Elective caesarean section at 38 weeks versus 39 weeks: neonatal and maternal outcomes in a randomised controlled trial

Glavind, SF Kindberg, N Uldbjerg, M Khalil, AM Mller, BB Mortensen,d OB Rasmussen, JT Christensen, JS Jrgensen, TB Henriksen

Introduction
British and American societies in obstetrics recommend elective caesarean section to be scheduled after 39 completed weeks of gestation. This recommendation is based on a subset of several observational studies suggesting a strong association between earlier gestational age at elective caesarean section delivery and risk of respiratory morbidity that showed a decreasing incidence of the composite outcome with increasing gestational age from 37 to 39 completed weeks of gestation

Introduction
In contrast, any maternal benefit of postponing elective caesarean section to 39 completed weeks has not been shown, but knowledge is sparse when it comes to maternal consequences of elective caesarean section timing. Confounding by indication may impair results from observational studies. In this case, neonates with a higher risk of an adverse outcome may be over-represented in caesarean sections undertaken before 39 weeks for reasons other than the caesarean section per se. This methodological problem would only be solved in a randomised controlled trial.

Objective
The purpose of this study was to investigate whether elective caesarean section before 39 completed weeks of gestation increases the risk of adverse neonatal or maternal outcomes

Methods
Design Randomised controlled multicentre open-label trial. Setting Seven Danish tertiary hospitals from March 2009 to June 2011. Population Women with uncomplicated pregnancies, a single fetus, and a date of delivery estimated by ultrasound scheduled for delivery by elective caesarean section

Methods
Methods Perinatal outcomes after elective caesarean section scheduled at a gestational age of 38 weeks and 3 days versus 39 weeks and 3 days (in both groups 2 days). Main outcome measures The primary outcome was neonatal intensive care unit (NICU) admission within 48 hours of birth. Secondary outcomes were neonatal depression, NICU admission within 7 days, NICU length of stay, neonatal treatment, and maternal surgical or postpartum adverse events.

Result
Among women scheduled for elective caesarean section at 38+3 weeks 88/635 neonates (13.9%) were admitted to the NICU, whereas in the 39+3 weeks group 76/637 neonates (11.9%) were admitted (relative risk [RR] 0.86, 95% confidence interval [95% CI] 0.651.15). Neonatal treatment with continuous oxygen for more than 1 day (RR 0.31; 95% CI 0.100.94) and maternal bleeding of more than 500 ml (RR 0.79; 95% CI 0.630.99) were less frequent in the 39 weeks group, but these findings were insignificant after adjustment for multiple comparisons. The risk of adverse neonatal or maternal outcomes, or a maternal composite outcome (RR 1.1; 95% CI 0.791.53) was similar in the two intervention groups.

Discussion
In this randomised controlled trial including 1274 pregnant women, scheduling elective caesarean section at 39+3 weeks compared with 38+3 weeks did not result in a significant decrease in neonatal admission within 2 days of birth. In addition, no secondary neonatal or maternal outcomes improved significantly with late scheduling

Discussion
Strengths of the study The randomised design The data presented reflect the whole spectrum of consequences of timing of elective caesarean from booking of the procedure to birth of the child The trial population was homogeneous 100% short-term follow-up rate Date validated by ultrasound in 99.8% of the participant

Discussion
Limitations of the study In terms of serious events such as stillbirth, hysterectomy, thrombo embolism, or death, the study was not powered to evaluate the influence of elective caesarean section timing. The outcomes evaluated were all short-term Delivery at 38 weeks may lead to increased healthcare use in early childhood or increased risk of special educational school needs compared with delivery at 39 weeks of gestation, but this association has not been investigated in elective deliveries only

Discussion
Before applying the results to other populations and settings, several factors have to be considered. Overall, the study population had a low body mass index and was very homogeneous, and the study aimed to only include healthy women with no a priori risks related to the neonate. In addition, the eligible non-participating women may have had a lower risk of an adverse neonatal outcome, because they were probably booked closer to their due date (more breech presentations) and fewer women were to have repeat procedures

