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Technique of foley insertion - A randomised clinical trial

Comparison of digital and speculum guided methods of transcervical Foley catheter placement on failure rates and insertion related pain among Primigravida undergoing cervical ripening at term gestation: A Randomised Controlled Trial.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/07/035081
Enrollment
446
Registered
2021-07-23
Start date
Unknown
Completion date
Unknown
Last updated
2023-07-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: O80- Encounter for full-term uncomplicated delivery

Interventions

Intervention1: Group A â??Digital placement arm: Women undergoing preinduction cervical ripening using digital placement of transcervical Foley catheter. Control Intervention1: Group B-Speculum placem

Sponsors

JIPMER Puducherry
Lead Sponsor

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
To compare the effect of digital technique of transcervical Foley placement with speculum technique among Primigravida at term gestation undergoing cervical ripening on â?? 1.Failure rate 2.Insertion related pain Timepoint: 1.Failure rate- immediately assessed 2.Insertion related pain- with 30 minutes of insertion—

Secondary

MeasureTime frame
1.Maternal satisfaction 2.Time taken for successful insertion of Foley 3.Fever within 24 hrs of insertion 4.Insertion related obstetric Complications Timepoint: 1.Maternal satisfaction- assessed within 30 minutes 2.Time taken for successful insertion of Foley-assessed immediately 3.Fever within 24 hrs of insertion- assessed within 24hrs 4.Insertion related obstetric Complications- assessed immediately—

Countries

India

Contacts

Public ContactDr Apurva Maheshwari

JIPMER

dr.niveditajha@gmail.com9487581663

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026