Het adviesrapport ‘Een goed begin’ in december 2009 (Stuurgroep zwangerschap en geboorte, 2009) beschreef aanbevelingen om ‘het aantal maternale en perinatale sterftegevallen door sub-standaard factoren in de zorg in vijf jaar te halveren’. Eind 2010 schreef de Minister van VWS aan de Tweede Kamer dat deze aanbevelingen grotendeels werden overgenomen. De maatregelen richtten zich vooral op het verbeteren van de samenwerking, de acute verloskundige zorg en de risicoselectie. In juni 2011 moest de nieuwe Minister toegeven dat het advies over de voorgestelde 15 minutennorm (het starten van een behandeling in geval van een potentieel levensbedreigende situatie binnen 15 minuten) en de voorgestelde begeleidings- en bewakingsnormen niet haalbaar waren. Driekwart van de ziekenhuizen kon destijds niet aan de voorgestelde normen voldoen. Belangrijkste knelpunten waren de onvoldoende beschikbare professionals (gynaecologen, verpleegkundigen, OK-personeel) en het ontbreken van extra financiële investeringen in mensen en middelen. Deze situatie is momenteel niet verbeterd. Daarnaast was er op basis van literatuur geen eenduidig bewijs dat verkorting van het Decision-to-Delivery Interval ook daadwerkelijk tot verbeterde uitkomsten leidt.

De NICE-richtlijn (2021) uit het Verenigd Koninkrijk hanteert de 30 minuten norm voor spoed keizersneden die worden uitgevoerd omdat sprake is van een levensbedreigende situatie (Caesarean Section Category I). Dit komt overeen met Categorie 1: binnen 30 minuten (zie module ‘Classificatiesystemen’). Voor Categorie 2 wordt zowel in de Britse als Nederlandse richtlijn een limiet van 75 minuten aangehouden. Hoewel de normen in de NICE-richtlijn oorspronkelijk bedoeld waren als audit-instrument en niet als aanbevelingen, zijn ze in de kliniek wel als zodanig gebruikt. Inmiddels zijn er nieuwe studies over dit onderwerp gepubliceerd.

Gezien het acute karakter, de enorme impact op de kwaliteit van leven van patiënten en de organisatorische en logistieke crisis in de huidige Nederlandse gezondheidszorg (waarbij bestuurders steeds meer roepen om concentratie van zorg) is praktijkvariatie zeer onwenselijk. Een éénduidig advies over de snelheid waarmee een spoedkeizersnede moet worden uitgevoerd is daarom op zijn plaats. Deze module betreft een herziening van de originele module uit 2018.

1. Unexpected NICU admission (critical)

2. Neonatal mortality (critical)

3. 5-minute Apgar score <7 (important)

4. Asphyxia arterial cord pH <7.10 (important)

Description of studies (updated search)

Ayele (2021) performed a retrospective cross-sectional study to assess whether a DDI of ≤30 minutes achieved in daily practice in women who underwent emergency caesarean section in hospitals in Ethiopia. Pregnant mothers, assigned in the prenatal unit for obstetrical service and who subsequently underwent emergency caesarean delivery were included in this cohort study. Mothers having insufficient information on the patient charts, with hypertensive disorders, and transferred from other health care facilities for critical obstetric service were excluded.

In total, 510 patients were included in the analysis, of which 89 patients had a DDI of ≤30 minutes and 421 patients had a DDI of >30 minutes. The study reported the following outcome measures: 5-minute Apgar score <7, unexpected NICU admission, and neonatal mortality.

Bello (2015) performed a prospective observational study to determine the DDI for emergency caesarean deliveries and to evaluate the effects of delays on perinatal outcomes, in women who underwent emergency caesarean sections at a tertiary centre in Nigeria. All emergency caesarean deliveries in women who signed informed consent were included in the cohort study. Diagnosis of intrauterine foetal death before the caesarean delivery were excluded.

In total, 235 patients were included in the analysis, of which 5 patients had a DDI of ≤30 minutes and 230 patients had a DDI of >30 minutes. The study reported the following outcome measures: 5-minute Apgar score <7 and perinatal mortality.

Bousleiman (2022) performed a retrospective analysis of a prospective observational caesarean registry dataset to assess the risk for foetal outcomes based on decision-to-incision (DTI) time interval in women who underwent emergency caesarean delivery in a hospital in the United States of America. Women with a gestational age of at least 37 weeks at delivery, with no more than one prior caesarean section (only with prior transverse or unknown incision), who underwent emergency caesarean delivery were included in the cohort study. Women with more than one prior caesarean section, multiple gestations, and stillbirth, and pregnancies resulting in neonates with major congenital anomalies or a birthweight below 2,500 grams, and women with prior caesarean sections with vertical incisions were excluded.

