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Package of care for active management in labour for reducing caesarean section rates in low-risk women

  1. Heather C Brown1,*,
  2. Shantini Paranjothy2,
  3. Therese Dowswell3,
  4. Jane Thomas4

Editorial Group: Cochrane Pregnancy and Childbirth Group

Published Online: 16 SEP 2013

Assessed as up-to-date: 27 JUN 2013

DOI: 10.1002/14651858.CD004907.pub3


How to Cite

Brown HC, Paranjothy S, Dowswell T, Thomas J. Package of care for active management in labour for reducing caesarean section rates in low-risk women. Cochrane Database of Systematic Reviews 2013, Issue 9. Art. No.: CD004907. DOI: 10.1002/14651858.CD004907.pub3.

Author Information

  1. 1

    Royal Sussex County Hospital, Department of Obstetrics and Gynaecology, Brighton, UK

  2. 2

    School of Medicine, Cardiff University, Cochrane Institute of Primary Care and Public Health, Cardiff, UK

  3. 3

    The University of Liverpool, Cochrane Pregnancy and Childbirth Group, Department of Women's and Children's Health, Liverpool, UK

  4. 4

    Auckland University, Cochrane MSDG FMHS, Auckland, New Zealand

*Heather C Brown, Department of Obstetrics and Gynaecology, Royal Sussex County Hospital, Eastern Road, Brighton, BN2 5BE, UK. heather.brown@bsuh.nhs.uk. h.brown249@btinternet.com.

Publication History

  1. Publication Status: New search for studies and content updated (no change to conclusions)
  2. Published Online: 16 SEP 2013

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Characteristics of included studies [ordered by study ID]
Cammu 1996

MethodsRCT.


ParticipantsStudy in hospital serving urban middle-class women.

Participants: 306 women.

Inclusion criteria: nulliparous women in spontaneous labour at or over 37 weeks' gestation, singleton fetus, cephalic presentation, normal cardiotocogram and clear amniotic fluid, maternal height > 150 cm, attended at least 1 antenatal appointment.


InterventionsActive management group: amniotomy within 1 hr of admission; hourly vaginal assessments of progress; oxytocin for delayed progress (< 1 cm cervical dilatation per hour) - incremental doses up to 30 mU per min after 120 mins unless contra-indicated.

Comparison group: selective management, amniotomy only after arrest of dilatation, oxytocin if 2 hrs behind schedule (at same dose as intervention group).

One-to-one care and electronic fetal monitoring in both groups.


OutcomesCaesarean section rates, assisted vaginal delivery rates, duration of labour.


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskNo information provided.

Allocation concealment (selection bias)Low riskNumbered, sealed, opaque envelopes.

Blinding (performance bias and detection bias)
Women
High riskDifferent treatment regimens compared.

Blinding (performance bias and detection bias)
Clinicians
High riskGroup allocation indicated on notes.

Blinding (performance bias and detection bias)
Outcome assessor
High riskGroup allocation indicated on notes.

Incomplete outcome data (attrition bias)
All outcomes
Low riskSmall number of post-randomisation exclusions (2% attrition).

Selective reporting (reporting bias)Low riskMain outcomes reported.

Other biasUnclear riskUnclear how many women were eligible.

Frigoletto 1995

MethodsRCT (stratified by site with block randomisation).


ParticipantsBoston, USA.

Participants: 1915 women.

Inclusion criteria: Nulliparous, English-speaking women 18 years of age or over.

Exclusion criteria: women at increased risk of caesarean delivery (e.g. cervical incompetence, diabetes, pregnancy-induced hypertension).

Women randomised at 30 weeks - only eligible for study protocol if spontaneous onset of labour, at term, vertex presentation, singleton fetus, without medical or obstetric complications.


InterventionsActive management group: attended special childbirth classes; 1:1 care in separate unit, standard criteria for labour diagnosis, amniotomy within 1 hr of labour diagnosis, cervical assessments every 2 hrs, oxytocin for delayed progress 4 mU per min increasing every 15 mins to a maximum dose of 40 mU unless contraindicated.

