NCT07423156

Brief 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. 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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
58

participants targeted

Target at below P25 for phase_3

Timeline
2mo left

Started Mar 2026

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress58%
Mar 2026Aug 2026

First Submitted

Initial submission to the registry

February 13, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 20, 2026

Completed
9 days until next milestone

Study Start

First participant enrolled

March 1, 2026

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2026

Last Updated

February 20, 2026

Status Verified

February 1, 2026

Enrollment Period

6 months

First QC Date

February 13, 2026

Last Update Submit

February 13, 2026

Conditions

Placenta Previa

Keywords

Obstetric HemorrhageCesarean SectionTranexamic AcidVasopressin

Outcome Measures

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.

    Assessed intraoperatively (during cesarean section) and finalized once postoperative hematocrit is available immediately after surgery.

Secondary Outcomes (2)

  • Need for Blood Transfusion

    Assessed within the immediate postoperative period (after surgery).

  • Drug Efficacy

    Assessed intraoperatively at completion of surgery.

Study Arms (2)

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

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.

Drug: Group B: Vasopressin

Interventions

Group A: Tranexamic acidDRUG

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
Tranexamic Acid (TXA) Group
Group B: VasopressinDRUG

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
Vasopressin Group

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsThis study includes women of reproductive age (18-45 years) with placenta previa undergoing elective cesarean section.
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Women of reproductive age
  • Age 18-45 years
  • Diagnosed placenta previa in current pregnancy
  • Scheduled for elective cesarean section
  • Singleton pregnancy

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jinnah Hospital

Lahore, Punjab Province, +92, Pakistan

Location

Related Publications (2)

  • 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.

    PMID: 24750470BACKGROUND

  • 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.

    PMID: 35287618BACKGROUND

MeSH Terms

Conditions

Placenta PreviaDiabetes Insipidus

Condition Hierarchy (Ancestors)

Obstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesPlacenta DiseasesKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesMale Urogenital DiseasesPituitary DiseasesEndocrine System Diseases

Study Officials

  • Aiman Sattar, MBBS

    Jinnah Hospital/AIMC/UHS

    PRINCIPAL INVESTIGATOR

  • Shazia Saaqib, FCPS,MCPS

    Jinnah Hospital/AIMC/UHS

    STUDY DIRECTOR

Central Study Contacts

Shazia Saaqib, FCPS,MCPS

CONTACT

+923214708583shaziasaaqib@gmail.com

Aimen Sattar, MBBS

CONTACT

+923190658053aimansattar7@gmail.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 13, 2026

First Posted

February 20, 2026

Study Start

March 1, 2026

Primary Completion (Estimated)

August 31, 2026

Study Completion (Estimated)

August 31, 2026

Last Updated

February 20, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

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.

Locations

PA(1)