RETRACTED ARTICLE: A randomized controlled study of the effect of hyoscine butylbromide on duration of labor in primigravida women with prolonged labor

Maged, Ahmed M.; Sorour, Ehab H; Elsadek, Mohamed; Hassan, S. M.; Shoab, Amira Y

doi:10.1007/s00404-021-06087-7

Cited by 2 publications

(5 citation statements)

References 11 publications

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“…Regarding neonatal outcome and in accordance with many studies [22][23][24][25][26], our results showed no significant effect of HBB on APGAR score at 1 & 5 min after birth. In a meta-analysis done by Zaynab and colleagues to assess the effectiveness of hyoscine n-butyl bromide in labor progress, analysis of 11 studies involving 1682 participants showed an insignificant difference in the APGAR score at 1 min between HBB and controls (mean difference =-0.04; 95% CI: [− 0.09, 0.01]).…”

Section: Discussionsupporting

confidence: 92%

Hemodynamic and antiemetic effects of prophylactic hyoscine butyl-bromide during cesarean section under spinal anesthesia: a randomized controlled trial

et al. 2022

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Background Abrupt bradycardia and hemodynamic instability during spinal anesthesia for cesarean section are not uncommon and are considered as one of the primary causes of intraoperative nausea and vomiting (IONV). We hypothesized that prophylactic use of hyoscine butyl-bromide (HBB) could improve hemodynamics and reduce IONV in parturients undergoing cesarean section. Methods A randomized, double-blind placebo-controlled trial was carried out in a tertiary university hospital, patients scheduled for elective cesarean section were equally randomized to receive either IV HBB 20 mg in 1 ml (Hyoscine group) or the same volume of 0.9% saline (Control group), one minute after spinal anesthesia. The primary endpoint was the incidence of intraoperative bradycardia (HR < 50 beats min−1). Secondary endpoints included changes in mean arterial blood pressure (MAP), the incidence of Intraoperative and Postoperative nausea or vomiting (IONV & PONV), the fetal heart rate and, Apgar score. Results Of the 160 subjects randomized, 80 received HBB and 80 received placebo. There was a significant reduction in the incidence of the primary endpoint of intraoperative bradycardia (HR < 50 beats min−1) in the Hyoscine group (0% vs 10%; OR = 0.05, 95% CI = [0.003, 0.93]; P = 0.004) compared with placebo. MAP showed an insignificant difference between groups over time. HBB significantly decreased incidences of IONV and PONV (p = 0.002 & 0.004) respectively. Conclusions In parturients undergoing cesarean section under spinal anesthesia, pretreatment with intravenous HBB was a safe measure for both the mother and the baby to reduce the risk of severe intraoperative bradycardia, but not hypotension. Furthermore, it was associated with less incidence of both IONV and PONV. Trial registration https://clinicaltrials.gov/ct2/show/NCT04069078

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Section: Discussionsupporting

confidence: 92%

Hemodynamic and antiemetic effects of prophylactic hyoscine butyl-bromide during cesarean section under spinal anesthesia: a randomized controlled trial

et al. 2022

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“…The mean age of the trial participants in our study was higher than in the studies by Mohaghegh and colleagues, Riemma and colleagues, and Maged and colleagues: 32 years versus 26, 25.5, and 24 years, respectively [ 29 , 30 , 33 ]. These 3 studies included both nulliparous and multiparous women, implying that the mean age of nulliparous women alone must have been even lower.…”

Section: Discussioncontrasting

confidence: 73%

“…Maged and colleagues studied the effect of hyoscine butylbromide on Egyptian women with slow labor [ 33 ]. The study found a statistically significant reduction in the mean duration of labor from IMP administration to a fully dilated cervix of 10 cm associated with hyoscine butylbromide when compared to placebo: 322 min versus 451 min [ 33 ]. The authors described a stepwise inclusion, where slow labor was defined as a cervical dilation rate of less than 1.2 cm per hour.…”

Section: Discussionmentioning

confidence: 99%

“…An advantage of our study compared to Maged and colleagues is that we used survival analysis (Weibull regression and Cox regression) for all time-to-event outcomes of duration of labor, thereby taking into account the incomplete observation of labors ending with emergency cesarean section. In the presence of such data, this analytical approach is preferable to, e.g., the two-sample t test and the Mann–Whitney U test, as used by Maged and colleagues [ 33 ]. The present study also has some limitations.…”