Usual care group: payment to attend childbirth education of choice, no protocol, amniotomy unusual.

Fetal monitoring and access to analgesia in both groups.


OutcomesCeasarean section rate, assisted vaginal delivery rates, duration of labour, complications and neonate adverse events.


NotesRandomisation at 30 weeks, therefore large numbers of women became ineligible between randomisation and the onset of labour. Attrition between randomisation and labour was similar (in numbers and reasons) in both study groups.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskRandom numbers in blocks.

Allocation concealment (selection bias)Low riskRandomisation by co-ordinating centre or sealed opaque, sequentially numbered envelopes.

Blinding (performance bias and detection bias)
Women
High riskDifferent intervention packages.

Blinding (performance bias and detection bias)
Clinicians
High riskDifferent intervention packages.

Blinding (performance bias and detection bias)
Outcome assessor
High riskDifferent intervention packages.

Incomplete outcome data (attrition bias)
All outcomes
High riskLarge number of post-randomisation exclusions, outcome data for exclusions were only given for caesarean section but not for the other outcomes. (Attrition rates: less than 1% for the caesarean section outcome, 35% attrition between randomisation and labour, this study has been excluded for these other outcomes)

Selective reporting (reporting bias)Unclear riskOnly main outcome reported for whole randomised sample.

Other biasUnclear riskChange in protocol during study.

Lopez-Zeno 1992

MethodsRCT (permuted block design).


ParticipantsChicago hospital, USA.

Participants: 705 women.

Inclusion criteria: nulliparous women admitted in spontaneous labour = to or > 37 weeks' gestation.

Exclusion criteria: multiple pregnancy, non-cephalic presentation, previous uterine surgery, amniotomy or oxytocin before labour diagnosis.


InterventionsActive management group: amniotomy within 1 hr of labour diagnosis, vaginal examinations hourly for 3 hrs and then every 2 hrs, oxytocin augmentation for delay (cervical dilatation < 1 cm per hr) 6 mU per min increasing by 6 mU per min every 15 mins to maximum of 36 mU unless contraindicated.

Traditional management group: care varied at the discretion of the attending obstetrician, oxytocin augmentation when used at a lower dose than the actively managed group.

Electronic fetal monitoring, cord blood gas analysis at delivery and monitoring of uterine efficiency and pressure in both groups.


OutcomesDystocia and caesarean section rates.


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskPermuted block design, but it was not clear whether block size was random.

Allocation concealment (selection bias)Low riskSequentially numbered, opaque, sealed envelopes.

Blinding (performance bias and detection bias)
Women
High riskDifferent intervention packages.

Blinding (performance bias and detection bias)
Clinicians
High riskDifferent intervention packages.

Blinding (performance bias and detection bias)
Outcome assessor
High riskDifferent intervention packages.

Incomplete outcome data (attrition bias)
All outcomes
Low riskSmall number of post-randomisation exclusions (2% attrition).

Selective reporting (reporting bias)Low riskMain outcomes reported.

Other biasLow risk

Rogers 1997

MethodsRCT.


ParticipantsNew Mexico, USA hospital serving Hispanic, white and native Americans.

Participants: 405 women.

Inclusion criteria: nulliparous women at term who had attended for antenatal care, cephalic presentation, no known medical or obstetric complications or fetal abnormality.

Exclusion criteria: multiple pregnancies, obstetric complications, previous uterine surgery.


InterventionsActive management group: strict diagnosis of labour, amniotomy within two hrs of admission, oxytocin for delay (< 1 cm cervical dilatation in the 1st stage or < 1 cm descent in 2nd stage) 6 mU per min increased by 6 mU every 15 mins to max of 36 mU per min unless contraindicated, vaginal examinations every 2 hrs.

