The relationship between antenatal indomethacin as a tocolytic drug and neonatal outcomes: a retrospective cohort study.

INTRODUCTION: Preterm birth is associated with increased mortality and morbidity. Tocolytic drugs, such as indomethacin, are often used to postpone preterm delivery. Indomethacin has been proven to be more effective than other tocolytic agents in terms of delaying birth but is often prescribed with caution because of its potential association with adverse neonatal outcomes. We aim to study the effects of antenatal indomethacin on neonatal outcomes after controlling for potential confounders, as compared to nifedipine and/or atosiban. METHODS: In this cohort study, we performed a retrospective analysis of maternal and neonatal data. Women were included if they received indomethacin, nifedipine or atosiban as a tocolytic drug for imminent preterm labor and gave birth at a gestational age (GA) between 235/7 and 320/7 weeks, between 2010 and 2015. Main outcome measures were: neonatal death, necrotizing enterocolitis (NEC), spontaneous intestinal perforation (SIP), intraventricular hemorrhage (IVH), periventricular leukomalacia (PVL), patent ductus arteriosus (PDA) and its treatment. RESULTS: Four hundred seventy-four women, delivering 610 infants were investigated. The incidence of the following adverse neonatal outcomes were significantly higher after indomethacin use: neonatal death (p = .017), NEC (p = .026), SIP (p = .008), PDA (p = .000) and PDA ligation (p = .000). However, these associations showed to be nonsignificant after adjusting for confounders (adjusted odds ratio neonatal mortality 1.6 (0.7-3.8)), NEC 1.6 (0.6-4.4), SIP 2.8 (0.3-30.0), PDA 1.1 (0.6-2.2) and PDA ligation 2.2 (0.7-6.5). CONCLUSIONS: The presumed association between antenatal indomethacin exposure and several adverse neonatal outcomes may be based upon indication bias. Taking important confounding factors, such as GA at birth and neonatal birth weight into account, antenatal indomethacin exposure does not result in a higher incidence of adverse neonatal outcomes. However, there may be a higher risk for spontaneous intestinal perforation.

The effect of intrauterine resuscitation by maternal hyperoxygenation on perinatal and maternal outcome: a randomized controlled trial.

BACKGROUND: Maternal hyperoxygenation is widely used during labor as an intrauterine resuscitation technique. However, robust evidence regarding its beneficial effect and potential side effects is scarce, and previous studies show conflicting results. OBJECTIVE: To assess the effect of maternal hyperoxygenation upon suspected fetal distress during the second stage of term labor on fetal heart rate, neonatal outcome, maternal side effects, and mode of delivery. MATERIALS AND METHODS: In a single-center randomized controlled trial in a tertiary hospital in The Netherlands, participants were randomized in case of an intermediary or abnormal fetal heart rate pattern during the second stage of term labor, to receive either conventional care or 100% oxygen at 10 L/min until delivery. The primary outcome was the change in fetal heart rate pattern. Prespecified secondary outcomes were Apgar score, umbilical cord blood gas analysis, neonatal intensive care unit admission, perinatal death, free oxygen radical activity, maternal side effects, and mode of delivery. We performed subgroup analyses for intermediary and abnormal fetal heart rate, and for small for gestational age fetuses. RESULTS: From March 2016 through April 2018, a total of 117 women were included. Fetal heart rate patterns could be analyzed in 71 women. Changes in fetal heart rate (defined as improvement, equal, or deterioration) in favor of maternal hyperoxygenation were significant (odds ratio, 5.7; 95% confidence interval, 1.7-19.1) using ordinal logistic regression. Apgar score, umbilical cord blood gas analysis, free oxygen radicals, and mode of delivery showed no significant differences between the intervention and control group. Among women with an abnormal fetal heart rate, there were fewer episiotomies on fetal indication in the intervention group (25%) than in the control group (65%, P < .01). CONCLUSION: Maternal hyperoxygenation has a positive effect on the fetal heart rate in the presence of suspected fetal distress during the second stage of labor. There was no significant difference in the mode of delivery or neonatal outcome; however, significantly fewer episiotomies on fetal indication were performed following maternal hyperoxygenation in the subgroup with abnormal fetal heart rate pattern.

