Induction of LaborPhase 4NCT06056141
Induction of Labour at Term With Low Dose Oral Misoprostol Versus a Foley Catheter
A Phase 4 study testing Misoprostol 200mcg Tab and Foley Catheter in people with Induction of Labor, run by Kazakhstan's Medical University "KSPH" at 2 sites in Kazakhstan.
Trial summary
Comparison of efficacy and safety of low-dose oral Misoprostol versus folley catheter for preinduction in women with an immature cervix at term. Read more about this study
- Who is it for?
- Ages 18 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Induction of Labor
- What is being tested?
- Misoprostol 200mcg Tab and Foley Catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 2 sitesKazakhstan
- Study dates
- 1 Oct 2023to 1 Dec 2024
- Phase
- Phase 4
- 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 49 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- women with an unfavourable cervix who will scheduled for induction of labour
Who cannot join
- Women with previous caesarean sections unable to give informed consent Multiple pregnancy History of allergy to misoprostol Ruptured membranes Chorioamnionitis All cases when physiological childbirth is impossible (placenta previa,transverse position of the fetus )
Trial locations and contacts
2 sites in 1 country.
Kazakhstan2 sites
City Perinatology Centre 3
Almaty, 050062
Center for Perinatology and Pediatric Cardiac Surgery
Almaty, A15H0K1
About this study
Official title: Induction of Labour at Term With Low Dose Oral Misoprostol Versus a Foley Catheter: a Multicentre Randomised Controlled Trial
Comparison of efficacy and safety of low-dose oral Misoprostol versus folley catheter for preinduction in women with an immature cervix at term.
Read the detailed description
Open-label randomised trial in 2 hospitals in the Almaty,Kazakhstan. Women with a term singleton pregnancy in cephalic presentation, an unfavourable cervix, intact membranes, and without a previous caesarean section will be randomly allocated to 2 groups: 1 group -cervical ripening with 25 μg oral misoprostol once every 2 hour, 2 nd group- a 30 mL transcervical Foley catheter. The primary outcome will be vaginal delivery within 24 hours(to evaluate effectiveness) and secondary outcoms 1-5-min Apgar score and hospitalization in ICU, hyperstimulation frequency and hemorrage (for evaluating safety)
- Conditions
- Induction of Labor
- Being tested
- Misoprostol 200mcg Tab, Foley Catheter
- Keywords
- Induction of labor, low dose misoprostol, Foley Catheter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Misoprostol 200mcg TabDrug
Misoprostol 200 mcg dissolvedwith 200 ml water and divided to 25ml solution every 2 hours per os for maximum of 8 doses
Foley CatheterDevice
Transcervical Foley catheter (silicone, size 20F with 30ml balloon)
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | Drug: Misoprostol 25mcg (200 mcg dissolved with 200 ml water and divided to 8 doses) every 2 hours Receives: Drug: Misoprostol 200mcg Tab |
| Group B | Active comparator | Device: Foley Catheter Transcervical Foley catheter (silicone, size 20F with 30ml balloon) Receives: Device: Foley Catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficiency of induction
Number of Participants with vaginal births within 24 hours.
Measured: 24 hours.
Secondary outcomes (2)
Safety for baby
Rate of cases Apgar score <7 points
Measured: 5 min
Safety for mother
incidence of hyperstimulation
Measured: during the labour induction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2023
- Study start1 Oct 2023
- Primary completion1 Oct 2024
- Study completion1 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Induction of LaborStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- multicentre randomised controlled trial
- Masking
- None (open label)
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kazakhstan's Medical University "KSPH"
- Sponsor type
- University, hospital or other
- Collaborators
- Asfendiyarov Kazakh National Medical University
- Responsible party
- Principal investigator, Dilfuza Sultanmuratova, Kazakhstan's Medical University "KSPH"
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06056141
- Sponsor's protocol ID
- IRB-23-2023
- Status last verified
- Feb 2025
- First submitted
- 18 Sep 2023
- Last updated
- 21 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Induction of Labour at Term With Low Dose Oral Misoprostol Versus a Foley Catheter: a Multicentre Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT06056141
- Acronym / sponsor ID
- IRB-23-2023
- Conditions
- Induction of Labor
- Keywords
- Induction of labor, low dose misoprostol, Foley Catheter
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Kazakhstan's Medical University "KSPH"University, hospital or other
- Collaborators
- Asfendiyarov Kazakh National Medical University
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 1 Oct 2024 (actual)
- Study completion
- 1 Dec 2024 (actual)
- First posted
- 28 Sep 2023 (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.
Comparison of efficacy and safety of low-dose oral Misoprostol versus folley catheter for preinduction in women with an immature cervix at term.
Detailed description
Open-label randomised trial in 2 hospitals in the Almaty,Kazakhstan. Women with a term singleton pregnancy in cephalic presentation, an unfavourable cervix, intact membranes, and without a previous caesarean section will be randomly allocated to 2 groups: 1 group -cervical ripening with 25 μg oral misoprostol once every 2 hour, 2 nd group- a 30 mL transcervical Foley catheter. The primary outcome will be vaginal delivery within 24 hours(to evaluate effectiveness) and secondary outcoms 1-5-min Apgar score and hospitalization in ICU, hyperstimulation frequency and hemorrage (for evaluating safety)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- multicentre randomised controlled trial
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Drug: Misoprostol 200mcg TabDrug: Misoprostol 25mcg (200 mcg dissolved with 200 ml water and divided to 8 doses) every 2 hours |
| Group B | Active comparator | Device: Foley CatheterDevice: Foley Catheter Transcervical Foley catheter (silicone, size 20F with 30ml balloon) |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- women with an unfavourable cervix who will scheduled for induction of labour
Key exclusion criteria (1 listed)
- Women with previous caesarean sections unable to give informed consent Multiple pregnancy History of allergy to misoprostol Ruptured membranes Chorioamnionitis All cases when physiological childbirth is impossible (placenta previa,transverse position of the fetus )
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 |
|---|---|---|
| Misoprostol 200mcg TabMisoprostol 200 mcg dissolvedwith 200 ml water and divided to 25ml solution every 2 hours per os for maximum of 8 doses | Drug | Group A |
| Foley CatheterTranscervical Foley catheter (silicone, size 20F with 30ml balloon) | Device | Group B |
Primary outcome
Efficiency of induction
Time frame: 24 hours.
Number of Participants with vaginal births within 24 hours.
2 secondary outcomes
Safety for baby
Time frame: 5 min
Safety for mother
Time frame: during the labour induction
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Misoprostol 200mcg Tab and Foley Catheter in people with Induction of Labor, run by Kazakhstan's Medical University "KSPH" at 2 sites in Kazakhstan.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 21 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Kazakhstan. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficiency of induction (time frame: 24 hours.). 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 21 Feb 2025.