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Intramuscular injection, intravenous infusion, and intravenous bolus of oxytocin in the third stage of labor for prevention of postpartum hemorrhage: a three-arm randomized control trial.

ABSTRACT: BACKGROUND:Oxytocin for postpartum hemorrhage (PPH) prophylaxis is commonly administered by either intramuscular (IM) injection or intravenous (IV) infusion with both routes recommended equally and little discussion of potential differences between the two. This trial assesses the effectiveness and safety of 10?IU oxytocin administered as IM injection versus IV infusion and IV bolus during the third stage of labor for PPH prophylaxis. METHODS:In two tertiary level Egyptian maternity hospitals, women delivering vaginally without exposure to pre-delivery uterotonics were randomized to one of three prophylactic oxytocin administration groups after delivery of the baby. Blood loss was measured 1 h after delivery, and side effects were recorded. Primary outcomes were mean postpartum blood loss and proportion of women with postpartum blood loss ?500?ml in this open-label, three-arm, parallel, randomized controlled trial. RESULTS:Four thousand nine hundred thirteen eligible, consenting women were randomized. Compared to IM injection, mean blood loss was 5.9% less in the IV infusion arm (95% CI: -8.5, -?3.3) and 11.1% less in the IV bolus arm (95% CI: -14.7, -?7.8). Risk of postpartum blood loss ?500?ml in the IV infusion arm was significantly less compared to IM injection (0.8% vs. 1.5%, RR?=?0.50, 95% CI: 0.27, 0.91). No side effects were reported in any arm. CONCLUSIONS:Intravenous oxytocin is more effective than intramuscular injection for the prevention of PPH in the third stage of labor. Oxytocin delivered by IV bolus presents no safety concerns after vaginal delivery and should be considered a safe option for PPH prophylaxis. TRIAL REGISTRATION:clinicaltrials.gov # NCT01914419 , posted August 2, 2013.

SUBMITTER: Charles D

PROVIDER: S-EPMC6339323 | biostudies-literature | 2019 Jan

REPOSITORIES: biostudies-literature

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Intramuscular injection, intravenous infusion, and intravenous bolus of oxytocin in the third stage of labor for prevention of postpartum hemorrhage: a three-arm randomized control trial.

Charles Dyanna D Anger Holly H Dabash Rasha R Darwish Emad E Ramadan Mohamed Cherine MC Mansy Amr A Salem Yomna Y Dzuba Ilana G IG Byrne Meagan E ME Breebaart Miral M Winikoff Beverly B

BMC pregnancy and childbirth 20190118 1

<h4>Background</h4>Oxytocin for postpartum hemorrhage (PPH) prophylaxis is commonly administered by either intramuscular (IM) injection or intravenous (IV) infusion with both routes recommended equally and little discussion of potential differences between the two. This trial assesses the effectiveness and safety of 10 IU oxytocin administered as IM injection versus IV infusion and IV bolus during the third stage of labor for PPH prophylaxis.<h4>Methods</h4>In two tertiary level Egyptian materni ...[more]

