RESUMO
Background: To assess the equivalence of tranexamic acid (TRAN) versus synthetic oxytocin (OXY) in reducing post-partum blood loss, in full-term patients (37-42 weeks), at low risk of post-partum hemorrhage, with vaginal childbirth. Methods: Phase III, randomized (1:1), open-label, longitudinal, multi-center, prospective clinical trial (Prot. n 63209, ClinicalTrials.gov Identifier: NCT02775773). From January 7, 2020, to June 30, 2023, a total of 256 women were enrolled at two general urban community hospitals in Italy, serving a multi-ethnic patient population with National Health Insurance. The primary outcome was to explore a potential equivalence between the two treatments (OXY and TRAN) in preventing total blood loss. Therefore, we randomized 231 women into two groups: Group A (OXY), 127 women who were administered 10UI intramuscularly within 5 min from childbirth; Group B (TRAN), 104 women to whom 1-g slow intravenous infusion was administered within 5 min from childbirth. Findings: At the time of delivery, mean blood loss for OXY group versus TRAN group was 269.12 mL versus 263.88 mL, respectively, with equivalence between the two groups. Similarly, there was equivalence in total blood loss between the OXY and the TRAN group (397.66 mL versus 405.64 mL, respectively. No statistical differences between Hb levels at admission and discharge in the two groups were reported. No difference was found in terms of additional uterotonic and surgical therapies between the two groups of patients. Neither group showed thrombotic complications at check-up performed after 7 days or after a questionnaire regarding adverse effects, subjected after 40 days. Interpretation: The study shows the equivalence of tranexamic acid versus synthetic oxytocin in post-partum blood loss prophylaxis in term patients at low risk of PPH with vaginal childbirth. The safety profiles of OXY and TRAN were similar. Funding: None.
RESUMO
BACKGROUND: The aim of this study was to evaluate the diagnostic accuracy of endocervicoscopy as a preoperative examination to improve the outcome of the excisional treatment (LEEP) of high-grade cervical preneoplastic lesions. METHODS: Patients with histologic diagnosis of CIN II-CIN III undergoing LEEP divided in two groups: in group A (85 women) a preoperative endocervicoscopy was performed, in group B (85 women) no additional examination was performed before LEEP. The size of the surgical specimen (H, D, W) and the margins of the lesion were evaluated. RESULTS: Seventy-four women in group A and 80 in group B completed the follow-up. group A showed significant correlation between colposcopic examination and endocervicoscopic examination (P=0.001, k=0.30) and between endocervicoscopic and definitive histological examination (P<0.05, k=0.16). The depth of the operative sample was significantly lower (P<0.0001) in group A (0.91±0.4) than in group B (1.58±0.2), group A showed fewer patients B with positive endocervical margins than group B (3 vs. 17, P<002). Colposcopic, cytological and virological follow-up did not show significant differences between the two groups. CONCLUSIONS: Endocervicoscopy as preoperative tool for excisional treatment of cervical lesions showed high diagnostic effectiveness and allows to perform a conservative surgery.