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Outpatient versus inpatient induction of labour for improving birth outcomes

  1. Anthony J Kelly1,*,
  2. Zarko Alfirevic2,
  3. Arpita Ghosh1

Editorial Group: Cochrane Pregnancy and Childbirth Group

Published Online: 12 NOV 2013

Assessed as up-to-date: 14 AUG 2013

DOI: 10.1002/14651858.CD007372.pub3


How to Cite

Kelly AJ, Alfirevic Z, Ghosh A. Outpatient versus inpatient induction of labour for improving birth outcomes. Cochrane Database of Systematic Reviews 2013, Issue 11. Art. No.: CD007372. DOI: 10.1002/14651858.CD007372.pub3.

Author Information

  1. 1

    Brighton and Sussex University Hospitals NHS Trust, Department of Obstetrics and Gynaecology, Brighton, UK

  2. 2

    The University of Liverpool, Department of Women's and Children's Health, Liverpool, UK

*Anthony J Kelly, Department of Obstetrics and Gynaecology, Brighton and Sussex University Hospitals NHS Trust, Royal Sussex County Hospital, Eastern Road, Brighton, BN2 5BE, UK. tony.kelly@bsuh.nhs.uk.

Publication History

  1. Publication Status: New search for studies and content updated (conclusions changed)
  2. Published Online: 12 NOV 2013

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Characteristics of included studies [ordered by study ID]
Biem 2003

MethodsRCT.


Participants300 women randomised (1 woman withdrew).

Inclusion criteria: singleton, term pregnancy, cephalic presentation, intact membranes, Bishop's score 6 or less, parity 5 or less, unscarred uterus, normal nonstress test, reliable transportation from home.

Exclusion criteria: congenital anomaly, dead fetus, IUGR, hypertension, abnormal placenta, poly- or oligohydramnios.


InterventionsBoth groups received vaginal controlled release prostaglandin E2 10 mg. Both groups were monitored in the antenatal ward for 1 hour.

Outpatient group: after initial monitoring women were discharged home to return when in labour or were reviewed after 12 hours (nonstress test). If they were not in labour 24 hours later they returned to hospital for induction of labour as an inpatient. Women were in telephone contact with a nurse every 4 hours and were given detailed instructions on when to seek help. They were asked to remain within easy travelling distance of the hospital.

Inpatient group: women remained on the antenatal ward throughout and managed in a similar way to the outpatient group.


OutcomesSatisfaction with care, length of hospital stay, length of labour, mode of delivery, labour interventions, maternal, fetal and neonatal complications.


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskComputer-generated sequence.

Allocation concealment (selection bias)Low risk"Sequential sealed opaque envelopes" opened immediately after the insertion of the PGE2.

Blinding (performance bias and detection bias)
Women
High riskNot feasible for this intervention.

Blinding (performance bias and detection bias)
Clinical staff
High riskNot feasible for this intervention.

Blinding (performance bias and detection bias)
Outcome assessors
High riskBlinding of the outcome assessors was not attempted.

Incomplete outcome data (attrition bias)
All outcomes
Low riskOnly 1 woman withdrew from the study after randomisation.

Selective reporting (reporting bias)Low riskNone apparent.

Other biasLow riskNone apparent. No baseline imbalance apparent.

Ryan 1998

MethodsRCT.


Participants201 women.

Inclusion and exclusion criteria were not clear. Women at "term... who met the eligibility criteria to receive PGE2 as an outpatient".


InterventionsUnclear. Information not provided. Inpatient and outpatient management after insertion of PGE2 gel (dose not stated) were compared.


OutcomesLength of hospital stay, mode of delivery, Apgar score and neonatal admission to special care.


NotesAbstract only available, we have attempted to contact the author for more information but to date (November 2008) we have had no response.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskDescribed as "randomised".

Allocation concealment (selection bias)Unclear riskNo information provided.

Blinding (performance bias and detection bias)
Women
High riskNot feasible.

Blinding (performance bias and detection bias)
Clinical staff
High riskNot feasible.

Blinding (performance bias and detection bias)
Outcome assessors
High riskBlinding of the outcome assessors was not attempted.

Incomplete outcome data (attrition bias)
All outcomes
Unclear riskNo loss to follow-up apparent but little information provided.

Selective reporting (reporting bias)Unclear riskAbstract only available.

