receive oxytocin. Compliance by staff was poor in the aggressive management group. Conclusions Aggressive management of labour reduces the caesarean ...
BJOG: an International Journal of Obstetrics and Gynaecology May 2003, Vol. 110, pp. 457 – 461
Aggressive or expectant management of labour: a randomised clinical trial R.C. Pattinsona,*, G.R. Howarthb, W. Mdlulib, A.P. Macdonaldc, J.D. Makind, M. Funke Objective To compare labour outcomes using aggressive or expectant management protocols. Design Randomised trial. Setting Pretoria Academic Complex, South Africa. It serves an indigent urban population. Population Healthy nulliparous women in active labour, at term, with a health singleton pregnancy and cephalic presentation. Methods The women were randomised to either aggressive (n ¼ 344) or expectant (n ¼ 350) management protocols. Aggressive management entailed using a single line partogram, a vaginal examination every two hours and use of an oxytocin infusion if the line was crossed. Expectant management entailed using a two line partogram, with the alert line and a parallel action line four hours to the right, with a vaginal examination every four hours. If the action line was reached, oxytocin was started. The women were reassessed every two hours thereafter. Analgesia was prescribed on request. Main outcome measures Mode of birth, use of oxytocin and analgesia and neonatal outcome. Results The groups were similar with respect to maternal age, cervical dilation at trial entry, number crossing the alert line and birthweight of the infants. Significantly fewer women managed aggressively had caesarean sections (16.0%) than those managed expectantly (23.4%) (relative risk [RR] 0.68, 95% confidence intervals [CI] 0.50, 0.93). Significantly more oxytocin was used in the aggressive management group, but there was no difference with respect to the use of analgesia or episiotomy or in neonatal outcome with respect to the Apgar score at 1 or 10 minutes. There were three perinatal deaths. One woman was found to have an intrauterine death before trial entry and the other two were in the aggressive management group but did not receive oxytocin. Compliance by staff was poor in the aggressive management group. Conclusions Aggressive management of labour reduces the caesarean section rate in nulliparous women but requires more intensive nursing.
INTRODUCTION The World Health Organisation (WHO) has published a series of monographs on the use of the partogram to prevent prolonged labour1. In these monographs, they recommend
a
MRC Maternal and Infant Health Strategies Research Unit, Department of Obstetrics and Gynaecology, Kalafong Hospital and University of Pretoria, South Africa b Department of Obstetrics and Gynaecology, Kalafong Hospital and University of Pretoria, South Africa c Department of Obstetrics and Gynaecology, Pretoria Academic Hospital and University of Pretoria, South Africa d Department of Obstetrics and Gynaecology, University of Pretoria, South Africa e Department of Paediatrics, Kalafong Hospital and University of Pretoria, South Africa * Correspondence: Professor R. C. Pattinson, MRC Maternal and Infant Health Care Strategies Research Unit, Department of Obstetrics and Gynaecology, Kalafong Hospital, Private Bag X396, Pretoria 0001, South Africa. D RCOG 2003 BJOG: an International Journal of Obstetrics and Gynaecology doi:10.1016/S1470-0328(03)02998-7
the use of oxytocin only after reaching an action line on the partogram. They published a randomised controlled trial using this protocol and compared it to not using a partogram and protocol. Use of a partogram significantly reduced the operative delivery rate, time in labour and neonatal mortality and morbidity2. Use of a partogram is not new, having been introduced by Philpott and Castle3 in 1972, in Harare. However, the protocol described for the use of a partogram in the WHO study differs markedly from accepted practice for the use of a partogram4. The generally accepted practice has been for immediate use of oxytocin once an alert line on the partogram has been crossed, after excluding cephalopelvic disproportion and ensuring fetal wellbeing. The alert line represents the mean progression of labour for the slowest 20% of primigravidas3. The action line is drawn parallel to, but four hours later than, the alert line. Hence, the WHO recommendation for the management of prolonged labour is expectant, whereas our generally accepted practice is aggressive. Dujardin et al.5 have shown there is a significant increase in the need for neonatal resuscitation once the alert line is crossed and a significant increase in perinatal mortality if the action line is crossed. www.bjog-elsevier.com
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Thornton and Lilford6 using meta-analysis have shown that there is no convincing evidence that the early use of oxytocin in slow progress of labour confers any advantage to the mother or baby. Hence, there is considerable doubt as to which protocol is best for management of labour. To resolve this dilemma, a randomised trial was conducted on nulliparous women in labour to compare a policy of aggressive management with expectant management as recommended by the WHO.
