Gestational Trophoblastic NeoplasiaNCT07333326
Uterine Artery Doppler Flow Velocimetry Parameters for Predicting the Occurrence of Persistent Gestational Trophoblastic Neoplasia After Evacuation of Complete Hydatiform Mole
An observational study of Gestational Trophoblastic Neoplasia and Complete Hydatiform Mole, run by Minia University.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Gestational Trophoblastic Neoplasia, Complete Hydatiform Mole
- How many people
- 175 participants
- Where
- No sites listed yet
- Study dates
- 10 Jan 2026to 10 Feb 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Study population: Female 18:45 years with complete hydatiform mole
Who may be able to join
- 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
Who cannot join
- 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 .
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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)
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 .
- Keywords
- Gestational trophoblastic neoplasia
- Medical subject headings
- Gestational Trophoblastic Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: We will perform DFV of uterine arteries on both sides at admission and 4 - 6 weeks after evacuation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2026
- Study start10 Jan 2026 (estimated)
- Primary completion10 Jan 2027 (estimated)
- Study completion10 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gestational Trophoblastic NeoplasiaStudies of the same condition, open and under way.
- More trials run by Minia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 175 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Montaser Ismail, Minia University
- Investigators
- Montaser Ismail Mahmoud, Assistant lecturer, Principal investigator, Minia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07333326
- Sponsor's protocol ID
- UD-GTN-2025-1
- Status last verified
- Dec 2025
- First submitted
- 17 Dec 2025
- Last updated
- 12 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT07333326
- Acronym / sponsor ID
- UD-GTN-2025-1
- Keywords
- Gestational trophoblastic neoplasia
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 175 participants (estimated)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 10 Jan 2026 (estimated)
- Primary completion
- 10 Jan 2027 (estimated)
- Study completion
- 10 Feb 2027 (estimated)
- First posted
- 12 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 .
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Female 18:45 years with complete hydatiform mole
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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 .
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Uterine artery Doppler flow velocimetry
Time frame: We 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Montaser Ismail Mahmoud, Assistant lecturer principal investigator
Minia University
Questions about this trial
What is this clinical trial studying?
An observational study of Gestational Trophoblastic Neoplasia and Complete Hydatiform Mole, run by Minia University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 12 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mohamed Tawfiek Gad el Rab, Professor (+201061174636, mohammedtawfiek@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Uterine artery Doppler flow velocimetry (time frame: We will perform DFV of uterine arteries on both sides at admission and 4 - 6 weeks after evacuation.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2026.