Uterine Artery Doppler Flow Velocimetry Parameters for Predicting the Occurrence of Persistent Gestational Trophoblastic Neoplasia After Evacuation of Complete Hydatiform Mole

NCT ID: NCT07333326

Last Updated: 2026-01-12

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 175 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2026-01-10
• Study Completion Date: 2027-02-10

Brief Summary

This Prospective study will be conducted To copare uterine blood flow using Doppler ultrasound before and after evacuation of hydatiform mole between female patients with remissions and those with development of post-molar persistent gestational trophoblastic neoplasia to detect accuracy,efficacy,predictive value and acceptability of uterine artery doppler in predicting gestional trophoblastic neoplasia .

Detailed Description

Progression of complete hydatidiform mole to gestational trophoblastic neoplasia was reported to occur in 9 - 20% of patients. Suction curettage is considered the standard method of complete hydatiform mole evacuation .

Identification of occurrence of post-molar malignancy was detected during follow-up by serial assessment of serum human chorionic gonadotropin (hCG) . hCG rising or plateau mostly points to progression to malignancy thus requiring chemotherapy.Predicting liability to occurrence of post-molar malignancy mainly in patients with difficult continuous assessment of hCG is very important for adequate prompt management avoiding exposure to unnecessary chemotherapy .

There are many established predictive factors of post-molar malignancy as; patients age, size of ovaries, size of uterus, previous molar pregnancy, serial assessment of hCG level ,levels of vascular endothelial growth factor,TGF- beta 3 and HIF- 1alpha.

Moreover Trans-vaginal ultrasound with power Doppler might be used as a predictive factor for delayed response and resistance to chemotherapy particularly low-risk trophoblastic diseases .

Pelvic Doppler ultrasound is considered an essential diagnostic tool for evaluating uterine size and blood flow in patients with gestational trophoblastic neoplasia.

Additionally changes in flow resistance might be able to assess appropriate chemotherapeutic regimen for management of gestational trophoblastic neoplasia in addition to evaluating chemotherapy response .

Dopplerultrasound which is anoninvasive procedure for functional assessment of neo-vascularization,could assess patterns of highly abnormal flow in cases with invasive gestational trophoblastic neoplasia about two weeks post-evacuation before appearance of gross lesions and before marked risng hCG levels .

However, it is still controversial whether evaluation of Doppler flow velocimetry (DFV)parameters of uterine artery was a good predictorof gestational trophoblastic neoplasia after complete hydatiform mole evacuation .

Conditions

Gestational Trophoblastic Neoplasia; Complete Hydatiform Mole

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• Patients with confirmed diagnosis of complete hydatiform mole.
• Hemodynamically stable patient .
• No contraindication for anesthetic materials used for the evacuation .
• Acceptance of possible prolonged follow up , repeated uterine artery doppler ultrasound ,repeated HCG tests

Exclusion Criteria

• Patient refusal to participate in the study.
• Patient with incomplete hydatiform mole .
• Patients who were lost during the follow-up period after this procedure.
• Contraindication for anesthetic materials used for the evacuation .

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Minia University

OTHER

Sponsor Role: lead

Responsible Party

Montaser Ismail

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Montaser Ismail Mahmoud, Assistant lecturer

Role: PRINCIPAL_INVESTIGATOR

Minia University

Central Contacts

Mohamed Tawfiek Gad el Rab, Professor

Role: CONTACT

mohammedtawfiek@gmail.com

+201061174636

Momen Mohamed Hassan, Professor

Role: CONTACT

montaserismail15@gmail.com

+201015224982

Other Identifiers

UD-GTN-2025-1

Identifier Type: -

Identifier Source: org_study_id