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

Induction of Labor Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06249815
• Other study ID #: IRB-23-2024
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: April 26, 2024
• Est. completion date: December 31, 2024

Study information

• Verified date: April 2024
• Source: Kazakhstan's Medical University "KSPH"
• Contact: DILFUZA SULTANMURATOVA
• Phone: +77787420209
• Email: sultanmuratova.dd[@]Gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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)

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 400
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 49 Years

Eligibility

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 )

Related Conditions & MeSH terms

• Induction of Labor

Intervention

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

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

Locations

Country	Name	City	State
Kazakhstan	Center for Perinatology and Pediatric Cardiac Surgery	Almaty
Kazakhstan	City Perinatology Centre 3	Almaty

Sponsors (2)

Lead Sponsor	Collaborator
Kazakhstan's Medical University "KSPH"	Asfendiyarov Kazakh National Medical University

Country where clinical trial is conducted

Kazakhstan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficiency of induction	Number of Participants with vaginal births	24 hours.
Secondary	Safety for baby	Rate of cases Apgar score <7 points	5 minutes
Secondary	Safety for mother	incidence of hyperstimulation	24 hour
Secondary	rete of hemorrage	bleeding more than 500 ml during the vaginal delivery, more than 1000 ml after c-section	24 hour
Secondary	rate of chorioamnionitis chorioamnionitis	meconial amniotic fluid, tachycardia, leukocytosis	24 hour