Second Uterine Evacuation for Low-risk Gestational Trophoblastic Neoplasia

• Status: Recruiting
• Trial end date: 2025-12-31
• Target enrollment: 0
• Participant gender: Female

Summary

To evaluate the efficacy and safety of second uterine curettage in patients with low-risk non-metastatic GTN.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Brigham and Women's Hospital
• Collaborator: Maternidade Escola da Universidade Federal do Rio de Janeiro

Criteria

Inclusion Criteria:

• Histopathological diagnosis of molar pegnancy according to the morphological criteria described by Sebire et al., who meet the diagnostic criteria for low-risk non-metastatic GTN according to FIGO 2000 criteria

Exclusion Criteria:

1. High risk GTN (FIGO risk score ≥ 7) or metastatic disease at diagnosis of GTN (stage II, III or IV);

2. Histopathological diagnosis of choriocarcinoma, placental site trophoblastic or epithelioid trophoblastic tumor at the second curettage;

3. Previous chemotherapy treatment;

4. Level of hCG at the time of GTN diagnosis less than 20 IU/L (to minimize the risk of inclusion of patients with false positive hCG, either by cross-reaction with pituitary hormones or by the presence of circulating heterophilic antibodies);

5. Relapsed GTN;

6. Incomplete medical records.

7. Loss to follow-up;

8. Voluntary desire to stop participating in the study.