An Exploratory Study on the Safety and Efficacy of Local Methotrexate Injection Therapy for Ectopic Pregnancy

Exploratory Evaluation of the Safety and Efficacy of Local Methotrexate Injection for Ectopic Pregnancies Including Cesarean Scar and Cervical pregnancies

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCTs031250822

Enrollment

Registered

2026-03-18

Start date

2026-04-15

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ectopic pregnancy (Cesarean scar pregnancy, Cervical pregnancy) Cesarean scar pregnancy, Cervical pregnancy

Interventions

Local administration of methotrexate 50 mg/m2 into the gestational sac of patients with cesarean scar pregnancy or cervical pregnancy.

Local administration of methotrexate

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: (1) Women aged 18 years or older (2) Patients diagnosed with implantation in the cesarean scar or cervical canal by transvaginal ultrasonography (3) Patients with a pregnancy of less than 9 weeks of gestation (4) Patients desiring fertility preservation (5) Patients who have provided voluntary written informed consent after receiving a full explanation of the study and fully understanding it (6) Patients capable of hospitalization and outpatient visits according to the study schedule

Exclusion criteria

Exclusion criteria: (1) Patients with active genital bleeding at the time of consent (2) Patients with a history of severe hypersensitivity to MTX (3) Patients with hepatic impairment, renal impairment, pleural effusion, ascites. (4) Patients who have received systemic or local administration of MTX within 4 weeks prior to obtaining consent (5) Patients with concurrent malignant tumors (6) Patients with a history of severe drug allergies such as anaphylactic shock or severe adverse reactions (7) Patients who are breastfeeding (8) Patients using concomitant prohibited medications (9) Any other patients deemed unsuitable for participation in this study by the Principal Investigator or Co-Investigator

Design outcomes

Primary

Measure	Time frame
Frequency of uterine bleeding of CTCAE Grade 3 or higher occurring until negative conversion of hCG	—

Secondary

Measure	Time frame
(1) Completion rate of treatment (2) Time to treatment completion (3) Adverse events related to the puncture procedure (4) Other adverse events	—

Contacts

Public ContactTomoko Makabe

The University of Tokyo Hospital

makabet-gyn@h.u-tokyo.ac.jp+81-338155411

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026