Role of medical therapyfor preventing malignant changes in high risk molar pregnancy

Post evacuation chemoprophylaxis with single dose injection methotrexate to prevent GTN in high risk patients

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2017/09/009723

Enrollment

Registered

2017-09-12

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

Health Condition 1: null- Patients with high risk molar pregnancy

Interventions

Intervention1: injection Methotrexate 100mg intramuscular single dose: group 1-Post evacuation Chemo prophylaxis with injection methotrexate group 2- follow up with serum beta hcg monitoring(control)

Eligibility

Inclusion criteria

Inclusion criteria: 60 patients with pelvic ultrasound showing complete mole having serum beta human chorionic gonadotrophin more than 100000 IU/L,uterine size larger for dates,presence of bilateral theca lutein cysts

Exclusion criteria

Exclusion criteria: partial mole,histological evidence of chorio ca,previous history of molar pregnancy,total leucocyte count less than 2500/mm3,neutrophil count less than 1500/mm3,SGOT more than 50IU/ml

Design outcomes

Primary

Measure	Time frame
effect of methotrexate on duration of normalisation and regression pattern of serum beta hcgTimepoint: with in 8 weeks of evacuation	—

Secondary

Measure	Time frame
Incidence of GTD in patients receiving chemoprophylaxisTimepoint: serum beta hcg more than 20,000mIU/ml after 4 weeks of evacuation,raised beta hcg after 6 months of evacuation	—

Countries

India

Contacts

Public ContactJhuma Biswas

Bankura Sammilani Medical College

drjhumabiswas@yahoo.in9433019780

Outcome results

None listed

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