Sequential Use of Foley's Catheter and Misoprostol Versus Misoprostol Alone for Induction of Labour: a Multicentre Randomised Controlled Trial

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Induction of Labor
• Intervention / Treatment: Drug: Misoprostol 200mcg Tab; Combination product: Misoprostol 200mcg Tab

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 Type: Interventional
• Enrollment (Estimated): 400
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: DILFUZA SULTANMURATOVA; Phone Number: +77787420209; Email: sultanmuratova.dd@Gmail.com

Study Locations

• Kazakhstan
  • Almaty, Kazakhstan, A15H0K1
    • Center for Perinatology and Pediatric Cardiac Surgery
  • Almaty, Kazakhstan, 050062
    • City Perinatology Centre 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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 All cases when physiological childbirth is impossible (placenta previa,transverse position of the fetus )

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Foley catheter + misoprostol; -cervical ripening with transcervical Foley catheter 22 F for 16 hours, then sequentially 25 μg oral misoprostol once every 2 hour.Max 200 μg	Combination product: Misoprostol 200mcg Tab; 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; Other Names: Transcervical Foley catheter (silicone, size 20F with 30ml balloon)
Active Comparator: misoprostol; 25 μg oral misoprostol alone once every 2 hour, Max 200 μg.	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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety for baby	Rate of cases Apgar score <7 points	5 minutes
Safety for mother	incidence of hyperstimulation	24 hour
rete of hemorrage	bleeding more than 500 ml during the vaginal delivery, more than 1000 ml after c-section	24 hour
rate of chorioamnionitis chorioamnionitis	meconial amniotic fluid, tachycardia, leukocytosis	24 hour

Collaborators and Investigators

• Sponsor: Kazakhstan's Medical University "KSPH"
• Collaborators: Asfendiyarov Kazakh National Medical University

Study record dates

Study Major Dates

• Study Start (Estimated): March 15, 2024
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: January 12, 2024
• First Submitted That Met QC Criteria: February 6, 2024
• First Posted (Actual): February 8, 2024

Study Record Updates

• Last Update Posted (Actual): March 15, 2024
• Last Update Submitted That Met QC Criteria: March 13, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Induction of labor; Foley Catheter; low dose misoprostol
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Gastrointestinal Agents; Reproductive Control Agents; Anti-Ulcer Agents; Abortifacient Agents, Nonsteroidal; Abortifacient Agents; Oxytocics; Misoprostol
• Other Study ID Numbers: IRB-23-2024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No