NCT03854383

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Mar 2019

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 20, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 26, 2019

Completed
5 days until next milestone

Study Start

First participant enrolled

March 3, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2019

Completed
Last Updated

March 12, 2019

Status Verified

March 1, 2019

Enrollment Period

2 months

First QC Date

February 20, 2019

Last Update Submit

March 9, 2019

Conditions

Induction of Labor

Outcome Measures

Primary Outcomes (1)

  • The duration of induction to active phase interval

    Measure the time between the beginning of the induction to enter the active phase of labor

    12 weeks

Study Arms (2)

Misoprostol alone

SHAM COMPARATOR

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

Drug: Misoprostol

Isosorbide mononitrate with misoprostol

ACTIVE COMPARATOR

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

Drug: Isosorbide mononitrateDrug: Misoprostol

Interventions

Isosorbide mononitrateDRUG

Administration of isosorbide mononitrate vaginaly together with misoprostol in induction of labor in postdate women

Isosorbide mononitrate with misoprostol
MisoprostolDRUG

Used intravaginally to ripe the cevix in induction of labor

Isosorbide mononitrate with misoprostolMisoprostol alone

Eligibility Criteria

Age20 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain Shams maternity hospital

Cairo, 11517, Egypt

RECRUITING

MeSH Terms

Interventions

isosorbide-5-mononitrateMisoprostol

Intervention Hierarchy (Ancestors)

Prostaglandins E, SyntheticProstaglandins, SyntheticProstaglandinsEicosanoidsFatty Acids, UnsaturatedFatty AcidsLipidsAutacoidsInflammation MediatorsBiological Factors

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

February 20, 2019

First Posted

February 26, 2019

Study Start

March 3, 2019

Primary Completion

May 1, 2019

Study Completion

July 1, 2019

Last Updated

March 12, 2019

Record last verified: 2019-03

Locations

EG(1)