Control group: less strict labour diagnosis and delay, oxytocin at lower doses (1 mU per min increased every 30-40 mins), amniotomy at the discretion of attending clinician.

Continuous fetal monitoring and 1:2 care in both groups.


OutcomesCaesarean section rate and length of labour.


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskComputer-generated list of random numbers.

Allocation concealment (selection bias)Low riskSealed, opaque envelopes.

Blinding (performance bias and detection bias)
Women
High riskDifferent intervention packages.

Blinding (performance bias and detection bias)
Clinicians
High riskDifferent intervention packages.

Blinding (performance bias and detection bias)
Outcome assessor
High riskDifferent intervention packages.

Incomplete outcome data (attrition bias)
All outcomes
Low riskLow numbers of post-randomisation exclusions (less than 1% attrition).

Selective reporting (reporting bias)Low riskNot apparent.

Other biasUnclear risk4-year recruitment period and not clear how many eligible women participated.

Sadler 2000

MethodsRCT.


ParticipantsWomen attending large New Zealand hospital recruited in 3rd trimester.

Participants: 651 women.

Inclusion criteria (to be eligible for protocol): nulliparous women, singleton pregnancy, cephalic presentation in spontaneous labour.

Exclusion criteria: cardiac disease, uterine scar, contracted pelvis, fetal distress on admission.


InterventionsActive management group: amniotomy offered at diagnosis of labour, oxytocin augmentation for delay (< 1 cm cervical dilatation/ hr in 1st stage or absence of descent for 30 mins in 2nd stage or contractions < 1 in 5 mins) 6 mU per min increasing by 6 mU every 15 mins to max of 36 mU per min unless contraindicated

Routine care group: no written guideline, care at the discretion of the attending clinician. Where given, oxytocin at lower dose (1 mU per min doubled every 10 mins to 8 mU per min then increasing by 2 mU to max of 40 mU per minute)

Both groups had 1:1 care and same antenatal care


OutcomesCeasarean section and operative delivery rates, prolonged labour, maternal and neonate complications and maternal satisfaction with care


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

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

Allocation concealment (selection bias)Low riskOpaque sealed envelopes.

Blinding (performance bias and detection bias)
Women
High riskDifferent intervention packages.

Blinding (performance bias and detection bias)
Clinicians
High riskDifferent intervention packages.

Blinding (performance bias and detection bias)
Outcome assessor
High riskDifferent intervention packages.

Incomplete outcome data (attrition bias)
All outcomes
High riskLow levels of attrition for labour outcomes, but for postnatal outcomes (breastfeeding and maternal satisfaction) attrition rates were 28% and attrition was greater in the control group (32%) than in the intervention group (24%).

Selective reporting (reporting bias)Low riskMain outcomes reported.

Other biasUnclear riskNot clear how many women were eligible for the study. Some missing data for some outcomes (e.g. maternal satisfaction questionnaire).

Somprasit 2005

MethodsRCT.


ParticipantsTeaching hospital in Thailand.

Participants: 960 women.

Inclusion criteria: nulliparous women in spontaneous labour with single, term fetus with no evidence of fetal distress. No known medical or surgical complications.

Exclusion criteria: vaginal delivery or oxytocin augmentation contraindicated, diabetes, cervical incompetence or pregnancy-induced hypertension.


InterventionsActive management group: strict criteria for labour diagnosis, amniotomy within 1 hr of admission, 2-hourly vaginal examinations, oxytocin augmentation for delay (< 1 cm cervical dilatation per hr) 6 mU, increasing by 2 mU every 30 mins to max 40 mU per min).

Conventional management group: variable care depending on clinician.

Intermittent fetal auscultation and 1:2 care both groups.

Epidural not available to either group.


OutcomesCaesarean section rate, duration of labour.


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskRandom number tables.

Allocation concealment (selection bias)Low riskNumbered, opaque, sealed envelopes.

Blinding (performance bias and detection bias)
Women
High riskDifferent intervention packages.

