JOURNAL CLUB 7-6-13
Mimosa Bruinooge, resident OBGYN
Introduction
• NICE / ACOG: electieve CS at GA>39 weeks
– Observational studies: early elective cs:
increased risk respiratory morbidity
– 2 cohort studies (2009/2010): earlier CS,
worse neonatal outcome (GA 37-39 wks)
– No influence maternal outcome
Introduction
• However: possible confounding by indication
• Outcomes for women with unscheduled
procedures who intended tot deliver by SC
should be in analyses.
• Therefore: RCT of neonatal and maternal
morbidity after elective SC at GA 38+3 vs
39+3.
Methods
• Multicentre, open label RCT in 7 Danish
ziekenhuizen met NICU
• Randomisatie 1:1
– Group GA 38+3 (+/- 2 d)
• preference: 38+3>38+2>38+4>38+5>38+1
– Group GA 39+3 (+/- 2d)
• preference: 39+3>39+4>39+2>39+1>39+5
Methods
• Data evaluation:
– Neonatal: 30 days pp or at dischargeNICU
(admission >30d)
– Maternal: 30 days pp
Methods
• Inclusion: singleton, GA determined through
early ultrasound (<15wks), indication for
elective caesarean.
• Exclusion: multiple gestations, age <18jr,
language difficulties, estimated risk sc has to
be undertaken <39 weeks(eg placenta previa,
PE, DM, fetal problem)
Methods
• Study outcomes
– Primary: admission NICU within 48hr
– Secondary (neonatal): admission NICU < 7dgn,
duration NICU admission, type and duration
treatment (e.g.ventilation, antibiotics etc), Apgar
score, umbilical cord pH
– Secondary (maternal): all complications
uterusrupture/dehiscence, blood transfusion,
vaginal delivery
Results
Median difference: 6d
Results
• 1097 (571/ 526) elective sc according plan
• 156 (59 / 97) onscheduled sc
– 49 (7.7%) vs 82 (12.9) spontaneous onset delivery
• 21 vaginal deliveries (5 /16) as result of
imminent delivery or spontaneous version to
cephalic presention
• 1 neonate died of congenital pulmonary
lymphangiectasia (39wks group, data
included in itt analysis)
• 2 IUFD (one in each group): vaginal delivery,
data not included in analysis
Results
• Per protocol analysis with exclusion 117 noncompliant and 4 not eligible
– Primary outcome: RR 0.90 (95% CI 0.671.21)
• Exclusion vaginal deliveries:
– RR 0.92 (95% CI 0.68 – 1.23)
Summary
•
•
•
•
•
RCT
1274 women
elective sc at GA 38+3 vs GA 39+3
No significant difference NICU admission
No significant difference secondary neonatal
and maternal outcomes
Discussion
• Insufficient power to evaluate serious events
such as IUFD, hysterectomy, tromboembolism
and death
• All short term follow-up
• Homogenous group: lean, healthy women with
a great a priori chance of a healthy baby
• Relative high incidence NICU admission, partly
explaned by prematurity or complication of
pregnancy. ITT analyse
Implications for daily practice
• Advise authors: elective sc at GA> 39 wks, but
3-5 days earlier is acceptable when an acute
situation needs to be prevented
• Corticosteroids?
Critical appraisal
A. Applicable for my patients: yes
B Validity
1. Radomisation?
Yes
2. Method of randomisation:
Computer generated
3. Secrecy before randomisation?
No, not possible
4 Comparable groups
Yes
5 Follow-up of all patients?
Yes
6. Are all radomised patients analysed in their original group? Yes
7 Is the study blinded?
Not possible
8. Are the groups, with exception of intervention, treated simularly? Yes
Critical appraisal
C. Results
Expressed in RR with CI and p-value
Wide CI
D. What is your advise to the patient?
No change in current policy
Questions #BlueJC
• Is the question relevant for daily practice? We already know
timing at 39 weeks is preferable, but in some cases we have to
weight pro's and contra's for earlier delivery, eg bleeding placenta
previa. What does this article add?
• Timing of randomisation. Now at 11 days before estimated due
date, why not at the moment when it was decided there was an
indication for sc? As in daily practise?
• Results. You can see the differences are all in favour of the 39
weeks group, even thought the difference is not statistically
significant. What does this mean? There is no difference or the
study is underpowered?
• Primary outcome: NICU admission. It seems to be a subjective
outcome, dependent on where the baby is born and who is on
call. Could you have thought of a more independent outcome?
• Should we rely on the results of this study because it is a RCT, or
on the cohort studies mentioned in the introduction with a much
larger number of patients included?