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

Amanda Henry, Arushi Madan, Rachel Reid, Sally K Tracy, Kathryn Austin, Alec Welsh, Daniel Challis, Amanda Henry, Arushi Madan, Rachel Reid, Sally K Tracy, Kathryn Austin, Alec Welsh, Daniel Challis

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.

Figures

Figure 1
Figure 1
Participant flow diagram (CONSORT 2010).
Figure 2
Figure 2
Induction to delivery interval comparison.
Figure 3
Figure 3
Comparison of Instrumental Delivery (ID) numbers.

References

    1. World Health Organization. WHO recommendations for induction of labour. Geneva, Switzerland: World Health Organisation; 2011. p. 32. (Department of reproductive health and research).
    1. Alfirevic Z, Kelly A, Dowsell T. Intravenous oxytocin alone for cervical ripening and induction of labour. Cochrane Database Systematic Rev. 2009. Art. No.: CD003246.
    1. Jozwiak M, Bloemenkamp K, Kelly A, Mol B, Irion O, Boulvain M. Mechanical methods for induction of labour. Cochrane Database Systematic Rev. 2012. Art. No.: CD001233.
    1. Hertelendy F, Zakar T. Prostaglandins and the myometrium and cervix. Prostaglandins leukotrienes essential fatty acids. 2004;70(2):207–222. doi: 10.1016/j.plefa.2003.04.009.
    1. Pennell C, Henderson J, O’Neill M, McCleery S, Doherty D, Dickinson J. Induction of labour in nulliparous women with an unfavourable cervix: a randomised controlled trial comparing double and single balloon catheters and PGE2 gel. BJOG. 2009;116:1443–1452. doi: 10.1111/j.1471-0528.2009.02279.x.
    1. Dowswell T, Kelly A, Livio S, Norman J, Alfirevic Z. Different methods for the induction of labour in outpatient settings. Cochrane Database Systematic Rev. 2010. Art. No.: CD007701.
    1. Kelly A, Alfirevic Z, Dowswell T. Outpatient versus inpatient induction of labour for improving birth outcomes. Cochrane Database Systematic Rev. 2009. Art. No.: CD007372.
    1. Scisione A, Muench M, Pollock M, Jenkins T, Tildon-Burnon J, Colmorgen G. Transcervical foley catheter for preinduction cervical ripening in an outpatient versus inpatient setting. Obstet Gynecol. 2001;98:751–756. doi: 10.1016/S0029-7844(01)01579-4.
    1. National institute for Health and Clinical Excellence (NICE) Intapartum care: care of healthy women and their babies during childbirth. London: NICE; 2007.
    1. Julious S. Sample sizes for clinical trials with normal data. Stat Med. 2004;23(12):1921–1986. doi: 10.1002/sim.1783.
    1. Ryan G, Oskamp M, Seaward P, Barrett J, Barrett H, O’Brien K. Randomized controlled trial of inpatient vs. outpatient administration of prostaglandin E2, gel for induction of labour at term. Am J Obstet Gynecol. 1998;178(Suppl 1 (2)):S92.
    1. Wilkinson C, Bryce R, Adelson P, Coffey J, Coomblas J, Ryan P, Stamp G, Turnbull D. Two center RCT of outpatient versus inpatient cervical ripening for induction of labour with PGE2. Am J Obstetrics Gynaecol. 2012;206(1 (Supplement):S137.
    1. Heinemann J, Gillen G, Sanchez-Ramos L, Kaunitz A. Do mechanical methods of cervical ripening increase infectious morbidity? A systematic review. Am J Obstet Gynecol. 2008;199(2):177–187. doi: 10.1016/j.ajog.2008.05.005.
    1. National Collaborating Centre for Women’s and Children’s Health. Induction of labour. London: RCOG Press; 2008.
    1. Pasupathy D, Wood A, Pell J, Mechan H, Fleming M, Smith G. Time of birth and risk of neonatal death at term: retrospective cohort study. BMJ. 2010;341:c3498. doi: 10.1136/bmj.c3498.
    1. de Graaf J, Ravelli A, Visser G, Hukkelhoven C, Tong W, Bonsel G, Steegers E. Increased adverse perinatal outcome of hospital delivery at night. BJOG. 2010;117:1098–1107. doi: 10.1111/j.1471-0528.2010.02611.x.

Source: PubMed

Sponsorer och medarbetare

Medicinska tillstånd

Läkemedelsinterventioner

3
Prenumerera