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Comparison between dinoprostone pessary and dinoprostone gel for induction of labour

A RANDOMIZED TRIAL TO COMPARE VAGINAL DINOPROSTONE PESSARY WITH INTRACERVICAL DINOPROSTONE GEL FOR PRE-INDUCTION CERVICAL RIPENING

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/06/034118
Enrollment
100
Registered
2021-06-09
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

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

Conditions

Health Condition 1: O998- Other specified diseases and conditions complicating pregnancy, childbirth and the puerperium

Interventions

Intervention1: Induction of labour with Intravaginal dinoprostone Pessary: patient comes for induction of labour and meets inclusion criteria
Willing to participate in study followed by written consent. After selection of subject
induction of labour will be done by intravaginal dinoprostone pessary (10mg). Determination of VAS Determination of Bishop score after every 8 hours, If Bishop score is 6. Either patient will go in sp
labour outcome and neonatal outcome will be recorded. Control Intervention1: Induction of labour with intracervical dinoprostone gel: patient comes for induction of labour and meets inclusion criter
induction of labour will be done by intracervical dinoprostone gel. Determination of VAS Determination of Bishop score after every 8 hours, If Bishop score is 6. Either patient will go in spontaneous
which counts for 24 hours. After monitoring and management of labour
labour outcome and neonatal outcome will be recorded.

Sponsors

nil
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Singleton pregnancy with cephalic presentation 2. Gestational age �34weeks 3. Bishop score �6 4. Intact membranes 5. Reactive non-stress test 6.Absence of uterine contractions

Exclusion criteria

Exclusion criteria: 1. Uterine scar 2. Antepartum haemorrhage 3. Intrauterine fetal anomaly or death 4. Cervicovaginal infection 5. Heart disease, seizure disorder, severe anaemia, uncontrolled diabetes 6. Severe fetal growth restriction, severe pre-eclampsia 7. Parity >3 8.Previous history of uterine hypertonus, asthma or glaucoma

Design outcomes

Primary

MeasureTime frame
To compare the induction delivery interval (IDI) with the two methods used for cervical ripening and IOLTimepoint: from time of induction to delivery time—

Secondary

MeasureTime frame
1. Change in Bishop score after 8 hours 2. Caesarean section (CS) rate 3. Uterine contraction abnormalities 4. Neonatal outcome [Birth weight, Apgar score at 1 and 5 minutes, need of resuscitation, meconium aspiration syndrome, need for neonatal intensive care unit (NICU) stay, mortality] 5. Patientââ?¬â?¢s discomfort measured by Visual Analog Scale (VAS) score after instillation of cervical ripening agent Timepoint: from time of induction to delivery time—

Countries

India

Contacts

Public ContactDr Mamta Choudhary

Postgraduate Institute of Medical and Research

drvanitajain@yahoo.com

Outcome results

None listed

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