In total, 4,760 patients were included in the analysis, of which 2751 patients had a DTI of ≤30 minutes and 2,009 patients had a DTI of >30 minutes. The study reported the following outcome measure: asphyxia arterial cord pH <7.10.

Grobman (2018) performed a secondary analysis of an observational cohort to estimate whether the DTI time for caesarean delivery was associated with differences in neonatal outcomes in women who underwent caesarean delivery in 25 medical centres in the USA. Women who had term, singleton nonanomalous gestation in the cephalic presentation, no prior caesarean delivery, intended to labour in the current pregnancy, and subsequently underwent an intrapartum caesarean delivery were included in the cohort study. Women who presented to labour with non-reassuring foetal status, with indication for ≤because of an abruption or cord prolapse, and women for whom data for time for decision for caesarean or incision was lacking (or so long as to be unlikely) in the medical record were excluded.

In total, 3,482 patients were included in the analysis, of which 1171 had a DDI of ≤30 minutes and 2311 had a DDI of >30 minutes. The study reported the following relevant outcome measures: unexpected NICU admission, neonatal mortality, and asphyxia arterial cord pH <7.10.

Heller (2017) performed a secondary analysis of perinatal survey data to explore relevant data to DDI for emergency caesarean sections performed for the most common indications: suspected and documented foetal asphyxia at a Healthcare institute in Germany. Data of new-borns with gestational age of 24-45 completed weeks of gestation, and if one of the following indications for emergency section applied: abnormal cardiotocography (CTG) findings, abnormal foetal heart rate, asphyxia detected by foetal blood analysis, were included in the cohort study. Emergency caesarean section with a DDI of >3 hours, stillbirths with time of death prior to admission to hospital or prior to delivery or unknown, and new-borns with congenital malformations were excluded. In total, data of 39,291 caesarean sections were included, of which 3,9171 had a DDI of ≤30 minutes and 120 had a DDI of >30 minutes. The study reported the following outcome measures: 5-minute Apgar score <7 and neonatal in-hospital mortality.

Kitaw (2021) performed a prospective cohort study to determine the average DDI and its effect on perinatal outcomes in women who underwent emergency caesarean sections at public hospitals in Ethiopia. Women who underwent emergency caesarean section during the study period were included in the cohort study. Women who underwent emergency caesarean section with a preterm foetus, uterine rupture before the decision, intra-uterine foetal death and foetuses with gross congenital anomalies were excluded. In total, 182 patients were included in the analysis, of which 26 patients had a DDI of ≤30 minutes and 156 patients had a DDI of >30 minutes. The study reported the following outcome measures: 5-minute Apgar score <7 and unexpected NICU admission.

Le Mitouard (2020) performed an observational study to assess neonatal outcomes for emergency caesareans with different DDIs in women who underwent emergency caesarean sections at 26 public and private maternity units in France. Prospectively included cases of caesareans performed as code orange emergencies or code red extreme emergencies, regardless of the type of pregnancy or foetal presentation were included in the cohort study.

In total, 354 patients were included in the analysis, of which 178 patients had a DDI of ≤30 minutes and 176 patients had a DDI of >30 minutes. The study reported the following outcome measure: neonatal mortality and asphyxia pH<7.10.

Mishra (2018) performed an observational study to assess the impact of DDI on obstetric outcomes in women who underwent emergency caesarean section in an obstetric unit in India. Pregnant women with single live foetus in pregnancy between 37 and 42 weeks with category I or category II indications (immediate threat to life of woman or foetus or maternal or foetal compromise) were included in the cohort study. Women with category III or IV (needing early delivery but no foetal or maternal compromise or planned or elective), with known congenital foetal anomaly and medical complications of pregnancy were excluded. In total, 480 patients were included in the analysis, of which 80 patients had a DDI of ≤30 minutes and 400 patients had a DDI of >30 minutes. The study reported the following outcome measures: 5-minute Apgar score <7, unexpected NICU admission, and neonatal mortality.

Sunsaneevihayakul (2022) performed a retrospective study to assess the frequency of emergency caesarean deliveries with DDI of ≤30 minutes and to compare differences in pregnancy outcomes for deliveries completed before and after DDIs of 30 minutes in a hospital in Thailand. Pregnant women who had an emergency caesarean delivery were included in the cohort study.

