A trial to to evaluate if oral administration of the drug Tranexamic acid during delivery will reduce bleeding in women after child birth including a pilot study to determine at what point during delivery it should be administered to achieve optimal effect.

A pilot study and randomized placebo-controlled trial on the effect and timing of oral Tranexamic acid (TA) administered prepartum on postpartum haemorrhage after vaginal delivery

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-002015-22-SE

Enrollment

1040

Registered

2021-06-07

Start date

2022-08-12

Completion date

Unknown

Last updated

2025-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postpartum hemorrhage which is defined as bleeding during and after delivery that exceeds 500 ml. It is most commonly due to an atony of the uterus but may also have other causes such as tissue damage (of the uterus, cervix or vagina), detained placental remains in the uterus or coagulopathy. MedDRA version: 20.0 Level: LLT Classification code 10071867 Term: Postpartum bleeding System Organ Class: 100000004868

Interventions

Trade Name: Tranexamic Acid Product Name: Cyklokapron/Tranexamic Acid Pharmaceutical Form: Oral solution Pharmaceutical form of the placebo: Oral solution Route of administration of the placebo: Oral

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Women eligible for the study will be women who are planned for vaginal delivery and are =18 years old. In our pilot study the women should also have had an uncomplicated pregnancy Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 1040 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: The following criteria make a woman ineligible for the study and are grounds for exclusion from the study: ongoing treatment for venous thrombosis, known bleeding disorder or coagulopathy, known hypersensitivity towards TA, threatening preterm labor before 36 gestational weeks or inability to understand spoken and written English, Swedish, Xhosa or Afrikaans (depending on the study site), or the contents of the written information about the study. In our pilor study we will also exclude women with pre-existing kidney or heart disease, pregnancy complicated by diabetes, preeclampsia, fetal growth restriction, stillbirth.

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the effect of orally administered TA compared to placebo on rate of PPH (>=500ml) assessed both by weight and pre-postpartum hemoglobin (Hb) decrease >10 units difference in vaginal deliveries. ;Secondary Objective: - To evaluate the effect of orally administered TA compared to placebo on mean blood loss, severe PPH (>=1000ml), and the need of blood transfusion - To evaluate adherence to administration of oral TA. - To evaluate the safety of administration of oral TA compared to placebo ;Primary end point(s): Primary endpoints - Weight-estimated rate of PPH (=500ml) - Pre-postpartum Hb difference (g/L) =10 units Primary endpoints of pilot study: - Level of maximum serum concentration of TA - Time from administration to maximum serum concentration of TA - Duration of therapeutic interval of TA. - Proportion of women able to adhere to intervention ;Timepoint(s) of evaluation of this end point: Dec 2025 Pilot study : December 2022	—

Measure

Time frame

Main Objective: To evaluate the effect of orally administered TA compared to placebo on rate of PPH (>=500ml) assessed both by weight and pre-postpartum hemoglobin (Hb) decrease >10 units difference in vaginal deliveries. ;Secondary Objective: - To evaluate the effect of orally administered TA compared to placebo on mean blood loss, severe PPH (>=1000ml), and the need of blood transfusion - To evaluate adherence to administration of oral TA. - To evaluate the safety of administration of oral TA compared to placebo ;Primary end point(s): Primary endpoints - Weight-estimated rate of PPH (=500ml) - Pre-postpartum Hb difference (g/L) =10 units Primary endpoints of pilot study: - Level of maximum serum concentration of TA - Time from administration to maximum serum concentration of TA - Duration of therapeutic interval of TA. - Proportion of women able to adhere to intervention ;Timepoint(s) of evaluation of this end point: Dec 2025 Pilot study : December 2022

—

Secondary

Measure	Time frame
Secondary end point(s): Secondary endpoints - Weight-estimated rate of severe PPH (=1000ml) - Mean blood loss (ml) - Mean pre-postpartum Hb decrease (units) - Rate of blood transfusion (%) - Adherence to intervention (%) - Rate of thromboembolic events up to 6 weeks postpartum (%) ;Timepoint(s) of evaluation of this end point: December 2025 Pilot study : December 2022	—

Countries

South Africa, Sweden

Contacts

Public ContactMargit Endler

Dept. of Obstetrics and Gynecology, Sodersjukhuset

margit.endler@ki.se

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026