Discontinuation of intravenous oxytocin in the active phase of induced labour.
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SUBMITTER: Boie S
PROVIDER: S-EPMC6513418 | biostudies-literature |
REPOSITORIES: biostudies-literature
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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.
| S-EPMC6513632 | biostudies-literature
Project description:154 patients requiring induction with unfavourable cervix at varying period of gestation were studied. Patients were distributed into two groups. 76 patients were induced with 0.5 mgm single dose intracervical application of Prostaglandin E2 gel and remaining 78 patients with Oxytocin and efficacy of the two methods of induction was compared. Labour was established within 24 hours in 71.4% of primigravidas and 91.7% of multigravidas in the prostaglandin treated group compared to 65.6% of primigravidas and 89.1% of multigravidas in the oxytocin group. The study found substantial improvement in cervical score 12 hours after application of intracervical prostaglandin E2 gel and decrease in Caesarean section rate with no major adverse effect to mother or neonate.
| S-EPMC5531574 | biostudies-other
Project description:ObjectiveTo determine whether discontinuing oxytocin stimulation in the active phase of induced labour is associated with lower caesarean section rates.DesignInternational multicentre, double blind, randomised controlled trial.SettingNine hospitals in Denmark and one in the Netherlands between 8 April 2016 and 30 June 2020.Participants1200 women stimulated with intravenous oxytocin infusion during the latent phase of induced labour.InterventionWomen were randomly assigned to have their oxytocin stimulation discontinued or continued in the active phase of labour.Main outcome measureDelivery by caesarean section.ResultsA total of 607 women were assigned to discontinuation and 593 to continuation of the oxytocin infusion. The rates of caesarean section were 16.6% (n=101) in the discontinued group and 14.2% (n=84) in the continued group (relative risk 1.17, 95% confidence interval 0.90 to 1.53). In 94 parous women with no previous caesarean section, the caesarean section rate was 7.5% (11/147) in the discontinued group and 0.6% (1/155)in the continued group (relative risk 11.6, 1.15 to 88.7). Discontinuation was associated with longer duration of labour (median from randomisation to delivery 282 v 201 min; P<0.001), a reduced risk of hyperstimulation (20/546 (3.7%) v 70/541 (12.9%); P<0.001), and a reduced risk of fetal heart rate abnormalities (153/548 (27.9%) v 219/537 (40.8%); P<0.001) but rates of other adverse maternal and neonatal outcomes were similar between groups.ConclusionsIn a setting where monitoring of the fetal condition and the uterine contractions can be guaranteed, routine discontinuation of oxytocin stimulation may lead to a small increase in caesarean section rate but a significantly reduced risk of uterine hyperstimulation and abnormal fetal heart rate patterns.Trial registrationClinicalTrials.gov NCT02553226.
| S-EPMC8044921 | biostudies-literature
Project description:BACKGROUND:Oxytocin is an effective drug for induction of labour, but is associated with serious adverse effects of which uterine tachysystole, fetal distress and the need of immediate delivery are the most common. Discontinuation of oxytocin once the active phase of labour is established could reduce the adverse effects. The objective is to investigate how the caesarean section rate is affected when oxytocin stimulation is discontinued in the active phase of labour compared to labours where oxytocin is continued. METHODS:CONDISOX is a double-blind multicentre randomised controlled trial conducted at Danish and Dutch Departments of Obstetrics and Gynaecology. The first participant was recruited on April 8 2016. Based on a clinically relevant relative reduction in caesarean section rate of 7%, an alpha of 0.05, a beta of 80%, we aim for 1200 participating women (600 in each arm). The CONDISOX trial includes women at a gestational age of 37-42 complete weeks of pregnancy, who have uterine activity stimulated with oxytocin infusion for the induction of labour. Women are randomised when the active phase of labour becomes established, to study medication containing either oxytocin (continuous group) or placebo (discontinued group) infusion. Women are stratified by birth site, indication for oxytocin stimulation (induction of labour, prelabour rupture of membranes) and parity (nulliparous, parous +/- previous caesarean section). We will compare the primary outcome, caesarean section rate, in the two groups using a chi-square test with a p-value of 0.05. If superiority is not demonstrated, we have a pre-defined post hoc non-inferiority boundary (margin, delta) at 1.09. Secondary outcomes include duration of the active phase of labour, incidence of uterine tachysystole, postpartum haemorrhage, admission to the neonatal intensive care unit, Apgar score, umbilical arterial blood pH, and birth experience. DISCUSSION:The high frequency of oxytocin use and the potential risks of both maternal and fetal adverse effects of oxytocin emphasise the need to determine the optimal oxytocin regime for induction of labour. TRIAL REGISTRATION:NCT02553226 (registered September 17, 2015). Eudra-CT number: 2015-002942-30.
