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

NCT06970483 | Completed Phase 4 DMC

• 1 other identifier: AEŞH-EK1-2023-774
• Study Type: interventional
• Target: 192
• 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

Cesarean Section Complications; Delivery Complication; Postpartum Hemorrhage

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

• operative time

  Perioperative

Study Arms (3)

Control Group

NO INTERVENTION

Participants received routine oxytocin prophylaxis only (Synpitan Forte, 20 IU IM/IV), with no additional pharmacological agent.

Misoprostol Group

EXPERIMENTAL

Participants received 400 mcg sublingual misoprostol (Cytotec) immediately after delivery and cord clamping, in addition to routine oxytocin prophylaxis (Synpitan Forte, 20 IU IM/IV).

Drug: Misoprostol 200mcg Tab

Tranexamic Acid (TXA) Group

EXPERIMENTAL

Participants received 1 g intravenous tranexamic acid (Transamin) at the time of the lower uterine segment incision, in addition to routine oxytocin prophylaxis (Synpitan Forte, 20 IU IM/IV).

Drug: Tranexamic acid

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

Tranexamic Acid (TXA) Group

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

Misoprostol Group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: women
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patients aged 18-45 years Gestational age between 37 and 41 weeks Prior cesarean delivery (repeat elective cesarean section) Performed cesarean 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 Officials

• tugba agbal

  Ankara Etlik City Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Doctor

Model Details: 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)

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: August 6, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)