Blinding (performance bias and detection bias)
Clinicians
High riskDifferent intervention packages.

Blinding (performance bias and detection bias)
Outcome assessor
High riskDifferent intervention packages.

Incomplete outcome data (attrition bias)
All outcomes
Low riskSome post-randomisation exclusions but analysis by intention to treat (1.5% attrition).

Selective reporting (reporting bias)Low riskReported on main outcomes.

Other biasUnclear riskNo clear description of the management of the comparison group.

Tabowei 2003

MethodsRCT.


ParticipantsDistrict hospital, Nigeria.

Participants: 448 women.

Inclusion criteria: nulliparous women with singleton, cephalic, term pregnancies with no contraindications for vaginal delivery or medical complications.


InterventionsActive management group: antenatal classes to reduce anxiety, diagnosis of labour, 1:1 care in separate area, 2-hourly vaginal examinations, delayed progress (< 1 cm hr in 1st stage or no descent for 1 hr in 2nd stage) led to high-dose oxytocin augmentation (6 mU per min increasing by 6 mU every 15 mins to maximum of 36 mU unless contraindicated).

Usual care group: amniotomy only when indicated, low-dose oxytocin for failure to progress (2 mU per min increasing by 2 mU every 30 mins to maximum of 36 mU).


OutcomesCaesarean section rate.


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

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

Allocation concealment (selection bias)Low riskOpaque sealed envelopes.

Blinding (performance bias and detection bias)
Women
High riskDifferent treatment packages.

Blinding (performance bias and detection bias)
Clinicians
High riskDifferent intervention packages.

Blinding (performance bias and detection bias)
Outcome assessor
High riskDifferent intervention packages.

Incomplete outcome data (attrition bias)
All outcomes
Unclear riskSome post-randomisation exclusions (11.7% attrition).

Selective reporting (reporting bias)Low riskMain outcomes reported.

Other biasUnclear riskNumber of women eligible for recruitment not stated.

 
Characteristics of excluded studies [ordered by study ID]

StudyReason for exclusion

Cohen 1987Study only included women already diagnosed with poor progress in labour.

Hinshaw 1995The intervention was not a package of care. A single intervention was compared between groups.

Hogston 1993Not RCT.

Jyoti 2006Not RCT (alternate allocation).

Lieberman 2000Subgroup analysis not according to random group allocation.

Pattinson 2003The intervention tested was not a package of care during labour. The control and intervention groups differed only in terms of the type of partogram used and frequency of associated vaginal examinations. Neither group had any other component of an active management of labour package such as continuous support during labour, higher dose of oxytocin or early amniotomy.

Peaceman 1993aNot RCT - review of other trials.

Serman 1995Not RCT. Group allocation by patient file number.

Treisser 1981Not RCT - study focusing on dystocia.

Wood 1974Intervention limited to the second stage of labour.

 
Characteristics of studies awaiting assessment [ordered by study ID]
Abo 2001

MethodsThis study is currently being investigated. Methods and findings were very similar to those reported in an included study (Cammu 1996).

Participants

Interventions

Outcomes

Notes

Manpreet 2011

MethodsIt was stated that groups were randomly divided.

Participants200 women in labour.

Interventions"Programmed labour protocol" when women entered the active stage of labour versus a "wait and watch policy".

OutcomesDuration of labour, pain and pain relief scores, side effects and complications.

NotesThis study was reported in a brief abstract and we were unable to assess eligibility as the intervention was not fully described, there was too little information to assess risk of bias, and results were not reported in detail. It was not clear that the intervention met our inclusion criteria. We will re-assess this study if a full trial report is published.

Snehlata, 2011

MethodsIt was stated that women were randomly assigned to groups.

Participants100 women in labour.

Interventions"active management" described as early amniotomy and augmentation with oxytocin versus "conservative care".

OutcomesLength of labour, mode of delivery, mortality and morbidity.

