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.
There has been limited research addressing whether behavioural change in relation to smoking is maintained throughout pregnancy and the effect on perinatal outcomes. A cohort study addressed lifestyle behaviours of 907 women who booked for antenatal care and delivered in a large urban teaching hospital in 2010–2011. Adverse perinatal outcomes were compared for “non-smokers”, “ex-smokers” and “current smokers”. Of the 907 women, 270 (30%) reported smoking in the six months prior to pregnancy, and of those 160 (59%) had stopped smoking and 110 (41%) continued to smoke at the time of the first antenatal visit. There was virtually no change in smoking behaviour between the first antenatal visit and the third trimester of pregnancy. Factors associated with continuing to smoke included unplanned pregnancy (OR 1.9; 95% CI 1.3, 2.9), alcohol use (OR 3.4; 95% CI 2.1, 6.0) and previous illicit drug use (OR 3.6; 95% CI 2.1, 6.0). Ex-smokers had similar perinatal outcomes to non-smokers. Current smoking was associated with an average reduction in birth weight of 191g (95% CI −294, −88) and an increased incidence of intrauterine growth restriction (24% versus 13%, adjusted OR 1.39 (95% CI 1.06, 1.84). Public Health campaigns emphasise the health benefits of quitting smoking in pregnancy. The greatest success appears to be pre-pregnancy and during the first trimester where women are largely self-motivated to quit.
Most studies of alcohol consumption in pregnancy have looked at one time point only, often relying on recall. The aim of this longitudinal study was to determine whether alcohol consumption changes in early and late pregnancy and whether this affects perinatal outcomes. We performed a prospective cohort study, conducted from November 2010 to December 2011 at a teaching hospital in the Republic of Ireland. Of the 907 women with a singleton pregnancy who booked for antenatal care and delivered at the hospital, 185 (20%) abstained from alcohol in the first trimester but drank in the third trimester, 105 (12%) consumed alcohol in the first and third trimesters, and the remaining 617 (68%) consumed no alcohol in pregnancy. Factors associated with continuing to drink in pregnancy included older maternal age (30–39 years), Irish nationality, private healthcare, smoking, and a history of illicit drug use. Compared to pre-pregnancy, alcohol consumption in pregnancy was markedly reduced, with the majority of drinkers consuming ≤ 5 units per week (92% in first trimester, 72–75% in third trimester). Perhaps because of this, perinatal outcomes were similar for non-drinkers, women who abstained from alcohol in the first trimester, and women who drank in the first and third trimester of pregnancy. Most women moderate their alcohol consumption in pregnancy, especially in the first trimester, and have perinatal outcomes similar to those who abstain.
BackgroundPrimary postpartum haemorrhage (PPH) is one of the leading causes of maternal morbidity and mortality worldwide. The most common cause of primary PPH is uterine atony. Atonic PPH rates are increasing in developed countries despite routine active management of the third stage of labour. In less-developed countries, primary PPH remains the leading cause of maternal death.Although the value of routine oxytocics in the third stage of labour has been well established, there is inconsistent practice in the choice of agent and route of administration. Oxytocin is the preferred agent because it has fewer side effects than other uterotonics with similar efficacy. It can be given intravenously or intramuscularly; however, to date, the most effective route of administering oxytocin has not been established.Methods/DesignA double-blind randomised controlled trial is planned. The aim of the study is to compare the effects of an intramuscular bolus of oxytocin (10 IU in 1 mL) and placebo intravenous injection (1 mL 0.9% saline given slowly) with an intravenous bolus of oxytocin (10 IU in 1 mL given slowly over 1 min) and placebo intramuscular injection (1 mL 0.9% saline) at vaginal delivery. The study will recruit 1000 women at term (>36 weeks) with singleton pregnancies who are aiming for a vaginal delivery. The primary outcome will be PPH (measured blood loss ≥ 500 mL). A study involving 1000 women will have 80% power at the 5% two-sided alpha level, to detect differences in the proportion of patients with measured blood loss > 500 ml of 10% vs 5%.DiscussionGiven the increasing trends of atonic PPH it is both important and timely that we evaluate the most effective route of oxytocin administration for the management of the third stage of labour. To date, there has been limited research comparing the efficacy of intramuscular oxytocin vs intravenous oxytocin for the third stage of labour.Trial registrationISRCTN Registry, ISRCTN14718882. Registered on 4 January 2016. Pilot commenced 12.12.2015; trial commenced 04.01.2016. The protocol (Ref 012012) was approved by the National Maternity Hospital Research Ethics Committee on 10.06.2015 and the Research Ethics Committee of the Coombe Women & Infants University Hospital (Ref 26-2015) on 09.12.2015.Electronic supplementary materialThe online version of this article (doi:10.1186/s13063-017-2269-9) contains supplementary material, which is available to authorized users.
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