NCT04482881

Brief Summary

Induction of labor is defined as the process of artificially initiating uterine contractions, prior to their spontaneous onset, with progressive effacement and dilatation of the cervix and ultimately, the delivery of the baby.

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
130

participants targeted

Target at P75+ for early_phase_1

Timeline
Completed

Started Jul 2020

Shorter than P25 for early_phase_1

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

July 19, 2020

Completed
2 days until next milestone

Study Start

First participant enrolled

July 21, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 23, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 20, 2020

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 25, 2020

Completed
Last Updated

July 23, 2020

Status Verified

July 1, 2020

Enrollment Period

2 months

First QC Date

July 19, 2020

Last Update Submit

July 19, 2020

Conditions

Labor Fast

Outcome Measures

Primary Outcomes (1)

  • the number of women who will be reach active phase within 24 hours

    how many women will reach active phase within 24 hours

    24 hours

Study Arms (3)

women receiving isosorbide mononitrates lower dose

ACTIVE COMPARATOR

women who will receive isosorbide mononitrates lower dose

Drug: Isosorbide Mononitrate 40 MG

women receiving isosorbide mononitrates higher dose

ACTIVE COMPARATOR

women who will receive isosorbide mononitrates higher dose

Drug: Isosorbide Mononitrate 60 MG

Women receiving misoprostol

ACTIVE COMPARATOR

Women who will receive misoprostol

Drug: Misoprostol

Interventions

Isosorbide Mononitrate 40 MGDRUG

giving women isosorbide mononitrate 40 MG

women receiving isosorbide mononitrates lower dose
Isosorbide Mononitrate 60 MGDRUG

giving women isosorbide mononitrate 60MG

women receiving isosorbide mononitrates higher dose
MisoprostolDRUG

Giving women misoprostol

Women receiving misoprostol

Eligibility Criteria

Age18 Years - 42 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailspregnant women
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Single vertex presentation. 2. Gestational age \> 37weeks calculated from last menstrual period or U/S scanning.

You may not qualify if:

  • Patients with rupture of membranes.
  • Previous uterine scar.
  • Fetal malpresentation.
  • Multiple pregnancies.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Algazeerah

Giza, Egypt

Location

MeSH Terms

Interventions

isosorbide-5-mononitrateMisoprostol

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Mahmoud Alalfy, PhD

    Algezeera hospitaland National Research Centre ,Egypt

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mahmoud Alalfy

CONTACT

01002611058mahmoudalalfy@ymail.com

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 19, 2020

First Posted

July 23, 2020

Study Start

July 21, 2020

Primary Completion

September 20, 2020

Study Completion

September 25, 2020

Last Updated

July 23, 2020

Record last verified: 2020-07

Locations

EG(1)