Using Isosorbide Mononitrate in Reducing Time in Induction of Labor in Post Date Women

Abdelrahman Ali Fadel Youssef Mohamed

Status and phase: Unknown; Phase 2

Conditions: Induction of Labor

Treatments: Drug: Misoprostol; Drug: Isosorbide mononitrate

Study type: Interventional

Funder types: Other

Identifiers

NCT03854383

600181

Details and patient eligibility

About

We will compare between using isosorbide mononitrate together with misoprostol versus the misoprostol alone in induction of labor in postdate women

Enrollment: 100 estimated patients

Sex: Female

Ages: 20 to 35 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• age (20-35 yrs)
• single fetus
• gestational age > 40weeks
• not in labor
• bishop score < 7
• no medical disorder

Exclusion criteria

• Gestational age ≤40 weeks
• patient with a ripe cervix
• rupture of membranes
• suspected chorioamnionitis
• placenta previa
• history of major uterine surgery
• hypertonic uterine pattern
• contraindicated to receive PG
• fetal malpresentation
• multiple pregnancy
• intrauterine growth retardation
• women with any general medical disorder

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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100 participants in 2 patient groups

Misoprostol alone

Sham Comparator group

Description:

Enrolled women will receive 25 πg of misoprostol which will be placed intravaginally 4 hourly, maximum up to 5 doses

Treatment:

Drug: Misoprostol

Isosorbide mononitrate with misoprostol

Active Comparator group

Description:

Enrolled women will receive 25 πg of misoprostol together with 40 mg isosorbide mononitrate which will be placed intravaginally 4 hourly, maximum up to 5 doses

Treatment:

Drug: Isosorbide mononitrate

Drug: Misoprostol