Obstetrics & Gynecology:
Expectant Management Compared With Elective Delivery at 37 Weeks for Gastroschisis
Baud, David MD, PhD; Lausman, Andrea MD; Alfaraj, Malikah A. MBBS; Seaward, Gareth MB, BCh; Kingdom, John MD; Windrim, Rory MB; Langer, Jacob C. MD; Kelly, Edmond N. MB; Ryan, Greg MB
Fetal Medicine Unit and the Department of Paediatrics, Mount Sinai Hospital, the Department of Paediatric Surgery, Hospital for Sick Children, and the University of Toronto, Toronto, Ontario, Canada.
Corresponding author: Greg Ryan, Fetal Medicine Unit, Mount Sinai Hospital, 600 University Avenue, Toronto ON, M5G 1X5, Canada; e-mail: email@example.com.
Financial Disclosure Dr. Baud was supported by the Société Académique Vaudoise through the Paul Blanc grant, the SICPA Foundation, an Air Canada Travel Grant, and the Rotary International Foundation. The other authors did not report any potential conflicts of interest.
Presented at the 11th World Congress in Fetal Medicine, June 24–28, 2012, Kos, Greece, and at the 22nd World Congress on Ultrasound in Obstetrics and Gynecology, International Society of Ultrasound in Obstetrics and Gynecology (ISUOG), September 9–12, 2012, Copenhagen, Denmark.
The authors thank Olena Berezovska for computer assistance.
OBJECTIVE: To estimate obstetric and neonatal outcomes after induction of labor at 37 weeks of gestation compared with expectant management in pregnancies complicated by fetal gastroschisis.
METHODS: The management of 296 pregnancies involving fetal gastroschisis (1980–2011) was reviewed from a single perinatal center. Ultrasound surveillance and nonstress testing were performed every 2 weeks from 30 weeks of gestation, weekly from 34 weeks of gestation, and twice weekly after 35 weeks of gestation until delivery. Labor was induced if fetal well-being testing was abnormal and, since 1994, labor was routinely induced at 37 weeks of gestation.
RESULTS: Of 153 pregnancies reaching 37 weeks of gestation, labor was induced in 77 (26%) and 76 (25.7%) were allowed to labor spontaneously. There were no significant differences in mean maternal age (22 years in both), parity (56% compared with 66% nulliparous), presence of other fetal anomalies (12% compared with 9%), cesarean delivery rate (20% in both), 5-minute Apgar score less than 7 (10% compared with 12%), meconium at birth (36% compared with 49%), or respiratory distress syndrome (16% compared with 7%) between the induced and expectantly managed groups. However, neonatal sepsis (25% compared with 42%; P=.02) and a composite outcome of neonatal death and bowel damage (necrosis, atresia, perforation, adhesion; 8% compared with 21%; P=.02) were more common in expectantly managed pregnancies. Moreover, time to oral feeds (-3.4 days), time on total parenteral nutrition (-6.2 days), and hospital stay (-6.7 days) were reduced when labor was induced.
CONCLUSION: In fetuses with gastroschisis, induction of labor at 37 weeks of gestation was associated with reduced risks of sepsis, bowel damage, and neonatal death compared with pregnancies managed expectantly beyond 37 weeks of gestation.
LEVEL OF EVIDENCE: II
Gastroschisis is an abdominal wall defect associated with herniation of the gut and sometimes other organs.1,2 The incidence is increasing worldwide, now reaching 1 in 4,000 live births.3 Gastroschisis tends to occur in younger women and is associated with a higher incidence of spontaneous preterm labor and delivery and low-birth-weight newborns.4 Currently, the majority of cases of gastroschisis are diagnosed prenatally, but this condition still has a significant risk of perinatal mortality and morbidity.5–7 Mortality ranges between 8% and 10%, whereas morbidity is strongly influenced by the presence of bowel pathology at birth (atresia, necrosis, perforation, or volvulus5). The latter may lead to a prolonged neonatal intensive care unit stay, long-term need for total parenteral nutrition (TPN), multiple surgical interventions, and neonatal complications including sepsis, necrotizing enterocolitis, and short bowel syndrome.
