Induction of Labour at Term With Low Dose Oral Misoprosto... | NCT06056141

Studies
Induction of Labour at Term With Low Dose Oral Misoprostol Versus a Foley Catheter

NCT06056141

Sponsor

Kazakhstan's Medical University "KSPH"

Status

Completed

Last Update Posted

Feb 21, 2025Actual

Enrollment

300Actual

Phase

Phase 4

Conditions

Induction of Labor

Interventions

Misoprostol 200mcg Tab
Foley Catheter

Countries

Kazakhstan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 1, 2023Actual

Primary Completion Date

Oct 1, 2024Actual

Completion Date

Dec 1, 2024Actual

First Submitted Date

Sep 18, 2023

First Submission Date that Met QC Criteria

Sep 24, 2023

First Posted Date

Sep 28, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 20, 2025

Last Update Posted Date

Feb 21, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Dilfuza Sultanmuratova, principal investigator, Kazakhstan's Medical University "KSPH"Principal Investigator

Lead Sponsor

Kazakhstan's Medical University "KSPH"OTHER

Collaborators

Name	Class
Asfendiyarov Kazakh National Medical University	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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)

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

300Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group A	Active Comparator	Drug: Misoprostol 25mcg (200 mcg dissolved with 200 ml water and divided to 8 doses) every 2 hours	Drug: Misoprostol 200mcg Tab
Group B	Active Comparator	Device: Foley Catheter Transcervical Foley catheter (silicone, size 20F with 30ml balloon)	Device: Foley Catheter

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Misoprostol 200mcg Tab	Drug	Misoprostol 200 mcg dissolvedwith 200 ml water and divided to 25ml solution every 2 hours per os for maximum of 8 doses	Group A

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Efficiency of induction	Number of Participants with vaginal births within 24 hours.	24 hours.

Secondary Outcomes

Measure	Description	Time Frame
Safety for baby	Rate of cases Apgar score <7 points	5 min
Safety for mother	incidence of hyperstimulation	during the labour induction

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

women with an unfavourable cervix who will scheduled for induction of labour

Exclusion Criteria:

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 )

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

49 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
City Perinatology Centre 3		Almaty		050062	Kazakhstan
Center for Perinatology and Pediatric Cardiac Surgery

Intervention Browse Module

MeSH Terms

ID	Term
D016595	Misoprostol

Ancestor Terms

ID	Term
D011459	Prostaglandins E, Synthetic
D011465	Prostaglandins, Synthetic
D011453	Prostaglandins
D015777	Eicosanoids

Browse Leaves

Not provided

Browse Branches

Not provided