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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05511727
Other study ID # Islam Mohamed
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date November 1, 2022
Est. completion date December 30, 2023

Study information

Verified date August 2022
Source Egymedicalpedia
Contact Yousry Selim, Professor
Phone +201024319294
Email elasuotyy88@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 84
Est. completion date December 30, 2023
Est. primary completion date December 1, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 34 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Egypt Faculty of Medicine - Al-Azhar University, Assiut

Sponsors (1)

Lead Sponsor Collaborator
Egymedicalpedia

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
See also
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Active, not recruiting NCT06324279 - Cervical Sliding Sign to Predict Outcome of Induction of Labor
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Recruiting NCT03854383 - Using Isosorbide Mononitrate in Reducing Time in Induction of Labor in Post Date Women Phase 2
Completed NCT01428037 - Safety and Efficacy Study of Vaginal Misoprostol for Cervical Ripening and Induction of Labor Phase 3
Terminated NCT03752073 - Comparison of Two Mechanical Methods of Outpatient Ripening of the Cervix N/A
Recruiting NCT03045939 - Cervical Ripening With the Double Balloon Device for 6 Hours Compared With 12 Hours N/A
Completed NCT03976037 - Buccal Versus Vaginal Misoprostol In Combination With Foley Bulb Early Phase 1