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A study comparing insertion of foley catheter through the cervix to sublingual misoprostol for delivering pregnant with high blood pressure between 28- 34 weeks.

Efficacy of combination of Foleys transcervical catheter and sublingual Misoprostol versus sublingual Misoprostol for induction of labour in Hypertensive disorders of pregnancy between 28-34 weeks- A Randomised Controlled Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2018/09/015766
Enrollment
140
Registered
2018-09-19
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: O149- Unspecified pre-eclampsia

Interventions

Intervention1: Transcervical Foley 22 French plus Misoprostol: 22f Foley placed transcervically for 24 hours along with 25 microgram Misoprostol given 4 hourly till maximum 4 doses Control Interventio

Sponsors

JIPMER
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Gestational age between 28-34 weeks. UNfavourable cervix defined by BISHOP score Hypertensive disorders of pregnancy defined as per ACOG 2013 which includes- Gestational hypertension, pre eclampsia, Chronic hypertension with or without superimposed pre eclampsia.

Exclusion criteria

Exclusion criteria: Rupture of membranes. Placenta Previa Abruptio placenta. Allergy to Misoprostol Previous uterine surgeries.

Design outcomes

Primary

MeasureTime frame
Vaginal delivery within 24 hoursTimepoint: 24 hours from start of induction of labor—

Secondary

MeasureTime frame
1.Induction to delivery interval 2.Side effects of Misoprostol 3.Fetal complications like fetal heart rate abnormalities, Meconeum aspiration. Clinical evidence of puerperal sepsis. 5. Neonatal complications- sepsis, HIE, NICU admissionsTimepoint: 24 hours to 1 weeek—

Countries

India

Contacts

Public ContactHaritha Sagili

JIPMER

harithasagili@gmail.com9489390630

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 11, 2026