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Use of Single Versus Double Foley's Catheter in Pre-induction Cervical Ripening

Primary Purpose

Post Date, Induction of Labor

Status
Not yet recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
single versus double Foley's catheter in pre-induction cervical ripening
Sponsored by
Egymedicalpedia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Post Date focused on measuring primigravida, pregnants, Cervical ripening, single and double Foley's catheter

Eligibility Criteria

18 Years - 34 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  1. Age from 18 to 34 years old
  2. Postdate Primigravida
  3. Single viable fetus.
  4. Cephalic presentation.
  5. Normal biophysical .
  6. Bishop score of four or less.
  7. RH positive women.

Exclusion Criteria:

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

Sites / Locations

  • Faculty of Medicine - Al-Azhar University,

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

single Foley's catheter group

Double Foley's catheter group

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
August 16, 2022
Last Updated
August 20, 2022
Sponsor
Egymedicalpedia
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1. Study Identification

Unique Protocol Identification Number
NCT05511727
Brief Title
Use of Single Versus Double Foley's Catheter in Pre-induction Cervical Ripening
Official Title
Use of Single Versus Double Foley's Catheter in Pre-induction Cervical Ripening in Postdate Primigravidae
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 1, 2022 (Anticipated)
Primary Completion Date
December 1, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Egymedicalpedia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Cervical ripening should be present before labor induction, which can generally be divided into two categories: pharmacological and mechanical
Detailed Description
With appropriate decision and timely intervention, labor induction decreases the risk of fetal and maternal morbidity and mortality. The single balloon catheter (i.e. Foley catheter [FC]) and Cook cervical ripening balloon have been the most commonly used mechanicalwith a minimal increase in risk of cesarean section. The single balloon catheter (i.e. Foley catheter [FC]) and Cook cervical ripening balloon have been the most commonly used mechanical method. The FC applies pressure on lower uterine segment and cervix in the direction from the uterus to the vagina. The Cook cervical ripening balloon is composed of a cervicovaginal balloon and a uterine balloon. Its mechanism is similar to that of the Foley balloon, but it can apply pressure in two directions simultaneously, on both the external and internal os. Although many studies have shown that the Cook cervical ripening balloon and FC have similar efficacy and safety. They each have district advantages and disadvantages in labor induction. In addition to the cost advantage and wide avail- ability of the FC, the safety of labor induction with the FC has been proven by many studies. However, some study have shown that the FC results in a higher pain score, and consequently, higher maternal request for cesarean section and higher cervical laceration incidence compared with the Cook cervical ripening balloon.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Date, Induction of Labor
Keywords
primigravida, pregnants, Cervical ripening, single and double Foley's catheter

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
84 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
single Foley's catheter group
Arm Type
Active Comparator
Arm Title
Double Foley's catheter group
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
single versus double Foley's catheter in pre-induction cervical ripening
Intervention Description
The single balloon catheter (i.e. Foley catheter [FC]) and Cook cervical ripening balloon have been the most commonly used mechanical method
Primary Outcome Measure Information:
Title
Cervical Ripening by using Foley's Catheter
Description
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
Time Frame
from 0 hours to 4 hours after induction of labour

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
34 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yousry Selim, Professor
Phone
+201024319294
Email
elasuotyy88@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Khaled Ahmed, Lecturer
Phone
+201003306532
Email
elasuotyy88@gmail.com
Facility Information:
Facility Name
Faculty of Medicine - Al-Azhar University,
City
Assiut
Country
Egypt
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Islam Ahmed, Resident
Phone
+201148920078
Email
elasuotyy88@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Use of Single Versus Double Foley's Catheter in Pre-induction Cervical Ripening

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