Nico Schuitemaker

Maternal mortality after cesarean section in The Netherlands

Background. To assess cesarean section‐related maternal mortality in The Netherlands during 1983–1992.

Confidential enquiry into maternal deaths in The Netherlands 1983–1992

OBJECTIVE To determine the causes of maternal death in The Netherlands. STUDY DESIGN Nationwide Confidential Enquiry into the Causes of Maternal Deaths during the period 1983-1992. RESULTS Of 192 direct and indirect maternal deaths, 154 (80%) were available for the Enquiry. The most frequent direct causes were (pre-)eclampsia, thrombo-embolism, obstetrical haemorrhage and sepsis. Cerebro- and cardiovascular disorders were the most frequent indirect causes of death. Age above 35 years and parity 3 or more are related to higher maternal mortality. Women from non-caucasian origin are more prone to death in comparison to caucasian women. Autopsy was performed in 88 cases (57%). Of the 24 women where labour started at home, the place of birth played a significant role in delay in four. CONCLUSIONS More efforts should be made to have a higher percentage than 80% available for the Confidential Enquiry as in the UK where only 1-4% of deaths are not available for similar purposes. Also, the autopsy rate of 57% is much lower than in the UK (82%). Special strategies should be developed to improve maternal health of populations at higher risk such as women of high age and parity and immigrant populations.

Maternal mortality and severe morbidity from sepsis in the Netherlands.

Objective. To assess incidence and risk factors of maternal mortality and severe morbidity from sepsis in the Netherlands. Design. A nationwide confidential enquiry into maternal mortality from 1993 to 2006 and severe maternal morbidity from 2004 to 2006. Setting. All 98 Dutch maternity units in the Netherlands. Population. All pregnant women in the Netherlands from 1993 to 2006. Methods. All reported cases of maternal death from sepsis during 1993–2006 were reported to the Maternal Mortality Committee. Cases of severe maternal morbidity from sepsis from 2004 to 2006 were collected in a nationwide design. Main outcome measures. Incidence, case fatality rates, and possible risk factors. Results. The maternal mortality ratio from direct maternal mortality from sepsis was 0.73 per 100,000 live births (20/2,742,265). The incidence of severe maternal morbidity from sepsis was 21 per 100,000 deliveries (78/371,021), of which 79% was admitted to the intensive care unit. High age, multiple pregnancies, and the use of artificial reproduction techniques were significant risk factors for developing sepsis in univariate analysis. The overall case fatality rate for sepsis during 2004–2006 was 7.7% (6/78). Group A streptococcal infection was in 42.9% (9/21), the cause of direct maternal mortality from sepsis (1993–2006). In 31.8% (14/44), Group A streptococcal infection was the cause of obstetric morbidity from sepsis (2004–2006). Conclusions. With a case fatality rate of 7.7%, sepsis is a life threatening condition for women during pregnancy, childbirth, and puerperium.

Maternal deaths after elective cesarean section for breech presentation in the Netherlands.

Background and methods. The cesarean section rate for term singleton breech babies in the Netherlands rose from 57 to 81% after the Term Breech Trial in 2000. The Dutch Maternal Mortality Committee registered and evaluated maternal mortality due to elective cesarean section for breech. Results. Four maternal deaths after elective cesarean section for breech presentation, from 2000 to 2002 inclusive, were registered, 7% of total direct maternal mortality in that period. Two women died due to massive pulmonary embolism, both were obese, and thromboprophylaxis was not adjusted to their weight. The other two women died from sepsis, one had not receive perioperative prophylactic antibiotics. The case fatality rate for elective cesarean section for breech presentation was 0.47/1,000 operations. No death after emergency cesarean section for breech presentation was registered at the committee. Conclusions. Elective cesarean section does not guarantee the improved outcome of the child, but may increase risks for the mother, compared to vaginal delivery.

Patient controlled analgesia with remifentanil versus epidural analgesia in labour : randomised multicentre equivalence trial

