Use of Single Versus Double Foley's Catheter in Pre-induction Cervical Ripening
NCT ID: NCT05511727
Last Updated: 2022-08-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
84 participants
INTERVENTIONAL
2022-11-01
2023-12-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
SINGLE
Study Groups
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single Foley's catheter group
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
Double Foley's catheter group
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
34 Years
FEMALE
Yes
Sponsors
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Egymedicalpedia
INDUSTRY
Responsible Party
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Locations
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Faculty of Medicine - Al-Azhar University,
Asyut, , Egypt
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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Islam Mohamed
Identifier Type: -
Identifier Source: org_study_id
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