Discussion
The NICU admission rate was quite high compared with those of other studies. This may be a consequence of all neonatal admissions being included, whereas studies conducted in facilities with differentiated levels of neonatal care may have excluded neonatal admissions that were not to the NICU. In terms of maternal morbidity, the most interesting aspect before the trial was whether more women with spontaneous onset of labour in the late ECS group would result in an increase in the number of women with infection or intraoperative complications because of the urgency of the procedure

Conclusion
This study found no significant reduction in neonatal admission rate after ECS scheduled at 39 weeks compared with 38 weeks of gestation

Critical Appraisal

POPULATION

4048 women with uncomplicated pregnancies, a single fetus, and a date of delivery estimated by ultrasound scheduled for delivery by elective caesarean section

INTERVENTION

No intervention

COMPARISON

Group of women with elective CS at 38+3 weeks vs women with elective CS at 39+3 weeks

OUTCOME

NICU admission within 48 hours of birth, neonatal depression, NICU admission within 7 days, NICU length of stay, neonatal treatment, and maternal surgical or postpartum adverse events

Are the aims clearly stated?

Yes. To investigate whether elective caesarean section before 39 completed weeks of gestation increases the risk of adverse neonatal or maternal outcomes

Were the basic data adequately described?

Data used in this study was women with uncomplicated pregnancies, a single fetus, and a date of delivery estimated by ultrasound scheduled for delivery by elective caesarean section in Seven Danish tertiary hospitals from March 2009 to June 2011.

Was the sample size justified?

Yes. From 4048 pregnant women who planned for CS, 1380 excluded for not met study criteria, 1394 who met study criteria excluded for reason stated in flowchart. Total 1274 women randomised to two study groups.

Was the statistical significance assessed?

Yes, the value 95% CI which passed 1 were considered to indicate statistical significance

Are the statistical methods described?

In the outcome analyses, relative risks and absolute risk differences with 95% confidence intervals (95% CI) were calculated for dichotomous outcomes using Fishers exact test. Non-Gaussian continuous variables were compared using the Wilcoxon rank-sum test, and birthweight was compared using Students t test. For the primary outcome and the maternal composite outcome a potential centre effect was evaluated by testing the hypothesis of no treatment by centre interaction in a multiple logistic regression model. Adjustment for multiple comparisons (Bonferroni) was made in evaluating the secondary outcomes

Where are the biases?

This study used homogenous sample, all the characteristics variable not significantly differ between two group. It also used strict sample selection, almost perfect follow-up and standardized measurement. Hence, lack of bias found here.

Did untoward events occur during the study?

One stillbirth found in each group during the follow-up, but they were excluded to further analyses

How do the results compare with previous reports?

Rosenstein et al found a similar risk of fetal and neonatal death associated with delivery and expectant management at 38 weeks, whereas at 39 weeks, delivery carried a lower risk of neonatal death than expectant management. Comparing the incidence of a composite adverse neonatal outcome after caesarean delivery at 38 and 39 weeks of gestation, Tita et al found an odds ratio of 0.67 and Wilmink et al found an odds ratio of 0.71 in favour of delivery at 39 weeks of gestation, which are both estimates that lie within our calculated 95% CI of 0.651.15.

What implications does the study have for your practice?

Study results could suggest that scheduling elective caesarean section after the prevailing cut-off at 39+0 weeks of gestation may have less impact on short-term neonatal morbidity than previously anticipated. In the mothers, timing of elective caesarean section at 38 or 39 weeks seems to carry a similar risk of adverse events. Accordingly, scheduling of elective caesarean section 35 days before 39+0 completed weeks may be an acceptable option in women in whom an acute caesarean section delivery should be avoided. Scheduling after 39 completed weeks may continue to be the best option

Thank You