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| Name | Class |
|---|---|
| Asfendiyarov Kazakh National Medical University | OTHER |
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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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Foley catheter + misoprostol | Active Comparator | -cervical ripening with transcervical Foley catheter 22 F for 16 hours, then sequentially 25 μg oral misoprostol once every 2 hour.Max 200 μg |
|
| misoprostol | Active Comparator | 25 μg oral misoprostol alone once every 2 hour, Max 200 μg. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Misoprostol 200mcg Tab | Combination Product | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Efficiency of induction | Number of Participants with vaginal births | 24 hours. |
| Measure | Description | Time Frame |
|---|---|---|
| Safety for baby | Rate of cases Apgar score <7 points | 5 minutes |
| Safety for mother | incidence of hyperstimulation | 24 hour |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Saule Issenova | Asfendiyarov Kazakh National Univercity | Study Chair |
| DILFUZA SULTANMURATOVA | Kazakhstans Medical Uivercity | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City Perinatology Centre 3 | Almaty | 050062 | Kazakhstan | |||
| Center for Perinatology and Pediatric Cardiac Surgery |
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|
| 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 |
|
| 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 |
| Almaty |
| A15H0K1 |
| Kazakhstan |
| ID | Term |
|---|---|
| D016595 | Misoprostol |
| D012828 | Silicones |
| ID | Term |
|---|---|
| D011459 | Prostaglandins E, Synthetic |
| D011465 | Prostaglandins, Synthetic |
| D011453 | Prostaglandins |
| D015777 | Eicosanoids |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |
| D012833 | Siloxanes |
| D017646 | Organosilicon Compounds |
| D009930 | Organic Chemicals |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
| D001697 | Biomedical and Dental Materials |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
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