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Status unknownNCT05511727Updated Aug 23, 2022

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

An interventional study of single versus double Foley's catheter in pre-induction cervical ripening in Post Date and Induction of Labor, sponsored by Egymedicalpedia. Status unknown at 1 site in Egypt. Open to female participants aged 18 Years to 34 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-08-23.

Sponsored by Egymedicalpedia · Not applicable, Interventional, and Diagnostic

The sponsor has not verified this record recently (last verified Aug 2022), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
84
Allocation
Randomized
Ages
18 Years to 34 Years
Sex
Female
01

Study summary

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

Read the 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.

02

Conditions studied

  • Post Date
  • Induction of Labor

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Keywords

  • primigravida
  • pregnants
  • Cervical ripening
  • single and double Foley's catheter
03

In context

Pregnancy, Prolonged

30 studies on the registry are indexed under Pregnancy, Prolonged; 2 are open to participants now.

This study's planned enrollment of 84 is below the median of 132 across 23 interventional studies indexed under Pregnancy, Prolonged.

Browse Pregnancy, Prolonged studies →

Lead sponsor

Egymedicalpedia is the lead sponsor of 53 studies on the registry; 13 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 34 Years
Sexes eligible
Female
Accepts 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

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.
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
84 participants (estimated)

Study arms

  • Active comparator
    single Foley's catheter group

    Device: single versus double Foley's catheter in pre-induction cervical ripening

  • Active comparator
    Double Foley's catheter group

    Device: single versus double Foley's catheter in pre-induction cervical ripening

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

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: from 0 hours to 4 hours after induction of labour

07

Study locations

1 site
  • Faculty of Medicine - Al-Azhar University,
    Assiut, Egypt
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 23, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05511727
Lead sponsor
Egymedicalpedia
Responsible party
Sponsor
First posted
Aug 23, 2022
Start date
Nov 1, 2022 (estimated)
Primary completion
Dec 1, 2023 (estimated)
Completion
Dec 30, 2023 (estimated)
Last update
Aug 23, 2022

Study contacts

Yousry Selim, Professor
Contact
elasuotyy88@gmail.com
+201024319294
Khaled Ahmed, Lecturer
Contact
elasuotyy88@gmail.com
+201003306532

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.

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