Development of Nationwide Recommendations to Support Prenatal Counseling in Extreme Prematurity.

OBJECTIVES: To develop a nationwide, evidence-based framework to support prenatal counseling in extreme prematurity, focusing on organization, decision-making, content, and style aspects. METHODS: A nationwide multicenter RAND-modified Delphi method study was performed between November 2016 and December 2017 in the Netherlands. Firstly, recommendations were extracted from literature and previous studies. Secondly, an expert panel (n = 21) with experienced parents, obstetricians, and neonatologists rated the recommendations on importance for inclusion in the framework. Thirdly, ratings were discussed in a consensus meeting. The final set of recommendations was approved and transformed into a framework. RESULTS: A total of 101 recommendations on organization, decision-making, content, and style were included in the framework, including tools to support personalization. The most important recommendations regarding organization were to have both parents involved in the counseling with both the neonatologist and obstetrician. The shared decision-making model was recommended for deciding between active support and comfort care. Main recommendations regarding content of conversation were explanation of treatment options, information on survival, risk of permanent consequences, impossibility to predict an individual course, possibility for multiple future decision moments, and a discussion on parental values and standards. It was considered important to avoid jargon, check understanding, and provide a summary. The expert panel, patient organization, and national professional associations (gynecology and pediatrics) approved the framework. CONCLUSIONS: A nationwide, evidence-based framework for prenatal counseling in extreme prematurity was developed. It contains recommendations and tools for personalization in the domains of organization, decision-making, content, and style of prenatal counseling.

Correction to: Intrauterine resuscitation during the second stage of term labour by maternal hyperoxygenation versus conventional care: study protocol for a randomised controlled trial (INTEREST O2).

Following publication of the original article [1], the authors noticed that the sample size for the study group was incorrectly reported in the Methods section.

Intrauterine resuscitation during the second stage of term labour by maternal hyperoxygenation versus conventional care: study protocol for a randomised controlled trial (INTEREST O2).

BACKGROUND: Perinatal asphyxia is, even in developed countries, one the major causes of neonatal morbidity and mortality. Therefore, if foetal distress during labour is suspected, one should try to restore foetal oxygen levels or aim for immediate delivery. However, studies on the effect of intrauterine resuscitation during labour are scarce. We designed a randomised controlled trial to investigate the effect of maternal hyperoxygenation on the foetal condition. In this study, maternal hyperoxygenation is induced for the treatment of foetal distress during the second stage of term labour. METHODS/DESIGN: This study is a single-centre randomised controlled trial being performed in a tertiary hospital in The Netherlands. From among cases of a suboptimal or abnormal foetal heart rate pattern during the second stage of term labour, a total of 116 patients will be randomised to the control group, where normal care is provided, or to the intervention group, where before normal care 100% oxygen is supplied to the mother by a non-rebreathing mask until delivery. The primary outcome is change in foetal heart rate pattern. Secondary outcomes are Apgar score, mode of delivery, admission to the neonatal intensive care unit and maternal side effects. In addition, blood gas values and malondialdehyde are determined in umbilical cord blood. DISCUSSION: This study will be the first randomised controlled trial to investigate the effect of maternal hyperoxygenation for foetal distress during labour. This intervention should be recommended only as a treatment for intrapartum foetal distress, when improvement of the foetal condition is likely and outweighs maternal and neonatal side effects. TRIAL REGISTRATION: EudraCT, 2015-001654-15; registered on 3 April 2015. Dutch Trial Register, NTR5461; registered on 20 October 2015.

Assessment tool for the instructional design of simulation-based team training courses: the ID-SIM.

