Clinical trial NCT05511727: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Post Date
Induction of Labor
Keywords: primigravida
pregnants
Cervical ripening
single and double Foley's catheter
Lead sponsor: Egymedicalpedia
Sponsor class: INDUSTRY
First posted: 2022-08-23
Enrollment: 84
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 34
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Cervical Ripening by using Foley's Catheter
timeFrame: from 0 hours to 4 hours after induction of labour
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Faculty of Medicine - Al-Azhar University,
Study officials:
References: