Cesarean Section Complications, Delivery Complication, Postpartum Hemorrhage
Conditions
Keywords
postpartum hemmorrhage, ceserean section, maternal complications of delivery, prostoglandine1, tranexamic asid
Brief summary
Postpartum hemorrhage (PPH) is an obstetric emergency, with an estimated incidence ranging from 2.8% to 7.9%. Recent studies indicate an increasing trend in the frequency of PPH.Although it is more commonly seen in developing countries, it remains a significant cause of maternal morbidity and mortality worldwide. Therefore, early diagnosis and prompt, accurate intervention are critically important. Despite the rising incidence of PPH, maternal mortality rates have declined. This improvement is largely attributed to better identification of risk factors, timely diagnosis, and effective intervention. To prevent PPH globally, active management of the third stage of labor has been widely implemented. This approach includes the use of pharmacologic agents, uterine massage, and controlled traction for placental delivery.Among pharmacological agents, the most commonly used include oxytocin, ergot alkaloids (e.g., ergometrine), tranexamic acid, prostaglandin E1 (misoprostol), prostaglandin F2α, and oxytocin analogues (e.g., carbetocin).Oxytocin is the most widely used agent for PPH prophylaxis. The aim of this study is to compare the efficacy of tranexamic acid and misoprostol in the prophylaxis of postpartum hemorrhage.
Detailed description
The study included elective cases scheduled for repeat cesarean delivery (women with a prior cesarean delivery) at the Obstetrics and Gynecology Clinic, Maternity Ward of Etlik City Hospital, between December 2023 and December 2024. Patients were divided into three groups. Group 1 received tranexamic acid (Transamin 10% ampoule, 2.5 mL/250 mg, Actavis Pharmaceuticals, Turkey); 1 gram was administered intravenously during the lower uterine segment incision. Group 2 received misoprostol (Cytotec, 200 mcg tablet, Pfizer Inc., USA); 400 mcg were administered sublingually immediately after delivery and cord clamping. Group 3 (control) received no additional pharmacological agent. All patients received 20 IU oxytocin (Synpitan Forte, 5 IU/mL ampoule, IM/IV, Deva Holding A.Ş., Turkey). Despite treatment, in cases of intraoperative or postoperative hemorrhage due to uterine atony, additional interventions were performed (additional oxytocin, Bakri balloon, uterine/hypogastric artery ligation, B-Lynch/Hayman sutures, or hysterectomy); these patients were excluded from the final analysis. Parameters examined: operative time; preoperative and 24-hour postoperative hemoglobin and hematocrit; pulse rate and shock index at 0 and 24 hours; postoperative complications; and blood transfusion requirement. Sample size was estimated using G\*Power 3.1. With α = 0.05, 80% power, and three study arms, the required sample size was calculated as 156 participants (52 per group). Seventy participants were initially enrolled per group to allow for losses; after exclusions, 192 participants (60 misoprostol, 67 TXA, 65 control) were included in the final analysis. Statistical analysis was performed using SPSS version 27. A 95% confidence interval was used, and p \< 0.05 was considered statistically significant.
Interventions
Cytotec 400 micrograms were administered sublingually immediately after delivery of the baby and clamping of the umbilical cord.
Transamine1 gram was administered intravenously during the lower segment incision.
Sponsors
Study design
Intervention model description
Patients were sequentially assigned (non-randomized, based on order of presentation) to one of three parallel groups. Group 1: tranexamic acid (Transamin) 1 g IV at the lower segment incision. Group 2: misoprostol (Cytotec) 400 mcg sublingual immediately after delivery and cord clamping. All groups additionally received 20 IU oxytocin IM/IV (Synpitan Forte). If hemorrhage occurred intraoperatively or postoperatively despite treatment, additional interventions were performed (extra oxytocin/TXA/misoprostol, Bakri balloon, uterine/hypogastric artery ligation, B-Lynch/Hayman sutures, or hysterectomy)
Eligibility
Inclusion criteria
Patients aged 18-45 years Gestational age between 37 and 41 weeks Prior cesarean delivery (repeat elective cesarean section) Performed cesarean section for delivery
Exclusion criteria
* did not provide informed consent, * with comorbidities (such as heart, liver, or lung diseases), * high-risk pregnancy (e.g., intrauterine growth restriction, cholestasis, preeclampsia, eclampsia, multiple pregnancies) * known allergies to tranexamic acid or misoprostol * known coagulation disorders
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of patients' preoperative and postoperative hemogram levels | 24 hours | Hemogram values were compared at 0-24 hours postoperatively |
| Comparison of patients' preoperative and postoperative hematocrit levels | 24 hours | Hematocrit values were compared at 0-24 hours postoperatively |
| Comparison of patients' postoperative shock indices | 24 hours | postoperative shock indices were compared at 0-24 hours postoperatively |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of the patients' postoperative heart rate | 24 hours | postoperative heart rates were compared at 0-24 hours postoperatively |
| operative time | Perioperative | the interval from skin incision to skin closure |
Countries
Turkey (Türkiye)
Contacts
Ankara Etlik City Hospital