Trial reportBMC pregnancy and childbirth2023
Intravenous tranexamic acid vs. sublingual misoprostol in high-risk women for postpartum haemorrhage following cesarean delivery; a randomised clinical trial.
Trial report in BMC pregnancy and childbirth, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It has been retracted, and should not be counted. It is linked to trial NCT04117243 (The Efficacy and Safety of Preoperative Intravenous Tranexamic Acid Versus Sublingual Misoprostol in Reducing Blood Loss During and After Elective Cesarean Section Among High Risk Pregnant Cases.), which is not on this map. Cited by 7 papers, 6 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
The Efficacy and Safety of Preoperative Intravenous Tranexamic Acid Versus Sublingual Misoprostol in Reducing Blood Loss During and After Elective Cesarean Section Among High Risk Pregnant Cases.
Who cites it
7 citing papers in PubMed, 6 syntheses or guidelines pooled it, 11 citations in OpenAlex.
- Comparing oxytocin alternatives for postpartum hemorrhage prevention in vaginal and caesarean births: a systematic review and meta-analysis.Archives of gynecology and obstetrics · 2026Pooled it
- Uterotonic agents for preventing postpartum haemorrhage: a network meta-analysis.The Cochrane database of systematic reviews · 2025Pooled it
- Meta-analysis: the prophylactic use of tranexamic acid to reduce blood loss during caesarean delivery.Irish journal of medical science · 2025Pooled it
- Tranexamic acid for preventing postpartum haemorrhage after vaginal birth.The Cochrane database of systematic reviews · 2025Pooled it
- Pooled it
- Tranexamic acid for preventing postpartum haemorrhage after caesarean section.The Cochrane database of systematic reviews · 2024Pooled it
- Article
Corrections and comments
- Expression of concern · 2025-06-24Concerns/Issues about Data · Updated to Expression of Concern ·
- Expression of concern · 2025-10-13Concerns/Issues about Data · Concerns/Issues about Human Subject Welfare · Concerns/Issues about Results and/or Conclusions · Investigation by Journal/Publisher · Objections by Author(s) · Original Data and/or Images not Provided and/or not Available · Upgrade/Update of Prior Notice(s) ·
- Expression of concern
Authors and funding
6 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveThis study compares the effectiveness of administering sublingual misoprostol combined with oxytocin to that of IV tranexamic acid combined with oxytocin to reduce intra and post-operative blood loss in high-risk women for postpartum haemorrhage (PPH) following cesarean section (CS).
methodsAbout 315 high-risk pregnant women undergoing CS participated in this trial. They were randomly assigned into three groups; tranexamic group, misoprostol group, and control group, according to the medication given in the operative theatre. All patients received oxytocin intraoperatively. They were assessed regarding intraoperative blood loss, the incidence of PPH, and the reduction in haemoglobin and hematocrit values.
resultsBoth tranexamic and misoprostol groups had similar results in reducing intra and post-operative blood loss. However, the reduction in haemoglobin and hematocrit were significantly lower in tranexamic and misoprostol groups compared to the control group (-0.78 ± 0.57 vs. -0.83 ± 0.52 vs. -1.32 ± 0.57 gm/dl, P < 0.001 and - 3.05 ± 1.28 vs. -3.06 ± 1.13 vs. -4.94 ± 1.82%, P < 0.001 respectively). In addition, the estimated blood loss was significantly lower in the tranexamic and misoprostol groups compared to the control group (641.6 ± 271.9 vs. 617.9 ± 207.4 vs. 1002.4 ± 340.7 ml, P < 0.001).
conclusionBoth tranexamic acid and misoprostol are equally capable of reducing blood loss, but the results were significantly better compared to using oxytocin alone in high-risk patients. CLINICAL
trial registrationRegistered at www. CLINICALTRIALS: govon07/10/2019 with registration number NCT04117243.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.