A Phase 4 interventional study of Misoprostol 200mcg Tab and Misoprostol 200mcg Tab in Induction of Labor, sponsored by Kazakhstan's Medical University "KSPH". Completed at 2 sites in Kazakhstan. Open to female participants aged 18 Years to 49 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-02-21.
Sponsored by Kazakhstan's Medical University "KSPH" · Phase 4, Interventional, and Treatment
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.
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)
Kazakhstan's Medical University "KSPH" is the lead sponsor of 4 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
-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
25 μg oral misoprostol alone once every 2 hour, Max 200 μg.
Drug: 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
Also known as: Transcervical 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
Efficiency of induction
Number of Participants with vaginal births
Time frame: 24 hours.
Safety for baby
Rate of cases Apgar score \<7 points
Time frame: 5 minutes
Safety for mother
incidence of hyperstimulation
Time frame: 24 hour
rete of hemorrage
bleeding more than 500 ml during the vaginal delivery, more than 1000 ml after c-section
Time frame: 24 hour
rate of chorioamnionitis chorioamnionitis
meconial amniotic fluid, tachycardia, leukocytosis
Time frame: 24 hour
Plan to share: Yes
Supporting information: Study protocol, Clinical study report
No publications or documents are linked to this record.
This study is completed, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Misoprostol
Kazakhstan's Medical University "KSPH"