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Addition of a new drug to the standard regimen of drugs to escalate abortion process in second trimester abortion in pregnancy

Efficacy of addition of vaginal Dinoprostone gel(PGE2) to the mifepristone-misoprostol regimen for the second trimester termination of pregnancy - NIL

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/02/102731
Enrollment
102
Registered
2026-02-02
Start date
Unknown
Completion date
Unknown
Last updated
2026-03-02

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: Dinoprostone gel: reduction in induction to abortion time interval by addition of 1 dinoprostone gel(0.5mg) to the standard regimen of second trimester abortion(oral mifepristone 200 mg

Sponsors

Dr Anjali Kumari
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Women with 12-24 weeks POG elih=gible for second trimester termination of pregnancy as per MTP act. Women with fetal demise between 12-24 weeks Signed informed consent to participate in the study

Exclusion criteria

Exclusion criteria: Women who refuse to give consent for this study. Women with multiple pregnancies. Women with previous Cesarean section. Women with a certain degree of cervical dilatation. Women with allergy or contraindication to either drug Those who have some contraindication to either drug

Design outcomes

Primary

MeasureTime frame
Induction-abortion time interval will be calculated(interval between the adminsitration of first misoprostol dose and the time fetus will be abortedTimepoint: time interval between 1st misoprostol dose and after every 3 hours of misoprostol application till a maximum of 5 doses

Secondary

MeasureTime frame
1. less failure rate 2. Decreased need for surgical evacuation in incomplete cases & comparatively lower side effectsTimepoint: failure rate assessment after a maximum of 5 misoprostol applications

Countries

India

Contacts

Public ContactDr Priyanka Kathuria

Aiims Jodhpur

dr.priyankathuria@gmail.com7014982778

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Mar 14, 2026