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

NCT06970483 | Completed DMC

• 1 other identifier: AEŞH-EK1-2023-774
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Postpartum Hemorrhage; Cesarean Section Complications; Delivery Complication

Keywords

postpartum hemmorrhage; ceserean section; maternal complications of delivery; prostoglandine1; tranexamic asid

Outcome Measures

Primary Outcomes (3)

• Comparison of patients' preoperative and postoperative hemogram levels

  Hemogram values were compared at 0-24 hours postoperatively

  24 hours

• Comparison of patients' preoperative and postoperative hematocrit levels

  Hematocrit values were compared at 0-24 hours postoperatively

  24 hours

• Comparison of patients' postoperative shock indices

  postoperative shock indices were compared at 0-24 hours postoperatively

  24 hours

Secondary Outcomes (2)

• Comparison of the patients' postoperative heart rate

  24 hours

• Comparison of the patients' postoperative systolic and diastolic blood pressure

  24 hours

Study Arms (3)

Group 1

Group 1 received tranexamic acid (Transamin 10% ampoule, 2.5 mL / 250 mg, Actavis Pharmaceuticals, Turkey); 1 gram was administered intravenously during the lower segment incision. In addition,patients received 20 International Units (IU) of oxytocin (Synpitan Forte, 5 IU/mL ampoule I.M./I.V., Deva Holding A.Ş., Turkey).

Drug: Tranexamic acid

Group 2

Group 2 received misoprostol (Cytotec, 200 mcg tablet, Pfizer Inc., USA); 400 mcg were administered sublingually immediately after delivery of the baby and clamping of the umbilical cord. In addition,patients received 20 IU of oxytocin (Synpitan Forte, 5 IU/mL ampoule I.M./I.V., Deva Holding Inc., Turkey).

Drug: Misoprostol 200mcg Tab

Group 3 control group

Group 3 received only 20 IU of oxytocin (Synpitan Forte, 5 IU/mL ampoule I.M./I.V., Deva Holding Inc., Turkey). No additional pharmacological agents were administered to this group.

Interventions

Tranexamic acid DRUG

Transamine1 gram was administered intravenously during the lower segment incision.

Also known as: Transamine 10% ampoule, 2.5 mL / 250 mg

Group 1

Misoprostol 200mcg Tab DRUG

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

Also known as: Cytotec 200 Mcg Tablet

Group 2

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: women
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

The study included emergency or elective cases scheduled for cesarean delivery at the Obstetrics and Gynecology Clinic, Maternity Ward of Etlik City Hospital, between December 2023 and December 2024

You may qualify if:

• Patients aged 18-45 years
• gestational age between 37 and 41 weeks
• Perfomed ceserean section for delivery

You may not qualify if:

• 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

Sponsors & Collaborators

• Ankara Etlik City Hospital: lead

Study Sites (1)

Etlik City Hospital

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Postpartum Hemorrhage

Interventions

Tranexamic Acid; Tranylcypromine; Misoprostol; Tablets

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Puerperal Disorders; Uterine Hemorrhage; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Propylamines; Amines; Prostaglandins E, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors; Dosage Forms; Pharmaceutical Preparations

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Doctor

Study Record Dates

• First Submitted: May 6, 2025
• First Posted: May 14, 2025
• Study Start: December 1, 2023
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: June 26, 2025

Record last verified: 2025-06

Locations

TU (1)