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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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05511727
Enrollment
84
Registered
2022-08-23
Start date
2022-11-01
Completion date
2023-12-30
Last updated
2022-08-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Induction of Labor, Post Date

Keywords

primigravida, pregnants, Cervical ripening, single and double Foley's catheter

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.

Interventions

DEVICEsingle 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

Sponsors

Egymedicalpedia
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 34 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Cervical Ripening by using Foley's Catheterfrom 0 hours to 4 hours after induction of labourTo 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

Countries

Egypt

Contacts

Primary ContactYousry Selim, Professor
elasuotyy88@gmail.com+201024319294
Backup ContactKhaled Ahmed, Lecturer
elasuotyy88@gmail.com+201003306532

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026