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

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Induction of Labor; Post Date
• Intervention / Treatment: Device: single versus double Foley's catheter in pre-induction cervical ripening

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.

• Study Type: Interventional
• Enrollment (Anticipated): 84
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yousry Selim, Professor; Phone Number: +201024319294; Email: elasuotyy88@gmail.com
• Study Contact Backup: Name: Khaled Ahmed, Lecturer; Phone Number: +201003306532; Email: elasuotyy88@gmail.com

Study Locations

• Egypt
  • Assiut, Egypt
    • Faculty of Medicine - Al-Azhar University,
    • Contact: Islam Ahmed, Resident; Phone Number: +201148920078; Email: elasuotyy88@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 34 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: single Foley's catheter group	Device: single versus double Foley's catheter in pre-induction cervical ripening; The single balloon catheter (i.e. Foley catheter [FC]) and Cook cervical ripening balloon have been the most commonly used mechanical method
Active Comparator: Double Foley's catheter group	Device: single versus double Foley's catheter in pre-induction cervical ripening; The single balloon catheter (i.e. Foley catheter [FC]) and Cook cervical ripening balloon have been the most commonly used mechanical method

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Egymedicalpedia

Study record dates

Study Major Dates

• Study Start (Anticipated): November 1, 2022
• Primary Completion (Anticipated): December 1, 2023
• Study Completion (Anticipated): December 30, 2023

Study Registration Dates

• First Submitted: August 16, 2022
• First Submitted That Met QC Criteria: August 20, 2022
• First Posted (Actual): August 23, 2022

Study Record Updates

• Last Update Posted (Actual): August 23, 2022
• Last Update Submitted That Met QC Criteria: August 20, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: Cervical ripening; primigravida; pregnants; single and double Foley's catheter
• Additional Relevant MeSH Terms: Pregnancy Complications; Pregnancy, Prolonged
• Other Study ID Numbers: Islam Mohamed

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No