Introduction: To achieve an expert performance of care teams, adequate simulation-based team training courses with an effective instructional design are essential. As the importance of the instructional design becomes ever more clear, an objective assessment tool would be valuable for educators and researchers. Therefore, we aimed to develop an evidence-based and objective assessment tool for the evaluation of the instructional design of simulation-based team training courses. Methods: A validation study in which we developed an assessment tool containing an evidence-based questionnaire with Visual Analogue Scale (VAS) and a visual chart directly translating the results of the questionnaire. Psychometric properties of the assessment tool were tested using five descriptions of simulation-based team training courses. An expert-opinion-based ranking from poor to excellent was obtained. Ten independent raters assessed the five training courses twice, by using the developed questionnaire with an interval of 2 weeks. Validity and reliability analyses were performed by using the scores from the raters and comparing them with the expert's ranking. Usability was assessed by an 11-item survey. Results: A 42-item questionnaire, using VAS, and a propeller chart were developed. The correlation between the expert-opinion-based ranking and the evaluators' scores (Spearman correlation) was 0.95, and the variance due to subjectivity of raters was 3.5% (VTraining*Rater). The G-coefficient was 0.96. The inter-rater reliability (intraclass correlation coefficient (ICC)) was 0.91 (95% CI 0.77 to 0.99), and intra-rater reliability for the overall score (ICC) was ranging from 0.91 to 0.99. Conclusions: We developed an evidence-based and reliable assessment tool for the evaluation of the instructional design of a simulation-based team training: the ID-SIM. The ID-SIM is available as a free mobile application.

Assessing teamwork performance in obstetrics: A systematic search and review of validated tools.

Teamwork performance is an essential component for the clinical efficiency of multi-professional teams in obstetric care. As patient safety is related to teamwork performance, it has become an important learning goal in simulation-based education. In order to improve teamwork performance, reliable assessment tools are required. These can be used to provide feedback during training courses, or to compare learning effects between different types of training courses. The aim of the current study is to (1) identify the available assessment tools to evaluate obstetric teamwork performance in a simulated environment, and (2) evaluate their psychometric properties in order to identify the most valuable tool(s) to use. We performed a systematic search in PubMed, MEDLINE, and EMBASE to identify articles describing assessment tools for the evaluation of obstetric teamwork performance in a simulated environment. In order to evaluate the quality of the identified assessment tools the standards and grading rules have been applied as recommended by the Accreditation Council for Graduate Medical Education (ACGME) Committee on Educational Outcomes. The included studies were also assessed according to the Oxford Centre for Evidence Based Medicine (OCEBM) levels of evidence. This search resulted in the inclusion of five articles describing the following six tools: Clinical Teamwork Scale, Human Factors Rating Scale, Global Rating Scale, Assessment of Obstetric Team Performance, Global Assessment of Obstetric Team Performance, and the Teamwork Measurement Tool. Based on the ACGME guidelines we assigned a Class 3, level C of evidence, to all tools. Regarding the OCEBM levels of evidence, a level 3b was assigned to two studies and a level 4 to four studies. The Clinical Teamwork Scale demonstrated the most comprehensive validation, and the Teamwork Measurement Tool demonstrated promising results, however it is recommended to further investigate its reliability.

Risk factors of incomplete Apgar score and umbilical cord blood gas analysis: a retrospective observational study.

OBJECTIVE: To investigate whether incomplete umbilical cord blood gas (UCBG) analysis occurs more often than the incomplete reporting of the Apgar score, and risk factors associated with the incomplete values. METHODS: A total of 8824 infants born alive after 26 weeks' gestation between January 2009 and April 2013 were included. We extracted data on five-minute Apgar score, UCBG analysis, gestational age, mode of delivery, time of delivery and multiple pregnancy. Univariate and multivariable logistic regression analyses were performed. RESULTS: Five-minute Apgar score was incomplete in 15 cases (0.2%) and UCBG analysis in 1960 cases (22.2%), p < 0.05. Incomplete UCBG analysis was significantly more likely to occur in situations with Apgar score below seven (Odds ratio (OR) 1.68, 95% CI;1.29-2.19), gestational age between 26 to 27 6/7 and 28 to 31 6/7 weeks (OR 3.14, 95% CI; 2.13-4.62 and OR 1.91, 95% CI; 1.57-2.32), cesarean section (OR 1.31, 95% CI; 1.11-1.55), and multiple pregnancy (OR 2.02, 95% CI; 1.69-2.43). Deliveries during night time had a lower risk of incomplete UCBG analysis (OR 0.78, 95% CI; 0.69-0.88). CONCLUSIONS: Measuring five-minute Apgar score generated less incomplete data compared with UCBG analysis. The risk factors associated with incomplete UCBG analysis were noted. Study outcomes with UCBG analysis as neonatal assessment tool should be interpreted with caution.

