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

Not Applicable

• Conditions: Post Date; Induction of Labor
• Interventions: Device: single versus double Foley's catheter in pre-induction cervical ripening

• Registration Number: NCT05511727
• Lead Sponsor: Egymedicalpedia

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.

Study Timeline

• Status Verified: 2022-08
• Study First Submitted: 2022-08-16
• Study First Submitted QC: 2022-08-20
• Last Update Submitted: 2022-08-20
• Study First Posted: 2022-08-23
• Last Update Posted: 2022-08-23
• Study Start: 2022-11-01
• Primary Completion: 2023-12-01
• Study Completion: 2023-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 84

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Double Foley's catheter group	single versus double Foley's catheter in pre-induction cervical ripening	-
single Foley's catheter group	single versus double Foley's catheter in pre-induction cervical ripening	-

Primary Outcome Measures

Name	Time	Method
Cervical Ripening by using Foley's Catheter	from 0 hours to 4 hours after induction of labour	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

Trial Locations

Locations (1)

Faculty of Medicine - Al-Azhar University,; 🇪🇬 Assiut, Egypt