The effect of prophylactic oral tranexamic acid plus buccal misoprostol on blood loss after vaginal delivery: a randomized controlled trial

Shady, Nahla W.; Sallam, Hany F.; Elsayed, Ahmed H.; Abdelkader, Ahmed; Ali, Shahzad; Alanwar, Ahmed; Abbas, Ahmed M.

doi:10.1080/14767058.2017.1418316

Cited by 13 publications

(11 citation statements)

References 24 publications

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“…examining the true potential of oral TXA. Nevertheless, a study testing 1000 mg oral TXA at the end of the first stage of labor followed by misoprostol showed that this regimen was associated with lower blood loss when compared to prophylactic IV oxytocin [11]. Another limitation of our study is that the rates of intervention were very different from our assumptions for sample size calculation (above).…”

Section: Discussionmentioning

confidence: 83%

“…Whereas IV TXA is recommended for use in the treatment of PPH, oral TXA may not confer the same effect as IV administration, which allows for much greater bioavailability [11]. Therefore, it is possible that the misoprostol treatment (in addition to other interventions), may have effectively controlled blood loss before oral TXA could take effect.…”

Section: Discussionmentioning

confidence: 99%

“…Currently, no information is available about its effectiveness in oral formulation for PPH treatment. Oral TXA has been explored for PPH prophylaxis and may be effective when combined with misoprostol when administered postpartum [11]. If oral TXA were helpful in reducing blood loss after delivery for women experiencing PPH, it could be administered by mid and low level providers at lower level health facilities or home births, where parenteral administration is not feasible and transfer to higher level of care may be delayed.…”

Section: Introductionmentioning

confidence: 99%

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A double-blind, randomized controlled trial to explore oral tranexamic acid as adjunct for the treatment for postpartum hemorrhage

et al. 2020

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Background: Oral tranexamic acid (TXA), if effective in reducing blood loss after delivery for women experiencing primary PPH, could be administered where parenteral administration is not feasible. This trial assessed the efficacy, safety, and acceptability of oral TXA when used as an adjunct to sublingual misoprostol to treat postpartum hemorrhage (PPH) following vaginal delivery. Methods: From October 2016 to January 2018, women presenting at four hospitals in Senegal and Vietnam for vaginal delivery were screened for enrollment in the trial. Women diagnosed with postpartum hemorrhage (defined as blood loss ≥700 ml) were randomized to receive either oral TXA (1950 mg) or placebo in addition to 800 mcg sublingual misoprostol. Postpartum blood loss was measured using a calibrated drape. Blood loss for all PPH cases was recorded for 2 h after administration of the drugs. The primary outcome measure was the proportion of women with bleeding controlled with the trial regimen without recourse to further treatment. Secondary outcomes including the rate of severe PPH, mean/median blood loss, use of additional uterotonics and/or interventions side effects, and acceptability were also recorded. Results: Of the 258 women who received treatment for PPH, 128 received placebo and misoprostol and 130 received TXA and misoprostol. The proportion of women who had active bleeding controlled with trial drugs alone and no additional interventions was similar in both groups: 77(60.2%) placebo; 74 (56.9%) TXA, p = 0.59). Use of other interventions to control bleeding, including uterotonics, did not differ significantly between groups. Median blood loss at PPH diagnosis was 700 ml in both groups. Uterine atony alone or in addition to another cause contributed to over 90% of PPH cases reported (92.2% placebo vs. 91.5% TXA), other causes included perineal and cervical lacerations and retained placenta. Reports of side effects and acceptability were similar in the two groups. Conclusion: Adjunct use of oral TXA with misoprostol to treat PPH resulted in similar clinical and acceptability outcomes when compared to treatment with misoprostol alone. Trial registration: This trial was registered with ClinicalTrials.gov, number NCT02805426. Registered on 3 September 2016.

