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Comparison of the Efficacy of Misoprostol and Tranexamic Acid for Postpartum Hemorrhage Prophylaxis in Cesarean Delivery

Comparison of the Efficacy of Sublingual Misoprostol and Intravenous Tranexamic Acid for Postpartum Hemorrhage Prophylaxis in Cesarean Delivery

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06970483
Enrollment
192
Registered
2025-05-14
Start date
2023-12-01
Completion date
2024-12-01
Last updated
2026-08-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cesarean Section Complications, Delivery Complication, Postpartum Hemorrhage

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.

DRUGTranexamic acid

Transamine1 gram was administered intravenously during the lower segment incision.

Sponsors

Ankara Etlik City Hospital
Lead SponsorOTHER_GOV

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

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

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes

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

MeasureTime frameDescription
Comparison of patients' preoperative and postoperative hemogram levels24 hoursHemogram values were compared at 0-24 hours postoperatively
Comparison of patients' preoperative and postoperative hematocrit levels24 hoursHematocrit values were compared at 0-24 hours postoperatively
Comparison of patients' postoperative shock indices24 hourspostoperative shock indices were compared at 0-24 hours postoperatively

Secondary

MeasureTime frameDescription
Comparison of the patients' postoperative heart rate24 hourspostoperative heart rates were compared at 0-24 hours postoperatively
operative timePerioperativethe interval from skin incision to skin closure

Countries

Turkey (Türkiye)

Contacts

PRINCIPAL_INVESTIGATORtugba agbal

Ankara Etlik City Hospital

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 7, 2026