Although advances in neonatal care over recent decades have contributed to an improvement in the overall prognosis for gastroschisis, timing of delivery remains controversial.8–21 Evidence suggests that prolonged amniotic fluid exposure may damage the fetal intestine.22,23 Inflammatory changes in the bowel tend to occur relatively late in pregnancy and may be attributable to pH changes or increased levels of meconium, urine, or both in the amniotic fluid.22,23 Several studies have suggested the possibility of reducing intestinal damage by either amnioexchange during the third trimester24 or early delivery. Some studies have suggested a benefit to limiting the period of intrauterine bowel exposure to amniotic fluid by early delivery,9,13–15,19 whereas others have failed to show any advantage from such a policy.8,10,11,16–18,20,25–28
In view of reports suggesting an increased risk of stillbirth close to term in fetuses with gastroschisis,6,7,29,30 our center changed its policy in 1994 to recommend elective induction of labor at 37 weeks of gestation. The aim of this study was to compare obstetric and neonatal outcomes in pregnancies electively delivered at 37 weeks of gestation with those managed expectantly.
MATERIALS AND METHODS
A review was conducted of all cases (n=296) of gastroschisis that were evaluated prenatally at Mount Sinai Hospital, Toronto, or those treated postnatally at the Hospital for Sick Children, Toronto, from 1980 to 2011. Those with incomplete prenatal or postnatal records were excluded from analysis (n=35, 11.8%). Approval for this study was obtained from the Institutional Review Boards at both hospitals (REB numbers MSH 11-0102-C and HSC-0020010238) to review the maternal, fetal, delivery, neonatal, pediatric surgical, and postoperative recovery details.
Ultrasound surveillance by biophysical profile scoring and nonstress testing were performed every 2 weeks from 30 weeks of gestation, weekly from 34 weeks of gestation, and twice weekly after 35 weeks of gestation until delivery. Delivery was undertaken if fetal welfare testing was abnormal. Before 1994, uneventful cases were followed-up until labor occurred spontaneously. From 1994, a policy of routine induction of labor at 37 weeks of gestation was instituted.
Pregnancies that were expectantly managed were compared with those in which labor was induced at 37 weeks of gestation. To eliminate potential bias related to patients who labored spontaneously and delivered before 37 weeks of gestation, and who were therefore irrelevant to a decision to induce or not to induce labor, only pregnancies delivered at 37 weeks of gestation or later were included in the comparison. Groups were compared for maternal age, parity, birth weight, presence of other fetal anomalies, intrauterine fetal death, mode of delivery, cesarean delivery rate and indications, presence or absence of meconium-stained amniotic fluid, Apgar score at 5 minutes, respiratory distress syndrome at birth, rate of primary abdominal wall closure, presence of bowel atresia or necrosis, neonatal death, neonatal sepsis, time to full enteral feeding, length of time on TPN, and length of hospital stay.
To estimate obstetric risks related to induction of labor in pregnancies with fetal gastroschisis, the cesarean delivery rate was compared between patients induced at 37 weeks of gestation for gastroschisis and 1,068 patients induced at 37 weeks of gestation for other maternal or fetal reasons during the same study period (1994 and beyond).
Possible changes in neonatal care over the 31-year study period were assessed by comparing the neonatal variables outlined between pregnancies spontaneously delivered at less than 37 weeks of gestation before and after 1994. Categorical variables were compared by the Pearson χ2 (or the Fisher exact test when indicated). For continuous variables, medians were compared by the Wilcoxon-Mann-Whitney test. P<.05 was considered statistically significant. Logistic regression was used for multivariable analyses and adjustment for covariables. Statistical analyses were performed using STATA-11.
