NCT05306405

Brief Summary

To compare the safety and effectiveness of vaginal misoprostol with combined vaginal misoprostol and estradiol for induction of labour in unfavorable cervix

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
120

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Feb 2022

Shorter than P25 for 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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 18, 2022

Completed
2 days until next milestone

Study Start

First participant enrolled

February 20, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 1, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2022

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2022

Completed
Last Updated

April 1, 2022

Status Verified

March 1, 2022

Enrollment Period

5 months

First QC Date

February 18, 2022

Last Update Submit

March 23, 2022

Conditions

Cervix; Pregnancy

Keywords

cervical dilatation, Uneffaced cervix, closed os

Outcome Measures

Primary Outcomes (1)

  • Induction of labour with closed cervix

    assessment of uterine contractions and cervical opening of the pregnant females who are currently not in labour, to help them to reach normal vaginal delivery process.

    from 0 hours to 14 hours after induction of labour

Secondary Outcomes (1)

  • The Whole Delivery time after induction of labour.

    from 0 hours to the end of the delivery

Study Arms (2)

vaginal misoprostol

ACTIVE COMPARATOR

only vaginal misoprostol 25 μg tablets will be applied for induction of laour

Drug: Vaginal Tablet

combined vaginal misoprostol and estradiol

ACTIVE COMPARATOR

vaginal misoprostol 25 μg (Vagiprost) tablets with vaginal estradiol 150 ml cream will be applied for induction of laour

Drug: Vaginal Tablet

Interventions

Vaginal TabletDRUG

Misoprostol alone will be repeated every 4 h in both groups for a maximum of 5 doses, reaching Bishop score \>8, rupture of membranes or occurrence of labor pain. Cervical evaluation will be done using Bishop's score. A score \< 5 will be taken as unfavorable Cervix will be termed as ripped when Bishop's score equal 8 or more. The endpoint of the study will be initiation of active phase of 1st stage of labor which commence from 6cm to full cervical dilatation

Also known as: vaginal misoprostol and vaginal estradiol
combined vaginal misoprostol and estradiolvaginal misoprostol

Eligibility Criteria

Age20 Years - 39 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Gestational age36:41 weeks.
  • Singleton pregnancy.
  • Absence of labour pain.
  • Living fetus with cephalic presentation.
  • Fetal weight \< 4 k.gs.
  • No previous uterine surgical procedures.
  • No liquor abnormalities.
  • Bishop score \< 5.

You may not qualify if:

  • \- Multiple gestations. one of the contraindications of induction of labor as it may cause rupture of the uterus.
  • Liquor abnormalities.one of contraindications of induction of labor as it may cause fetal distress.
  • Abnormal umbilical artery Doppler indices or non-stress test as these indicate fetal distress.
  • Fetal weight \> 4 kgs.as macrosomia is an indication of caesarean section for fear of shoulder dystocia .
  • Previous uterine surgery.contraindication of labor induction for fear of rupture uterus.
  • Asthmatic patient or women with allergy to prostaglandins or steroidal.
  • Non-vertex presentation.contraindication of labor induction as it may cause rupture uterus.
  • Fetal or maternal complications that might cause cesarean section.
  • Intrauterine fetal death.often induction of labor in women with a dead fetus is performed before term when the uterus may be less responsive to uterotonics than it is at term and this will affect the results of the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain Shams University

Cairo, Egypt

RECRUITING

MeSH Terms

Interventions

Vaginal Creams, Foams, and Jellies

Intervention Hierarchy (Ancestors)

Dosage FormsPharmaceutical PreparationsFeminine Hygiene ProductsEquipment and Supplies

Central Study Contacts

Amira M Ahmed, MSC

CONTACT

+201090904528dr_amiramaher@yahoo.com

Rania G Anwar, Lecturer

CONTACT

+2012832627054dr.raniagamal2015@yahoo.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident of Obstetrics and Gynecology at Al-Delengat General Hospital

Study Record Dates

First Submitted

February 18, 2022

First Posted

April 1, 2022

Study Start

February 20, 2022

Primary Completion

August 1, 2022

Study Completion

August 30, 2022

Last Updated

April 1, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)