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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:Objectives: Subject to ethical constraints, real-world data are an important resource for evaluating treatment effects of medication use during pregnancy and the postpartum period. This study investigated whether motherwort injection, a traditional Chinese medicine preparation, was more effective than intramuscular (IM) oxytocin for preventing postpartum hemorrhage (PPH) in a real-world setting when intravenous (IV) oxytocin is administered. Methods: We conducted an active-controlled, propensity-score matched cohort study using an established pregnancy registry database. Women who underwent cesarean section and received IV oxytocin at the third stage of labor were included. We used an active-comparator design to minimize indication bias, in which we compared IM motherwort injection in the uterus versus IM oxytocin, both on top of IV oxytocin use. We applied 1:1 propensity-score matching (PSM) to balance patient baseline characteristics and used a logistic regression model to estimate treatment effect (i.e., risk difference (RD) and odds ratio (OR)) by using the counterfactual framework. The outcomes of interest were blood loss over 500 ml within 2 h after delivery (PPH, primary) and blood loss over 1,000 ml (severe PPH, secondary). We conducted four sensitivity analyses to examine the robustness of the results. Results: A total of 22,519 pregnant women underwent cesarean sections, among which 4,081 (18.12%) PPH and 480 (2.13%) severe PPH occurred. Among included women, 586 (2.60%) were administrated with IM motherwort injection, and 21,933 (97.40%) used IM oxytocin. After PSM, patient baseline characteristics were well balanced. Compared with IM oxytocin, the use of IM motherwort injection was associated with significantly lower risk of PPH (RD -25.26%, 95% CI -30.04% to -20.47%, p < 0.001; OR 0.25, 95% CI 0.18 to 0.32, p < 0.001) and severe PPH (RD -3.58%, 95% CI -5.87% to -1.30%, p < 0.001; OR 0.39, 95% CI 0.20 to 0.71, p < 0.002). Sensitivity analyses showed that the results were similar. Conclusion: With the use of data from a real-world setting, the findings consistently showed that among women undergoing cesarean section who had received IV oxytocin, the additional use of IM motherwort injection could achieve a lower risk of PPH as compared to the additional use of IM oxytocin. Our study suggested a paradigm for investigating the treatment effect of Chinese herbal medicine in the real-world practice setting.

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:BackgroundNewer research comparing routes of medication administration has extended beyond efficacy as a primary endpoint to incorporate patient preference. However, little is known about the preferences of pregnant women in terms of routes of medication administration, specifically with regards to hemorrhage prevention and control.ObjectiveThis study aimed to understand the preferences of pregnant women in terms of medical interventions to prevent hemorrhage at the time of delivery.Study designSurveys were distributed from April 2022 to September 2022 using electronic tablets at a single urban center with an annual delivery volume of 3000 women per year to women >18 years of age who were either currently pregnant or have been pregnant in the past. Subjects were asked to choose their preferred route of administration from the following options: intravenous, intramuscular, or subcutaneous. The primary outcome was patient preference on the route of medication administration during a hemorrhage event.ResultsThe study cohort included 300 patients, mostly African American (39.8%) followed by White (32.1%), and the majority of the participants ranged from 30 to 34 years of age (31.7%). When asked which method of administration they would prefer to prevent hemorrhage before birth, the results were as follows: 31.1% would prefer intravenous, 23.0% had no preference, 21.2% were unsure, 15.9% preferred subcutaneous, and 8.8% preferred intramuscular administration. In addition, 69.4% of respondents reported that they have never declined or avoided intramuscular administration of medication if recommended by their physician.ConclusionAlthough some survey participants preferred an intravenous route of administration, 68.9% of subjects were unsure, had no preference, or preferred nonintravenous routes. This information is helpful particularly in low-resource settings where intravenous treatments are not readily available or in urgent clinical situations in which intravenous administration routes are not easily obtainable in high-risk patients.

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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