METHOD A randomised multicentre clinical trial was undertaken in the Pretoria Academic Complex. This complex comprises two Pretoria hospitals, Pretoria Academic Hospital and Kalafong Hospital, in South Africa. The complex serves a mainly indigent black urban population. Both hospitals receive referrals from other areas and function as both secondary and tertiary institutions. At the complex, the protocol used for managing labour has traditionally been left to the discretion of the consultant on call. There was a general mix of aspects of the active management of labour of O’Driscoll and Meagher4 and the WHO protocol1. Two more large secondary hospitals from the area also agreed to participate in the study, but unfortunately did not randomise any patients. Nulliparous women in the active phase of labour without exclusion criteria were invited to participate in the trial. The active phase of labour was identified when contractions were regular and painful, and the cervix was four or more centimetres dilated. Exclusion criteria were obstructed labour, fetal distress on admission, severe maternal disease (e.g. pre-eclampsia, breech or abnormal lie), a cervix of more than 8 cm dilated and a gestational age of less than 36 weeks or an estimated fetal weight of less than 2.5 kg where gestational age was uncertain. The midwives or doctors working in the labour ward of a collaborating centre were responsible for recruitment and consent. The protocol used was determined by taking the next sealed opaque study envelope from a box in the labour ward. Each envelope contained the detailed protocol and assigned partogram. Batches of 50 envelopes were sent to each site. Randomisation was based on a computergenerated list of random numbers. The aggressive management protocol used a partogram with a single alert line. The cervical dilatation was plotted on the alert line and a repeat vaginal examination was performed after two hours. If cervical dilation had progressed on or to the left (above) the alert line, the cervix was re-evaluated in two to four hours depending upon when full cervical dilation was anticipated. If cervical dilation had moved to the right of the alert line, the managing clinician was asked to confirm fetal wellbeing and exclude gross cephalopelvic disproportion. As long as neither condition was present, the clinician started an oxytocin
infusion according to the standard labour ward protocol to ensure adequate contractions. Initially, the protocol requested that intact membranes be ruptured at this stage. However, shortly after the study started, the association of ruptured membranes and vertical transmission of HIV became apparent and an amendment to the protocol was introduced whereby there was to be no artificial rupture of membranes in any labour. (During the study, the estimated prevalence of HIV infected women at the complex was 20%.) Reassessment was to occur after two hours. If obstructed labour or fetal distress was diagnosed, a caesarean section was performed. If progress was good, the woman was reassessed every two hours until delivery. Analgesia was prescribed according to request. The expectant management protocol used a two line partogram with an alert line and a parallel action line drawn four hours later. On entry into the trial, the cervix was plotted on the alert line of the partogram and the next vaginal examination was performed four hours later. If cervical dilation had progressed along or to the left (above) the alert line, the cervix was re-evaluated two to four hours later depending on cervical dilation and when full dilation was anticipated. If cervical dilation moved to the right of the alert line, the next vaginal examination was planned for when it was anticipated that the action line would be crossed. Once the action line was reached or crossed, the managing clinician confirmed fetal wellbeing, excluded gross cephalopelvic disproportion and started an oxytocin infusion according to the standard labour ward protocol to ensure adequate contractions. The cervix was reassessed after two hours. If obstructed labour or fetal distress was diagnosed, a caesarean section was performed. Analgesia was prescribed according to the request. The standard labour ward protocol for augmentation of labour using oxytocin was to start by giving 1 mU (milliunit) oxytocin per minute and increasing by 1 mU oxytocin per minute every 30 minutes until there were three contractions lasting at least 40 seconds every 10 minutes. From 4 mU oxytocin, the rate of oxytocin administration was increased by 2 mU oxytocin per minute every 30 minutes. The maximum dose was 10 mU oxytocin per minute. When five or more contractions occurred in 10 minutes, the dose was decreased to the previous setting. Neither hospital in the complex was able to offer an epidural service and the analgesia given was a combination of pethidine and hydroxycine. The attending physician made the diagnosis of cephalopelvic disproportion when there were three pluses of moulding of the fetal skull and poor cervical dilation. Where there were no signs of severe moulding, the indication for caesarean section was recorded as poor progress. The diagnosis of fetal distress was made when recurrent late decelerations on continuous electronic fetal heart rate monitoring was present. The end points for the study were the mode of delivery, the use of oxytocin, use of analgesia, the Apgar score at 1 D RCOG 2003 Br J Obstet Gynaecol 110, pp. 457 – 461
AGGRESSIVE OR EXPECTANT MANAGEMENT OF LABOUR Table 1. A comparison of the demographic data between the aggressive and expectant management groups. Values are given as n (%) and mean [SD].