PMID: 30658605

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Project description:BackgroundThere is general agreement that oxytocin given either through the intramuscular or intravenous route is effective in reducing postpartum blood loss. However, it is unclear whether the subtle differences between the mode of action of these routes have any effect on maternal and infant outcomes. This is an update of a review first published in 2012.ObjectivesTo determine the comparative effectiveness and safety of oxytocin administered intramuscularly or intravenously for prophylactic management of the third stage of labour after vaginal birth.Search methodsWe searched Cochrane Pregnancy and Childbirth's Trials Register, ClinicalTrials.gov, the WHO International Clinical Trials Registry Platform (ICTRP) (7 September 2017) and reference lists of retrieved studies.Selection criteriaRandomised trials comparing intramuscular with intravenous oxytocin for prophylactic management of the third stage of labour after vaginal birth. We excluded quasi-randomised trials.Data collection and analysisTwo review authors independently assessed studies for inclusion and risk of bias, extracted data and checked them for accuracy. We assessed the quality of the evidence using the GRADE approach.Main resultsThree studies with 1306 women are included in the review and compared intramuscular versus intravenous oxytocin administered just after the birth of the anterior shoulder or soon after the birth of the baby. Studies were carried out in hospital settings in Turkey and Thailand and recruited women with singleton, term pregnancies. Overall, the included studies were at moderate risk of bias: none of the studies provided clear information on allocation concealment or attempted to blind staff or women. For GRADE outcomes the quality of the evidence was very low, with downgrading due to study design limitations and imprecision of effect estimates.Only one study reported severe postpartum haemorrhage (blood loss 1000 mL or more) and showed no clear difference between the intramuscular and intravenous oxytocin groups (risk ratio (RR) 0.11, 95% confidence interval (CI) 0.01 to 2.04; 256 women; very low-quality evidence). No woman required hysterectomy in either group in one study (no estimable data, very low-quality evidence), and in another study one woman in each group received a blood transfusion (RR 1.00, 95% CI 0.06 to 15.82; 256 women; very low-quality evidence). Other important outcomes (maternal death, hypotension, maternal dissatisfaction with the intervention and neonatal jaundice) were not reported by any of the included studies. There were no clear differences between groups for other prespecified secondary outcomes reported (postpartum haemorrhage 500 mL or more, use of additional uterotonics, retained placenta or manual removal of the placenta).Authors' conclusionsVery low-quality evidence indicates no clear difference between the comparative benefits and risks of intramuscular and intravenous oxytocin when given to prevent excessive blood loss after vaginal birth. Appropriately designed randomised trials with adequate sample sizes are needed to assess whether the route of prophylactic oxytocin after vaginal birth affects maternal or infant outcomes. Such studies could be large enough to detect clinically important differences in major side effects that have been reported in observational studies and should also consider the acceptability of the intervention to mothers and providers as important outcomes.

Project description:ObjectiveTo determine whether intravenous oxytocin is more effective than intramuscular oxytocin at preventing postpartum haemorrhage at vaginal delivery.DesignDouble blind placebo controlled randomised trial.SettingUniversity affiliated maternity unit in the Republic of Ireland.Participants1075 women aged 18 years or older, at term with a singleton pregnancy who were aiming for a vaginal delivery with an actively managed third stage of labour.InterventionsWomen were allocated to an intravenous bolus of oxytocin (10 IU in 1 mL given slowly over one minute) and placebo intramuscular injection (1 mL 0.9% saline) or an intramuscular bolus of oxytocin (10 IU in 1 mL) and placebo intravenous injection (1 mL 0.9% saline given slowly over one minute) at vaginal delivery. Allocation was by a secure web based randomisation service with masking of participants and clinicians to the trial intervention.Main outcome measuresThe primary outcome was postpartum haemorrhage (PPH, measured blood loss ≥500 mL). Secondary outcomes were severe PPH (measured blood loss ≥1000 mL), need for blood transfusion, admission to a high dependency unit, and side effects to oxytocin.ResultsBetween 4 January 2016 and 13 December 2017, 1075 women were randomised and 1035 (96.3%) included in the primary and secondary analyses (517 in the intravenous oxytocin group and 518 in the intramuscular oxytocin group). The incidence of PPH was not significantly lower in the intravenous group (18.8%, 97/517) compared with intramuscular group (23.2%, 120/518): adjusted odds ratio 0.75 (95% confidence interval 0.55 to 1.03). The incidence of severe PPH, however, was significantly lower in the intravenous group (4.6%, 24/517) compared with intramuscular group (8.1%, 42/518): 0.54 (0.32 to 0.91) as was the need for blood transfusion (1.5% v 4.4%, 0.31, 0.13 to 0.70) and admission to a high dependency unit (1.7% v 3.7%, 0.44, 0.20 to 0.98). The number needed to treat to prevent one case of severe PPH was 29 (95% confidence interval 16 to 201) and to prevent one case of blood transfusion was 35 (20 to 121). The incidence of side effects to oxytocin was not increased in the intravenous group compared with intramuscular group (4.1% v 5.2%, 0.75, 0.42 to 1.35).ConclusionIntravenous oxytocin for the third stage of labour results in less frequent severe PPH, blood transfusion, and admission to a high dependency unit than intramuscular oxytocin, and without excess side effects.Trial registrationCurrent Controlled Trials ISRCTN14718882.

