Effectiveness of using tranexamic acid to reduce blood loss after vaginal delivery at Federal Teaching Hospital, Ido-Ekiti: a randomized controlled trial

Effectiveness of tranexamic acid in reducing blood loss after vaginal delivery at Federal Teaching Hospital, Ido-Ekiti: a randomized controlled trial

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

PACTR

Registry ID

PACTR202502637769375

Enrollment

200

Registered

2025-02-10

Start date

2024-10-14

Completion date

Unknown

Last updated

2026-09-14

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

Conditions

Postpartum hemorrhage

Interventions

Sterile water for injection Placebo group GROUP B

Tranexamic acid group GROUP A

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1. Clinically healthy pregnant women (booked and unbooked) in labour 2. Planned vaginal delivery 3. Singleton pregnancy 4. Term pregnancy (at 37 weeks or more gestational age) 5. Cephalic presentation 6. Parturient (-individual) without any contraindications to the administration of tranexamic acid.

Exclusion criteria

Exclusion criteria: 1. Females who have previously experienced thromboembolism 2. Sickle cell disease 3. Bleeding disorders 4. Any known cardiovascular, renal or liver disorders 5. Multiple pregnancies. 6. Intrauterine fetal death. 7. Previous uterine surgeries. 8. Patients with chronic hypertension, preeclampsia, eclampsia and HELLP syndrome 9. Antepartum haemorhage. 10. Ruptured uterus. 11. Varicose veins at increased risk of deep vein thrombosis. 12. History of epilepsy or seizures.

Design outcomes

Secondary

Measure	Time frame
4. Tranexamic side effects which could be: a) Mild maternal side effects (nausea, vomiting diarrhea, abdominal pain, headache, skin rash) and the time frame up to discharge from recovery ward on day of delivery. b) Major maternal side effects (thromboembolism; pulmonary embolism, deep vein thrombosis, myocardial infarction, maternal death). ;5. Vital signs before delivery and at 1 hour post-delivery; HR, SBP, DBP.;6. Incidence of emergency surgical intervention for PPH up to day 1 post-delivery.;7. Satisfaction of parturient with interventions to reduce blood loss after delivery.;1. Incidence of primary PPH following vaginal delivery defined as blood loss > 500ml (based on gravimetric method and calculated EBL from the difference between the pre- and post-delivery haematocrit).;2. The need for additional uterotonics to control bleeding such as oxytocin infusion or prostaglandins, and the number of participants who required additional uterotonics.;3. Need for blood transfusion (volume and amount) after vaginal delivery, mean or median number of units of whole blood or red blood cells transfused up to day 1 postpartum.	—

Measure

Time frame

4. Tranexamic side effects which could be: a) Mild maternal side effects (nausea, vomiting diarrhea, abdominal pain, headache, skin rash) and the time frame up to discharge from recovery ward on day of delivery. b) Major maternal side effects (thromboembolism; pulmonary embolism, deep vein thrombosis, myocardial infarction, maternal death). ;5. Vital signs before delivery and at 1 hour post-delivery; HR, SBP, DBP.;6. Incidence of emergency surgical intervention for PPH up to day 1 post-delivery.;7. Satisfaction of parturient with interventions to reduce blood loss after delivery.;1. Incidence of primary PPH following vaginal delivery defined as blood loss > 500ml (based on gravimetric method and calculated EBL from the difference between the pre- and post-delivery haematocrit).;2. The need for additional uterotonics to control bleeding such as oxytocin infusion or prostaglandins, and the number of participants who required additional uterotonics.;3. Need for blood transfusion (volume and amount) after vaginal delivery, mean or median number of units of whole blood or red blood cells transfused up to day 1 postpartum.

—

Primary

Measure	Time frame
Primary outcome measure will be blood loss following vaginal delivery as total blood loss following vaginal delivery = estimated blood from difference in weight of collecting sheet + difference in the weight of pad.	—

Countries

Nigeria

Contacts

Public ContactKikelomo Adesina

Professor of Obstetrics and Gynaecology

teminikike@yahoo.com+2348033813442

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Sep 19, 2026