Number Maternal age (years) Cervical dilation on entry (cm) Rupture of membranes before entry Birthweight (g) Number crossing the alert line
Aggressive
Expectant
344 21.9 [4.0] 4.6 [1.1] 220 (64.4) 3069 [440] 165 (48.0)
350 21.7 [3.4] 4.6 [1.1] 206 (58.6) 3080 [416] 174 (49.7)
and 10 minutes and the number of neonates developing morbidity or mortality. The 1-minute Apgar score was chosen to represent the need for resuscitation and the 10-minute score as the best indicator of long term outcome. The key end points for the study were the number of women requiring operative delivery (vaginally or abdominally) and neonatal morbidity or mortality. We felt that to be clinically important, there should be at least a 30% difference in operative delivery rates or in the need for neonatal resuscitation. At the time of drafting the protocol, the rate of operative births for nulliparous women at Kalafong Hospital was 16%. Thus, the sample size required to show a 30% difference in operative birth rate with a power of 80% and error risk of 0.05 was 725 women in each limb. It was estimated that 30 nulliparous women who would qualify for the study would deliver at the complex per month, thus it was estimated that the trial would take about five years to complete. More hospitals were sought to make the study feasible in a shorter period. Two secondary hospitals fairly close by were recruited. Both conducted more than 5000 births per year. The study was anticipated to take three years and funding was obtained for that period. Informed written consent was obtained from each woman in the labour ward before entry to the study as the majority of women attend antenatal care at peripheral
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clinics. The Ethics Committee of the Faculty of Medicine at the University of Pretoria approved the study.
RESULTS A total of 696 nulliparous women were recruited and randomised to the study, 344 women in the aggressive management group and 352 in the expectant management group. The discrepancy arose as the study was stopped before the required sample size had been reached. This was because of slow recruitment and limitation of funding. As no women were recruited at the two other sites invited to join the study, all women were recruited from the Pretoria Academic Complex. There were 20 protocol violations. Sixteen protocol violations were in the aggressive management group: nine because fetal weight estimation was less than 2.5 kg, four because the women had pre-eclampsia, one because a breech was diagnosed in labour, one because she was a multiparous woman and one because an intrauterine death was found on admission to the labour ward. Four were in the expectant management group: two because fetal weight estimation was less than 2.5 kg and two because the women had pre-eclampsia. There was no information recorded in the last two women and they were excluded from the study. All other women were included and the data were analysed by intention-to-treat. The randomisation gave two very similar groups (Table 1). Surprisingly, almost half of the women in each group had labour progress in which cervical dilatation crossed the alert line. Membranes ruptured after randomisation in 124 and 144 women in the aggressive and expectant management groups, respectively. Of these, 19 (15.3%) were artificially ruptured in the aggressive management group and 29 (20.1%) in the expectant management group. The main outcome measures are shown in Table 2. Significantly fewer women in the aggressive management
Table 2. A comparison of the main outcome measures between the aggressive and expectant management groups. Values are given as n (%) and RR [95% CL]. Outcome
Aggressive (n ¼ 344)
Caesarean sections Operative deliveries Oxytocin use Received analgesia
55 70 77 257
Neonatal outcome Apgar at 1 minute 0–3 4–7 8–9 Apgar at 10 minutes