Among the 296 women in the case group, 35 (11.8%) were excluded because of incomplete data, 53 (17.9%) delivered at less than 37 weeks of gestation (including 32 who labored spontaneously and 21 delivered for maternal or fetal indications), 27 (9.1%) had an elective cesarean delivery at more than 37 weeks of gestation, and 28 (9.5%) with labor induced for reasons other than gastroschisis or for evidence of fetal distress at 38–41 weeks of gestation. Of 153 remaining women, labor was induced at 37 weeks of gestation (per protocol) in 77 (26%), and these were compared with 76 (25.7%) who were allowed to labor spontaneously (Fig. 1). Figure 2 shows the rate of neonatal death by gestational age. In the population studied and in our experience, it is extremely rare that termination of pregnancy is requested for fetal gastroschisis.
Table 1 shows maternal, obstetric, and neonatal characteristics comparing the group managed expectantly after 37 weeks of gestation and the group induced at 37 weeks of gestation. Maternal age, parity, birth weight, presence of other anomalies, and rate of primary closure of the defect were similar between both groups. Induction of labor did not have a significant effect on obstetric or neonatal outcomes. Similar results were obtained when the group induced at 37 weeks of gestation was compared with all deliveries that occurred after 37 weeks of gestation. Moreover, the cesarean delivery rate when labor was induced for gastroschisis (15 of 77, 19.5%) was similar to that when labor was induced for other feto-maternal indications at 37 weeks of gestation (214 of 1,068, 20%; P>.99) during the same study period.
Three (4%) compared with two (2.6%) neonatal deaths occurred in the expectantly managed group compared with the induced group (Table 2). There was significantly more bowel damage, defined as presence of atresia, stricture, perforation, or necrosis at birth in the expectantly managed group (18.4% compared with 7.8%; P=.05). Because severe bowel damage may lead to neonatal death, we created a composite outcome with both variables. Neonatal death, bowel damage, or both were significantly more common in expectantly managed pregnancies compared with those with labor induced at 37 weeks of gestation. When patients induced at 37 weeks of gestation were compared with all those who delivered after 37 weeks of gestation, the differences in neonatal death, bowel damage, and sepsis all were confirmed (Table 2, last column).
Neonatal sepsis was less frequent when labor was induced compared with expectantly managed (24.7% compared with 42.1%, P=.02; crude relative risk 0.58, 95% confidence interval 0.36--0.93). Because sepsis in the expectant group could be related to intrauterine bowel damage, we adjusted for this and the effect remained (adjusted relative risk 0.62, 95% confidence interval 0.38--0.99). After induction of labor at 37 weeks of gestation (Table 3), time to oral feeding, length of time on TPN, and duration of hospital stay were shorter by 3.4 days, 6.2 days, and 6.7 days, respectively, when compared with expectant management, but these differences did not reach statistical significance. However, length of time on TPN was significantly shorter for patients induced at 37 weeks of gestation compared with those who delivered after 37 weeks of gestation (P=.04), and time to oral feeding and hospital stay were almost significant when these two groups were compared.
When a subset of patients who delivered spontaneously at 37 weeks of gestation or less (n=79) was analyzed, there were no significant differences in neonatal death (9% compared with 6%; P=.68), time to oral feeding (32.2 compared with 34.7 days; P=.72), or hospital stay (57.5 compared with 56.2 days; P=.91) before and after 1994. When the total 261 gastroschisis pregnancies were considered, Apgar score less than 7 at 5 minutes (17.5% compared with 14%; P=.480), respiratory distress syndrome (13.7% compared with 17%; P=.578), and cesarean delivery rate (24.7% compared with 28%; P=.665) were similar before and after 1994, showing no significant change in obstetric management and outcomes during the two study periods. Moreover, the mean duration of hospital stay (46.7 compared with 48.2 days; P=.781) also was similar before and after 1994, showing that any changes in neonatal management over the long study period were unlikely to detract significantly from the reliability of the findings.