| S-EPMC6720847 | biostudies-literature
Project description:BackgroundThere is not enough data regarding practices and protocols on the dose of oxytocin administrated to women during labour. Empirical evidence indicates that compliance with the guidelines improves the quality of healthcare and reduces adverse effects. The study aimed to evaluate practices of oxytocin provision for labour induction and augmentation in two maternity units in Poland.MethodsThe article presents a prospective observational study. Data from 545 (n = 545) labours was collected in two maternity units. First, the total dose (the total amount of oxytocin provided from the beginning in the labour ward until delivery including the III and IV stage of labour) and cumulative dose of oxytocin (the amount of oxytocin given until the birth of the neonate) administered to women during labour was calculated. Then, the relationship between the cumulative dose of oxytocin and short term perinatal outcomes (mode of delivery, use of epidural anaesthesia, Apgar scores, birth weight and postpartum blood loss) was analysed. Finally, the compliance of oxytocin supply during labour with national guidelines in the following five criteria: medium, start dose, escalation rate, interval, the continuation of infusion after established labour was examined.ResultsThe average cumulative dose of oxytocin administrated to women before birth was 4402 mU following labour induction and 2366 mU following labour augmentation. The actual administration of oxytocin deviated both from the unit and national guidelines in 93.6% of all observed labours (mainly because of continuation of infusion after established labour). We found no statistically significant correlation between the cumulative dose of oxytocin administered and mode of delivery, immediate postpartum blood loss or Apgar scores. There was no observed effect of cumulative dose oxytocin on short-term perinatal outcomes. The two units participating in the study had similar protocols and did not differ significantly in terms of total oxytocin dose, rates of induction and augmentation - the only observed difference was the mode of delivery.ConclusionsThe study showed no effect of the mean cumulative oxytocin dose on short-term perinatal outcomes and high rate of non-compliance of the practice of oxytocin administration for labour induction and augmentation with the national recommendations. Cooperation between different professional groups of maternity care providers should be considered in building national guidelines for maternity care.. Further studies investigating possible long-term effects of the meant cumulative dose of oxytocin and the reasons for non-compliance of practice with guidelines should be carried out.
| S-EPMC8582102 | biostudies-literature
Project description:BackgroundThere are several international guidelines on oxytocin regimens for induction and augmentation of labour, but no agreement on a standardised regimen in Germany. This study collated and reviewed the oxytocin regimens used for labour augmentation in university hospitals, with the long-term aim of contributing to the development of a national clinical guideline.MethodsGermany has 34 university hospital compounds, representing 39 maternity units. In this observational study we asked units to provide standard operational procedures on oxytocin augmentation during labour or provide the details in a structured survey. Data were collected on the dosage of oxytocin, type and volume of solutions used, indications and contraindications for use and discontinuation, case-specific administration, and on who developed the procedures. Findings were analysed descriptively.ResultsA total of 35 (90%) units participated in this study. Standard operating procedures were available in 24 units (69%), seven units (20%) did not have procedures and information was missing from four units (11%). Midwives participated in the development of standard operating procedures in 15 units (43%). Infusions were most commonly prepared using six units of oxytocin in 500 ml 0.9% normal saline solution (12 mU/ml). The infusions were started at 120 mU/hour and increased by 120 mU/hour at 20-min intervals up to a maximum dosage of 1200 mU/hour. The most common indication for use was delayed progress in labour. Infusions were stopped when uterine contractions became hypertonic and/or the fetal heart rate showed signs of distress. Most of the practices described aligned with international guidance. All units used reduced oxytocin dosages for women with a history of previous caesareans section, as recommended in the international guidelines, and restrictive use was advised in multiparous women. The main difference between units related to combined use of amniotomy and oxytocin, recommended by three guidelines but used in only four maternity units (11%).ConclusionsWhile there was considerable variation in the oxytocin augmentation procedures, most but not all practices used in these 35 German maternity units were comparable. Establishing a national guideline on the criteria for and administration of oxytocin for augmentation of labour would eliminate the observed differences and minimise risk of administration and medication error.
| S-EPMC6617790 | biostudies-literature
Project description:[8-Lysine]oxytocin was synthesized on a solid support and possessed an oxytocic activity of 100 +/- 6 units mumol on the isolated rat uterus. The epsilon-carbamoyl, epsilon-3-carboxypropionyl and epsilon-3-carboxybutryl derivatives were prepared and had uterotonic activities of 400, 55 and 50 units/mumol respectively. [8-Lysine]oxytocin was coupled unambiguously through the epsilon-amino group to the carboxyl groups of carboxymethylated dextrans or epsilon-3-carboxypropionly-gelatin. The macromolecular oxytocins were water-soluble and retained signigicant oxytocic activity. [8-Lysine]oxytocin should prove a useful ligand for affinity chromatography of oxytocin-binding proteins.
| S-EPMC1164866 | biostudies-other
Project description:Oxytocin (OT) is a potential treatment for multiple neuropsychiatric disorders. As OT is a peptide, delivery by the intranasal (IN) route is the preferred method in clinical studies. Although studies have shown increased cerebrospinal fluid (CSF) OT levels following IN administration, this does not unequivocably demonstrate that the peripherally administered OT is entering the CSF. For example, it has been suggested that peripheral delivery of OT could lead to central release of endogenous OT. It is also unknown whether the IN route provides for more efficient entry of the peptide into the CSF compared to the intravenous (IV) route, which requires blood-brain barrier penetration. To address these questions, we developed a sensitive and specific quantitative mass spectrometry assay that distinguishes labeled (d5-deuterated) from endogenous (d0) OT. We administered d5 OT (80 IU) to six nonhuman primates via IN and IV routes as well as IN saline as a control condition. We measured plasma and CSF concentrations of administered and endogenous OT before (t=0) and after (t=10, 20, 30, 45 and 60?min) d5 OT dosing. We demonstrate CSF penetrance of d5, exogenous OT delivered by IN and IV administration. Peripheral administration of d5 OT did not lead to increased d0, endogenous OT in the CSF. This suggests that peripheral administration of OT does not lead to central release of endogenous OT. We also did not find that IN administration offered an advantage compared to IV administration with respect to achieving greater CSF concentrations of OT.
| S-EPMC5862033 | biostudies-literature
Project description:ObjectiveTo evaluate oxytocin use for augmentation of labour in relation to body mass index (BMI) on admission to the labour ward, focusing on cumulative oxytocin dose and maximum rate of oxytocin infusion during the first stage of labour.DesignProspective observational study.SettingSeven hospitals in Sweden.Participants1097 nulliparous women with singleton cephalic presentation pregnancy, ≥37 weeks of gestation, spontaneous onset of labour and treatment with oxytocin infusion for labour augmentation. The study population was classified into three BMI subgroups on admission to the labour ward: normal weight (18.5-24.9), overweight (25.0-29.9) and obese (≥30.0). The cumulative oxytocin dose was measured from the start of oxytocin infusion until the neonate was born.Primary outcomeCumulative oxytocin dose.Secondary outcomeMaximum rate of oxytocin infusion during the active phase of first stage of labour.ResultsThe mean cumulative oxytocin dose increased in the BMI groups (normal weight 2278 mU, overweight 3108 mU and obese 4082 mU (p<0.0001)). However, when adjusted for the confounders (cervical dilatation when oxytocin infusion was started, fetal birth weight, epidural analgesia), the significant difference was no longer seen. The maximum oxytocin infusion rate during the first stage of labour differed significantly in the BMI groups when adjusted for the confounding factors individually but not when adjusted for all three factors simultaneously. In addition, the maximum oxytocin infusion rate was significantly higher in women with emergency caesarean section compared with women with vaginal delivery.ConclusionsWomen with increasing BMI with augmentation of labour received a higher cumulative oxytocin dose and had a higher maximum oxytocin infusion rate during first stage of labour, however, when adjusted for relevant confounders, the difference was no longer seen. In the future, the guidelines for augmentation of labour with oxytocin infusion might be reconsidered and include modifications related to BMI.
| S-EPMC8006853 | biostudies-literature
Project description:Objectives Postpartum haemorrhage (PPH) is a major cause of maternal mortality and morbidity worldwide. Experimental studies support the hypothesis that oxytocin administration during labour, a common although not evidence-based practice, may increase the risk of atonic PPH. The clinical studies, however, are inconclusive. The objectives of this study was to investigate the association between the level of oxytocin exposure during labour and the risk of severe PPH and to explore whether the prophylactic use of oxytocin after birth modifies this association. Design Population-based, cohort-nested case-control study. Setting 106 French hospitals from December 2004 through November 2006. Participants Women with term singleton vaginal deliveries, after an uncomplicated pregnancy. Cases were 1483 women with severe PPH, defined by peripartum change in haemoglobin of ?4 g/dl or need for blood transfusion. Controls were 1758 women from a random sample of parturients without PPH. Main outcome measures The independent association between the level of oxytocin during labour and the risk of severe PPH was tested and quantified with ORs through two-level multivariable logistic regression modelling. Results Oxytocin was administered during labour to 73% of cases and 61% of controls (crude OR: 1.7, 95% CI 1.5 to 2.0). After adjustment for all potential confounders, oxytocin during labour was associated with a significantly higher risk of severe PPH (adjusted OR: 1.8, 95% CI 1.3 to 2.6) in women who did not receive prophylactic oxytocin after delivery; the OR for haemorrhage increased from 1 to 5 according to the level of oxytocin exposure. In women who had prophylactic oxytocin after delivery, this association was significant only for the highest exposure categories. Conclusions Oxytocin during labour appears to be an independent risk factor for severe PPH. The results emphasise the need for guidelines clarifying the evidence-based indications for this procedure and the minimal useful regimens.
| S-EPMC3334825 | biostudies-other