Adjunctive sublingual misoprostol for secondary prevention of post-partum hemorrhage during cesarean delivery: double blind placebo randomized controlled trial

Sallam, Hany F.; Shady, Nahla W.

doi:10.18203/2320-1770.ijrcog20180161

Cited by 5 publications

(5 citation statements)

References 25 publications

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“…This is in line with Khalafalah [19] as he found that the blood loss was 366.4 ±165 in the carbetocin group and was 434.7 ± 191.7 in the misoprostol group [p=0.01]. In another study done by Sallam and Shady [20] , at Aswan University Hospital comparing misoprostol with placebo in reduced blood loss and prevention of PPH. It was found that high significant reduction in blood loss with misoprostol group than placebo group.…”

Section: Discussionsupporting

confidence: 72%

Carbetocin versus Rectal Misoprostol to Decrease Blood Loss in Vaginal Delivery in High Risk Patients for Postpartum Hemorrhage

Hetiba¹,

Mahmoud

Oun

2021

International Journal of Medical Arts

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Background: Postpartum hemorrhage is a critical complication after delivery. Methods to decrease or prevent postpartum hemorrhage continue to develop. The medical prophylaxis is frequently used with extension of the utilized drugs. Aim of the work:The current study aims to evaluate the effects of intravenous carbetocin versus rectal misoprostol to decrease blood loss in vaginal delivery in high risk patients for postpartum hemorrhage. Patients and Methods:The study included 94 Patients. They were selected from those attending for normal vaginal delivery and categorized as high risk for postpartum hemorrhage. All were evaluated on clinical basis, laboratory investigations and abdominal ultrasound. Then patients were randomly assigned into two equal groups; group A [Carbetocin group] received 1 ampoule of Carbetocin [100 μg/ml] intravenously as a bolus injection slowly over one minute after neonatal delivery, and group B [Misoprostol group] received three rectal misoprostol tablets [600 μg] after neonatal delivery. Each group was assessed for hemodynamic changes [blood pressure, pulse and respiratory rate], gastrointestinal [GIT] side effects as nausea, vomiting and metallic taste, vasomotor effects as flushing, headache, itching. Results: The amount of blood loss was significantly lower in the carbetocin group than in the misoprostol group [365.53±41.12 ml vs. 404.68±67.27 ml]. Need for uterotonics reported among 17.0% of misoprostol group compared to none [0.0%] in carbetocin group [P=0.003]. On the other side, need for blood transfusion and uterine massage was also increased in misoprostol than carbetocin groups, but the difference was not statistically significant. The complications [drug side effects] revealed that, there was significant increase of fever, nausea & vomiting, diarrhea and abdominal pain in misoprostol than carbetocin group [21.3%, 10.6%, 19.14% and 21.3% vs. 0.0%, 0.0%, 2.12% and 0.0% successively]. Conclusion:Carbetocin is superior to misoprostol for postpartum hemorrhage, regarding efficacy and safety.

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Section: Discussionsupporting

confidence: 72%

Carbetocin versus Rectal Misoprostol to Decrease Blood Loss in Vaginal Delivery in High Risk Patients for Postpartum Hemorrhage

Hetiba¹,

Mahmoud

Oun

2021

International Journal of Medical Arts

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“…The efficacy of misoprostol alone as well as an adjunct to oxytocin for prevention of PPH is well documented. [9][10][11][12][13][14][15][16][17][18][19][20] In contrast very few studies have reported a contrary view but have used a lower dose. 21 Choosing the optimal dose is imperative to achieve the goal as discussed later.…”

Section: Discussionmentioning

confidence: 99%

Adjunctive misoprostol for prevention of post-partum haemorrhage: a pragmatic strategy of selective sequential administration

Mishra

Nekkanti

Barma

et al. 2021

Int J Reprod Contracept Obstet Gynecol

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Background: To evaluate the effect of adjunctive misoprostol in preventing postpartum haemorrhage (PPH) by selective administration above threshold bleeding in order to reduce its side effects in comparison with primary prevention with oxytocin alone.Methods: It was a prospective observational cohort study conducted at Government medical College of central India. Population included 500 low risk women delivering vaginally. After having received oxytocin as primary prevention, women were monitored for bleeding by quantitative assessment of blood loss (QBL) using an innovative drape (kept prepared at the point of care) and once bleeding crossed 350 ml mark, alternate women were given 800 µg misoprostol sublingually as an adjuvant (study group) and compared with those who did not receive adjuvant misoprostol (control group). Main outcome measure: Comparing the incidence of PPH and side effects between study and control group.Results: 150 women had blood loss >350 ml which constituted 76 women in study and control group each. Incidence of PPH was significantly less in the study group (10.52 versus 22.36%, p<0.05, RR 0.470 95% CI= 0.216-1.024). Though side effects were more (38.15%) in study group but these were mild in nature and when the number was extrapolated to all recruited women, the incidence came down to 11.6%.Conclusions: Sequential adjuvant misoprostol at 350 ml blood loss after primary prevention with oxytocin is an effective and pragmatic strategy for preventing PPH when compared to oxytocin alone but with reduced overall side effects owing to less number of women receiving misoprostol.

