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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06056141
Recruitment Status : Active, not recruiting
First Posted : September 28, 2023
Last Update Posted : January 17, 2024
Sponsor:
Collaborator:
Asfendiyarov Kazakh National Medical University
Information provided by (Responsible Party):
Dilfuza Sultanmuratova, Kazakhstan's Medical University "KSPH"

Study Description
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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.

Condition or disease Intervention/treatment Phase
Induction of Labor Drug: Misoprostol 200mcg Tab Device: Foley Catheter Phase 4

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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 782 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: multicentre randomised controlled trial
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Induction of Labour at Term With Low Dose Oral Misoprostol Versus a Foley Catheter: a Multicentre Randomised Controlled Trial
Actual Study Start Date : October 1, 2023
Estimated Primary Completion Date : October 1, 2024
Estimated Study Completion Date : October 1, 2024

Resource links provided by the National Library of Medicine

Drug Information available for: Misoprostol

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Group A
Drug: Misoprostol 25mcg (200 mcg dissolved with 200 ml water and divided to 8 doses) every 2 hours
 Drug: Misoprostol 200mcg Tab
Misoprostol 200 mcg dissolvedwith 200 ml water and divided to 25ml solution every 2 hours per os for maximum of 8 doses
Active Comparator: Group B
Device: Foley Catheter Transcervical Foley catheter (silicone, size 20F with 30ml balloon)
 Device: Foley Catheter
Transcervical Foley catheter (silicone, size 20F with 30ml balloon)


Outcome Measures
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Primary Outcome Measures :
  1. Efficiency of induction [ Time Frame: 24 hours. ]
    Number of Participants with vaginal births within 24 hours.


Secondary Outcome Measures :
  1. Safety for baby [ Time Frame: 5 min ]
    Rate of cases Apgar score <7 points

  2. Safety for mother [ Time Frame: during the labour induction ]
    incidence of hyperstimulation


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 49 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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 )
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06056141


Locations
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Kazakhstan
City Perinatology Centre 3
Almaty, Kazakhstan, 050062
Center for Perinatology and Pediatric Cardiac Surgery
Almaty, Kazakhstan, A15H0K1
Sponsors and Collaborators
Kazakhstan's Medical University "KSPH"
Asfendiyarov Kazakh National Medical University
More Information
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Responsible Party: Dilfuza Sultanmuratova, principal investigator, Kazakhstan's Medical University "KSPH"
ClinicalTrials.gov Identifier: NCT06056141    
Other Study ID Numbers: IRB-23-2023
First Posted: September 28, 2023    Key Record Dates
Last Update Posted: January 17, 2024
Last Verified: January 2024

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dilfuza Sultanmuratova, Kazakhstan's Medical University "KSPH":
Induction of labor
low dose misoprostol
Foley Catheter
Additional relevant MeSH terms:
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Misoprostol
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
 Physiological Effects of Drugs
Anti-Ulcer Agents
Gastrointestinal Agents
Oxytocics