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?