Among the 261 patients in this study, 191 (73.2%) delivered vaginally and 70 (26.8%) had cesarean delivery. Maternal age (22.4 years compared with 22.7 years; P=.631), nulliparity (78% compared with 83%; P=.395), intrauterine growth restriction (less than 10th percentile; 33% compared with 30%; P=.656), presence of other anomalies (10% compared with 13%; P=.657), and rate of primary closure of the defect (82% compared with 73%; P=.118) were similar between patients delivered vaginally or by cesarean. Apgar score less than 7 at 5 minutes of life was more frequent after cesarean than vaginal delivery (26% compared with 12%; P=.007). There was no significant difference in terms of neonatal death (4% compared with 7%; P=.357), bowel damage (16%; both P>.99), sepsis (27% compared with 34%; P=.284), and the composite outcome of neonatal death and bowel damage (18% compared with 20%; P=.858) between neonates delivered vaginally or by cesarean. Moreover, time to oral feeds (28.7 days compared with 30.5 days; P=.664), length of time on TPN (39.4 days compared with 41.6 days; P=.652), and hospital stay (46.7 days compared with 50.3 days; P=.551) were similar for neonates delivered vaginally or by cesarean.
Table 4 shows time to oral feeding, length of time on TPN, and duration of hospital stay among 19 other studies of timing of delivery in pregnancies with gastroschisis. Seven studies showed some benefit to induction of labor, whereas 12 failed to show any advantage associated with early delivery.
Table 4-a Review of ...Image Tools
Table 4-b Review of ...Image Tools
Studies have reported an increased stillbirth rate after 37 weeks of gestation in fetuses with gastroschisis, which has prompted many perinatal centers to implement a program of increased fetal surveillance in later pregnancy.6,7,31 Animal and human studies also have described inflammatory changes in the bowel of fetuses with gastroschisis, suggesting that such changes are attributable to prolonged bowel exposure to amniotic fluid, especially in later pregnancy.22,23 Elective delivery by induction thus has been proposed to minimize this harmful exposure of the bowel to amniotic fluid; however, this management remains controversial.1,5 Our data suggest that a policy of elective induction of labor at 37 weeks of gestation is reasonable because, in our experience, it reduced the risk of neonatal sepsis, bowel damage, and neonatal death. In addition, elective delivery decreased the median time to oral feeding, length of time on TPN, and duration of hospital stay, although significance was not reached. These improved neonatal outcomes were not at the expense of increased obstetric intervention because the rate of cesarean was similar between the two treatment groups. Similar to other findings,32–34 cesarean delivery was not found to be associated with better neonatal survival of newborns with gastroschisis.
Those who oppose early elective delivery usually argue that this strategy can result in increased prematurity-related complications, such as respiratory distress syndrome. We observed no significant difference for this complication between the two groups, perhaps because induction was not electively performed before 37 weeks of gestation. Similar results were observed in the HYPITAT study, in which adverse neonatal outcomes were similar in women induced at 37 weeks of gestation and those managed expectantly for mild preeclampsia.35 In the DIGITAT study, there were no differences in adverse obstetric or neonatal outcomes after induction of labor compared with expectant monitoring in women with suspected intrauterine growth restriction at term.29 An increased risk of stillbirth has been reported in fetuses with gastroschisis,6,7,30,36 which supports the rationale for elective (relatively) preterm delivery. Unlike previous reports,29 we did not observe a single intrauterine fetal death among 261 cases of gastroschisis, although this may be related to our policy of increased surveillance of fetal well-being in the majority of pregnancies in this study.
