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      Outpatient Foley catheter versus inpatient prostaglandin E2 gel for induction of labour: a randomised trial

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          Abstract

          Background

          Induction of labour (IOL) is one of the commonest obstetric interventions, with significant impact on both the individual woman and health service delivery. Outpatient IOL is an attractive option to reduce these impacts. To date there is little data comparing outpatient and inpatient IOL methods, and potential safety concerns (hyperstimulation) if prostaglandins, the standard inpatient IOL medications, are used in the outpatient setting. The purpose of this study was to assess feasibility, clinical effectiveness and patient acceptability of outpatient Foley catheter (OPC) vs. inpatient vaginal PGE2 (IP) for induction of labour (IOL) at term.

          Methods

          Women with an unfavourable cervix requiring IOL at term (N = 101) were randomised to outpatient care using Foley catheter (OPC, n = 50) or inpatient care using vaginal PGE2 (IP, n = 51). OPC group had Foley catheter inserted and were discharged overnight following a reassuring cardiotocograph. IP group received 2 mg/1 mg vaginal PGE2 if nulliparous or 1 mg/1 mg if multiparous. Main outcome measures were inpatient stay (prior to birth, in Birthing Unit, total), mode of birth, induction to delivery interval, adverse reactions and patient satisfaction.

          Results

          OPC group had shorter hospital stay prior to birth (21.3 vs. 32.4 hrs, p < .001), IP were more likely to achieve vaginal birth within 12 hours of presenting to Birthing Unit (53% vs. 28%, p = .01). Vaginal birth rates (66% OPC Vs. 71% IP), total induction to delivery time (33.5 hrs vs. 31.3 hrs) and total inpatient times (96 hrs OPC Vs. 105 hrs IP) were similar. OPC group felt less pain (significant discomfort 26% Vs 58%, p = .003), and had more sleep (5.8 Vs 3.4 hours, p < .001), during cervical preparation, but were more likely to require oxytocin IOL (88 Vs 59%, p = .001).

          Conclusions

          OPC was feasible and acceptable for IOL of women with an unfavourable cervix at term compared to IP, however did not show a statistically significant reduction in total inpatient stay and was associated with increased oxytocin IOL.

          Trial registration

          Australian New Zealand Clinical Trials Registry, ACTRN:12609000420246.

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          Most cited references7

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          Sample sizes for clinical trials with normal data.

          S Julious (2004)
          This article gives an overview of sample size calculations for parallel group and cross-over studies with Normal data. Sample size derivation is given for trials where the objective is to demonstrate: superiority, equivalence, non-inferiority, bioequivalence and estimation to a given precision, for different types I and II errors. It is demonstrated how the different trial objectives influence the null and alternative hypotheses of the trials and how these hypotheses influence the calculations. Sample size tables for the different types of trials and worked examples are given. Copyright 2004 John Wiley & Sons, Ltd.
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            Induction of labour in nulliparous women with an unfavourable cervix: a randomised controlled trial comparing double and single balloon catheters and PGE2 gel.

            To compare the efficacy and patient satisfaction of three methods of labour induction (double balloon catheters, single balloon catheters and prostaglandin gel) in term nulliparous women with unfavourable cervices. Randomised controlled trial. A total of 330 nulliparous women with unfavourable cervices induced at term. Three cervical ripening study arms were used: double balloon catheter (107 women); 16F Foley catheter (110 women) and PGE(2) gel (2 mg) (113 women). Caesarean section, induction to delivery interval, adverse reactions and patient satisfaction. There was no difference in caesarean delivery rates between groups (double balloon 43%, single balloon 36%, PGE(2) 37%, P = 0.567). The induction to delivery interval was longer in the double balloon group (median 24.5; 95% CI 23.7, 30.6 hours) than the single balloon (23.2; 20.8, 25.8 hours) or PGE(2) (23.8; 21.7, 26.8 hours) (P = 0.043). Uterine hyperstimulation occurred in 14% of the PGE(2) group with none occurring with mechanical cervical ripening. Cord blood gases were worse in the PGE(2) group: median arterial pH double balloon 7.26 (range 7.03-7.40); single balloon 7.26 (7.05-7.44); PGE(2) 7.25 (6.91-7.41) (P = 0.050). Cervical ripening with the single balloon catheter was associated with significantly less pain (pain score > or =4: double balloon 55%, single balloon 36%, PGE(2) 63%, P < 0.001). Labour induction in nullipara with unfavourable cervices results in high caesarean delivery rates. Although all methods in this study had similar efficacy, the single balloon catheter offers the best combination of safety and patient comfort.
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              Time of birth and risk of neonatal death at term: retrospective cohort study

              Objective To determine the effect of time and day of birth on the risk of neonatal death at term. Design Population based retrospective cohort study. Setting Data from the linked Scottish morbidity records, Stillbirth and Infant Death Survey, and birth certificate database of live births in Scotland, 1985-2004. Subjects Liveborn term singletons with cephalic presentation. Perinatal deaths from congenital anomalies excluded. Final sample comprised 1 039 560 live births. Main outcome measure All neonatal deaths (in the first four weeks of life) unrelated to congenital abnormality, plus a subgroup of deaths ascribed to intrapartum anoxia. Results The risk of neonatal death was 4.2 per 10 000 during the normal working week (Monday to Friday, 0900-1700) and 5.6 per 10 000 at all other times (out of hours) (unadjusted odds ratio 1.3, 95% confidence interval 1.1 to 1.6). Adjustment for maternal characteristics had no material effect. The higher rate of death out of hours was because of an increased risk of death ascribed to intrapartum anoxia (adjusted odds ratio 1.7, 1.2 to 2.3). Though exclusion of elective caesarean deliveries attenuated the association between death ascribed to anoxia and delivery out of hours, a significant association persisted (adjusted odds ratio 1.5, 1.1 to 2.0). The attributable fraction of neonatal deaths ascribed to intrapartum anoxia associated with delivery out of hours was 26% (95% confidence interval 5% to 42%). Conclusions Delivering an infant outside the normal working week was associated with an increased risk of neonatal death at term ascribed to intrapartum anoxia.
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                Author and article information

                Journal
                BMC Pregnancy Childbirth
                BMC Pregnancy Childbirth
                BMC Pregnancy and Childbirth
                BioMed Central
                1471-2393
                2013
                29 January 2013
                : 13
                : 25
                Affiliations
                [1 ]School of Women’s and Children’s Health, University of New South Wales, Kensington, Australia
                [2 ]Department of Maternal-Fetal Medicine, Royal Hospital for Women, Sydney, Australia
                [3 ]Midwifery and Women’s Health Research Unit, University of Sydney, Sydney, Australia
                Article
                1471-2393-13-25
                10.1186/1471-2393-13-25
                3564932
                23356673
                24d7cc70-531c-47a0-8593-29c60b567cad
                Copyright ©2013 Henry et al.; licensee BioMed Central Ltd.

                This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

                History
                : 9 August 2012
                : 24 January 2013
                Categories
                Research Article

                Obstetrics & Gynecology
                induction of labour,mechanical ripening,prostaglandin,foley catheter,randomised controlled trial,unfavourable cervix

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