Other biasUnclear riskAbstract only available.

Sciscione 2001

MethodsRCT.


Participants111 women.

Inclusion criteria: singleton, term pregnancy, cephalic position, intact membranes with a Bishop's score < 6, with reactive nonstress test, "...attending physician had requested pre-induction cervical ripening using the Foley catheter".

Exclusion criteria: fetal anomaly or dead fetus, hypertension, vaginal bleeding, ruptured membranes, placenta praevia, IUGR, active herpes infection, without access to phone, without reliable transportation or living more than 30 minutes' distance from the hospital.


InterventionsBoth groups had a number 16 Foley catheter inserted into the endocervical canal to or past the internal os; the balloon was filled with 30 mL of sterile water, the end of the catheter was taped to the thigh. After placement of the catheter if there was a reactive nonstress test and no signs of uterine hyperstimulation and the amniotic fluid index was > 5th percentile women were randomised.

Outpatient group: women received detailed oral and written guidelines on when to seek advice and then were discharged home. 24 hour phone access to a doctor was provided.They were asked to return for review the next morning for induction of labour with oxytocin.

Inpatient group: women were admitted to the labour ward. They were allowed to ambulate. The catheter was checked every 2-4 hrs and the fetal heart rate was assessed hourly.


OutcomesPrimary outcome: Bishop score.


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskComputer-generated random number table.

Allocation concealment (selection bias)Low riskSequentially numbered envelopes.

Blinding (performance bias and detection bias)
Women
High riskBlinding not feasible.

Blinding (performance bias and detection bias)
Clinical staff
High riskBlinding not feasible.

Blinding (performance bias and detection bias)
Outcome assessors
High riskBlinding of the outcome assessors was not attempted.

Incomplete outcome data (attrition bias)
All outcomes
Low riskComplete data for main outcomes. Only the outpatient group was followed up in the postnatal period and there was high attrition (40%) for this longer-term follow-up.

Selective reporting (reporting bias)Unclear riskSome of the results were difficult to interpret.

Other biasUnclear riskNot clear how many of the women approached were eligible for this trial. Not clear how women were managed as regards oxytocin and this may have had an impact on results. Not clear how many women in the outpatient group were surveyed in the postnatal period; figures differ between the main study paper and an abstract reporting survey results.

Wilkinson 2012

Methods2-centre RCT.


Participants827 women from 2 tertiary centres were randomised to 411 women in experimental arm (outpatient group) and 416 in control arm (inpatient group). 215 women in experimental group and 210 women in the control group received the intervention. The rest of the women either went into labour spontaneously or did not need the intervention by induction date.

Inclusion and exclusion criteria were not clear. It states, women were low risk, induced for postdates or social reasons. Women with glucose intolerance in pregnancy were excluded.


InterventionsPGE2. Dose not stated. The study compared inpatient to outpatient cervical ripening for induction of labour with PG2.


OutcomesOxytocin use, spontaneous birth, instrumental delivery or caesarean section, maternal, fetal and neonatal complications.


Notes51% patients were analysed post randomisation.

22% patients receiving PGE2 as an intended outpatient did not go home.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskOnly abstract available for this study. It states women were randomised and stratified for parity but its unclear what method was used to generate random sequence.

Allocation concealment (selection bias)Unclear riskNot stated.

Blinding (performance bias and detection bias)
Women
High riskNot feasible.

Blinding (performance bias and detection bias)
Clinical staff
High riskNot feasible.

Blinding (performance bias and detection bias)
Outcome assessors
Unclear riskNot stated.

Incomplete outcome data (attrition bias)
All outcomes
Unclear risk51% of patients who were randomised were not analysed. This cohort of patients was balanced between the groups and this was judged to be a factor relating to the point of randomisation rather than a flaw in the actual study design.

Selective reporting (reporting bias)Unclear riskUnclear - only abstract available.

Other biasUnclear riskUnclear - only abstract available.

 
Characteristics of excluded studies [ordered by study ID]

StudyReason for exclusion

Henry 2011The study compared 2 different methods of induction in outpatient and inpatient setting. It compared intracervical Foley catheter in the outpatient setting with intravaginal PGE2 gel in the inpatient setting for cervical ripening at term. The study reports clinical effectiveness, safety and cost-effectiveness.

