Methods
bleeding, renal/hepatic failure, blood loss, thromboembolic, allergy, DVT, dural sinus thrombosis, allergic reactions
PULMONARY EMBOLISM, BLEEDING, ATRIAL FIBRILLATION (AF), DEEP VENOUS THROMBOSIS, ALLERGIC REACTION, BLOOD LOSS, POSTOPERATIVE COMPLICATIONS, WOUND INFECTION, ALLERGY, SECONDARY, PLACENTA PREVIA, THROMBOEMBOLISM, PLACENTAL ABRUPTION, DVT
According to the CONSORT criteria, a randomized clinical trial was conducted at Kasr Al Ainy Obstetrics and Gynecology Hospital from June 2022 to October 2022 after being approved by the Research Ethics Committee (MS-127-2022). The study was registered at ClinicalTrials.gov in June 2022 (NCT05439694).Eighty-one pregnant women who attended the outpatient clinic with an indication for warfarin anticoagulation postnatally were assessed for eligibility. Five patients refused to participate in the study, and ten did not meet our inclusion criteria. Of the remaining 66 patients, three were excluded, being had emergency CS. Therefore, only 63 women were enrolled in our study, as shown in Fig. Flow-chart of the study participantsThe study included pregnant women attended for elective CS, who on antenatal warfarin anticoagulation started from 13 weeks gestation to 36 weeks, then shifted to low-molecular-weight heparin (LMWH) or unfractionated heparin (UFH), and with an indication for postnatal warfarin anticoagulation, e.g., cases of a prosthetic valve, deep venous thrombosis (DVT), dural sinus thrombosis, pulmonary embolism, and atrial fibrillation (AF). The eligibility criteria also included age between 20 and 40 years and body mass index (BMI) between 18.5 and 30.Women with a risk of obstetric bleeding (i.e., abnormally invasive placenta, placenta previa, placental abruption), renal/hepatic failure, or known allergy to Tranexamic acid were excluded. Women with Hb below 8g/dl were also excluded.Informed consent was obtained from all participants after being fully informed about the study. Upon admission, precise history taking and thorough clinical examination were conducted for each case, including vital signs, weight, height, and abdominal examination (for assessment of fundal level). Preoperative laboratory investigations, including complete blood count (CBC), as well as abdominal ultrasound, were done for each patient. All enrolled women had elective LSCS by senior obstetricians, using a standardized technique, with visceral and parietal peritoneum re-approximation and inserting a passive intraperitoneal drain.The participants (Fascial closure was done using continuous, slowly absorbable sutures. Meticulous hemostasis was achieved using monopolar cauterization. In all patients, an active drain (HemovacAll patients were followed up for vital signs and manifestations of allergic reactions in the immediate postoperative period. The intraperitoneal drain was removed after 24 h in all groups. All patients received bridging anticoagulation using LMWH (Enoxaparin) alone for 3 days in therapeutic doses (1 mg/kg twice daily), initiated 12 h after surgery in most cases. Then Warfarin was initiated on postoperative day 3, and LMWH was withdrawn after achieving the target INR.Finally, the drain was removed, and postoperative assessment was done for hemoglobin (Hb), hematocrit (HCT), estimated blood loss (EBL), amount and nature of discharge collected from the sub-rectus drain, postoperative hospital stay, and incidence of postoperative complications (RHS, wound infection, thromboembolism), need for re-operation, and need for blood transfusion.The estimated blood loss (EBL) was calculated by the following formula: EBL = EBV x Our primary outcomes were the occurrence of RHS and measuring the sub-rectus space drain output. The secondary outcomes were the occurrence of thromboembolic manifestations, the need for postoperative blood transfusion, and the need for surgical management of RHS.