NCT05511727

Brief Summary

Cervical ripening should be present before labor induction, which can generally be divided into two categories: pharmacological and mechanical

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
84

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2022

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

August 16, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 23, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

November 1, 2022

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2023

Completed
Last Updated

August 23, 2022

Status Verified

August 1, 2022

Enrollment Period

1.1 years

First QC Date

August 16, 2022

Last Update Submit

August 20, 2022

Conditions

Post DateInduction of Labor

Keywords

primigravidapregnantsCervical ripeningsingle and double Foley's catheter

Outcome Measures

Primary Outcomes (1)

  • Cervical Ripening by using Foley's Catheter

    To compare the efficacy of two mechanical devices as single and double Foley's catheter for pre-induction of labor by making cervical ripening in primigravidae whom delayed on the expected date of delivery

    from 0 hours to 4 hours after induction of labour

Study Arms (2)

single Foley's catheter group

ACTIVE COMPARATOR
Device: single versus double Foley's catheter in pre-induction cervical ripening

Double Foley's catheter group

ACTIVE COMPARATOR
Device: single versus double Foley's catheter in pre-induction cervical ripening

Interventions

single versus double Foley's catheter in pre-induction cervical ripeningDEVICE

The single balloon catheter (i.e. Foley catheter \[FC\]) and Cook cervical ripening balloon have been the most commonly used mechanical method

Double Foley's catheter groupsingle Foley's catheter group

Eligibility Criteria

Age18 Years - 34 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age from 18 to 34 years old
  • Postdate Primigravida
  • Single viable fetus.
  • Cephalic presentation.
  • Normal biophysical .
  • Bishop score of four or less.
  • RH positive women.

You may not qualify if:

  • Premature rupture of membranes (PROM).
  • Oligo or Polyhydramnios
  • Antepartum hemorrhage and placenta praevia.
  • Current cervical cerclage.
  • Invasive cervical carcinoma.
  • Known fetal anomaly.
  • Previous uterine scar due to myomectomy or metroplasty.
  • Cephalopelvic disproportion due to pelvic contraction or Macrosomic baby.
  • Active genital Herpes infection.
  • Chronic maternal illness.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine - Al-Azhar University,

Asyut, Egypt

Location

MeSH Terms

Conditions

Pregnancy, Prolonged

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Central Study Contacts

Yousry Selim, Professor

CONTACT

+201024319294elasuotyy88@gmail.com

Khaled Ahmed, Lecturer

CONTACT

+201003306532elasuotyy88@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 16, 2022

First Posted

August 23, 2022

Study Start

November 1, 2022

Primary Completion

December 1, 2023

Study Completion

December 30, 2023

Last Updated

August 23, 2022

Record last verified: 2022-08

Locations

EG(1)