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

Uterine Artery Doppler Flow Velocimetry Parameters for Predicting the Occurrence of Persistent Gestational Trophoblastic Neoplasia After Evacuation of Complete Hydatiform Mole ( a Prospective Cohort Study)

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07333326
Enrollment
175
Registered
2026-01-12
Start date
2026-01-10
Completion date
2027-02-10
Last updated
2026-01-12

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

Conditions

Complete Hydatiform Mole, Gestational Trophoblastic Neoplasia

Keywords

Gestational trophoblastic neoplasia

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 .

Interventions

None listed

Sponsors

Minia University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No

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 .

Design outcomes

Primary

MeasureTime frameDescription
Uterine artery Doppler flow velocimetryWe will perform DFV of uterine arteries on both sides at admission and 4 - 6 weeks after evacuation.First the patient will evaluate the urinary bladder Positioning of patient:supine position Amidsagittal section of uterus and cervical canal is obtained and the transducer is moved laterally untill the paracervical vessels are visualized color flow doppler is applied the uterine arteriesare seen as aliasing vessels along the side of the cervix Uterine artery doppler indices will be measured PSV=peak systolic velocity EDV=end diastolic velocity TAMV=time average medium velocity P.I(pulsatile index)=PSV-EDV/TAMV R.I(resistance index)=(PSV-EDV)/PSV SD(systolic diastolic ratio)=PSV/EDF

Contacts

Primary ContactMohamed Tawfiek Gad el Rab, Professor
mohammedtawfiek@gmail.com+201061174636
Backup ContactMomen Mohamed Hassan, Professor
montaserismail15@gmail.com+201015224982

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026