Objective To determine women’s satisfaction with pain relief using patient controlled analgesia with remifentanil compared with epidural analgesia during labour. Design Multicentre randomised controlled equivalence trial. Setting 15 hospitals in the Netherlands. Participants Women with an intermediate to high obstetric risk with an intention to deliver vaginally. To exclude a clinically relevant difference in satisfaction with pain relief of more than 10%, we needed to include 1136 women. Because of missing values for satisfaction this number was increased to 1400 before any analysis. We used multiple imputation to correct for missing data. Intervention Before the onset of active labour consenting women were randomised to a pain relief strategy with patient controlled remifentanil or epidural analgesia if they requested pain relief during labour. Main outcome measures Primary outcome was satisfaction with pain relief, measured hourly on a visual analogue scale and expressed as area under the curve (AUC), thus providing a time weighted measure of total satisfaction with pain relief. A higher AUC represents higher satisfaction with pain relief. Secondary outcomes were pain intensity scores, mode of delivery, and maternal and neonatal outcomes. Analysis was done by intention to treat. The study was defined as an equivalence study for the primary outcome. Results 1414 women were randomised, of whom 709 were allocated to patient controlled remifentanil and 705 to epidural analgesia. Baseline characteristics were comparable. Pain relief was ultimately used in 65% (447/687) in the remifentanil group and 52% (347/671) in the epidural analgesia group (relative risk 1.32, 95% confidence interval 1.18 to 1.48). Cross over occurred in 7% (45/687) and 8% (51/671) of women, respectively. Of women primarily treated with remifentanil, 13% (53/402) converted to epidural analgesia, while in women primarily treated with epidural analgesia 1% (3/296) converted to remifentanil. The area under the curve for total satisfaction with pain relief was 30.9 in the remifentanil group versus 33.7 in the epidural analgesia group (mean difference −2.8, 95% confidence interval −6.9 to 1.3). For who actually received pain relief the area under the curve for satisfaction with pain relief after the start of pain relief was 25.6 in the remifentanil group versus 36.1 in the epidural analgesia group (mean difference −10.4, −13.9 to −7.0). The rate of caesarean section was 15% in both groups. Oxygen saturation was significantly lower (SpO2 <92%) in women who used remifentanil (relative risk 1.5, 1.4 to 1.7). Maternal and neonatal outcomes were comparable between both groups. Conclusion In women in labour, patient controlled analgesia with remifentanil is not equivalent to epidural analgesia with respect to scores on satisfaction with pain relief. Satisfaction with pain relief was significantly higher in women who were allocated to and received epidural analgesia. Trial registration Netherlands Trial Register NTR2551.

Pyoderma gangrenosum after caesarean section: a case report

BackgroundPyoderma gangrenosum is a rare ulcerative skin disease. The diagnosis is based on clinical features and excluding other causes of skin ulcers, as it does not have characteristic histopathology or laboratory findings. The etiology is poorly understood. Lesions can develop spontaneously, after surgery or after trauma.Case presentationWe present the case of a 32-year-old woman with ulcerative wound defect after caesarean section. The wound was not healing despite standard wound care and antibiotic treatment. Pyoderma gangrenosum was diagnosed and after high dose corticosteroids wound healing started.ConclusionEarly diagnosis and subsequent treatment of pyoderma gangrenosum are crucial for limiting scar tissue. Diagnosis of pyoderma gangrenosum could easily be missed since gynaecologists are rarely confronted with this disorder.

Foley catheter or prostaglandin E2 inserts for induction of labour at term: an open-label randomized controlled trial (PROBAAT-P trial) and systematic review of literature

OBJECTIVE To assess the safety and effectiveness of a transcervical Foley catheter compared to vaginal prostaglandin E2 inserts for term induction of labour. STUDY DESIGN We conducted an open-label randomized controlled trial in five hospitals in the Netherlands. Women with a singleton term pregnancy in cephalic presentation, intact membranes, unfavourable cervix, and no prior caesarean section were enrolled. Participants were randomly allocated by a web-based randomization system to induction of labour with a 30 ml Foley catheter or 10mg slow-release vaginal prostaglandin E2 inserts in a 1:1 ratio. Due to the nature of the intervention this study was not blinded. The primary outcome was the caesarean section rate. Secondary outcomes were maternal and neonatal morbidity and time from intervention to birth. Additionally, we carried out a systematic review and meta-analysis of similar studies. RESULTS We analyzed 226 women: 107 received a Foley catheter and 119 inserts. Caesarean section rates were comparable (20% versus 22%, RR 0.90, 95% CI 0.54-1.50). Secondary outcomes showed no differences. We observed no serious maternal or neonatal morbidity. Meta-analysis showed comparable caesarean section rates, but significantly fewer cases of hyperstimulation during the ripening phase when a Foley catheter was used. CONCLUSIONS We found, in this relatively small study, no differences in effectiveness and safety of induction of labour with a Foley catheter and 10mg slow release vaginal prostaglandin E2 inserts. Meta-analysis confirmed a comparable caesarean section rate, and showed fewer cases of hyperstimulation when a Foley catheter was used.

Indirect maternal mortality increases in the Netherlands

Objective. To assess causes, trends, and substandard care in indirect maternal mortality in the Netherlands. Design. Confidential enquiry into causes of maternal death. Setting. Nationwide in the Netherlands. Population. A total of 2,557,208 live births. Methods. Data analysis of indirect maternal deaths in the period 1993–2005. Main outcome measures. Indirect maternal mortality. Results. Of the study subjects, 97 were classified as indirect deaths, representing a maternal mortality ratio of 3.3/100,000 live births, a significant increase compared to the preceding enquiry in the period 1983–1992 (MMR 2.4, OR 1.5, 95%CI 1.0–2.1). The percentage of cases not directly reported to the Maternal Mortality Committee decreased from 15 to 5%. Cardiovascular disorders were the leading cause of indirect maternal mortality, followed by cerebrovascular disorders. Vascular dissection (n = 19) was the most frequent specified cause of death. Risk factors were advanced maternal age, non‐indigenous origin (Surinam and Dutch Antilles), and medical health risks before pregnancy. Substandard care was present in 35%, mainly being misjudgment of the severity of the condition and delay in initiating therapy. Conclusion. The rise of mortality due to indirect causes is considered a reflection of the change in risk profile of women of childbearing age and the result of demographic alterations concerning ethnicity and maternal age. The identification of high risk groups, preferably by programs of preconception care, should lead to improved care for these women, with a multidisciplinary approach when needed.

