Technique of foley insertion - A randomised clinical trial
Not Applicable
Completed
- Conditions
- Health Condition 1: O80- Encounter for full-term uncomplicated delivery
- Registration Number
- CTRI/2021/07/035081
- Lead Sponsor
- JIPMER Puducherry
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 446
Inclusion Criteria
1.Primigravida of more than or equal to 18 years of age
2.Bishop score less than or equal to 5
3.Term gestation (37 or more weeks of gestation)
4.Singleton pregnancy with Cephalic presentation
5.Intact membranes
6.Reassuring preinduction fetal heart rate tracing
Exclusion Criteria
1.Prior use of an induction agent
2.Suspicion of chorio-amnionitis or reported a fever in the 48 hours before induction
3.Antepartum hemorrhage (Placental Abruption, placenta previa)
4.Latex allergy
5.Contraindications to vaginal delivery
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To compare the effect of digital technique of transcervical Foley placement with speculum technique among Primigravida at term gestation undergoing cervical ripening on â?? <br/ ><br>1.Failure rate <br/ ><br>2.Insertion related pain <br/ ><br>Timepoint: 1.Failure rate- immediately assessed <br/ ><br>2.Insertion related pain- with 30 minutes of insertion <br/ ><br>
- Secondary Outcome Measures
Name Time Method 1.Maternal satisfaction <br/ ><br>2.Time taken for successful insertion of Foley <br/ ><br>3.Fever within 24 hrs of insertion <br/ ><br>4.Insertion related obstetric Complications <br/ ><br>Timepoint: 1.Maternal satisfaction- assessed within 30 minutes <br/ ><br>2.Time taken for successful insertion of Foley-assessed immediately <br/ ><br>3.Fever within 24 hrs of insertion- assessed within 24hrs <br/ ><br>4.Insertion related obstetric Complications- assessed immediately <br/ ><br>