Project description:BackgroundThis study aimed to compare the effect of breast pump stimulation with that of oxytocin administration regarding the duration of the third stage of labor, postpartum hemorrhage, and anemia after delivery.MethodsIn this study, 108 women were randomly assigned to two groups of breast pump stimulation (n = 54) and oxytocin administration (n = 54). Women in the breast stimulation group received breast pump stimulation (10 min intermittently for each breast with a negative pressure of 250 mmHg), while the women in the oxytocin (control) group received an infusion of 30 IU oxytocin in 1000 mL of Ringer's serum with a maximum rate of 10 mL infusion per min after delivery. The duration of the third stage of labor, blood loss during the third stage of labor and 24 h after delivery, hemoglobin and hematocrit (before and 24 h after delivery), after-birth pain, and the number of breastfeedings during the 24 h after delivery were recorded. The data were analyzed using the chi-square test, independent t-test, and Wilcoxon test.ResultsThe mean duration of the third stage was 5 ± 1.97 and 5.4 ± 2.5 min in the breast stimulation and women that received intravenous oxytocin respectively (p = 0.75). Most participants had mild postpartum hemorrhage (98.1 and 96.2% in the breast stimulation and women that received intravenous oxytocin, respectively, p = 0.99). Although hemoglobin and hematocrit levels significantly decreased in both groups 24 h after delivery, there was no significant difference between both groups regarding both parameters. After-birth pain was significantly lower and the number of breastfeeding during the 24 h after delivery was significantly more in the breast stimulation group compared to the control group.ConclusionsOur results demonstrated no differences between breast pump stimulation and oxytocin administration regarding the duration of the third stage of labor, postpartum hemorrhage, anaemia, after-birth pain, and the number of breastfeedings during the 24 h after delivery.Trial registration numberThe study protocol was registered in the Iranian Randomized Controlled Trial Registry (Ref. No.: IRCT2015050722146N1 ; Registration date: 2015-11-04). The study was registered prospectively and the enrollment date was 23/8/2015.