Practice variation in the management of intrapartum fetal distress in The Netherlands and the Western world.

OBJECTIVE: Solid evidence on the effect of intrauterine resuscitation on neonatal outcome is limited, and superiority of one intervention over the others is not clear. We therefore surveyed the clinical practice variation in fetal monitoring and the management of fetal distress during labor, in Dutch labor wards. In addition, we have compared recommendations from international guidelines. STUDY DESIGN: We conducted a survey among all 86 Dutch hospitals, using a questionnaire on fetal monitoring and management of fetal distress. In addition, we requested international guidelines of 28 Western countries to study international recommendations regarding labor management. RESULTS: The response rate of the national survey was 100%. Labor wards of all hospitals use CTG for fetal monitoring, 98% use additional fetal scalp blood sampling, and 23% use ST-analysis. When fetal distress is suspected, oxytocin is discontinued and tocolytic drugs are applied in all hospitals. Nearly all hospitals (98%) use maternal reposition for fetal resuscitation, 33% use amnioinfusion, and 58% provide maternal hyperoxygenation. Management is mainly based on the Dutch national guideline (58%) or on local guidelines (26%). Eight international guidelines on fetal monitoring were obtained for analysis. Fetal scalp blood sampling facilities are recommended in all the obtained guidelines. Use of ST-analysis is recommended in three guidelines and advised against in three guidelines. Five guidelines also advised on intrauterine resuscitation: discontinuation of oxytocin and use of tocolytic drugs was advised in all guidelines, amnioinfusion was recommended in two guidelines and advised against in two guidelines, whereas maternal hyperoxygenation was recommended in two guidelines and advised against in one guideline. CONCLUSION: Nationwide clinical practice, and recommendations from international guidelines agree on the use of fetal scalp blood sampling in addition to cardiotocography during labor. The opinion on the use of ST-analysis differs per clinic and per guideline. Discontinuation of oxytocin, administration of tocolytic drugs and maternal repositioning are rather uniform, on national and international level. However, there is a large variation in the use of amnioinfusion and maternal hyperoxygenation, which may be explained by the contradictory recommendations of the different guidelines.

Effectiveness of team training in managing shoulder dystocia: a retrospective study.

OBJECTIVES: To evaluate the effectiveness of simulation team training for the management of shoulder dystocia. Primary outcome measures were the number of reported cases of shoulder dystocia, as well as fetal injury that occurred from it. Secondary outcome is documentation of manoeuvres used to alleviate shoulder dystocia. METHODS: Retrospective cohort study in a teaching hospital in the Netherlands, in a 38 month period before and after implementation of team training. RESULTS: We compared 3492 term vaginal cephalic deliveries with 3496 deliveries before and after team training. Incidence of shoulder dystocia increased from 51 to 90 cases (RR 1.8 (95% CI: 1.3-2.5)). Fetal injury occurred in 16 and eight cases, respectively (RR 0.50 (95% CI: 0.21-1.2)). Before team training started, the all-fours manoeuvre was never used, while after team training it was used in 41 of 90 cases (45%). Proper documentation of all manoeuvres used to alleviate shoulder dystocia significantly increased after team training (RR 1.6 (95% CI: 1.05-2.5)). CONCLUSIONS: Simulation team training increased the frequency of shoulder dystocia, facilitated implementation of the all-fours technique, improved documentation of delivery notes and may have a beneficial effect on the number of children injured due to shoulder dystocia.

Interventions for Intrauterine Resuscitation in Suspected Fetal Distress During Term Labor: A Systematic Review.

