Methods
nausea, FGR, blood loss, shivering, vomiting, fetal anomalies, intrauterine fetal death, pyrexia, IUFD, headache, PPH, misoprostol-related
THROMBOEMBOLIC EVENT, INTRAUTERINE FETAL DEATH, BLOOD LOSS, TRANEXAMIC ACID ALLERGY, GROWTH RETARDATION, ADVERSE EFFECTS, SECONDARY
A randomised clinical trial was carried out, following the CONSORT guidelines, in Kasr Al-Ainy Hospital (Obstetrics and Gynaecology Department, Faculty of Medicine, Cairo University) from January 2020 to December 2020 after approval of the Medical Ethical Committee. Informed consent was obtained from all participants after explaining the nature of the study, expected value, outcome, and possible adverse effects. This clinical trial was registered at The study included 345 pregnant women who were candidates for lower segment cesarean section (LSCS) under spinal anaesthesia. Inclusion criteria were maternal age 20–40 years, term pregnancy (≥ 37 weeks), with one or more of the high risk for PPH criteria [On the other hand, exclusion criteria were (1) intrauterine fetal death (IUFD), (2) fetal anomalies or growth retardation (FGR), (3) emergency CS, (4) more than two previous CS procedures, (5) prolonged procedure (more than two hours from skin incision to skin closure), (6) abnormally invasive placenta, (7) known or history of thromboembolic events, (8) history of prostaglandin or Tranexamic acid allergy.All participants underwent the following steps to confirm their eligibility for this study: (1) full medical and obstetric history, (2) general and obstetric examination, (3) obstetric ultrasound, and (4) pre-operative laboratory tests: including complete blood count (CBC), coagulation profile, and liver and kidney function tests.On the day of the scheduled surgery, the participants were randomly assigned into three groups; Tranexamic Group, Misoprostol Group, and Oxytocin-only Group (as a control group). Randomisation was performed using computer-generated random numbers.In the tranexamic group, 1 gm (10 ml) of tranexamic acid (Kapron, Amoun, Egypt) was diluted in 20 ml of Glucose 5%, then given to the patients as an intravenous infusion over 5 min, at least 15 min before skin incision. In the misoprostol group, 400 micrograms of misoprostol (2 tablets - Cytotec, Pfizer, G.D. Searle LLC) were administered sublingually by the patients immediately before starting the skin incision.Following the baby’s delivery, all patients in the three groups received an intravenous bolus of 5 IU oxytocin (Syntocinon, Novartis, Basel, Switzerland) and 20 IU oxytocin in 500 mL lactated Ringer’s solution (infused at a rate of 125 mL/h). The operative time was recorded, the blood volume in the suction unit was observed, and the number of operative towels was counted.All patients were observed for primary PPH for the first 24 h. They were also followed regarding the occurrence of misoprostol-related side effects (shivering, pyrexia > 38 C, headache, nausea, and vomiting in the first 6 h) and the occurrence of tranexamic acid-related side effects (thromboembolic events within one week of delivery).CBC was repeated 12 h after delivery, and the estimated blood loss (EBL) after CS was calculated by this formula:
where EBV is the estimated blood volume of the patient in mL = weight in kg × 85 [The primary outcome was to compare the estimated blood loss (EBL) during and after cesarean delivery among the three groups, while the secondary outcomes were to evaluate the incidence of PPH and the possible side effects.