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The Efficacy of Misoprostol Compared to Tranexamic Acid in Augmenting Oxytocin Versus Oxytocin Alone in Reducing Postpartum Blood Loss in Vaginal Deliveries: A Randomized Controlled Trial

The Efficacy of Misoprostol Compared to Tranexamic Acid in Augmenting Oxytocin Versus Oxytocin Alone in Reducing Postpartum Blood Loss in Vaginal Deliveries: A Randomized Controlled Trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
TCTR
Registry ID
TCTR20260226001
Enrollment
324
Registered
2026-02-26
Start date
2025-05-23
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Postpartum Hemorrhage (PPH): Defined in this study as blood loss of 500 mL or more following a vaginal delivery. Postpartum Blood Loss: Specifically, the quantification of total blood loss within the first 24 hours after childbirth. Uterine Atony: The failure of the uterus to contract sufficiently after delivery, which is the leading cause of postpartum hemorrhage. Postpartum Hemorrhage, Misoprostol , Tranexamic Acid, Oxytocin, Vaginal Delivery, Uterotonic Agents , Uterine Atony , Third Stage

Interventions

Participants received 600 micrograms of misoprostol administered sublingually immediately after neonatal delivery and cord clamping, in addition to the standard prophylactic dose of 10 international u
Misoprostol group,Tranexamic Acid group,Oxytocin group

Sponsors

Department of Obstetrics and Gynecology, Buddhachinaraj Phitsanulok Hospital, Phitsanulok, Thailand.
Lead Sponsor
Department of Obstetrics and Gynecology, Faculty of Medicine, Chulalongkorn University.
Collaborator

Eligibility

Sex/Gender
Female
Age
18 Years to 45 Years

Inclusion criteria

Inclusion criteria: 1. Maternal age between 18 and 45 years 2. Term singleton pregnancy with gestational age of at least 37 weeks 3. Cephalic presentation 4.Planned vaginal delivery 5. For women on antenatal aspirin prophylaxis, discontinuation of aspirin for more than seven days prior to delivery

Exclusion criteria

Exclusion criteria: 1. Known contraindications or hypersensitivity to any of the study medications (misoprostol, tranexamic acid, or oxytocin) 2. Coagulopathy with an INR greater than 1.5 3. Concurrent use of other antiplatelet or anticoagulant agents 4. Preeclampsia with severe feature 5. Antepartum hemorrhage 6. Hepatic or renal impairment 7. A history of thromboembolic disease 8. Inability to provide informed consent 9. Intrapartum event requiring unplanned cesarean delivery, such as cephalopelvic disproportion or non-reassuring fetal status

Design outcomes

Primary

MeasureTime frame
Total Quantitative Blood Loss within 24 hours postpartum a calibrated under-buttocks drape for direct volume collection combined with gravimetric method (weighing all blood-soaked materials, where 1 gram equals 1 milliliter)

Secondary

MeasureTime frame
Postpartum Hemorrhage within 24 hours postpartum Incidence,Additional Uterotonic Medications within 24 hours postpartum Incidence ,Uterine Atony within 24 hours postpartum Incidence ,Adverse events within 24 hours postpartum Incidence

Countries

Thailand

Contacts

Public ContactKanchapan Sukonpan

Buddhachinaraj Phitsanulok Hospital

puimfm@gmail.com0815673593

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026