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A Clinical Trial comparing the Efficacy of Two Drug Regimens for Second-Trimester Pregnancy termination

Randomized controlled trial comparing efficacy between a vaginal misoprostol loading and non-loading dose regimen for second-trimester pregnancy termination - Nil

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/09/057640
Enrollment
60
Registered
2023-09-14
Start date
Unknown
Completion date
Unknown
Last updated
2023-09-18

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

Conditions

Health Condition 1: O048- (Induced) termination of pregnancywith other and unspecified complications

Interventions

Intervention1: Group A: Loading dose misoprostol regimen: 30 women receive 200mg mifepristone and followed after 48 hours by 800mcg misoprostol, which is subsequently followed by 5 doses of 400mcg mis

Sponsors

Dr Rajendra Prasad Government Medical College Kangra
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients aged 18 to 40 years 2. Singleton pregnancy

Exclusion criteria

Exclusion criteria: 1. Incomplete/Inevitable abortion 2. Any contraindication to prostaglandins and/or its analogues (asthma, glaucoma, any history suggestive of allergy to misoprostol) 3. Previous scared uterus (caesarean section/ hysterotomy) 4. Any uterine anomaly (as evident on ultrasonography) 5. Renal failure, respiratory distress, adrenal insufficiency, liver failure, cardiovascular diseases and uncontrolled seizures disorders 6. Blood clotting disease or on anticoagulant therapy. 7. Anaemia (haemoglobin

Design outcomes

Primary

MeasureTime frame
a.Successful abortion (complete abortion) within 36 h b.The induction-to-abortion interval from the start of treatment to expulsion of foetus c.The dosage of Misoprostol used Timepoint: a.Successful abortion (complete abortion) within 36 h b.The induction-to-abortion interval from the start of treatment to expulsion of foetus c.The dosage of Misoprostol used

Secondary

MeasureTime frame
Failure rateTimepoint: 3 hours post 5th dose of misoprostol ;side effects Timepoint: During & post 48 hours of delivery;The need of blood transfusionTimepoint: During & post 48 hours of delivery

Countries

India

Contacts

Public ContactDr Anjali Soni

Dr Rajendra Prasad Government Medical College, Kangra at Tanda

ishumehta95@gmail.com7018044695

Outcome results

None listed

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