Postpartum Hemorrhage Reduction With Oral Tranexamic Acid: a Clinical Trial

NCT06025916 | Recruiting Phase 4 DMC

• 1 other identifier: 2022-00327
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

This is a multicentre randomized placebo-controlled double-blinded phase IV study among 1000 women in Sweden and South Africa on the effect of oral tranexamic acid on PPH after vaginal delivery. The main purpose of the study is to evaluate the effect of orally administered tranexamic acid (TA) compared to placebo on rate of postpartum hemorrhage (PPH) after vaginal birth. Participants will be randomized to receive either 20 ml (2g) of the investigational medicinal product (TA100mg/ml) or 20ml of a placebo solution during labor. Our main endpoint, assessed at 24 hours after delivery is PPH defined as blood loss \>=500ml and assessed both by weight and pre-postpartum hemoglobin (Hb) decrease \>10 units difference in vaginal deliveries. This RCT was preceded by a pilot intervention, included in the current protocol, aiming to assess uptake of oral forms of Tranexamic acid (TA) during active labour. The study took place at Södersjukhuset, Stockholm, Sweden between December 2022 and February 2023 among 51 women ≥ 36 gestational weeks with planned vaginal delivery who were randomized 1:1:1:1 to receive two grams of TA as oral solution, tablets, effervescent tablets, or 1g of intravenous (IV) TA, near full cervical dilatation. Blood samples were taken 30, 60, 120, 240, 360, and 480 minutes after TA administration. Plasma concentration of TA was measured using Liquid Chromatography-Tandem Mass Spectrometry. Mean values were compared between groups using ANOVA. Our main outcomes measures were time-to-therapeutic level, therapeutic interval, and maximum plasma concentration of TA.

Conditions

PPH

Outcome Measures

Primary Outcomes (1)

• PPH

  Proportion of participants with weight-assessed blood loss after delivery \>/= 500ml

  24 hours

Secondary Outcomes (9)

• Severe PPH

  24 hours

• Blood transfusion

  72 hours

• Mean blood loss

  24 hours

• Mean pre-post partal hemoglobin

  24 hours

• Pre-post partal hemoglobin

  24 hours

Study Arms (2)

Tranexamic acid

ACTIVE COMPARATOR

Will receive 20ml of tranexamic acid 100mg/ml at a timepoint when the cervix is dilated 6 cn (for multipara) and 8 cm for primipara

Drug: Tranexamic acid

Placebo

PLACEBO COMPARATOR

Will receive 20ml of placebo solution, equivalent in appearance and taste to tranexamic acid solution but with no active ingredient, at a timepoint when the cervix is dilated 6 cn (for multipara) and 8 cm for primipara

Drug: Tranexamic acid

Interventions

Tranexamic acid DRUG

20 ml of oral solution TA (100mg/ml)

Also known as: Cyklokapron

Placebo; Tranexamic acid

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Enrolled women will be ≥18 years, ≥36 gestational weeks, and planned for vaginal delivery. Women with known bleeding disorders, known allergy to TA, ongoing treatment for venous thrombosis, or inability to make an informed consent will be ineligible.

You may not qualify if:

• Opposite of above

Sponsors & Collaborators

• Karolinska Institutet: lead
• Stockholm South General Hospital: collaborator
• University of Cape Town: collaborator

Study Sites (1)

Södersjukhuset (South General Hospital)

Stockholm, 118 83, Sweden

RECRUITING

MeSH Terms

Interventions

Tranexamic Acid

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Margit Endler, MD PhD, Associate Professor

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Margit Endler, MD PhD

CONTACT

0706747227; margit.endler@ki.se

Helena Paul

CONTACT

helena.paul@regionstockholm.se

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D. Associate Professor

Study Record Dates

• First Submitted: August 29, 2023
• First Posted: September 6, 2023
• Study Start: September 27, 2023
• Primary Completion: December 1, 2025
• Study Completion: March 1, 2026
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)