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Local vs Systemic Methotrexate in Management of Uterine Ectopic Pregnancy

ConditionsLocalSystemicMethotrexateUterine Ectopic Pregnancy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age20-40
SponsorTanta University

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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).

Treatment groups

34 Participants
are divided into 2 treatment groups
Group A: Systemic MethotrexateExperimental treatment 1 intervention
Group B: Local MethotrexateExperimental treatment 1 intervention

Trial outcomes

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Tanta University

Lead sponsor

Source ClinicalTrials.gov
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