NotesThis study was reported in a brief abstract and we were unable to assess eligibility as the intervention was not fully described and it was not clear that the intervention met our inclusion criteria. In addition, there was too little information to assess risk of bias. We will re-assess this study if a full trial report is published.

 
Comparison 1. Active management versus routine care: caesarean section rate

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

 1 Caesarean section rate - all women75390Risk Ratio (M-H, Fixed, 95% CI)0.88 [0.77, 1.01]

 2 Caesarean section rate (Sensitivity analysis: Frigoletto (1995) study excluded)63475Risk Ratio (M-H, Fixed, 95% CI)0.77 [0.63, 0.94]

 
Comparison 2. Active management versus routine care: maternal satisfaction with care

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

 1 Overall satisfaction with care1468Risk Ratio (M-H, Fixed, 95% CI)1.04 [0.94, 1.15]

 2 Maternal views - would choose this style of care again1466Risk Ratio (M-H, Fixed, 95% CI)1.05 [0.94, 1.18]

 3 Maternal views - mother feels strong sense of achievement1477Risk Ratio (M-H, Fixed, 95% CI)1.07 [0.96, 1.19]

 4 Maternal views - staff always explained enough1468Risk Ratio (M-H, Fixed, 95% CI)1.03 [0.91, 1.17]

 5 Maternal views - pain relief was adequate1455Risk Ratio (M-H, Fixed, 95% CI)1.03 [0.92, 1.15]

 
Comparison 3. Active mangement versus routine care: duration of labour

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

 1 Prolonged labour (> 12 hours)63242Risk Ratio (M-H, Random, 95% CI)0.47 [0.32, 0.69]

 2 Length of labour (admission to delivery)42431Mean Difference (IV, Random, 95% CI)-1.69 [-2.08, -1.31]

 3 Duration of first stage of labour (hours)42431Mean Difference (IV, Random, 95% CI)-1.56 [-2.17, -0.96]

 4 Duration of second stage (hours)52737Mean Difference (IV, Random, 95% CI)-0.02 [-0.06, 0.02]

 
Comparison 4. Active management versus routine care: epidural analgesia

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

 1 Number of women having epidural analgesia42067Risk Ratio (M-H, Fixed, 95% CI)1.06 [0.98, 1.14]

 
Comparison 5. Active management versus routine care: use of analgesia (other than epidural)

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

 1 Use of analgesia (other than epidural)1960Risk Ratio (M-H, Fixed, 95% CI)1.06 [0.84, 1.32]

 
Comparison 6. Active management versus routine care: assisted vaginal deliveries

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

 1 Assisted vaginal delivery rates63475Risk Ratio (M-H, Fixed, 95% CI)0.99 [0.87, 1.14]

 
Comparison 7. Active management versus routine care: neonatal outcome

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

 1 Low APGAR score at 5 minutes52515Risk Ratio (M-H, Fixed, 95% CI)1.12 [0.76, 1.64]

 2 Meconium staining42376Risk Ratio (M-H, Fixed, 95% CI)0.93 [0.70, 1.24]

 3 Admission to special care (various definitions)42067Risk Ratio (M-H, Fixed, 95% CI)0.92 [0.59, 1.43]

 
Comparison 8. Active management versus routine care: maternal complications

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

 1 Maternal infection (various definitions)53169Risk Ratio (M-H, Random, 95% CI)1.14 [0.65, 1.98]

 2 Postpartum haemorrhage (blood loss > 500 ml)31504Risk Ratio (M-H, Fixed, 95% CI)0.93 [0.67, 1.31]

 
Comparison 9. Active management versus routine care: breastfeeding

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

 1 Breastfeeding (various measurement points)2774Risk Ratio (M-H, Random, 95% CI)0.94 [0.84, 1.05]

 
Table 1. Characteristics of Active Management Protocols and Routine Care

StudyRoutine Amniotomy-time from admissionCriteria for diagnosing delay-cm-per-hr cervical dilatationIV-oxytocin-dosageOne-to-one care