Project description:Postpartum hemorrhage (PPH) is a leading cause of maternal death in sub-Saharan Africa. Although the World Health Organization recommends use of oxytocin for prevention of PPH, misoprostol use is increasingly common owing to advantages in shelf life and potential for sublingual administration. There is a lack of data about the comparative efficacy of oxytocin and sublingual misoprostol, particularly at the recommended dose of 600 µg, for prevention of PPH during active management of labor.We performed a double-blind, double-dummy randomized controlled non-inferiority trial between 23 September 2012 and 9 September 2013 at Mbarara Regional Referral Hospital in Uganda. We randomized 1,140 women to receive 600 µg of misoprostol sublingually or 10 IU of oxytocin intramuscularly, along with matching placebos for the treatment they did not receive. Our primary outcome of interest was PPH, defined as measured blood loss ? 500 ml within 24 h of delivery. Secondary outcomes included measured blood loss ? 1,000 ml; mean measured blood loss at 1, 2, and 24 h after delivery; death; requirement for blood transfusion; hemoglobin changes; and use of additional uterotonics. At 24 h postpartum, primary PPH occurred in 163 (28.6%) participants in the misoprostol group and 99 (17.4%) participants in the oxytocin group (relative risk [RR] 1.64, 95% CI 1.32 to 2.05, p<0.001; absolute risk difference 11.2%, 95% CI 6.44 to 16.1). Severe PPH occurred in 20 (3.6%) and 15 (2.7%) participants in the misoprostol and oxytocin groups, respectively (RR 1.33, 95% CI 0.69 to 2.58, p = 0.391; absolute risk difference 0.9%, 95% CI -1.12 to 2.88). Mean measured blood loss was 341.5 ml (standard deviation [SD] 206.2) and 304.2 ml (SD 190.8, p = 0.002) at 2 h and 484.7 ml (SD 213.3) and 432.8 ml (SD 203.5, p<0.001) at 24 h in the misoprostol and oxytocin groups, respectively. There were no significant differences between the two groups in any other secondary outcomes. Women in the misoprostol group more commonly experienced shivering (RR 1.91, 95% CI 1.65 to 2.21, p<0.001) and fevers (RR 5.20, 95% CI 3.15 to 7.21, p = 0.005). This study was conducted at a regional referral hospital with capacity for emergency surgery and blood transfusion. High-risk women were excluded from participation.Misoprostol 600 µg is inferior to oxytocin 10 IU for prevention of primary PPH in active management of labor. These data support use of oxytocin in settings where it is available. While not powered to do so, the study found no significant differences in rate of severe PPH, need for blood transfusion, postpartum hemoglobin, change in hemoglobin, or use of additional uterotonics between study groups. Further research should focus on clarifying whether and in which sub-populations use of oxytocin would be preferred over sublingual misoprostol.ClinicalTrials.gov NCT01866241 Please see later in the article for the Editors' Summary.

Project description:IntroductionPostpartum hemorrhage (PPH) is an important contributor to maternal morbidity and mortality. Predicting which laboring women are likely to have a PPH is an active area of research and a component of quality improvement bundles. The purpose of this study was to identify phenotypes of labor processes (ie, labors that have similar features, such as duration and type of interventions) in a cohort of women who had vaginal births, estimate the likelihood of PPH by phenotype, and analyze how maternal and fetal characteristics relate to PPH risk by phenotype.MethodsThis study utilized the Consortium for Safe Labor dataset (2002-2008) and examined term, singleton, vaginal births. Using 16 variables describing the labor and birth processes, a latent class analysis was performed to describe distinct labor process phenotypes.ResultsOf 24,729 births, 1167 (4.72%) women experienced PPH. Five phenotypes best fit the data, reflecting labor interventions, duration, and complications. Women who had shorter duration of admission after spontaneous labor onset (admitted in latent or active labor) had the lowest rate of PPH (3.8%-3.9%). The 2 phenotypes of labor progress characterized by women who had complicated prolonged labors (spontaneous or induced) had the highest rate of PPH (8.0% and 12.0%, respectively). However, the majority of PPH (n = 881, 75%) occurred in the phenotypes with fewer complications. Prepregnancy body mass index did not predict PPH. Overall, the odds of PPH were highest among nulliparous women (odds ratio [OR], 1.52; 95% CI, 1.30-1.77), as well as Black women (OR, 1.39; 95% CI, 1.13-1.73) and Hispanic women (OR, 1.85; 95% CI, 1.56-2.20). Within phenotypes, maternal race and ethnicity, nulliparity, macrosomia, hypertension, and depression were associated with increased odds of PPH.DiscussionWomen who were classified into a lower-risk labor phenotype and still experienced PPH were more likely to be nulliparous, a person of color, or diagnosed with hypertension.

