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Not yet recruitingNCT07333326Updated Jan 12, 2026

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

An observational study in Gestational Trophoblastic Neoplasia and Complete Hydatiform Mole, sponsored by Minia University. Not yet recruiting. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2026-01-12.

Sponsored by Minia University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
175
Ages
18 Years to 45 Years
Sex
Female
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Study 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 .

Read the 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 .

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Conditions studied

  • Gestational Trophoblastic Neoplasia
  • Complete Hydatiform Mole

Keywords

  • Gestational trophoblastic neoplasia
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In context

Gestational Trophoblastic Disease

57 studies on the registry are indexed under Gestational Trophoblastic Disease; 16 are open to participants now.

This study's planned enrollment of 175 is above the median of 150 across 13 observational studies indexed under Gestational Trophoblastic Disease.

Browse Gestational Trophoblastic Disease studies →

Lead sponsor

Minia University is the lead sponsor of 370 studies on the registry; 117 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Female 18:45 years with complete hydatiform mole

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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.
  • for anesthetic materials used for the evacuation .
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
175 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Uterine artery Doppler flow velocimetry

    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

    Time frame: We will perform DFV of uterine arteries on both sides at admission and 4 - 6 weeks after evacuation.

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 12, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07333326
Lead sponsor
Minia University
Responsible party
Montaser Ismail (Principal investigator, Minia University) — Principal investigator
First posted
Jan 12, 2026
Start date
Jan 10, 2026 (estimated)
Primary completion
Jan 10, 2027 (estimated)
Completion
Feb 10, 2027 (estimated)
Last update
Jan 12, 2026

Study contacts

Mohamed Tawfiek Gad el Rab, Professor
Contact
mohammedtawfiek@gmail.com
+201061174636
Momen Mohamed Hassan, Professor
Contact
montaserismail15@gmail.com
+201015224982
Montaser Ismail Mahmoud, Assistant lecturer
principal investigator · Minia University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.

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