Cicatrix
Conditions
Interventions
This is a randomized, non-inferiority, multicenter, two-arm clinical trial that will follow the CONSORT guidelines. Randomization will be carried out in a few steps: generation of the random sequence
allocation and allocation blinding (the sequence will remain restricted in a telephone exchange)
implementation (the sequence will be generated by one of the researchers, the patients will be included and allocated to one of the treatments by the doctor on duty responsible for the ectopic pregnan
blinding (blinding will not be carried out for the intervention once allocated)
and statistical analysis (to verify that there was no crossing of the established delta (14.2%), the confidence interval of the difference between two independent proportions will be used, as describe
Sponsors
Escola Paulista de Medicina da Universidade Federal de São Paulo
Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo
Faculdade de Ciências Médicas da Universidade Estadual de Campinas
Faculdade de Medicina da Universidade de Brasília
Faculdade de Medicina da Universidade Federal do Rio Grande do Sul
Setor de Ciências da Saúde da Universidade Federal do Paraná
Faculdade de Medicina da Universidade Federal de Minas Gerais
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 18 years of age or older; Hemodynamic stability, defined as diastolic blood pressure greater than or equal to 60 mmHg and systolic blood pressure greater than or equal to 90 mmHg, heart rate less than 100 bpm, and capillary refill time less than or equal to 3 seconds; Gestational age less than 12 weeks; Intact gestational sac in topography of the cesarean scar with embryo with heartbeat; Absence of signs of peritonism; Pregnancy in the exogenous cesarean section scar (COS-1); Myometrial mantle less than 5mm; Desire for a future pregnancy or not wanting to have a hysterectomy; Ease of returning to the hospital if necessary; Signed consent form
Exclusion criteria
Exclusion criteria: Hemoglobin less than 10 g/dl; Leukopenia (leukocytes less than 2,000 cells/mm3); Thrombocytopenia (platelets less than 100,000/mm3); Immunodeficiency, defined by the use of immunosuppressive drugs such as corticoids; Allergy to methotrexate; Current chronic lung disease, such as chronic obstructive pulmonary disease; Liver transaminases above the maximum reference value; Creatinine above the maximum reference value; Breastfeeding; Refusal to receive blood transfusion; Inability to continue the follow-up
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| It is expected to evaluate which of the minimally invasive methods is the most effective in preserving the patient's uterus after the treatment has been instituted, with success being considered if the patient progresses without the need for any additional intervention until ß-hCG levels are < 5mIU/ ml | — |
Secondary
| Measure | Time frame |
|---|---|
| Weekly evolution of b-hCG, expressed in mIU/mL, based on the 4th international standard of the World Health Organization.;Presence of uterine infections, defined by: vaginal bleeding that requires clinical intervention or the need for blood transfusions.;Surgical interventions according to notes in the patient's medical record, considering absent or present.;Side effects of methotrexate described by patients, such as mucositis, conjunctivitis, changes in the gastrointestinal tract, changes in the sensorium, such as peripheral neuropathy.;Time interval necessary for the regression of the GECC image on TVUS, also indicated in weeks, based on exams carried out in the Service itself.;Some demographic variables will be determined, with the aim of better characterizing the population included in the study: number of pregnancies; parities; number of cesarean deliveries and indication; previous uterine surgery; number of miscarriages, characterized as pregnancy loss before 20/22 weeks weighing less than 500 grams; maternal age; gestational age in weeks; position of the uterus (anteversoflexion or retroversoflexion).;Route of administration of methotrexate (local or chemoembolization).;Result of treatment with local Methotrexate e result of chemoembolization treatment.;Maternal morbidity and mortality. | — |
Countries
Brazil
Contacts
Public ContactJulio Junior
Universidade Federal de São Paulo
Outcome results
None listed