A Double-Blind Randomized Controlled Trial of Oral Misoprostol and Intramuscular Syntometrine in the Management of the Third Stage of Labor

Abstract

Background: The aim of this study was to compare the efficacy and safety of oral misoprostol 400 µg with intramuscular syntometrine in the management of the third stage of labor. Material and Methods: This was a double-blind randomized controlled trial conducted in a tertiary care hospital. Three hundred and fifty-five women randomized to receive either oral misoprostol 400 µg or intramuscular syntometrine in the third stage of labor were studied. The change in hemoglobin level from before to 48 h after delivery, use of additional oxytocics and treatment related side effects were the main outcome measures. Results: There were no significant differences between the two groups in terms of the change in hemoglobin level and mean blood loss. The incidence of shivering was significantly higher in the misoprostol group whilst that of vomiting was significantly higher in the syntometrine group. There were no differences in the incidence of nausea, headache, diarrhea and pyrexia between the two groups. Conclusion: Orally administeredmisoprostol at a dose of 400 µg is an acceptable alternative in preventing post-partum blood loss, as measured by the peri-partum change in hemoglobin level and was not associated with an increased incidence of side effects.

Misoprostol versus ergometrine‐oxytocin for preventing postpartum haemorrhage: a systematic review and meta‐analysis of randomized controlled trials

“…As shown in Figure 1, finally, 6 RCTs with 4034 women enrolled were included (16)(17)(18)(19)(20)(21). Two of them were multicentre studies (17,18).…”

“…The doses of misoprostol were 400 and 600 μg with three administration routes: oral, rectal, or sublingual. The use of ergometrine-oxytocin in the form of 1 ml intramuscular synometrine R (fixed dose of 5 IU oxytocin and 0.5 mg ergometrine) was in four studies (16,18,20,21), and in the form of 1 ml of intravenous administration in one study (19) ( Table 1). In addition, the measurements of amount of blood loss were reported as "objective measurement and specific description" (17,19,21), "Clinical estimation" (18,20), and "unclear" (16).…”

“…It was assumed that the performance biases were unclear for other no blinding studies. The detection bias could be low as the objective and specific measurement was adopted for postpartum blood loss (17,(19)(20)(21), and risk was unclear if the measurement was subjective or not specific (16,18). The attrition bias was low as numbers of missing data (<10%) between two arms of six studies for primary outcomes were similar, and the selective reporting bias was also low under the preset primary outcomes reported in each study.…”

Reply

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83We have repeatedly stressed this point in our previous studies related to the use of misoprostol in the management of PPH [1,2] . More importantly, the amount of clinical estimation of blood loss does not reflect the actual hemoglobin change.

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“…Over 25% of the women who were defined as having PPH had a peripartum hemoglobin drop of over 20%. That is the reason why we chose to use the peripartum change in hemoglobin level as our primary outcome measure.We thank Dr. Mahajan and colleagues for their comments on our study [1] . We agree with them that misoprostol is a useful uterotonic drug in developing countries for the prevention of postpartum hemorrhage (PPH).…”