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to study the safety and efficacy of a mechanical osmotic dilator device for making the uterine cervix mature to respond to labor pain inducing agents in women with previous delivery by caesarean.

Study of efficacy and safety of hygroscopic dilators for pre-induction ripening of cervix in women with previous one caesarean section undergoing trial of vaginal delivery.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2019/03/017927
Enrollment
81
Registered
2019-03-06
Start date
Unknown
Completion date
Unknown
Last updated
2023-02-06

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

Conditions

Health Condition 1: O758- Other specified complications of labor and delivery

Interventions

Intervention1: hygroscopic dilator for ripening of cervix: After approval of the project for funding and after approval from JIPMER scientific advisory Council and Ethics Committee, the study will be

Sponsors

JIPMER
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: a. Women with age >18 years b. Women with previous single lower segment caesarean delivery c. Singleton pregnancy more than 37 weeks requiring induction of labour. d. Vertex presentation e. Eligible for trial of labour after caesarean (TOLAC) Eligibility for Trial Of labour after caesarean as per the Department protocol include: i. Inter pregnancy interval greater than18 months ii. Estimated fetal weight less than 3.5 kg as per the scan iii. Non-recurrent indication for previous section iv. Previous scar restricted to lower segment v. Scar thickness more than 3 mm. vi. Previous caesarean should not have been done for placenta previa, transverse lie, preterm and late in second stage of labor. vii. No clinical evidence of uterocervical infections after previous caesarean section. viii. No clinical evidence of cephalopelvic disproportion

Exclusion criteria

Exclusion criteria: 1 Multiple gestations. 2 Women not willing for trial of labour after caesarean. 3 Women with premature rupture of membranes

Design outcomes

Primary

MeasureTime frame
Among women with previous one caesarean section with unfavorable cervix undergoing trial of vaginal delivery 1. To study the vaginal birth rates with the use hygroscopic dilators used for ripening cervix before induction of labour 2. To study the safety of hygroscopic dilators Timepoint: from application till delivery—

Secondary

MeasureTime frame
To study the rate of improvement of bishop score with the use of hygroscopic dilatorsTimepoint: before application and 24 hours after application or earlier anytime if labour starts.—

Countries

India

Contacts

Public ContactGowri Dorairajan

Professor Obstetrics and Gynecology Department. JIPMER

gowridorai@hotmail.com9894348518

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 6, 2026