Project description:BACKGROUND:Tanzania has a maternal mortality ratio of 556 per 100,000 live births, representing 21% of all deaths of women of reproductive age. Hemorrhage, mostly postpartum hemorrhage (PPH), is estimated to cause at least 25% of maternal deaths in Tanzania. In 2008, the Ministry of Health, Community Development, Gender, Elderly and Children launched interventions to improve efforts to prevent PPH. Competency-based training for skilled birth attendants and ongoing quality improvement prioritized the practice of active management of the third stage of labor (AMTSL). METHODS:A cross-sectional study was conducted in 52 health facilities in Tanzania utilizing direct observations of women during labor and delivery. Observations were conducted in 2010 and, after competency-based training and quality improvement interventions in the facilities, in 2012. A total of 489 deliveries were observed in 2010 and 558 in 2012. Steps for AMTSL were assessed using a standardized structured observation checklist that was based on World Health Organization guidelines. RESULTS:The proportion of deliveries receiving all three AMTSL steps improved significantly by 19 percentage points (p?<?0.001) following the intervention, with the most dramatic increase occurring in health centers and dispensaries (47.2 percentage point change) compared to hospitals (5.2 percentage point change). Use of oxytocin for PPH prevention rose by 37.1 percentage points in health centers and dispensaries but remained largely the same in hospitals, where the baseline was higher. There was substantial improvement in the timely provision of uterotonics (within 3 min of birth) across all facilities (p?=?0.003). Availability of oxytocin, which was lower in health centers and dispensaries than hospitals at baseline, rose from 73 to 94% of all facilities. CONCLUSION:The quality of PPH prevention increased substantially in facilities that implemented competency-based training and quality improvement interventions, with the most dramatic improvement seen at lower-level facilities. As Tanzania continues with efforts to increase facility births, it is imperative that the quality of care also be improved by promoting use of up-to-date guidelines and ensuring regular training and mentoring for health care providers so that they adhere to the guidelines for care of women during labor. These measures can reduce maternal and newborn mortality.

Project description:BackgroundPostpartum hemorrhage (PPH) and the amount of blood loss are directly related to management of the third stage of labor. No previous report has compared the effects of carbetocin to those of misoprostol. The aim of this systematic review was to compare the effects of carbetocin to those of misoprostol for management of the third stage of labor and for the prevention of PPH.MethodsWe searched the Cochrane Library (Central), Web of Science, Scopus, Science Direct, Ovid, clinicaltrial.gov , and PubMed databases on December 28, 2017. Data extraction and risk of bias assessment were performed by 2 of the authors independently. Individual and pooled incidences were calculated for the included studies, with 95% confidence intervals (CIs). We used a fixed model for forest plots without heterogeneity and a random effect model for those with heterogeneity.ResultsOur search identified 117 studies; however, 29 studies were duplicate. Of the 88 non-duplicate studies, 5 met the inclusion criteria. Of these five studies, two are currently underway. Hence, three studies were finally included in our meta-analysis. The pooled estimate of the impact of carbetocin on PPH (500-1000 ml) was (OR 0.27, 95% CI 0.14-0.50). Carbetocin significantly reduced the need for additional uterotonics (RR 0.28, 95% CI 0.15 to 0.49). Reduction in the hemoglobin level and blood loss during the third stage of labor was significantly lower in women who received carbetocin than in those who received misoprostol. The length of the third stage of labor was significantly lower in women who received carbetocin than in those who received misoprostol. The incidence of side effects, such as heat sensation, metallic taste, fever, and shivering, were significantly lower in women who received carbetocin than in those who received misoprostol.ConclusionAlthough this review showed that carbetocin is effective for decreasing PPH, blood loss, the length of the third stage of labor, and the need for additional uterotonics, this conclusion should be considered with caution. Because assessment of PPH is a subjective issue and it is uncertain whether outcomes were assessed blindly in respect to treatment. We recommend future research to verify our findings. Also clinicians may like to consider use of carbetocin for women with low risk for PPH.

Dataset Information

Intramuscular injection, intravenous infusion, and intravenous bolus of oxytocin in the third stage of labor for prevention of postpartum hemorrhage: a three-arm randomized control trial.

Publications

Intramuscular injection, intravenous infusion, and intravenous bolus of oxytocin in the third stage of labor for prevention of postpartum hemorrhage: a three-arm randomized control trial.

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