IMPORTANCE: Intrauterine resuscitation techniques during term labor are commonly used in daily clinical practice. Evidence, however, to support the beneficial effect of intrauterine resuscitation techniques on fetal distress during labor is limited and sometimes contradictory. In contrast, some of these interventions may even be harmful. OBJECTIVE: To give insight into the current evidence on intrauterine resuscitation techniques. In addition, we formulate recommendations for current clinical practice and propose directions for further research. EVIDENCE ACQUISITION: We systematically searched the electronic PubMed, EMBASE, and CENTRAL databases for studies on intrauterine resuscitation for suspected fetal distress during term labor until February 2015. Eligible articles and their references were independently assessed by 2 authors. Judgment was based on methodological quality and study results. RESULTS: Our literature search identified 15 studies: 4 studies on amnioinfusion, 1 study on maternal hyperoxygenation, 1 study on maternal repositioning, 1 study on intravenous fluid administration, and 8 studies on tocolysis. Of these 15 research papers, 3 described a randomized controlled trial; all other studies were observational reports or case reports. CONCLUSIONS AND RELEVANCE: Little robust evidence to promote a specific intrauterine resuscitation technique is available. Based on our literature search, we support the use of tocolysis and maternal repositioning for fetal distress. We believe the effect of amnioinfusion and maternal hyperoxygenation should be further investigated in properly designed randomized controlled trials to make up the balance between beneficial and potential hazardous effects.

The Effect of Multiprofessional Simulation-Based Obstetric Team Training on Patient-Reported Quality of Care: A Pilot Study.

INTRODUCTION: This study aimed to explore whether multiprofessional simulation-based obstetric team training improves patient-reported quality of care during pregnancy and childbirth. METHODS: Multiprofessional teams from a large obstetric collaborative network in the Netherlands were trained in teamwork skills using the principles of crew resource management. Patient-reported quality of care was measured with the validated Pregnancy and Childbirth Questionnaire (PCQ) at 6 weeks postpartum. Before the training, 76 postpartum women (sample I) completed the questionnaire 6 weeks postpartum. Three months after the training, another sample of 68 postpartum women (sample II) completed the questionnaire. RESULTS: In sample II (after the training), the mean (SD) score of 108.9 (10.9) on the PCQ questionnaire was significantly higher than the score of 103.5 (11.6) in sample I (before training) (t = 2.75, P = 0.007). The effect size of the increase in PCQ total score was 0.5. Moreover, the subscales "personal treatment during pregnancy" and "educational information" showed a significant increase after the team training (P < 0.001). Items with the largest increase in mean scores included communication between health care professionals, clear leadership, involvement in planning, and better provision of information. CONCLUSIONS: Despite the methodological restrictions of a pilot study, the preliminary results indicate that multiprofessional simulation-based obstetric team training seems to improve patient-reported quality of care. The possibility that this improvement relates to the training is supported by the fact that the items with the largest increase are about the principles of crew resource management, used in the training.

A simulation model to study maternal hyperoxygenation during labor.

OBJECTIVE: To investigate the effect of maternal hyperoxygenation on fetal oxygenation and fetal heart rate decelerations during labor, using a simulation model. DESIGN: Use of a mathematical model that simulates feto-maternal hemodynamics and oxygenation, designed in Matlab R2012a. SETTING: Clinical and engineering departments in the Netherlands. METHODS: We simulated variable and late fetal heart rate decelerations, caused by uterine contractions with a different contraction interval. We continuously recorded oxygen pressure in different feto-placental compartments and fetal heart rate, during maternal normoxia and during hyperoxygenation with 100% oxygen. MAIN OUTCOME MEASURES: Changes in oxygen pressure in the intervillous space, umbilical vein and arteries, fetal cerebral and microcirculation as well as fetal heart rate deceleration depth and duration. RESULTS: Maternal hyperoxygenation leads to an increase in fetal oxygenation: in the presence of variable decelerations, oxygen pressure in the intervillous space increased 9-10 mmHg and in the cerebral circulation 1-2 mmHg, depending on the contraction interval. In addition, fetal heart rate deceleration depth decreased from 45 to 20 beats per minute. In the presence of late decelerations, oxygen pressure in the intervillous space increased 7-10 mmHg and in the cerebral circulation 1-2 mmHg, depending on the contraction interval. The fetus benefited more from maternal hyperoxygenation when contraction intervals were longer. CONCLUSIONS: According to the simulation model, maternal hyperoxygenation leads to an increase in fetal oxygenation, especially in the presence of variable decelerations. In addition, in the presence of variable decelerations, maternal hyperoxygenation leads to amelioration of the fetal heart rate pattern.

