A Study to Compare Adhatoda vasica Root Extract Gel and PGE2 Gel for Induction of Labour in Term Pregnant Women

To evaluate the efficacy of adhatoda vasica root extract gel for induction of labour-a comparative clinical study with pge2 gel - Nil

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/06/111650

Enrollment

Registered

2026-06-01

Start date

Unknown

Completion date

Unknown

Last updated

2026-06-22

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

Conditions

Health Condition 1: O80- Encounter for full-term uncomplicated delivery

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: Gestational age between 37 weeks to 42 weeks of pregnancy Singleton pregnancy Cephalic presentation Indication for labour induction Bishop score is less then and equal 6 No contraindication of vaginal delivery Willing to provide informed consent

Exclusion criteria

Exclusion criteria: Multiple Pregnancy like twins, triplet. Abnormal fetal presentation. Pregnant women with cephalopelvic disproportion. Previous cesarian section, uterine surgery and other uterine surgeries. Obstetric or medical emergencies. Vaginismus. Pregnant women diagnosed with benign or malignant tumor of the reproductive system. Diagnosed case of HIV, HBsAg, and VDRL. High risk pregnancy with hypertensive disorders, gestational diabetes mellitus, pulmonary diseases, renal diseases, psychiatric illness, cardiac disease, epilepsy, severe anemia. Refuse to give informed consent.

Design outcomes

Primary

Measure	Time frame
To compare the efficacy of Adhatoda vasica root extract gel in successful induction of labour as assessed by change in Bishop score and onset of active labour within 24 hoursTimepoint: Baseline Before gel administration 6 hours after gel insertion Bishop score reassessment 12 hours after gel insertion onset and progress of active labour assessment 24 hours after gel insertion successful induction of labour and active labour achievement assessment	—

Measure

Time frame

To compare the efficacy of Adhatoda vasica root extract gel in successful induction of labour as assessed by change in Bishop score and onset of active labour within 24 hoursTimepoint: Baseline Before gel administration 6 hours after gel insertion Bishop score reassessment 12 hours after gel insertion onset and progress of active labour assessment 24 hours after gel insertion successful induction of labour and active labour achievement assessment

—

Secondary

Measure	Time frame
Requirement of oxytocin augmentation Mode of delivery (NVD/Instrumental/LSCS) Need for repeat gel application Maternal adverse effects Fetal outcome Neonatal outcome (APGAR score, NICU admission) Induction failure rateTimepoint: During labour At delivery After 6 hours During labour and 2 hours postpartum During labour and immediately after delivery At 1 minute and 5 minutes after birth Within 24 hours after gel application	—

Measure

Time frame

Requirement of oxytocin augmentation Mode of delivery (NVD/Instrumental/LSCS) Need for repeat gel application Maternal adverse effects Fetal outcome Neonatal outcome (APGAR score, NICU admission) Induction failure rateTimepoint: During labour At delivery After 6 hours During labour and 2 hours postpartum During labour and immediately after delivery At 1 minute and 5 minutes after birth Within 24 hours after gel application

—

Countries

India

Contacts

Public ContactDr Nisha Soni

Pt Khushilal Sharma Government Autonomus Ayurveda College and Institute Bhopal

basantiayu75@gmail.com9827579276

Outcome results