LocalNCT06554470
Local vs Systemic Methotrexate in Management of Uterine Ectopic Pregnancy
A study testing Systemic Methotrexate and Local Methotrexate in people with Local and Systemic, run by Tanta University at 1 site in Egypt.
Trial summary
This study aims to compare local and systemic methotrexate in the management of uterine ectopic pregnancy regarding the duration of beta human chorionic gonadotropin (hCG) clearance and need for further management options. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Local, Systemic, Methotrexate
- What is being tested?
- Systemic Methotrexate and Local Methotrexate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Aug 2024to 1 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 20 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Age from 20 to 40 years.
- Women with uterine ectopic pregnancy (interstitial pregnancy, cervical pregnancy, or cesarean scar pregnancy).
- Gestational age is less than 9 weeks, the embryo size is smaller than 10 mm, and the serum beta-human chorionic gonadotropin (β-hCG) levels are less than 10,000 mIU/mL.
Who cannot join
- Patients with basal beta hCG levels less than 1500 mIU/Ml.
- Any contraindications to MTX as a hepatic disorder, renal disorder and thrombocytopenia
- Diabetes mellitus.
- Severe vaginal bleeding or hemodynamic changes or hemoperitoneum.
- History of cancer.
- Ascites.
- Pleural effusion.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Tanta University
Tanta, El-Gharbia, 31527
Mai N Ageez, MD, 00201062388870, mai.ageez@med.tanta.edu.eg
Amr A Habib, MD
About this study
Official title: Local Versus Systemic Methotrexate in Management of Uterine Ectopic Pregnancy: A Randomized Trial
This study aims to compare local and systemic methotrexate in the management of uterine ectopic pregnancy regarding the duration of beta human chorionic gonadotropin (hCG) clearance and need for further management options.
Read the detailed description
Ectopic pregnancy is considered a life-threatening condition which requires immediate intervention. Owing to the advancements in medical technology, ectopic pregnancy can now be diagnosed in the early stages.
Methotrexate (MTX) is an antimetabolite drug showing a competitive reversible binding concerning natural dihydrofolates and acting as an inhibitor of the dihydrofolate-reductase (DHFR), a key enzyme synthesizing the tetrahydrofolates needed for the synthesis of purine and pyrimidine rings.
- Conditions
- Local, Systemic, Methotrexate, Uterine Ectopic Pregnancy
- Being tested
- Systemic Methotrexate, Local Methotrexate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Systemic MethotrexateDrug
Patients will receive systemic methotrexate (intramuscular; 50 mg/m2 body weight).
Local MethotrexateDrug
Patients will receive local methotrexate (25 mg methotrexate as a fixed dose).
| Study group | Role | What they receive |
|---|---|---|
| Systemic Methotrexate | Experimental | Patients will receive systemic methotrexate (intramuscular; 50 mg/m2 body weight). Receives: Drug: Systemic Methotrexate |
| Local Methotrexate | Experimental | Patients will receive local methotrexate (25 mg methotrexate as a fixed dose). Receives: Drug: Local Methotrexate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time for serum b-hCG remission
Time for serum b-hCG remission will be recorded to be less than 20 iu/ml.
Measured: Post intervention for 3 months
Secondary outcomes (3)
Success rate
Success rate will be recorded.
Measured: Post intervention for 3 months
Time for uterine-mass disappearance
Time for uterine-mass disappearance will be recorded.
Measured: Post intervention for 3 months
Hospitalization time
Hospitalization time will be recorded from admission till discharge from hospital.
Measured: 15 days after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2024
- Study start15 Aug 2024
- Primary completion1 Jul 2025 (estimated)
- Study completion1 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LocalStudies of the same condition, open and under way.
- More trials run by Tanta 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mai Nabil Ageez, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06554470
- Sponsor's protocol ID
- 36264PR751/7/24
- Status last verified
- Aug 2024
- First submitted
- 11 Aug 2024
- Last updated
- 16 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Local Versus Systemic Methotrexate in Management of Uterine Ectopic Pregnancy: A Randomized Trial
- ClinicalTrials.gov ID
- NCT06554470
- Acronym / sponsor ID
- 36264PR751/7/24
- Conditions
- Local, Systemic, Methotrexate, Uterine Ectopic Pregnancy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 15 Aug 2024 (actual)
- Primary completion
- 1 Jul 2025 (estimated)
- Study completion
- 1 Jul 2025 (estimated)
- First posted
- 15 Aug 2024 (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 study aims to compare local and systemic methotrexate in the management of uterine ectopic pregnancy regarding the duration of beta human chorionic gonadotropin (hCG) clearance and need for further management options.
Detailed description
Ectopic pregnancy is considered a life-threatening condition which requires immediate intervention. Owing to the advancements in medical technology, ectopic pregnancy can now be diagnosed in the early stages.
Methotrexate (MTX) is an antimetabolite drug showing a competitive reversible binding concerning natural dihydrofolates and acting as an inhibitor of the dihydrofolate-reductase (DHFR), a key enzyme synthesizing the tetrahydrofolates needed for the synthesis of purine and pyrimidine rings.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Systemic Methotrexate | Experimental | Drug: Systemic MethotrexatePatients will receive systemic methotrexate (intramuscular; 50 mg/m2 body weight). |
| Local Methotrexate | Experimental | Drug: Local MethotrexatePatients will receive local methotrexate (25 mg methotrexate as a fixed dose). |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age from 20 to 40 years.
- Women with uterine ectopic pregnancy (interstitial pregnancy, cervical pregnancy, or cesarean scar pregnancy).
- Gestational age is less than 9 weeks, the embryo size is smaller than 10 mm, and the serum beta-human chorionic gonadotropin (β-hCG) levels are less than 10,000 mIU/mL.
Key exclusion criteria (7 listed)
- Patients with basal beta hCG levels less than 1500 mIU/Ml.
- Any contraindications to MTX as a hepatic disorder, renal disorder and thrombocytopenia
- Diabetes mellitus.
- Severe vaginal bleeding or hemodynamic changes or hemoperitoneum.
- History of cancer.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Systemic MethotrexatePatients will receive systemic methotrexate (intramuscular; 50 mg/m2 body weight). | Drug | Systemic Methotrexate |
| Local MethotrexatePatients will receive local methotrexate (25 mg methotrexate as a fixed dose). | Drug | Local Methotrexate |
Primary outcome
Time for serum b-hCG remission
Time frame: Post intervention for 3 months
Time for serum b-hCG remission will be recorded to be less than 20 iu/ml.
3 secondary outcomes
Success rate
Time frame: Post intervention for 3 months
Time for uterine-mass disappearance
Time frame: Post intervention for 3 months
Hospitalization time
Time frame: 15 days after intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2024.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Systemic Methotrexate and Local Methotrexate in people with Local and Systemic, run by Tanta University at 1 site in Egypt.
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 3 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 16 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mai N Ageez, MD (00201062388870, mai.ageez@med.tanta.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time for serum b-hCG remission (time frame: Post intervention for 3 months). 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 16 Aug 2024.