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Tranexamic Acid vs Vasopressin in Placenta Previa Trial

ConditionPlacenta Previa
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age18-45
SponsorAllama Iqbal Medical College

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Group A: Tranexamic acid

    Drug

    Injection Tranexamic Acid 1 gram diluted in 20 mL of 5% dextrose will be administered intravenously 15 minutes before cesarean section. (prophylactically)

  • Group B: Vasopressin

    Drug

    Injection Vasopressin 4 units diluted in 20 mL of normal saline will be injected locally at the placenta implantation site after delivery of placenta.

Treatment groups

58 Participants
are divided into 2 treatment groups
Group A: Tranexamic Acid (TXA) GroupExperimental treatment 1 intervention
Group B: Vasopressin GroupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Secondary outcomes

1

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).
2

Drug Efficacy

Drug will be considered efficacious if estimated intraoperative blood loss is ≤ 500 mL.

Time frame
Assessed intraoperatively at completion of surgery.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Allama Iqbal Medical College

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: