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Comparision of different methods to initiate cervical changes before labour.

Evaluation of Efficacy and Safety of Dilapan-S vs Dinoprostone Gel for ripening of cervix prior to induction of labour-A Randomized Control Trial - NIL

Status
Active, not recruiting
Phases
Phase 3Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/04/066341
Enrollment
212
Registered
2024-04-25
Start date
Unknown
Completion date
Unknown
Last updated
2024-04-29

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

Conditions

Health Condition 1: O00-O9A- Pregnancy, childbirth and the puerperium

Interventions

Intervention1: Dilapan-S: Participants will be randomized between Group A (Dilapan-S)and Group B (Dinoprostone gel) at KLES DR Prabhakar Kore Hospital and Medical Research Centre, Belagavi.Cervical ri

Sponsors

Kshirabdhi Tanaya Mohapatra
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1)Singleton pregnancy 2)Term gestation (37-42 weeks) 3)Cephalic presentation 4)Reactive admission NST 5)Bishop score less than or equal to 6 6)Intact Membranes

Exclusion criteria

Exclusion criteria: 1)Previous Lower Segment Cesarean Section 2)Contra-indications of prostaglandins and Vaginal delivery 3)Malpresentation 4)Already diagnosed Mullerian anomalies 5)Hypersensitivity to Prostaglandins and Mifepristone 7)Active Vaginal infections. 8)Placental abnormalities (low lying Placenta)

Design outcomes

Primary

MeasureTime frame
To determine the efficacy of synthetic osmotic cervical dilator (DILAPAN-S) vs Dinoprostone vaginal gel for cervical ripening in induction of labourTimepoint: Baseline (48-72 hours)

Secondary

MeasureTime frame
To determine fetomaternal outcomeTimepoint: Baseline (48-72 hours)

Countries

India

Contacts

Public ContactShridevi Metgud

Jawaharlal Nehru Medical College, KLE University

shridevi.metgud@gmail.com7353195431

Outcome results

None listed

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