Post DateNCT05511727
Use of Single Versus Double Foley's Catheter in Pre-induction Cervical Ripening
A study testing single versus double Foley's catheter in pre-induction cervical ripening in people with Post Date and Induction of Labor, run by Egymedicalpedia at 1 site in Egypt.
Trial summary
Cervical ripening should be present before labor induction, which can generally be divided into two categories: pharmacological and mechanical Read more about this study
- Who is it for?
- Ages 18 to 34 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Post Date, Induction of Labor
- What is being tested?
- single versus double Foley's catheter in pre-induction cervical ripening
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2022to 30 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 34 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- Premature rupture of membranes (PROM).
- Oligo or Polyhydramnios
- Antepartum hemorrhage and placenta praevia.
- Current cervical cerclage.
- Invasive cervical carcinoma.
- Known fetal anomaly.
Show all 10Show fewer
- Previous uterine scar due to myomectomy or metroplasty.
- Cephalopelvic disproportion due to pelvic contraction or Macrosomic baby.
- Active genital Herpes infection.
- Chronic maternal illness.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of Medicine - Al-Azhar University,
Asyut
Islam Ahmed, Resident, +201148920078, elasuotyy88@gmail.com
About this study
Official title: Use of Single Versus Double Foley's Catheter in Pre-induction Cervical Ripening in Postdate Primigravidae
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.
- Conditions
- Post Date, Induction of Labor
- Being tested
- single versus double Foley's catheter in pre-induction cervical ripening
- Keywords
- primigravida, pregnants, Cervical ripening, single and double Foley's catheter
- Medical subject headings
- Pregnancy, Prolonged
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
single versus double Foley's catheter in pre-induction cervical ripeningDevice
The single balloon catheter (i.e. Foley catheter [FC]) and Cook cervical ripening balloon have been the most commonly used mechanical method
| Study group | Role | What they receive |
|---|---|---|
| single Foley's catheter group | Active comparator | Not described Receives: Device: single versus double Foley's catheter in pre-induction cervical ripening |
| Double Foley's catheter group | Active comparator | Not described Receives: Device: single versus double Foley's catheter in pre-induction cervical ripening |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: from 0 hours to 4 hours after induction of labour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2022
- Study start1 Nov 2022 (estimated)
- Primary completion1 Dec 2023 (estimated)
- Study completion30 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post DateStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Egymedicalpedia
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05511727
- Sponsor's protocol ID
- Islam Mohamed
- Status last verified
- Aug 2022
- First submitted
- 16 Aug 2022
- Last updated
- 23 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Single Versus Double Foley's Catheter in Pre-induction Cervical Ripening in Postdate Primigravidae
- ClinicalTrials.gov ID
- NCT05511727
- Acronym / sponsor ID
- Islam Mohamed
- Conditions
- Post Date, Induction of Labor
- Keywords
- primigravida, pregnants, Cervical ripening, single and double Foley's catheter
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- EgymedicalpediaIndustry (pharma, biotech, devices)
- Study start
- 1 Nov 2022 (estimated)
- Primary completion
- 1 Dec 2023 (estimated)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 23 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| single Foley's catheter group | Active comparator | Device: single versus double Foley's catheter in pre-induction cervical ripening |
| Double Foley's catheter group | Active comparator | Device: single versus double Foley's catheter in pre-induction cervical ripening |
Who may qualify
- Ages
- 18 to 34 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Age from 18 to 34 years old
- Postdate Primigravida
- Single viable fetus.
- Cephalic presentation.
- Normal biophysical .
Key exclusion criteria (10 listed)
- Premature rupture of membranes (PROM).
- Oligo or Polyhydramnios
- Antepartum hemorrhage and placenta praevia.
- Current cervical cerclage.
- Invasive cervical carcinoma.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| single versus double Foley's catheter in pre-induction cervical ripeningThe single balloon catheter (i.e. Foley catheter [FC]) and Cook cervical ripening balloon have been the most commonly used mechanical method | Device | Double Foley's catheter group, single Foley's catheter group |
Primary outcome
Cervical Ripening by using Foley's Catheter
Time frame: from 0 hours to 4 hours after induction of labour
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing single versus double Foley's catheter in pre-induction cervical ripening in people with Post Date and Induction of Labor, run by Egymedicalpedia at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yousry Selim, Professor (+201024319294, elasuotyy88@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cervical Ripening by using Foley's Catheter (time frame: from 0 hours to 4 hours after induction of labour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2022.