Ignite Creation Date:
2024-05-06 @ 8:04 PM
Last Modification Date:
2024-10-26 @ 3:20 PM
Study NCT ID:
NCT06249815
Status:
RECRUITING
Last Update Posted:
2024-07-03
First Post:
2024-01-12
Brief Title:
Sequential Use of Foleys Catheter and Misoprostol Versus Misoprostol Alone for Induction of Labour a Multicentre Randomised Controlled Trial
Sponsor:
Kazakhstans Medical University KSPH
Organization:
Kazakhstans Medical University KSPH
Study Overview
Official Title:
Sequential Use of Foleys Catheter and Low Dose Oral Misoprostol Versus Misoprostol Alone for Induction of Labour a Multicentre Randomised Controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Evaluation of efficacy of inducing labour using a Foleys catheter and low dose oral misoprostol sequentially in comparison with low dose oral misoprostol alone
Detailed Description:
a multicentre open-label randomised controlled trial in 2 hospitals in the AlmatyKazakhstan 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 Foleys 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 hoursto evaluate effectiveness and secondary outcoms 1-5-min Apgar score and hospitalization in ICU rate of hyperstimulation hemorragechorioamnionitis for evaluating safety
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None