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A study comparing two methods of early expedited delivery using a Foley catheter with either Dinoprostone gel or Misoprostol in pregnant women with severe pre eclampsia after 34 weeks

Combination of Foley/Dinoprostone Gel versus Foley/Misoprostol for early expedited delivery in women with severe preeclampsia undergoing Induction of labor more than 34 weeks gestation - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/12/098720
Enrollment
218
Registered
2025-12-10
Start date
Unknown
Completion date
Unknown
Last updated
2026-01-12

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

Conditions

Health Condition 1: O141- Severe pre-eclampsia

Interventions

Intervention1: Women undergoing Induction of labour with Transcervical foley combined with 4 doses of sublingual misoprostol: For placement of Foleys catheter, women would be asked to lay in dorsal po

Sponsors

JIPMER
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Women more than 18 years of age with severe pre-eclampsia with Bishop score less than or equal to 5, Live, singleton pregnancy with Cephalic presentation more than 34 weeks gestation with unscarred uterus.

Exclusion criteria

Exclusion criteria: 1. Planned for urgent caesarean delivery in view of pulmonary oedema or HELLP Syndrome 2. Foetal anomaly 3. Placental Abruption 4. Stage 2,3 FGR 5. Overt diabetes mellitus/uncontrolled gestational diabetes mellitus

Design outcomes

Primary

MeasureTime frame
Primary outcome under study: Proportion of women delivering within 24 hours of induction. Those delivering within 12 hours, beyond 24 hours will also be noted.Timepoint: 12 hours 24 hours 36 hours

Secondary

MeasureTime frame
1.Changes in Bishop score (Difference between pre induction Bishop & post ripening Bishop) 2.Induction Delivery Interval (IDI), measured as: Duration of Foley insertion to spontaneous expulsion/removal Duration of Foley expulsion/removal to delivery 3.Maternal satisfaction (Annexure 1) Composite of maternal satisfaction score for which participants would be asked to complete a satisfaction within 24 hours of delivery. The questionnaire will consist of five questions, which are to be scored on a Likert scale. The questionnaire will be made available in both the languages namely, English & Tamil. 4.Maternal & Perinatal outcomesTimepoint: 12 hours 24 hours 36 hours

Countries

India

Contacts

Public ContactBhavana R Mashetty

Jawaharlal Institute of Post graduate Medical education and Research

dr.niveditajha@gmail.com9505206669

Outcome results

None listed

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