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A Prospective and Retrospective Cohort Study Protocol for the Development of a Prediction Model on Response to Single-Dose Methotrexate Therapy in Tubal Ectopic Pregnancy

A Prospective and Retrospective Cohort Study Protocol for the Development of a Prediction Model on Response to Single-Dose Methotrexate Therapy in Tubal Ectopic Pregnancy

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400085829
Enrollment
Unknown
Registered
2024-06-19
Start date
2024-07-01
Completion date
Unknown
Last updated
2024-07-08

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

Conditions

Tubal Ectopic Pregnancy

Interventions

Single-Dose Methotrexate Therapy in Tubal Ectopic Pregnancy Successful group/ Failed group:None

Sponsors

Zhejiang Provincial Hospital of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 55 Years

Inclusion criteria

Inclusion criteria: (1) Patients presenting with vaginal bleeding or pelvic pain during early pregnancy. (2) Serum ß-hCG values below 4500 IU/L. (3) Transvaginal ultrasound revealing tubal ectopic pregnancy, excluding intrauterine pregnancy. When no intrauterine or ectopic pregnancy is detected, a series of serum ß - hCG measurements are performed to determine ectopic pregnancy. (4) Patients with an unruptured mass and stable hemodynamics. (5) Patients opting for medical management with methotrexate will receive a single-dose intramuscular injection (50 mg/m2) and will be informed of precautions and closely monitored.

Exclusion criteria

Exclusion criteria: (1) Hemodynamically unstable patients. (2) Patients preferring surgical or expectant management. (3) Patients diagnosed with non-tubal pregnancy. (4) Absolute contraindications to methotrexate (MTX) treatment, including intrauterine pregnancy, immunodeficiency, anemia, leukopenia, thrombocytopenia, MTX allergy, renal or hepatic insufficiency, pulmonary disease, active peptic ulcer disease, simultaneous use of intrauterine devices, breastfeeding, or fetal cardiac activity.

Design outcomes

Primary

MeasureTime frame
respond to single-dose methotrexate therapy (Whether to conversions to surgery or receive MTX treatment again in the end);

Countries

China

Contacts

Public ContactHu Yunyun

Zhejiang Provincial Hospital of Chinese Medicine

fuddyhu@163.com+86 138 5719 6940

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026