In total, 254 patients were included in the analysis, of which 246 patients had a DDI of ≤30 minutes and 8 patients had a DDI of >30 minutes. The study reported the following outcome measures: 5-minute Apgar score <7, unexpected NICU admission, and neonatal mortality.

Tashfeen (2017) performed a cross-sectional study to assess DDIs in emergency caesarean section cases to identify the impact of a delayed DDI on perinatal outcomes in all women who underwent caesarean sections at a hospital in Oman. All women with singleton pregnancies delivered by emergency caesarean section procedures due to fetal distress, antepartum haemorrhage or umbilical cord prolapse were included in the cohort study. Women with multiple pregnancies or pre-term deliveries were excluded.

In total, 246 patients were included in the analysis, of which 105 had a DDI of ≤30 minutes and 141 patients had a DDI of >30 minutes. The study reported the following outcome measures: 5-minute Apgar score <7 and unexpected NICU admission.

Temesgen (2020) performed a prospective cohort study to evaluate the DDI and its effect on fetal-maternal outcomes in women undergoing emergency caesarean delivery in a specialized hospital in Northwest Ethiopia. All women who underwent category 1 emergency caesarean delivery under both general and regional anaesthesia were included in the cohort study. Women who underwent category 1 caesarean delivery with preterm foetus, uterine rupture before decision, refused to give consent and foetus with gross congenital anomalies were excluded.

In total, 166 patients were included in the analysis, of which 32 patients had a DDI of ≤30 minutes and 131 patients had a DDI of >30 minutes. The study reported the following outcome measures: 5-minute Apgar score <7, unexpected NICU admission, and neonatal mortality.

Results

In the following outcome measures, eleven studies (Ayele, 2021; Bello, 2015; Bousleiman, 2022; Grobman, 2018; Heller, 2017; Kitaw, 2021; Le Mitouard, 2020; Mishra, 2018; Sunsaneevithayakul, 2022; Tashfeen, 2017; Temesgen, 2020) from the updated search and ten studies (Bloom, 2006; Chauleur, 2009; Hillemanns, 2003; Holcroft, 2005; Huissoud, 2010; Kolas, 2006; Nasrallah, 2004; Pearson, 2011; Roy, 2008; Thomas, 2004) from the original search were taken into account.

1. Unexpected NICU admission (critical)

In total, twelve studies reported the outcome measure unexpected NICU admission. Seven studies were retrieved from the updated search (Ayele, 2021; Grobman, 2018; Kitaw, 2021; Mishra, 2018; Sunsaneevithayakul, 2022; Tashfeen, 2017; Temesgen, 2020) and five studies were retrieved from the original search (Chauleur, 2009; Hillemanns, 2003; Kolas, 2006; Nasrallah, 2004; Roy, 2008).

In the ≤30 minutes-group (n=2,726) and in the >30 minutes-group (n=4,438) 538 patients and 674 patients were admitted to NICU, respectively. The pooled data show a risk ratio of 1.10 (95% CI 0.89 to 1.36), favouring the >30 minutes-group (Figure 1). This difference is clinically relevant.

Figure 1. NICU admission

2. Neonatal mortality (critical)

In total, eleven studies reported the outcome measures neonatal mortality. Eight studies were retrieved from the updated search (Ayele, 2021; Bello, 2015; Grobman, 2018; Heller, 2017; Le Mitouard, 2020; Mishra, 2018; Sunsaneevithayakul, 2022; Temesgen, 2020) and three studies were retrieved from the original search (Bloom, 2005; Holcroft, 2005; Huissoud, 2010).

In the ≤30 minutes-group (n=42,895) and in the >30 minutes-group (n=5,148) 250 neonates and 62 neonates died, respectively. The pooled data show a risk ratio of 1.32 (95% CI 0.76 to 2.31), favouring the >30 minutes-group (Figure 2). This difference is clinically relevant.

Figure 2. Neonatal mortality

3. 5-minute Apgar score <7 (important)

In total, eight studies reported the outcome measure 5-minute Apgar score <7. All eight studies were retrieved from the updated search (Ayele, 2021; Bello, 2015; Heller, 2017; Kitaw, 2021; Mishra, 2018; Sunsaneevithayakul, 2022; Tashfeen, 2017; Temesgen, 2020).

In the ≤30 minutes-group (n=39,754) and in the >30 minutes-group (n=1,607) 3,375 patients and 210 patients had a 5-minute Apgar score <7, respectively. The pooled data show a risk ratio of 0.89 (95% CI 0.46 to 1.73), favouring the ≤30 minutes-group (Figure 3). This difference is not clinically relevant.