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Section: Discussionmentioning

confidence: 83%

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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A double-blind, randomized controlled trial to explore oral tranexamic acid as adjunct for the treatment for postpartum hemorrhage

et al. 2020

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“…The risk of bias was assessed independently by LH and AW for 14 trials [10][11][12][13][14][15][16][17][18][19][20][21][22][23]. Six assessments [24][25][26][27][28][29] were produced during a review by Gallos et al [30].…”

Section: Risk Of Bias Of Included Trialsmentioning

confidence: 99%

Postpartum haemorrhage (PPH) rates in randomized trials of PPH prophylactic interventions and the effect of underlying participant PPH risk: a meta-analysis

Hawker

Weeks

2020

BMC Pregnancy Childbirth

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Background: Postpartum haemorrhage (PPH) remains a leading cause of maternal mortality. Many trials assessing interventions to prevent PPH base their data on low risk women. It is important to consider the impact data collection methods may have on these results. This review aims to assess trials of PPH prophylaxis by grading trials according to the degree of risk status of the population enrolled in these trials and identify differences in the PPH rates of low risk and high risk populations. Methods: Systematic review and meta-analysis using a random-effects model. Trials were identified through CENTRAL. Trials were assessed for eligibility then graded according to antenatal risk factors and method of birth into five grades. The main outcomes were overall trial rate of minor PPH (blood loss ≥500 ml) and major PPH (> 1000 ml) and method of determining blood loss (estimated/measured).

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“…[4][5][6] rectal and intrauterine. [7][8][9][10] Beside that, it can be used for termination of pregnancy in cases of missed or incomplete miscarriage. [11][12][13] Also, in cases with retained placenta it may have a role in management of associated bleeding which mostly result from atony.…”

Section: Introductionmentioning

confidence: 99%

Intrauterine Misoprostol versus intravenous Oxytocin infusion during cesarean delivery to reduce intraoperative and postoperative blood loss: a randomised clinical trial

Abdelaleem

Abdelaleem²,

Abbas

2019

Int J Reprod Contracept Obstet Gynecol

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Background: The objective of the present study was to compare the efficacy of intrauterine misoprostol with intravenous oxytocin infusion in reducing blood loss during and after cesarean section (CS).Methods: An open, randomized, clinical trial, registered (ClinicalTrials.gov ID: NCT03148574) conducted between July 1, 2017 and April 1, 2018. The study included 240 pregnant females that were recruited at term (37-40 weeks) gestation scheduled for either elective or emergency CS. Eligible participants were randomly allocated into two equal groups: Group A: patients who receive intravenous infusion of 10 I.U diluted to 500ml of normal saline for 30 minute after delivery. Group B: patients received 400μg misoprostol intrauterine just after cord clamping and delivery of the placenta. Primary outcome measure was assessment of amount of intraoperative and postoperative blood loss.Results: The intraoperative and 2h postoperative blood loss in the misoprostol group was higher than oxytocin group (p<0.001). Hemoglobin level decreased significantly among both groups, manifested by the highly significant p value in comparison of pre and postoperative Hb level in the two groups (p<0.001). However, the blood loss in the misoprostol group was higher than oxytocin group (p=0.004). There was a statistical significant differences between both groups as regards the need for additional uterotonic drug (66% in misoprostol group vs 5% in oxytocin group, P<0.001). Shivering and pyrexia were more in common in the misoprostol group while vomiting, headache and giddiness were significantly higher among oxytocin group.Conclusions: Administration of misoprostol 400mcg through intrauterine route appears to be less effective than intravenous oxytocin infusion in reducing blood loss during and after CS.

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The effect of prophylactic oral tranexamic acid plus buccal misoprostol on blood loss after vaginal delivery: a randomized controlled trial

Abstract: In settings like rural area or home delivery in which oxytocin is not available, alternative oral TA plus buccal misoprostol may be considered as an effective line in prevention of PPH.

Cited by 13 publications

References 24 publications

A double-blind, randomized controlled trial to explore oral tranexamic acid as adjunct for the treatment for postpartum hemorrhage

A double-blind, randomized controlled trial to explore oral tranexamic acid as adjunct for the treatment for postpartum hemorrhage

Postpartum haemorrhage (PPH) rates in randomized trials of PPH prophylactic interventions and the effect of underlying participant PPH risk: a meta-analysis

Intrauterine Misoprostol versus intravenous Oxytocin infusion during cesarean delivery to reduce intraoperative and postoperative blood loss: a randomised clinical trial

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