documented data.;Delivery mode. Timepoint: Post partum. Method of measurement: Based on Documented data.;Bleeding volume in labor and post partum. Timepoint: Control of labor course. Method of measurement: Based on Documented data.;Hospitalization duration and active phase initiation. Timepoint: Control of labor course. Method of measurement: Based on Documented data.	—

Measure

Time frame

Labor course. Timepoint: Hospitalization to delivery. Method of measurement: Based on Documented data.;Delivery mode. Timepoint: Post partum. Method of measurement: Based on Documented data.;Bleeding volume in labor and post partum. Timepoint: Control of labor course. Method of measurement: Based on Documented data.;Hospitalization duration and active phase initiation. Timepoint: Control of labor course. Method of measurement: Based on Documented data.

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Secondary

Measure	Time frame
Newborn apgar score. Timepoint: Immediately after delivery. Method of measurement: Based on documented data.;NICU requirement. Timepoint: Post partum. Method of measurement: Based on documented data.;The rate of maternal palpitation. Timepoint: During labor. Method of measurement: Based on documented data.;The occurance of maternal headache. Timepoint: Control during labor & delivery. Method of measurement: Based on documented data.;The ocurrance of tachysystol/hypersystol and hyperstimulated syndrome. Timepoint: FHR monitoring during labor. Method of measurement: Based on documented data.	—

Measure

Time frame

Newborn apgar score. Timepoint: Immediately after delivery. Method of measurement: Based on documented data.;NICU requirement. Timepoint: Post partum. Method of measurement: Based on documented data.;The rate of maternal palpitation. Timepoint: During labor. Method of measurement: Based on documented data.;The occurance of maternal headache. Timepoint: Control during labor & delivery. Method of measurement: Based on documented data.;The ocurrance of tachysystol/hypersystol and hyperstimulated syndrome. Timepoint: FHR monitoring during labor. Method of measurement: Based on documented data.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactMandana Mansuor Ghanaie

Guilan University of Medical Sciences

m_m_ghanie@gums.ac.ir+98 13 1322 5624

Outcome results

None listed

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