Induction of LaborPhase 4NCT06249815
Sequential Use of Foley's Catheter and Misoprostol Versus Misoprostol Alone for Induction of Labour: a Multicentre Randomised Controlled Trial
A Phase 4 study testing Misoprostol 200mcg Tab in people with Induction of Labor, run by Kazakhstan's Medical University "KSPH" at 2 sites in Kazakhstan.
Trial summary
Evaluation of efficacy of inducing labour using a Foley's catheter and low dose oral misoprostol sequentially, in comparison with low dose oral misoprostol alone. 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
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 2 sitesKazakhstan
- Study dates
- 26 Apr 2024to 31 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 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: Sequential Use of Foley's Catheter and Low Dose Oral Misoprostol Versus Misoprostol Alone for Induction of Labour : a Multicentre Randomised Controlled Trial
Evaluation of efficacy of inducing labour using a Foley's catheter and low dose oral misoprostol sequentially, in comparison with low dose oral misoprostol alone.
Read the detailed description
a multicentre, open-label randomised controlled 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 Foley's catheter for 16 hour and sequentially 25 μg oral misoprostol once every 2 hour, 2 nd group- 25 μg oral misoprostol once every 2 hour. 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, rate of hyperstimulation ,hemorrage,chorioamnionitis (for evaluating safety)
- Conditions
- Induction of Labor
- Being tested
- Misoprostol 200mcg Tab
- 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 TabCombination product
Also called Transcervical Foley catheter (silicone, size 20F with 30ml balloon)
ranscervical Foley catheter (silicone, size 20F with 30ml balloon)+Misoprostol 200 mcg dissolvedwith 200 ml water and divided to 25ml solution every 2 hours per os for maximum of 8 doses
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
| Study group | Role | What they receive |
|---|---|---|
| Foley catheter + misoprostol | Active comparator | -cervical ripening with transcervical Foley catheter 22 F for 16 hours, then sequentially 25 μg oral misoprostol once every 2 hour.Max 200 μg Receives: Combination Product: Misoprostol 200mcg Tab |
| misoprostol | Active comparator | 25 μg oral misoprostol alone once every 2 hour, Max 200 μg. Receives: Drug: Misoprostol 200mcg Tab |
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
Measured: 24 hours.
Secondary outcomes (4)
Safety for baby
Rate of cases Apgar score <7 points
Measured: 5 minutes
Safety for mother
incidence of hyperstimulation
Measured: 24 hour
rete of hemorrage
bleeding more than 500 ml during the vaginal delivery, more than 1000 ml after c-section
Measured: 24 hour
rate of chorioamnionitis chorioamnionitis
meconial amniotic fluid, tachycardia, leukocytosis
Measured: 24 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2024
- Study start26 Apr 2024
- Primary completion31 Dec 2024
- Study completion31 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
- Masking
- None (open label)
- Enrolment
- 400 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"
- Investigators
- Saule Issenova, Study chair, Asfendiyarov Kazakh National UnivercityDILFUZA SULTANMURATOVA, Principal investigator, Kazakhstans Medical Uivercity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06249815
- Sponsor's protocol ID
- IRB-23-2024
- Status last verified
- Feb 2025
- First submitted
- 12 Jan 2024
- Last updated
- 21 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
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
- Sequential Use of Foley's Catheter and Low Dose Oral Misoprostol Versus Misoprostol Alone for Induction of Labour : a Multicentre Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT06249815
- Acronym / sponsor ID
- IRB-23-2024
- Conditions
- Induction of Labor
- Keywords
- Induction of labor, low dose misoprostol, Foley Catheter
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Kazakhstan's Medical University "KSPH"University, hospital or other
- Collaborators
- Asfendiyarov Kazakh National Medical University
- Study start
- 26 Apr 2024 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 8 Feb 2024 (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.
Evaluation of efficacy of inducing labour using a Foley's catheter and low dose oral misoprostol sequentially, in comparison with low dose oral misoprostol alone.
Detailed description
a multicentre, open-label randomised controlled 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 Foley's catheter for 16 hour and sequentially 25 μg oral misoprostol once every 2 hour, 2 nd group- 25 μg oral misoprostol once every 2 hour. 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, rate of hyperstimulation ,hemorrage,chorioamnionitis (for evaluating safety)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Foley catheter + misoprostol | Active comparator | Combination Product: Misoprostol 200mcg Tab-cervical ripening with transcervical Foley catheter 22 F for 16 hours, then sequentially 25 μg oral misoprostol once every 2 hour.Max 200 μg |
| misoprostol | Active comparator | Drug: Misoprostol 200mcg Tab25 μg oral misoprostol alone once every 2 hour, Max 200 μg. |
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 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 TabAlso: Transcervical Foley catheter (silicone, size 20F with 30ml balloon)ranscervical Foley catheter (silicone, size 20F with 30ml balloon)+Misoprostol 200 mcg dissolvedwith 200 ml water and divided to 25ml solution every 2 hours per os for maximum of 8 doses | Combination product | Foley catheter + misoprostol |
| 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 | misoprostol |
Primary outcome
Efficiency of induction
Time frame: 24 hours.
Number of Participants with vaginal births
4 secondary outcomes
Safety for baby
Time frame: 5 minutes
Safety for mother
Time frame: 24 hour
rete of hemorrage
Time frame: 24 hour
rate of chorioamnionitis chorioamnionitis
Time frame: 24 hour
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.
- Individual participant dataSharing planned: Yes
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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.
Saule Issenova study chair
Asfendiyarov Kazakh National Univercity
DILFUZA SULTANMURATOVA principal investigator
Kazakhstans Medical Uivercity
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 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.