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

Study Overview
=================
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.

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

Conditions
-----------------
Post Date, Induction of Labor

Intervention / Treatment
-----------------
* Device: single versus double Foley's catheter in pre-induction cervical ripening


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 34 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
primigravida, pregnants, Cervical ripening, single and double Foley's catheter