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Response to the Clinical Treatment of Tubal Pregnancy

Clinical Treatment of Ectopic Pregnancy - Response to the intravenous administration of Methotrexate

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-7nkf8tn
Enrollment
Unknown
Registered
2022-05-18
Start date
2019-09-13
Completion date
Unknown
Last updated
2025-10-27

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

Conditions

Tubal Pregnancy

Interventions

This is an open study, with block randomization (blocks of 4 patients). Intervention group: 90 pacients diagnosed with ectopic pregnancy will be treated with endovenous Methotrexate, in single dose of

Sponsors

Universidade Federal do Paraná
Lead Sponsor
Universidade Federal do Paraná
Collaborator

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: Stable patients diagnosed with ectopic pregnancy; beta-hCG levels below 5000 mU/mL; unruptured gestacional sac/mass; gestacional sac/mass below 4cm of length; no sign of fetal heartbeat on the ultrasound

Exclusion criteria

Exclusion criteria: Patients that don't fill the criteria for clinical treatment; patients who don't agree with the Informed Consent Form after reading and comprehending it

Design outcomes

Primary

MeasureTime frame
We hope to find a reduced proportion of cases with gestacional sac rupture with endovenous administration of methotrexate, by verifyng at least 5% difference between control and intervention groups.

Secondary

MeasureTime frame
We hope to observe similar rates of collateral offects between control and intervention groups, assessed by laboratory tests, verifying the safety of the new treatment method.

Countries

Brazil

Contacts

Public ContactRafael Bruns

Universidade Federal do Paraná

rafaelbruns@gmail.com+55-41-99929-7700

Outcome results

None listed

Source: REBEC (via WHO ICTRP)