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NCT Number: NCT06970483

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

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.

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Key information

Conditions

Postpartum Hemorrhage Cesarean Section Complications Delivery Complication Female Urogenital Diseases and Pregnancy Complications Hemorrhage Obstetric Labor Complications Pathologic Processes Pathological Conditions, Signs and Symptoms Pregnancy Complications Puerperal Disorders Urogenital Diseases Uterine Hemorrhage

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Etlik City Hospital

Ankara, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tranexamic Acid

Drug

Transamine1 gram was administered intravenously during the lower segment incision.

Other names: Transamine 10% ampoule, 2.5 mL / 250 mg

Misoprostol 200Mcg Tab

Drug

Cytotec 400 micrograms were administered sublingually immediately after delivery of the baby and clamping of the umbilical cord.

Other names: Cytotec 200 Mcg Tablet

Primary outcomes

  1. Comparison of patients' preoperative and postoperative hemogram levels

    Time frame: 24 hours

    Hemogram values were compared at 0-24 hours postoperatively

  2. Comparison of patients' preoperative and postoperative hematocrit levels

    Time frame: 24 hours

    Hematocrit values were compared at 0-24 hours postoperatively

  3. Comparison of patients' postoperative shock indices

    Time frame: 24 hours

    postoperative shock indices were compared at 0-24 hours postoperatively

Secondary outcomes

  1. Comparison of the patients' postoperative heart rate

    Time frame: 24 hours

    postoperative heart rates were compared at 0-24 hours postoperatively

  2. operative time

    Time frame: Perioperative

    the interval from skin incision to skin closure

Sponsors and collaborators

Lead sponsor

Ankara Etlik City Hospital

Other Gov

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
May 14, 2025
Registry last updated
Aug 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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