Cammu 1996AM- routine within 1 hr of admission

RC-only for arrest or at 2nd stage
AM-hourly vaginal exam. Delay = < 1cm/hr

RC-Delay = < 0.5 cm/hr up to 4 cm, then < 1 cm/hr
AM- 2 mU/min, 4 mU at 20 min, 6 mU 40 min up to 30 mU at 120 min

RC- as above
One-to-one care in both groups

Frigoletto 1995AM- routine within 1hr of admission

RC-variable
AM- Delay = < 1 cm/hr

RC- variable
AM- 4 mU/min increasing by 4 mU every 15 min to max 40 mU/min

RC- 1-2 mU/min increasing every 15 min by 1-2 mU/min
AM- one-to-one care in separate unit

RC- one-to-two care

Lopez-Zeno 1992AM- routine within one hour of admission

RC-variable
AM- hrly vaginal examination for 3 hrs. Delay = < 1 cm/hr

RC-at discretion of clinician, generally 1 cm/hr
AM- 6 mU/min increasing 6 mU every 15min to max of 36 mU/min

RC- 1 mU/min increasing 1 or 2 mU/min every 15 min
Not clear

Rogers 1997AM- routine within 2 hrs admission

RC- not clear
AM- Delay = < 1 cm/hr

RC- Delay = <1.25 cm/hr
AM- 6 mU/min increasing 6 mU every 15min to max of 36 mU/min

RC- 1 mU/min increasing by 1 mU/min every 30-40min
One-to-two care in both groups

Sadler 2000AM- amniotomy offered on diagnosis of labour

RC- variable
AM - 2-hrly vaginal exam. Delay = < 1 cm/hr cervical dilatation

RC- variable
AM- 6 mU/min increasing by 6 mU per min up to max of 36 mU/min

RC- 1 mU/min doubling every 10 min to 8 mU/min then increase of 2 mU/min to 40 mU/min
One-to one care in both groups

Somprasit 2005AM - routine within 1hr admission

RC- variable/not clear
AM- Delay = < 1 cm/hr

RC- variable/ not clear
AM- 6 mU/min increasing by 2 mU/min every 30 min to max of 40 mU/min

RC- variable/not clear
Both groups -aimed for 1:1 but actually 1:2

Tabowei 2003AM - routinely at labour diagnosis

RC- when indicated/ variable
AM - Delay < 1 cm/hrAM- 6 mU/min increasing by 6 mU per min up to max of 36 mU/min

RC- 2 mU/min increasing 2 mU every 30 min to 36 mU
AM - one-to-one in separate ward

RC- not clear

 AM: active management group
cm: centimetre
hr: hour
hrly: hourly
IV: intravenous
max: maximum
min: minutes
mU: milli-unit
RC: routine care group
 
Table 2. Active Management and Routine Care - Interventions in labour

StudyAmniotomy-performed

n (%)
Oxytocin-augmentation n (%)

Cammu 1996AM- 86 (91%)

RC- 56 (57%)*

*In first stage (not clear for later in labour)
AM- 80 (53%)

RC- 41 (27%)

Frigoletto 1995Not clear

AM- 61%

RC - 51%
Not clear

AM- 70%

RC- 56%

Lopez-Zeno 1992Not clearAM- 250 (71.2%)

RC- 234 (66.1%)

Rogers 1997Not clear - spontaneous rupture of membranes:

AM- 28 (14%)

RC- 41 (20%)
AM- 112 (56%)

RC- 105 (51%)

Sadler 2000AM - 231 (72%)

RC- 209 (63%)
AM -168 (53%)

RC -129 (39%)

Somprasit 2005Not clearAM - 178 (55.6%)

RC- 305 (47.7%)

Tabowei 2003AM - 171 (77%)

RC- 114 (50%)
AM - 130 (59%)

RC- 89 (39%)

 AM: active management group
RC: routine care group