Comparison of oral misoprostol vs intracervical Foley catheter for 24 hours for preparation of uterine cervix before induction of labour
Not Applicable
- Conditions
- Cervical ripening
- Registration Number
- SLCTR/2014/030
- Lead Sponsor
- Department of Obstetrics & Gynecology
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow up complete
- Sex
- Not specified
- Target Recruitment
- Not specified
Inclusion Criteria
1.Women with uncomplicated pregnancies at 40 weeks+ 6 days gestation with a Modified Bishop score (MBS)<5
2.Having a singleton fetus in a cephalic presentation
Exclusion Criteria
1.Pregnancy Induced Hypertension
2.Gestational Diabetes Mellitus
3.Multiple pregnancies
4.Planned Caesarean section,
5.Fetal Growth Restriction ,
6.Scarred uteruses
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.Number of women establishing spontaneous onset of labour (SOL) within 24 hours of the interventions.<br>2.MBS after 24 hours of the interventions<br>3.The change of MBS after 24 hours of the interventions <br>4.Number of women with MBS> 7 after 24 hours of the interventions <br>5.The induction delivery interval following Induction of labor (IOL) with amniotomy and oxytocin intravenous infusion,24 hours after the interventions, in those favourable for IOL<br><br> [After 24 hours of the interventions]<br>
- Secondary Outcome Measures
Name Time Method 1. Mode of delivery and the reason for operative delivery<br>2. Oxytocin use <br>3. Maternal morbidity<br>•Post partum blood transfusion and number of packed cells <br>•Tachysystole<br>•Hyperstimulation<br>•Uterine rupture <br>•Maternal infection during labour <br>•Use of intravenous antibiotics <br><br><br> 4. Fetal and Neonatal outcome and morbidity: <br>•Fetal tachycardia <br>•Weight at birth <br>•Meconium-stained liquor <br>•Apgar scores <5 at 1 minute <br>•Admission to the neonatal ward/NICU and its reason<br> [Between 24 to 48 hours after the intervention]<br>
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms underlie cervical ripening with misoprostol versus mechanical dilation using Foley catheter?
How does the effectiveness of intracervical Foley catheter compare to standard-of-care oral misoprostol regimens in postdated pregnancies?
Are there specific biomarkers that predict response to mechanical versus pharmacological cervical ripening methods?
What are the potential adverse events associated with prolonged Foley catheter use versus multiple oral misoprostol doses?
What combination therapies or alternative compounds show promise alongside cervical ripening agents like misoprostol?