A randomised clinical trial on cardiotocography plus fetal blood sampling versus cardiotocography plus ST-analysis of the fetal electrocardiogram (STAN®) for intrapartum monitoring

BackgroundCardiotocography (CTG) is worldwide the method for fetal surveillance during labour. However, CTG alone shows many false positive test results and without fetal blood sampling (FBS), it results in an increase in operative deliveries without improvement of fetal outcome. FBS requires additional expertise, is invasive and has often to be repeated during labour. Two clinical trials have shown that a combination of CTG and ST-analysis of the fetal electrocardiogram (ECG) reduces the rates of metabolic acidosis and instrumental delivery. However, in both trials FBS was still performed in the ST-analysis arm, and it is therefore still unknown if the observed results were indeed due to the ST-analysis or to the use of FBS in combination with ST-analysis.Methods/DesignWe aim to evaluate the effectiveness of non-invasive monitoring (CTG + ST-analysis) as compared to normal care (CTG + FBS), in a multicentre randomised clinical trial setting. Secondary aims are: 1) to judge whether ST-analysis of fetal electrocardiogram can significantly decrease frequency of performance of FBS or even replace it; 2) perform a cost analysis to establish the economic impact of the two treatment options.Women in labour with a gestational age ≥ 36 weeks and an indication for CTG-monitoring can be included in the trial.Eligible women will be randomised for fetal surveillance with CTG and, if necessary, FBS or CTG combined with ST-analysis of the fetal ECG.The primary outcome of the study is the incidence of serious metabolic acidosis (defined as pH < 7.05 and Bdecf > 12 mmol/L in the umbilical cord artery). Secondary outcome measures are: instrumental delivery, neonatal outcome (Apgar score, admission to a neonatal ward), incidence of performance of FBS in both arms and cost-effectiveness of both monitoring strategies across hospitals.The analysis will follow the intention to treat principle. The incidence of metabolic acidosis will be compared across both groups. Assuming a reduction of metabolic acidosis from 3.5% to 2.1 %, using a two-sided test with an alpha of 0.05 and a power of 0.80, in favour of CTG plus ST-analysis, about 5100 women have to be randomised. Furthermore, the cost-effectiveness of CTG and ST-analysis as compared to CTG and FBS will be studied.DiscussionThis study will provide data about the use of intrapartum ST-analysis with a strict protocol for performance of FBS to limit its incidence. We aim to clarify to what extent intrapartum ST-analysis can be used without the performance of FBS and in which cases FBS is still needed.Trial Registration NumberISRCTN95732366

Cost-effectiveness of cardiotocography plus ST analysis of the fetal electrocardiogram compared with cardiotocography only

Objective. To assess the cost‐effectiveness of addition of ST analysis of the fetal electrocardiogram (ECG; STAN®) to cardiotocography (CTG) for fetal surveillance during labor compared with CTG only. Design. Cost‐effectiveness analysis based on a randomized clinical trial on ST analysis of the fetal ECG. Setting. Obstetric departments of three academic and six general hospitals in The Netherlands. Population. Laboring women with a singleton high‐risk pregnancy, a fetus in cephalic presentation, a gestational age >36weeks and an indication for internal electronic fetal monitoring. Methods. A trial‐based cost‐effectiveness analysis was performed from a health‐care provider perspective. Main Outcome Measures. Primary health outcome was the incidence of metabolic acidosis measured in the umbilical artery. Direct medical costs were estimated from start of labor to childbirth. Cost‐effectiveness was expressed as costs to prevent one case of metabolic acidosis. Results. The incidence of metabolic acidosis was 0.7% in the ST‐analysis group and 1.0% in the CTG‐only group (relative risk 0.70; 95% confidence interval 0.38–1.28). Per delivery, the mean costs per patient of CTG plus ST analysis (n= 2 827) were €1 345 vs. €1 316 for CTG only (n= 2 840), with a mean difference of €29 (95% confidence interval −€9 to €77) until childbirth. The incremental costs of ST analysis to prevent one case of metabolic acidosis were €9 667. Conclusions. The additional costs of monitoring by ST analysis of the fetal ECG are very limited when compared with monitoring by CTG only and very low compared with the total costs of delivery.