Figure 3. 5-minute Apgar score <7

4. Asphyxia arterial cord pH <7.10 (important)

In total, ten studies reported the outcome measure asphyxia arterial cord pH <7.10. Three studies were retrieved from the updated search (Bousleiman, 2022; Grobman, 2018; Le Mitouard, 2020), and seven studies were retrieved from the original search (Bloom, 2006; Hillemanns, 2003; Holcroft, 2005; Huissoud, 2010; Nasrallah, 2004; Pearson, 2011; Roy, 2008).

In the ≤30 minutes-group (n=6,417) and in the >30 minutes-group (n=6,111) 245 patients and 79 patients had asphyxia due to an arterial cord pH <7.10, respectively. The pooled data show a risk ratio of 2.80 (95% CI 1.96 to 4.00), favouring the >30 minutes-group (Figure 4). This difference is clinically relevant.

Figure 4. Asphyxia arterial cord pH <7.10

Level of evidence of the literature

The level of evidence regarding the four outcome measures was based on observational studies and therefore starts at low.

1. The level of evidence regarding unexpected NICU admission was downgraded by 4 levels to very low, because of study limitations (risk of bias, -1), because the confidence interval exceeds the levels for clinical relevance (imprecision, -2), and because of conflicting results (inconsistency, -1).

2. The level of evidence regarding neonatal mortality was downgraded by 3 levels to very low, because of study limitations (risk of bias, -1), the confidence interval exceeds the levels for clinical relevance (imprecision, -1), and conflicting results (inconsistency, -1).

3. The level of evidence regarding 5-minute Apgar score <7 was downgraded by 3 levels to very low, because of study limitations (risk of bias, -1), the confidence interval exceeds the levels for clinical relevance (imprecision, -1), and conflicting results (inconsistency, -1).

4. The level of evidence regarding asphyxia arterial cord pH <7.10 was downgraded by 1 level to very low, because of study limitations (risk of bias, -1).

A systematic review of the literature was performed to answer the following question: What is the effect of a decision-to-delivery interval on short term (DDI ≤30 minutes) in comparison to long term (DDI >30 minutes) in women with emergency caesarean section?

P: Women undergoing an unplanned emergency caesarean section

I: DDI ≤30 min

C: DDI >30 min

O: Unexpected NICU admission, neonatal mortality, 5-minute Apgar score <7, asphyxia arterial cord pH <7.10

Relevant outcome measures

The guideline development group considered unexpected NICU admission and neonatal in-hospital mortality as critical outcome measures for decision making; and 5-minute Apgar score and asphyxia arterial cord pH <7.10 as important outcome measures for decision making.

A priori, the working group did not define the outcome measures listed above but used the definitions used in the studies.

The working group defined the following differences as a minimal clinically (patient) important difference (dichotomous outcomes, relative risk; yes/no):

• Unexpected NICU admission: 10% (≤0.9 or ≥1.10)
• Neonatal mortality: 5% (≤0.95 or ≥1.05)
• 5 minute Apgar score: 25% (≤0.8 or ≥1.25)
• Asphyxia arterial cord pH <7.10: 25% (≤0.8 or ≥1.25)

Search and select (Methods)

For this update, the databases Medline (via OVID), Embase (via Embase.com) and Cochrane were searched with relevant search terms starting from 2015 until 8 November 2022. The detailed search strategy is depicted under the tab Methods. The systematic literature search resulted in 807 hits. Studies were selected based on the following criteria:

• systematic reviews (searched in at least two databases, and detailed search strategy, risk of bias assessment and results of individual studies available), randomized controlled trials, or observational comparative studies,
• studies including ≥ 20 (ten in each study arm) patients,
• full-text English language publication, and
• studies according to the PICO.

In total, 30 studies were initially selected from the updated search, based on title and abstract screening. After reading the full text, nineteen studies were excluded (see the table with reasons for exclusion under the tab Methods), and eleven studies were included, in addition to the ten studies which were included in the original search (see Appendix 'Evidence en Risk of Bias tabellen behorende bij de module ‘Timing van decision-to-delivery bij ongeplande sectio’s’ (Beoordeeld: 23-04-2018)').

Results

Eleven observational studies were included in the updated analysis of the literature. Important study characteristics and results are summarized in the evidence tables. The assessment of the risk of bias is summarized in the risk of bias tables.