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NCT Number: NCT06554470

Local vs Systemic Methotrexate in Management of Uterine Ectopic Pregnancy

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.

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Key information

Age range

20 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Tanta University

Tanta, El-Gharbia, 31527, Egypt

Location status: Recruiting

Location contact

Amr A Habib, MD

PRINCIPAL_INVESTIGATOR

Mai N Ageez, MD

CONTACT

[email protected]

00201062388870

Shereef L Elshwaikh, MD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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.

Treatment and study plan

Systemic Methotrexate

Drug

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

Local Methotrexate

Drug

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. Success rate

    Time frame: Post intervention for 3 months

    Success rate will be recorded.

  2. Time for uterine-mass disappearance

    Time frame: Post intervention for 3 months

    Time for uterine-mass disappearance will be recorded.

  3. Hospitalization time

    Time frame: 15 days after intervention

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

Study contacts

Contact information is provided by the study sponsor or research team.

Mai N Ageez, MD

CONTACT

[email protected]

00201062388870

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

Local Versus Systemic Methotrexate in Management of Uterine Ectopic Pregnancy: A Randomized Trial

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 15, 2024
Registry last updated
Aug 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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