A Phase 3 interventional study of Group A: Tranexamic acid and Group B: Vasopressin in Placenta Previa, sponsored by Allama Iqbal Medical College. Not yet recruiting at 1 site in Pakistan. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2026-02-20.
Sponsored by Allama Iqbal Medical College · Phase 3, Interventional, and Treatment
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.
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.
80 studies on the registry are indexed under Placenta Previa; 17 are open to participants now.
This study's planned enrollment of 58 is below the median of 109 across 45 interventional studies indexed under Placenta Previa.
Browse Placenta Previa studies →Allama Iqbal Medical College is the lead sponsor of 11 studies on the registry; 7 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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
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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Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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 Tranexamic Acid 1 gram diluted in 20 mL of 5% dextrose will be administered intravenously 15 minutes before cesarean section. (prophylactically)
Also known as: Inj Transamin 1gm
Injection Vasopressin 4 units diluted in 20 mL of normal saline will be injected locally at the placenta implantation site after delivery of placenta.
Also known as: Novapressin
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.
Time frame: Assessed intraoperatively (during cesarean section) and finalized once postoperative hematocrit is available immediately after surgery.
Need for Blood Transfusion
Requirement of blood transfusion if postoperative hemoglobin is \< 9 g/dL.
Time frame: Assessed within the immediate postoperative period (after surgery).
Drug Efficacy
Drug will be considered efficacious if estimated intraoperative blood loss is ≤ 500 mL.
Time frame: Assessed intraoperatively at completion of surgery.
Plan to share: No — 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.
Start is estimated for Mar 2026; primary completion for Aug 2026, 5 months later.
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Studies of the drugs tested here: Tranexamic Acid · Arginine Vasopressin
Allama Iqbal Medical College