Section: Discussionmentioning

confidence: 99%

“…Previous studies have been conducted in India, Pakistan, Iran, Iraq, Turkey, Nigeria, Mexico, Egypt, and Jamaica [ 29 , 30 , 32 ]. We have only found 1 Egyptian study on the effect of hyoscine butylbromide on slow labor [ 33 ].…”

Section: Introductionmentioning

confidence: 99%

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The effect of intravenous hyoscine butylbromide on slow progress in labor (BUSCLAB): A double-blind randomized placebo-controlled trial

Gaudernack,

Einarsen,

Sørbye

et al. 2024

PLoS Med

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Background Prolonged labor is a common condition associated with maternal and perinatal complications. The standard treatment with oxytocin for augmentation of labor increases the risk of adverse outcomes. Hyoscine butylbromide is a spasmolytic drug with few side effects shown to shorten labor when used in a general population of laboring women. However, research on its effect on preventing prolonged labor is lacking. We aimed to assess the effect of hyoscine butylbromide on the duration of labor in nulliparous women showing early signs of slow labor. Methods and findings In this double-blind randomized placebo-controlled trial, we included 249 nulliparous women at term with 1 fetus in cephalic presentation and spontaneous start of labor, showing early signs of prolonged labor by crossing the alert line of the World Health Organization (WHO) partograph. The trial was conducted at Oslo University Hospital in Norway from May 2019 to December 2021. One hundred and twenty-five participants were randomized to receive 1 ml hyoscine butylbromide (Buscopan) (20 mg/ml), while 124 received 1 ml sodium chloride intravenously. Randomization was computer-generated, with allocation concealment by opaque sequentially numbered sealed envelopes. The primary outcome was duration of labor from administration of the investigational medicinal product (IMP) to vaginal delivery, which was analyzed by Weibull regression to estimate the cause-specific hazard ratio (HR) of vaginal delivery between the 2 treatment groups, with associated 95% confidence interval (CI). A wide range of secondary maternal and perinatal outcomes were also evaluated. Time-to-event outcomes were analyzed by Weibull regression, whereas continuous and dichotomous outcomes were analyzed by median regression and logistic regression, respectively. All main analyses were based on the modified intention-to-treat (ITT) set of eligible women with signed informed consent receiving either of the 2 treatments. The follow-up period lasted during the postpartum hospital stay. All personnel, participants, and researchers were blinded to the treatment allocation. Median (mean) labor duration from IMP administration to vaginal delivery was 401 (440.8) min in the hyoscine butylbromide group versus 432.5 (453.6) min in the placebo group. We found no statistically significant association between IMP and duration of labor from IMP administration to vaginal delivery: cause-specific HR of 1.00 (95% CI [0.77, 1.29]; p = 0.993). Among 255 randomized women having received 1 dose of IMP, 169 women (66.3%) reported a mild adverse event: 75.2% in the hyoscine butylbromide group and 57.1% in the placebo group (Pearson’s chi-square test: p = 0.002). More than half of eligible women were not included in the study because they did not wish to participate or were not included upon admission. The participants might have represented a selected group of women reducing the external validity of the study. Conclusions One intravenous dose of 20 mg hyoscine butylbromide was not found to be superior to placebo in preventing slow labor progress in a population of first-time mothers at risk of prolonged labor. Further research is warranted to answer whether increased and/or repeated doses of hyoscine butylbromide might have an effect on duration of labor. Trial registration ClinicalTrials.gov (NCT03961165) EudraCT (2018-002338-19)

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RETRACTED ARTICLE: A randomized controlled study of the effect of hyoscine butylbromide on duration of labor in primigravida women with prolonged labor

Cited by 2 publications

References 11 publications

Hemodynamic and antiemetic effects of prophylactic hyoscine butyl-bromide during cesarean section under spinal anesthesia: a randomized controlled trial

Hemodynamic and antiemetic effects of prophylactic hyoscine butyl-bromide during cesarean section under spinal anesthesia: a randomized controlled trial

The effect of intravenous hyoscine butylbromide on slow progress in labor (BUSCLAB): A double-blind randomized placebo-controlled trial

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