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

A

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

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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