Clinical trial NCT06970483: Comparison of the Efficacy of Misoprostol and Tranexamic Acid for Postpartum Hemorrhage Prophylaxis in Cesarean Delivery
Official title: Comparison of the Efficacy of Sublingual Misoprostol and Intravenous Tranexamic Acid for Postpartum Hemorrhage Prophylaxis in Cesarean Delivery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Postpartum Hemorrhage
Cesarean Section Complications
Delivery Complication
Keywords: postpartum hemmorrhage
ceserean section
maternal complications of delivery
prostoglandine1
tranexamic asid
Lead sponsor: Ankara Etlik City Hospital
Sponsor class: OTHER_GOV
First posted: 2025-05-14
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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

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 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.

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 segment incision.

Group 2 received misoprostol (Cytotec, 200 mcg tablet, Pfizer Inc., USA); 400 micrograms were administered sublingually immediately after delivery of the baby and clamping of the umbilical cord.

In addition, all patients received 20 International Units of oxytocin (Synpitan Forte, 5 IU/mL ampoule I.M./I.V., Deva Holding A.Ş., Turkey).

Despite the medical treatments administered, in cases where hemorrhage developed intraoperatively or postoperatively, additional interventions were performed, including medical (additional doses of oxytocin/tranexamic acid/misoprostol), mechanical (Bakri balloon), or surgical methods (uterine artery/hypogastric artery ligation, B-Lynch/Hayman sutures, postpartum hysterectomy).

The parameters to be examined in the research are as follows:

1. Patients' postoperative 1st, 2nd, and 6th-hour vital signs (pulse rate, systolic and diastolic blood pressure, temperature, oxygen saturation).
2. Shock indices.
3. Hemogram and hematocrit values at 6-24 hours postoperatively.
4. Duration of the surgery.
5. Adverse effects experienced by the patients.
6. Additional treatments administered.
7. Whether blood transfusion was performed or not. In this study, the G-power analysis program was used to determine the minimum sample size, taking into account a 10% margin of error. According to the analysis results, the minimum number of patients to be included in the study for a total of 75 patients across 3 groups was determined. Statistical analysis of the data obtained in the study will be conducted using the SPSS Statistics 22 software package. A 95% confidence interval will be calculated for each variable, and results will be considered statistically significant for p \< 0.05.

Eligibility criteria: Inclusion Criteria:

* Patients aged 18-45 years
* gestational age between 37 and 41 weeks
* Perfomed ceserean 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

Primary outcomes:
measure: Comparison of patients' preoperative and postoperative hemogram levels
timeFrame: 24 hours
measure: Comparison of patients' preoperative and postoperative hematocrit levels
timeFrame: 24 hours
measure: Comparison of patients' postoperative shock indices
timeFrame: 24 hours
Secondary outcomes:
measure: Comparison of the patients' postoperative heart rate
timeFrame: 24 hours
measure: Comparison of the patients' postoperative systolic and diastolic blood pressure
timeFrame: 24 hours
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Etlik City Hospital
Study officials:
References: