Tranexamic Acid vs Vasopressin in Placenta Previa Trial (TXA-VASO-PP)

Comparison of Efficacy of Tranexamic Acid Versus Vasopressin in Blood Loss Among Placenta Previa Patients Undergoing Cesarean Section

Placenta previa is a major obstetric condition associated with increased risk of excessive blood loss during cesarean section, leading to maternal morbidity and mortality. Different pharmacological agents have been used to minimize intraoperative hemorrhage. Tranexamic acid is an antifibrinolytic agent, while vasopressin reduces blood loss by causing vasoconstriction and myometrial contraction at the injection site. Both drugs have been used separately in placenta previa cases, however direct comparison between tranexamic acid and vasopressin is limited.

This randomized controlled trial will be conducted at the Department of Obstetrics & Gynecology, AIMC/Jinnah Hospital Lahore. A total of 58 women (29 in each group), aged 18-45 years, with singleton pregnancy and diagnosed placenta previa undergoing elective cesarean section will be included. Participants will be randomly allocated into two groups. Group A will receive 1 gram tranexamic acid diluted in 20 ml of 5% dextrose intravenously 15 minutes before cesarean section. Group B will receive 4 units vasopressin diluted in 20 ml normal saline injected at placental implantation site after delivery of placenta.

The primary outcome will be intraoperative blood loss measured by gauze saturation assessment and suction drain measurement. The study will help determine which drug is more effective in reducing blood loss in placenta previa patients undergoing cesarean section.

Study Overview

• Status: Not yet recruiting
• Conditions: Placenta Previa
• Intervention / Treatment: Drug: Group A: Tranexamic acid; Drug: Group B: Vasopressin

Detailed Description

This study is a randomized controlled trial designed to compare the efficacy of tranexamic acid versus vasopressin in reducing intraoperative blood loss among patients with placenta previa undergoing elective cesarean section. The study will be conducted in the Department of Obstetrics & Gynecology, Allama Iqbal Medical College (AIMC)/Jinnah Hospital, Lahore, over a maximum duration of 12 months after approval of synopsis.

A total sample size of 58 patients will be enrolled through non-probability purposive sampling. Women aged 18-45 years with singleton pregnancy and placenta previa scheduled for elective cesarean section will be included. Patients undergoing emergency cesarean section, having coagulation disorders, chronic liver/kidney disease, gestational diabetes, hypertensive disorders of pregnancy, history of postpartum hemorrhage, or using anticoagulant/antiplatelet drugs will be excluded.

After informed consent, baseline characteristics including age, gravida, para, abortion history, grade of placenta previa, and pre-operative hemoglobin will be recorded. Patients will be randomized into two groups using paper lottery method.

Group A will receive injection tranexamic acid 1 gram diluted in 20 ml of 5% dextrose administered intravenously 15 minutes before cesarean section. Group B will receive injection vasopressin 4 units diluted in 20 ml normal saline injected at placental implantation site after delivery of placenta. Both groups will receive standard uterotonic management with oxytocin 40 units in 500 ml of 5% glucose solution.

Blood loss will be assessed intraoperatively using visual gauze saturation method and suction drain volume. Post-operative hematocrit will be measured after achieving hemostasis and closure. Data will be analyzed using SPSS(statistical package of social sciences) version 26. Quantitative variables will be expressed as mean ± standard deviation and categorical variables as frequency and percentage. Independent sample t-test or Mann Whitney U test will be applied for comparison of quantitative variables, and Chi-square test for categorical variables. Stratification will be done for age and grade of placenta previa. A p-value ≤ 0.05 will be considered statistically significant.

The findings will help identify which intervention is more effective and safer for reducing intraoperative blood loss in placenta previa patients undergoing cesarean section.

• Study Type: Interventional
• Enrollment (Estimated): 58
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Shazia Saaqib, FCPS,MCPS; Phone Number: +923214708583; Email: shaziasaaqib@gmail.com
• Study Contact Backup: Name: Aimen Sattar, MBBS; Phone Number: +923190658053; Email: aimansattar7@gmail.com

Study Locations

• Pakistan
  • Punjab Province
    • Lahore, Punjab Province, Pakistan, +92
      • Jinnah Hospital
      • Contact: Aimen Sattar, MBBS; Phone Number: +923190658053; Email: aimansattar7@gmail.com
      • Contact: SHAZIA SAAQIB, FCPS, MCPS; Phone Number: 0923214708583; Email: shaziasaaqib@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

Women of reproductive age

Age 18-45 years

Diagnosed placenta previa in current pregnancy

Scheduled for elective cesarean section

Singleton pregnancy

Exclusion Criteria:

Emergency cesarean section

Platelet or coagulation disorder

Use of anti-platelet or anti-coagulant drugs

Previous history of postpartum hemorrhage

Chronic liver disease

Chronic kidney disease

Gestational diabetes

Pregnancy-related hypertensive disorders

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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tranexamic Acid (TXA) Group; Arm 1: Tranexamic Acid Group (TXA Group) Number of participants: 29 Description: Patients with placenta previa undergoing elective cesarean section receiving tranexamic acid prophylactically before surgery	Drug: Group A: Tranexamic acid; Injection Tranexamic Acid 1 gram diluted in 20 mL of 5% dextrose will be administered intravenously 15 minutes before cesarean section. (prophylactically); Other Names: Inj Transamin 1gm
Experimental: Vasopressin Group; Arm 2: Vasopressin Group Number of participants: 29 Description: Patients with placenta previa undergoing elective cesarean section receiving vasopressin prophylactically.	Drug: Group B: Vasopressin; Injection Vasopressin 4 units diluted in 20 mL of normal saline will be injected locally at the placenta implantation site after delivery of placenta.; Other Names: Novapressin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intraoperative Blood Loss	Total estimated blood loss during cesarean section measured using the per-operative visual assessment method (gauze saturation method) plus the amount of blood collected in the suction drain.	Assessed intraoperatively (during cesarean section) and finalized once postoperative hematocrit is available immediately after surgery.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Need for Blood Transfusion	Requirement of blood transfusion if postoperative hemoglobin is < 9 g/dL.	Assessed within the immediate postoperative period (after surgery).
Drug Efficacy	Drug will be considered efficacious if estimated intraoperative blood loss is ≤ 500 mL.	Assessed intraoperatively at completion of surgery.

Collaborators and Investigators

• Sponsor: Allama Iqbal Medical College
• Investigators: Principal Investigator: Aiman Sattar, MBBS, Jinnah Hospital/AIMC/UHS; Study Director: Shazia Saaqib, FCPS,MCPS, Jinnah Hospital/AIMC/UHS

Publications and helpful links

General Publications

• Shalaby MA, Maged AM, Al-Asmar A, El Mahy M, Al-Mohamady M, Rund NMA. Safety and efficacy of preoperative tranexamic acid in reducing intraoperative and postoperative blood loss in high-risk women undergoing cesarean delivery: a randomized controlled trial. BMC Pregnancy Childbirth. 2022 Mar 14;22(1):201. doi: 10.1186/s12884-022-04530-4.
• Kato S, Tanabe A, Kanki K, Suzuki Y, Sano T, Tanaka K, Fujita D, Terai Y, Kamegai H, Ohmichi M. Local injection of vasopressin reduces the blood loss during cesarean section in placenta previa. J Obstet Gynaecol Res. 2014 May;40(5):1249-56. doi: 10.1111/jog.12356. Epub 2014 Apr 21.

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2026
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2026

Study Registration Dates

• First Submitted: February 13, 2026
• First Submitted That Met QC Criteria: February 13, 2026
• First Posted (Actual): February 20, 2026

Study Record Updates

• Last Update Posted (Actual): February 20, 2026
• Last Update Submitted That Met QC Criteria: February 13, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Cesarean Section; Vasopressin; Tranexamic Acid; Obstetric Hemorrhage
• Additional Relevant MeSH Terms: Urogenital Diseases; Endocrine System Diseases; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Obstetric Labor Complications; Pregnancy Complications; Placenta Diseases; Pituitary Diseases; Diabetes Insipidus; Placenta Previa
• Other Study ID Numbers: No 17 CMD/AIMC; CNIC No.: 32103-9070878-6 (Other Grant/Funding Number: Allama Iqbal Medical College Lahore)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be shared publicly to maintain patient confidentiality and privacy. The study involves sensitive clinical and obstetric information, and no personal identifiers will be disclosed. Data may be made available upon reasonable request to the principal investigator.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No