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“…Misoprostol was compared with a placebo in a different trial conducted by Sallam and Shady [ 28 ] at an Egyptian hospital to determine which drug minimized blood loss and prevented PPH. It was discovered that the misoprostol arm substantially lowered blood loss compared with placebo.…”

Section: Reviewmentioning

confidence: 99%

Intravenous Carbetocin Versus Rectal Misoprostol for the Active Management of the Third Stage of Labor: A Systematic Review and Meta-Analysis of Randomized Controlled Trials

Albazee¹,

Alrashidi²,

Laqwer³

et al. 2022

Cureus

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Globally, postpartum hemorrhage (PPH) is the top cause of maternal death. Multiple uterotonic medications are available to prevent PPH; however, it is still unclear whether one is the most effective. The current study compared the efficacy and safety of intravenous carbetocin with rectal misoprostol for the active management of the third stage of labor in order to prevent PPH. Eligible studies were found utilizing digital medical sources, including the Cochrane Central Register of Controlled Trials (CENTRAL), Web of Science (WOS), PubMed, Scopus, and Google Scholar, from inception until September 2022. Only randomized controlled trials (RCTs) that matched the inclusion requirements were chosen. We used the Cochrane Risk of Bias scale (version 2) to assess the quality of the included studies. The Review Manager (version 5.4 for Windows) was used to conduct the meta-analysis. The results were summarized as mean difference (MD) or risk ratio (RR) with a 95% confidence interval (CI) in fixed- or random-effects models according to the degree of between-study heterogeneity. Collectively, we screened 621 articles after omitting duplicates and eventually included three RCTs for analysis. Overall, 404 patients were included in these studies; 202 patients were allocated to the intravenous carbetocin group whereas 202 patients were allocated to the rectal misoprostol group. Two RCTs were judged as “low” risk of bias, whereas one RCT was judged as having “some concerns” regarding the quality assessment. Regarding efficacy endpoints, the intravenous carbetocin group had significantly lower blood loss (n=3 RCTs, MD=-117.74 mL, 95% CI [-185.41, -50.07], p<0.001), need for additional uterotonics (n=2 RCTs, RR=0.06, 95% CI [0.01, 0.46], p=0.007), need for uterine massage (n=2 RCTs, RR=0.40, 95% CI [0.20, 0.80], p=0.009), and need for blood transfusion (n=2 RCTs, RR=0.38, 95% CI [0.15, 0.95], p=0.04) compared with the rectal misoprostol group. Regarding safety endpoints, the rates of diarrhea (n=3 RCTs, RR=0.18, 95% CI [0.06, 0.55], p=0.003) and chills (n=2 RCTs, RR=0.31, 95% CI [0.12, 0.83], p=0.02) were significantly lower in the intravenous carbetocin group compared with the rectal misoprostol group. However, there was no significant difference between both groups regarding the rates of headache (n=3 RCTs, RR=1.23, 95% CI [0.06, 1.91], p=0.35) and facial flushing (n=2 RCTs, RR=0.88, 95% CI [0.46, 1.68], p=0.70). In conclusion, it was discovered that intravenous carbetocin was a superior substitute for rectal misoprostol for the active management of the third stage of labor. With far fewer side effects, intravenous carbetocin decreased postpartum blood loss and further uterotonic use. For women who have a high risk of PPH, intravenous carbetocin is advised.

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Adjunctive sublingual misoprostol for secondary prevention of post-partum hemorrhage during cesarean delivery: double blind placebo randomized controlled trial

Cited by 5 publications

References 25 publications

Carbetocin versus Rectal Misoprostol to Decrease Blood Loss in Vaginal Delivery in High Risk Patients for Postpartum Hemorrhage

Carbetocin versus Rectal Misoprostol to Decrease Blood Loss in Vaginal Delivery in High Risk Patients for Postpartum Hemorrhage

Adjunctive misoprostol for prevention of post-partum haemorrhage: a pragmatic strategy of selective sequential administration

Intravenous Carbetocin Versus Rectal Misoprostol for the Active Management of the Third Stage of Labor: A Systematic Review and Meta-Analysis of Randomized Controlled Trials

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