There are conflicting recommendations in the literature concerning timing of delivery in pregnancies with gastroschisis. Part of this may be attributable to the variability in the definition of “early delivery” in different studies, ranging from 33 weeks to 38 weeks of gestation. Moreover, many studies mixed vaginal, elective, and emergency cesarean deliveries in the same report. We have identified 19 other studies that examined the timing of delivery for Gastroschisis. Seven showed some benefit to induction of labor (possibly explained by limiting the period of bowel exposure to amniotic fluid),9,13–15,19,37 whereas 12 failed to show any advantage associated with early delivery8,10,11,16–18,20,25–28 (Table 4). To our knowledge, only one randomized controlled trial18 (RCT) and one prospective study19 have investigated the effect of timing of delivery on neonatal outcome. All other reports were retrospective and observational, and only one of which27 included more than 100 patients. Two studies, including the RCT, did not support a policy of early delivery, although there was a trend toward a shorter neonatal hospital stay and a shorter length of time on TPN.17,18 Of note, the RCT18 included seven emergency cesarean deliveries for fetal distress in the elective preterm group, thus minimizing any benefit of early delivery. Emergency cesarean delivery is usually indicated in the case of fetal distress and, arguably, these cases should be excluded when assessing different management strategies for otherwise uncomplicated gastroschisis.14 Of the 12 studies that failed to show any significant benefit to early delivery, eight also failed to show any significant benefit to expectant management.8,10,11,17,18,25,26,38
The study design and groups evaluated differed between reports that showed a benefit to elective delivery and those that did not. Eleven of 12 studies8,10,11,16,17,20,25–28,38 that failed to support elective delivery compared only the effect of gestational age and not the effect of a specific intervention (eg, scheduled delivery) on neonatal outcome. In those studies, preterm deliveries were a result of spontaneous labor (eg, attributable to polyhydramnios), abnormal ultrasound findings, or nonreassuring fetal heart rate monitoring. It is possible that these fetuses may have been somewhat compromised, with higher complication rates, and thus may have had worse neonatal outcomes than a comparative group of fetuses delivered at term.
In contrast, all but one study37 that suggested a benefit to elective delivery compared expectant management with a specific intervention, either elective cesarean delivery or induction of labor between 35 and 37 weeks of gestation. The latter may be a more scientifically correct approach to investigate the actual effect of an intervention but, unfortunately, is often biased by the comparison of a contemporary cohort with an historic cohort, thereby not allowing differentiation between the effects of the intervention per se and the changes in neonatal management over time.
The U-shape of the curve plotting neonatal death against gestational age at birth (Fig. 2) shows that an optimal compromise exists between mortality and prematurity. Figure 2 also shows that preterm neonates born before 34 weeks of gestation are at high risk for neonatal death. If these newborns are compared with term newborns, as was performed in several studies,8,10,11,16,26–28,38 this would favor term delivery, because the power of global prematurity is higher than its benefit on the fetal intestine.
Several limitations of our study must be acknowledged. First, lack of randomization is a study limitation. Second, these are retrospective data, collected over a lengthy time period. The groups have been stratified by time, given our change in policy to favor elective delivery at 37 weeks of gestation in 1994. Incremental improvements in pediatric surgical and medical care over this long study period may explain some of the differences observed between expectant management and induction at 37 weeks of gestation. As noted, however, there were no differences in neonatal outcome in patients who labored and delivered spontaneously before 37 weeks of gestation before and after 1994. Moreover, time to oral feeds, length of time on TPN, and hospital stay were all increased after 1994 compared with before 1994, when all 261 gastroschisis cases were considered.
Despite the retrospective design of our study and thus possible information bias, our population of 261 fetuses with gastroschisis is one of the largest reported series studying the effect of timing of delivery (Table 4). Moreover, our study was conducted in a single tertiary care perinatal center, thus minimizing the effect of multiple prenatal and postnatal management policies. According to our results (Table 2), RCTs comparing induction of labor at 37 weeks of gestation with expectant management (with a power of 0.90) would require 3,561 patients in each arm to demonstrate significance for a reduction in neonatal death from 4% to 2.6%, or 160 patients in each arm to demonstrate significance for a reduction in composite neonatal outcome (neonatal death and bowel damage) from 21.1% to 7.8%. Given the substantial research costs of mounting such a study, together with the implied additional health care costs of nonintervention at 37 weeks of gestation, we believe it is unlikely that this level of evidence will ever be attained.
In conclusion, our study supports elective delivery at 37 weeks of gestation for fetuses with uncomplicated gastroschisis. In addition to improving neonatal outcomes, this policy also is likely to be cost-effective because it reduces antenatal costs and shortens the duration of neonatal hospital stay.39,40 A multicenter, prospective, randomized study with stringent recruitment criteria would be needed to reach a definitive conclusion.
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