Rijnders 2007It is a multicentre RCT that aims to explore costs and effects of amniotomy at home for induction of post term pregnancy. However, only trial registration form for this study is available for analysis. According to this, the study commenced in 2004 and its anticipated end date was 2007. Litrature search did not reveal any published results for this study and the authors were not contactable via e-mail or phone for any further information.

 
Comparison 1. Outpatient versus inpatient induction with vaginal PGE2

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size

 1 Additional induction agent required (oxytocin)2626Risk Ratio (M-H, Fixed, 95% CI)1.00 [0.87, 1.14]

 2 Total length of hospital stay1201Mean Difference (IV, Fixed, 95% CI)0.20 [-8.86, 9.26]

 3 Length of stay: admission to delivery1201Mean Difference (IV, Fixed, 95% CI)-9.60 [-13.02, -6.18]

 4 Postnatal hospital stay1201Mean Difference (IV, Fixed, 95% CI)7.60 [-0.12, 15.32]

 5 Serious neonatal morbidity or death1425Risk Ratio (M-H, Fixed, 95% CI)1.42 [0.68, 2.99]

 6 Women receiving epidural analgesia1201Risk Ratio (M-H, Fixed, 95% CI)0.97 [0.88, 1.08]

 7 Instrumental vaginal delivery2626Risk Ratio (M-H, Random, 95% CI)1.29 [0.79, 2.13]

 8 Caesarean section rate2626Risk Ratio (M-H, Fixed, 95% CI)0.97 [0.73, 1.29]

 9 Apgar score less than 7 at 5 minutes1201Risk Ratio (M-H, Fixed, 95% CI)2.23 [0.21, 24.22]

 10 Neonatal intensive care unit admission1201Risk Ratio (M-H, Fixed, 95% CI)1.30 [0.45, 3.74]

 
Comparison 2. Outpatient versus inpatient induction with controlled release PGE

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size

 1 Vaginal delivery or labour not achieved within 24 hours1299Risk Ratio (M-H, Fixed, 95% CI)0.80 [0.54, 1.17]

 2 Oxytocin required1299Risk Ratio (M-H, Fixed, 95% CI)0.76 [0.46, 1.27]

 3 Mean satisfaction score measured during induction1299Mean Difference (IV, Fixed, 95% CI)0.90 [0.34, 1.46]

 4 High level of maternal satisfaction measured during induction period1299Risk Ratio (M-H, Fixed, 95% CI)1.42 [1.11, 1.81]

 5 Overall satisfaction score with labour and delivery measured in the postnatal period1299Mean Difference (IV, Fixed, 95% CI)0.20 [-0.31, 0.71]

 6 Number receiving epidural1299Risk Ratio (M-H, Fixed, 95% CI)1.02 [0.91, 1.16]

 7 Uterine hyperstimulation (with or without fetal heart rate changes)1299Risk Ratio (M-H, Fixed, 95% CI)1.01 [0.51, 1.98]

 8 Instrumental vaginal delivery1299Risk Ratio (M-H, Fixed, 95% CI)1.34 [0.83, 2.17]

 9 Caesarean section rate1299Risk Ratio (M-H, Fixed, 95% CI)0.95 [0.64, 1.42]

 10 Neonatal intensive care admission1299Risk Ratio (M-H, Fixed, 95% CI)1.38 [0.57, 3.34]

 11 Nonreassuring fetal heart rate1299Risk Ratio (M-H, Fixed, 95% CI)1.48 [0.80, 2.73]

 12 Anxiety score measured during induction period (not pre-specified outcome)1299Mean Difference (IV, Fixed, 95% CI)-0.20 [-0.60, 0.20]

 
Comparison 3. Outpatient versus inpatient induction with Foley catheter

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size

 1 Women receiving epidural analgesia1111Risk Ratio (M-H, Fixed, 95% CI)1.00 [0.95, 1.06]

 2 Caesarean section rate1111Risk Ratio (M-H, Fixed, 95% CI)0.67 [0.41, 1.10]

 3 Neonatal intensive care unit admission1111Risk Ratio (M-H, Fixed, 95% CI)0.20 [0.02, 1.78]

 4 Total induction time (insertion of catheter to delivery)1111Mean Difference (IV, Fixed, 95% CI)2.0 [-292.61, 296.61]