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Not yet recruitingNCT06515535Updated Jul 23, 2024

Efficacy of Topical Tranexamic Acid in Reducing Blood Loss During CS in Patients With Placenta Previa

An interventional study of Topical tranexamic acid and Intravenous tranexamic acid in Placenta Previa, sponsored by Cairo University. Not yet recruiting. Open to female participants aged 20 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-07-23.

Sponsored by Cairo University · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Primary completion was expected by Dec 2024, 1 year 10 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
56
Allocation
Randomized
Ages
20 Years to 40 Years
Sex
Female
01

Study summary

Objectives: To evaluate the efficacy of topical tranexamic acid applied on the placental bed after placental delivery to reduce blood loss during cesarean delivery in women with placenta previa.

Patients will be randomly assigned into two groups:

Group (A) - Study group (n=28): The topical tranexamic acid group will receive topical tranexamic acid after placental delivery applied on the placental bed for 5 minutes by using a sterile towel soaked with 2g tranexamic acid (Kapron, Amoun, Cairo, Egypt) (4 ampules 500ug) diluted in 100ml of sodium chloride 0.9%, in addition to the IV infusion of 1g tranexamic acid (2 ampules 500ug) diluted with 20ml of 5% glucose administered just after delivery of the fetus.

Group (B) - Control group (n=28): The intravenous tranexamic acid group will receive only an IV infusion of 1g of tranexamic acid (2 ampules 500ug) diluted with 20 ml of 5% glucose administered just after delivery of the fetus.

02

Conditions studied

  • Placenta Previa

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03

In context

Placenta Previa

80 studies on the registry are indexed under Placenta Previa; 17 are open to participants now.

This study's planned enrollment of 56 is below the median of 109 across 45 interventional studies indexed under Placenta Previa.

Browse Placenta Previa studies →

Lead sponsor

Cairo University is the lead sponsor of 4,941 studies on the registry; 1,458 are open to participants now.

Of its 37 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 40 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

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.

Inclusion criteria

  • Age: 20-40 years old.
  • less than 30 kg/m2.
  • Pregnancy of singleton living fetus.
  • Placenta previa by ultrasound assessment
  • Gestational age > 36 weeks.

Exclusion criteria

Exclusion Criteria:

  • Women with a history of any medical disorder with pregnancy, e.g., Gestational diabetes and hypertension.
  • Women with systemic diseases, e.g., diabetes mellites, systemic immune disorders such as systemic lupus erythematosus
  • Women with bleeding tendency or coagulopathy.
  • Women on anticoagulants or hemodynamically unstable women.
  • Women with uterine abnormalities, such as fibroids or polyps.
  • Emergency termination of pregnancy.
  • Intrauterine fetal death.
  • Pregnancy with obstetric hemorrhage, e.g., antepartum hemorrhage
  • Cases of placenta accrete spectrum disorder or placental abruption
  • Women with known allergies to Tranexamic acid
Terms in these criteria, in plain language(1)

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.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
56 participants (estimated)

Study arms

  • Experimental
    Study group (n=28)

    The topical tranexamic acid group will receive topical tranexamic acid after placental delivery applied on the placental bed for 5 minutes by using a sterile towel soaked with 2g tranexamic acid (Kapron, Amoun, Cairo, Egypt) (4 ampules 500ug) diluted in 100ml of sodium chloride 0.9%, in addition to the IV infusion of 1g tranexamic acid (2 ampules 500ug) diluted with 20ml of 5% glucose administered just after delivery of the fetus.

    Drug: Topical tranexamic acid · Drug: Intravenous tranexamic acid

  • Active comparator
    Control group (n=28)

    The intravenous tranexamic acid group will receive only an IV infusion of 1g of tranexamic acid (2 ampules 500ug) diluted with 20 ml of 5% glucose administered just after delivery of the fetus.

    Drug: Intravenous tranexamic acid

Interventions

  • Topical tranexamic acid will be applied after placental delivery on the placental bed for 5 minutes by using a sterile towel soaked with 2g tranexamic acid (Kapron, Amoun, Cairo, Egypt) (4 ampules 500ug) diluted in 100ml of sodium chloride 0.9%

  • Intravenous tranexamic acid will be given in the form of an IV infusion of 1g of tranexamic acid (2 ampules 500ug) diluted with 20 ml of 5% glucose administered just after delivery of the fetus.

06

What researchers measure

Primary outcomes

  1. Amount of blood loss

    amount of intraoperative blood loss during CS in patients with placenta previa

    Time frame: during operation

Secondary outcomes

  1. operative time

    Time frame: during operation

07

Study locations

No study locations are listed for this record.

08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Jul 2024; primary completion for Dec 2024, 5 months later.

Of 23 interventional studies with no phase under Placenta Previa, half reached primary completion within 14 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 36. This study's planned 5 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 17, 2024
First posted
Jul 23, 2024
StartEst.
Jul 24, 2024
Primary completionEst.
Dec 31, 2024
CompletionEst.
Dec 31, 2024
Last update
Jul 23, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 23, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06515535
Lead sponsor
Cairo University
Responsible party
Abdalla Mousa (Lecturer of obgyn Cairo university, Cairo University) — Principal investigator
First posted
Jul 23, 2024
Start date
Jul 24, 2024 (estimated)
Primary completion
Dec 31, 2024 (estimated)
Completion
Dec 31, 2024 (estimated)
Last update
Jul 23, 2024

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: Tranexamic Acid

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