Placenta PreviaPhase 3TXA-VASO-PPNCT07423156
Tranexamic Acid vs Vasopressin in Placenta Previa Trial
A Phase 3 study testing Group A: Tranexamic acid and Group B: Vasopressin in people with Placenta Previa, run by Allama Iqbal Medical College at 1 site in Pakistan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Placenta Previa
- What is being tested?
- Group A: Tranexamic acid and Group B: Vasopressin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Mar 2026to 31 Aug 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women of reproductive age
- Age 18-45 years
- Diagnosed placenta previa in current pregnancy
- Scheduled for elective cesarean section
- Singleton pregnancy
Who cannot join
- 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
Show all 9Show fewer
- Gestational diabetes
- Pregnancy-related hypertensive disorders
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site
Jinnah Hospital
Lahore, Punjab Province, +92
SHAZIA SAAQIB, FCPS, MCPS, 0923214708583, shaziasaaqib@gmail.com
Aimen Sattar, MBBS, +923190658053, aimansattar7@gmail.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Placenta Previa
- Being tested
- Group A: Tranexamic acid, Group B: Vasopressin
- Keywords
- Obstetric Hemorrhage, Cesarean Section, Tranexamic Acid, Vasopressin
- Medical subject headings
- Placenta Previa, Diabetes Insipidus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group A: Tranexamic acidDrug
Also called Inj Transamin 1gm
Injection Tranexamic Acid 1 gram diluted in 20 mL of 5% dextrose will be administered intravenously 15 minutes before cesarean section.
(prophylactically)
Group B: VasopressinDrug
Also called Novapressin
Injection Vasopressin 4 units diluted in 20 mL of normal saline will be injected locally at the placenta implantation site after delivery of placenta.
| Study group | Role | What they receive |
|---|---|---|
| Tranexamic Acid (TXA) Group | Experimental | 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 Receives: Drug: Group A: Tranexamic acid |
| Vasopressin Group | Experimental | Arm 2: Vasopressin Group Number of participants: 29 Description: Patients with placenta previa undergoing elective cesarean section receiving vasopressin prophylactically. Receives: Drug: Group B: Vasopressin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Assessed intraoperatively (during cesarean section) and finalized once postoperative hematocrit is available immediately after surgery.
Secondary outcomes (2)
Need for Blood Transfusion
Requirement of blood transfusion if postoperative hemoglobin is < 9 g/dL.
Measured: Assessed within the immediate postoperative period (after surgery).
Drug Efficacy
Drug will be considered efficacious if estimated intraoperative blood loss is ≤ 500 mL.
Measured: Assessed intraoperatively at completion of surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2026
- Study start1 Mar 2026 (estimated)
- Primary completion31 Aug 2026 (estimated)
- Study completion31 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Placenta PreviaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel two-arm randomized controlled trial. Eligible participants will be randomly allocated into two groups (1:1). Group A will receive intravenous tranexamic acid 1 g pre-operatively, and Group B will receive local vasopressin 4 units at placental implantation site after delivery of placenta.
- Masking
- None (open label)
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Allama Iqbal Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aiman Sattar, MBBS, Principal investigator, Jinnah Hospital/AIMC/UHSShazia Saaqib, FCPS,MCPS, Study director, Jinnah Hospital/AIMC/UHS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07423156
- Sponsor's protocol ID
- No 17 CMD/AIMC
- Other IDs
- CNIC No.: 32103-9070878-6
- Acronym
- TXA-VASO-PP
- Status last verified
- Feb 2026
- First submitted
- 13 Feb 2026
- Last updated
- 20 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
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.
PubMed 24750470Shalaby 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.
PubMed 35287618
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Efficacy of Tranexamic Acid Versus Vasopressin in Blood Loss Among Placenta Previa Patients Undergoing Cesarean Section
- ClinicalTrials.gov ID
- NCT07423156
- Acronym / sponsor ID
- TXA-VASO-PP / No 17 CMD/AIMC
- Conditions
- Placenta Previa
- Keywords
- Obstetric Hemorrhage, Cesarean Section, Tranexamic Acid, Vasopressin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- Allama Iqbal Medical CollegeUniversity, hospital or other
- Study start
- 1 Mar 2026 (estimated)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 20 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Parallel two-arm randomized controlled trial. Eligible participants will be randomly allocated into two groups (1:1). Group A will receive intravenous tranexamic acid 1 g pre-operatively, and Group B will receive local vasopressin 4 units at placental implantation site after delivery of placenta.
| Arm | Type | Receives |
|---|---|---|
| Tranexamic Acid (TXA) Group | Experimental | Drug: Group A: Tranexamic acidArm 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 |
| Vasopressin Group | Experimental | Drug: Group B: VasopressinArm 2: Vasopressin Group Number of participants: 29 Description: Patients with placenta previa undergoing elective cesarean section receiving vasopressin prophylactically. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Women of reproductive age
- Age 18-45 years
- Diagnosed placenta previa in current pregnancy
- Scheduled for elective cesarean section
- Singleton pregnancy
Key exclusion criteria (9 listed)
- Emergency cesarean section
- Platelet or coagulation disorder
- Use of anti-platelet or anti-coagulant drugs
- Previous history of postpartum hemorrhage
- Chronic liver disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group A: Tranexamic acidAlso: Inj Transamin 1gmInjection Tranexamic Acid 1 gram diluted in 20 mL of 5% dextrose will be administered intravenously 15 minutes before cesarean section. (prophylactically) | Drug | Tranexamic Acid (TXA) Group |
| Group B: VasopressinAlso: NovapressinInjection Vasopressin 4 units diluted in 20 mL of normal saline will be injected locally at the placenta implantation site after delivery of placenta. | Drug | Vasopressin Group |
Primary outcome
Intraoperative Blood Loss
Time frame: Assessed intraoperatively (during cesarean section) and finalized once postoperative hematocrit is available immediately after surgery.
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.
2 secondary outcomes
Need for Blood Transfusion
Time frame: Assessed within the immediate postoperative period (after surgery).
Drug Efficacy
Time frame: Assessed intraoperatively at completion of surgery.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2026.
- Background: PubMed 24750470Kato 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.
- Background: PubMed 35287618Shalaby 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.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Aiman Sattar, MBBS principal investigator
Jinnah Hospital/AIMC/UHS
Shazia Saaqib, FCPS,MCPS study director
Jinnah Hospital/AIMC/UHS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Group A: Tranexamic acid and Group B: Vasopressin in people with Placenta Previa, run by Allama Iqbal Medical College at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shazia Saaqib, FCPS,MCPS (+923214708583, shaziasaaqib@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraoperative Blood Loss (time frame: Assessed intraoperatively (during cesarean section) and finalized once postoperative hematocrit is available immediately after surgery.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07423156, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2026.