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: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.
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.
Project description:BackgroundLabour dystocia (LD) is associated with maternal and foeto-neonatal complications and increased rate of caesarean section. There are scant studies on predictive factors of labour dystocia in Iran, as well as in other countries. Therefore, this study aimed to identify the predictive factors of LD using an integrated and collaborative pre- and during- labour factors to help formulate more effective intervention strategies for prevention and management of LD.MethodsIn this case-control study, 350 women with and 350 women without LD, matched individually in terms of parity and hospital, were compared. The participants were in active labor, had singleton pregnancy, live foetus with a cephalic presentation, gestational age of 37+ 0-41+ 6 weeks, and were hospitalized for vaginal birth in two teaching hospitals in Tabriz, Iran. Data related to the socio-demographic characteristics, anxiety status (using the Spielberger State Anxiety Inventory), and woman dehydration were collected at cervical dilatation between 4 and 6 cm (before dystocia detection) and the other data at different phases of labour, and after birth (before discharge). The multivariate logistic regression was used to determine the predictors.ResultsThe predictors of LD were severe [OR 58.0 (95% CI 26.9 to 125.1)] and moderate [8.6 (4.2 to 17.4)] anxiety, woman dehydration > 3 h [18.67 (4.0 to 87.3)] and ≤ 3 h [2.8 (1.7 to 4.8], insufficient support by the medical staff in the delivery room [5.8 (1.9 to 17.9)], remifentanil administration [3.1 (1.5 to 6.2)], labour induction [4.2 (2.5 to 7.2], low income [2.0 (1.2 to 3.3)], woman's height < 160 cm [2.0 (1.1 to 3.3)], and woman age of 16-20 y [0.3 (0.2 to 0.6)]. The proportion of the variance explained by all these factors was 74%.ConclusionThe controllable predictors, such as woman anxiety and dehydration, and insufficient support from medical staff during labour were strongly associated with the risk of LD. Therefore, it seems that responding to woman physical, psychological, and supportive needs during labour can play a significant role in LD prevention and control.Ethical codeIR.TBZMED.REC.1397.624.
Project description:BackgroundOxytocin 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.MethodsCONDISOX 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.DiscussionThe 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 registrationNCT02553226 (registered September 17, 2015). Eudra-CT number: 2015-002942-30.
Project description:ObjectiveTo systematically assess the effect of discontinued vs continued oxytocin after active stage of labour is established.MethodsPubmed, Embase, and the Cochrane Library were systematically searched to 18 April 2021. The risk ratio or mean difference with corresponding 95% confidence interval were computed to investigate the effect of intervention or control on maternal and fetus outcomes. This review was registered in the International Prospective Register of Systematic Reviews: CRD42021249635.ResultsDiscontinuing oxytocin when the active labour was established might decrease the risk of cesarean delivery [RR (95% CI): 0.84 (0.72-0.98), P = 0.02]. However, when we restricted our analysis to women who performed cesarean section after the active phase was reached, the difference was no longer significant [RR (95% CI): 0.82 (0.60-1.10), P = 0.19]. The incidence of uterine tachysystole [RR (95% CI): 0.36 (0.27-0.49)], postpartum hemorrhage [RR (95% CI): 0.78 (0.65-0.93)], and non-reassuring fetal heart rate [RR (95% CI): 0.66 (0.58-0.76)] were significantly lower in the oxytocin discontinuation group. We also found a possible decrease in the risk of chorioamnionitis in discontinued oxytocin group [RR (95% CI): 2.77 (1.02-5.08)]. An increased duration of active [MD (95% CI): 2.28 (2.86-41.71)] and second [MD (95% CI): 5.36 (3.18-7.54)] phase of labour was observed in discontinued oxytocin group, while the total delivery time was not significantly different [MD (95% CI): 20.17 (-24.92-65.26)].ConclusionAfter the active labor is reached, discontinuation of oxytocin could be considered a new recommendation for the improved maternal and fetal outcomes without delaying labour.
Project description:BackgroundHigh rates of labour augmentation with oxytocin have been found in some low- and lower-middle-income countries, causing potential perinatal harm. It is critical to understand the reasons for this overuse. Aim was to explore factors that shape practices around using oxytocin for labour augmentation in a high-volume labour ward in Dar es Salaam, Tanzania.MethodsMixed-methods data collection was conducted from March 2021 to February 2022, including structured observations of 234 births, 220 h of unstructured labour ward observations and 13 individual in-depth interviews with birth attendants. Thematic network analysis and descriptive statistics were used to analyse data. We used a time-lens to understand practices of oxytocin for labour augmentation in time-pressured labour wards.ResultsBirth attendants constantly had to prioritise certain care practices over others in response to time pressure. This led to overuse of oxytocin for augmentation to ensure faster labour progression and decongestion of the, often overburdened, ward. Simultaneously, birth attendants had little time to monitor foetal and maternal condition. Surprisingly, while oxytocin was used in 146 out of 234 (62.4%) structured labour observations, only 9/234 (4.2%) women had active labour lasting more than 12 h. Correspondingly, 21/48 (43.8%) women who were augmented with oxytocin in the first stage of labour had uncomplicated labour progression at the start of augmentation. While the partograph was often not used for decision-making, timing of starting oxytocin often correlated with natural cycles of ward-rounds and shift-turnovers instead of individual women's labour progression. This resulted in co-existence of 'too early' and 'too late' use of oxytocin. Liberal use of oxytocin for labour augmentation was facilitated by an underlying fear of prolonged labour and low alertness of oxytocin-related risks.ConclusionsTime scarcity in the labour ward often made birth attendants deviate from clinical guidelines for labour augmentation with oxytocin. Efforts to navigate time pressure resulted in too many women with uncomplicated labour progression receiving oxytocin with little monitoring of labour. Fear of prolonged labour and low alertness to oxytocin-mediated risks were crucial drivers. These findings call for research into safety and benefits of oxytocin in low-resource settings and interventions to address congestion in labour wards to prevent using oxytocin as a time-management tool.
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.
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.
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.