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RecruitingNCT06554470Updated Aug 16, 2024

Local vs Systemic Methotrexate in Management of Uterine Ectopic Pregnancy

An interventional study of Systemic Methotrexate and Local Methotrexate in Local, Systemic and Methotrexate, sponsored by Tanta University. Recruiting at 1 site in Egypt. Open to female participants aged 20 Years to 40 Years. Per ClinicalTrials.gov, last updated 2024-08-16.

Sponsored by Tanta University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jul 2025, 1 year 4 months ago, but the record still lists the study as recruiting.
  • Started Aug 2024; still recruiting 2 years 2 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
34
Allocation
Randomized
Ages
20 Years to 40 Years
Sex
Female
01

Study 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 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.

02

Conditions studied

  • Local
  • Systemic
  • Methotrexate
  • Uterine Ectopic Pregnancy

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03

In context

Pregnancy, Ectopic

83 studies on the registry are indexed under Pregnancy, Ectopic; 21 are open to participants now.

This study's planned enrollment of 34 is below the median of 100 across 43 interventional studies indexed under Pregnancy, Ectopic.

Browse Pregnancy, Ectopic studies →

Lead sponsor

Tanta University is the lead sponsor of 1,010 studies on the registry; 321 are open to participants now.

Of its 15 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
20 Years to 40 Years
Sexes eligible
Female
Accepts healthy volunteers
No

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

  • 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.

Exclusion criteria

Exclusion Criteria:

  • Patients with basal beta hCG levels less than 1500 mIU/Ml.
  • Any 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.
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.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
34 participants (estimated)

Study arms

  • Experimental
    Systemic Methotrexate

    Patients will receive systemic methotrexate (intramuscular; 50 mg/m2 body weight).

    Drug: Systemic Methotrexate

  • Experimental
    Local Methotrexate

    Patients will receive local methotrexate (25 mg methotrexate as a fixed dose).

    Drug: Local Methotrexate

Interventions

  • DrugSystemic Methotrexate

    Patients will receive systemic methotrexate (intramuscular; 50 mg/m2 body weight).

  • DrugLocal Methotrexate

    Patients will receive local methotrexate (25 mg methotrexate as a fixed dose).

06

What researchers measure

Primary outcomes

  1. Time for serum b-hCG remission

    Time for serum b-hCG remission will be recorded to be less than 20 iu/ml.

    Time frame: Post intervention for 3 months

Secondary outcomes

  1. Success rate

    Success rate will be recorded.

    Time frame: Post intervention for 3 months

  2. Time for uterine-mass disappearance

    Time for uterine-mass disappearance will be recorded.

    Time frame: Post intervention for 3 months

  3. Hospitalization time

    Hospitalization time will be recorded from admission till discharge from hospital.

    Time frame: 15 days after intervention

07

Study locations

1 of 1 sites recruiting
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References and documents

Individual participant data

Plan to share: Yes — The data will be available upon a reasonable request from the corresponding author after the end of study for one year.

Supporting information: Study protocol

Time frame: After the end of study for one year.

Access criteria: The data will be available upon a reasonable request from the corresponding author.

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 Aug 16, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06554470
Lead sponsor
Tanta University
Responsible party
Mai Nabil Ageez (Lecturer of Obstetrics and Gynecology, Faculty of Medicine, Tanta University, Tanta, Egypt., Tanta University) — Principal investigator
First posted
Aug 15, 2024
Start date
Aug 15, 2024
Primary completion
Jul 1, 2025 (estimated)
Completion
Jul 1, 2025 (estimated)
Last update
Aug 16, 2024

Study contacts

Mai N Ageez, MD
Contact
mai.ageez@med.tanta.edu.eg
00201062388870

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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