The impact of transmural multiprofessional simulation-based obstetric team training on perinatal outcome and quality of care in the Netherlands.

BACKGROUND: Perinatal mortality and morbidity in the Netherlands is relatively high compared to other European countries. Our country has a unique system with an independent primary care providing care to low-risk pregnancies and a secondary/tertiary care responsible for high-risk pregnancies. About 65% of pregnant women in the Netherlands will be referred from primary to secondary care implicating multiple medical handovers. Dutch audits concluded that in the entire obstetric collaborative network process parameters could be improved. Studies have shown that obstetric team training improves perinatal outcome and that simulation-based obstetric team training implementing crew resource management (CRM) improves team performance. In addition, deliberate practice (DP) improves medical skills. The aim of this study is to analyse whether transmural multiprofessional simulation-based obstetric team training improves perinatal outcome. METHODS/DESIGN: The study will be implemented in the south-eastern part of the Netherlands with an annual delivery rate of over 9,000. In this area secondary care is provided by four hospitals. Each hospital with referring primary care practices will form a cluster (study group). Within each cluster, teams will be formed of different care providers representing the obstetric collaborative network. CRM and elements of DP will be implemented in the training. To analyse the quality of care as perceived by patients, the Pregnancy and Childbirth Questionnaire (PCQ) will be used. Furthermore, self-reported collaboration between care providers will be assessed. Team performance will be measured by the Clinical Teamwork Scale (CTS). We employ a stepped-wedge trial design with a sequential roll-out of the trainings for the different study groups.Primary outcome will be perinatal mortality and/or admission to a NICU. Secondary outcome will be team performance, quality of care as perceived by patients, and collaboration among care providers. CONCLUSION: The effect of transmural multiprofessional simulation-based obstetric team training on perinatal outcome has never been studied. We hypothesise that this training will improve perinatal outcome, team performance, and quality of care as perceived by patients and care providers. TRIAL REGISTRATION: The Netherlands National Trial Register, http://www.trialregister.nl/NTR4576, registered June 1, 2014.

Development of the Pregnancy and Childbirth Questionnaire (PCQ): evaluating quality of care as perceived by women who recently gave birth.

OBJECTIVE: To develop an instrument to the assess quality of care during pregnancy and delivery as perceived by women who recently gave birth. STUDY DESIGN: Prospective design from focus group interviews to validation of the questionnaire. The focus groups consisted of seven care providers, ten pregnant women and six women who recently gave birth. With the results of the focus group interviews, a draft questionnaire of 52 items was composed and its psychometric properties were tested in a first cohort of 300 women who recently gave birth (sample I) by means of exploratory factor analysis (EFA) and reliability analysis. The final version was further explored by confirmatory factor analyses (CFA) in another sample of 289 women (sample II) with similar characteristics as sample I. RESULTS: EFA in sample I suggested an 18-item scale with two components concerning the quality of care during pregnancy: 'personal treatment' (11 items, Cronbach's alpha (α)=0.87) and 'educational information' (7 items, α=0.90); the 'delivery' scale showed a single domain (7 items, α=0.88). CFA in sample II confirmed both factor structures with an adequate model fit. Overall, satisfaction with care was highest among women who only received midwife-led care, while women who were referred to an obstetrician during pregnancy reported less satisfaction. CONCLUSIONS: The 25-item PCQ, primarily based on the experiences and perceptions of pregnant women and women who recently gave birth, showed adequate psychometric properties evaluating the quality of care during pregnancy and delivery. This user-friendly instrument might be a valuable instrument for future research to further evaluate the quality of care to pregnant women.

HELLP syndrome is associated with an increased inflammatory response, which may be inhibited by administration of prednisolone.

OBJECTIVE: To investigate the effect of prednisolone on HELLP syndrome by assessing several markers of the inflammatory response and hepatic damage associated with HELLP syndrome. DESIGN: Prospective study. SETTING: Single-center, tertiary obstetric care facility at the University Medical Centre Utrecht, The Netherlands. POPULATION: Study subjects included normal controls, patients with non-HELLP preeclampsia, and patients with preeclampsia and HELLP syndrome. METHODS: HELLP syndrome was defined by hemolysis (serum lactate dehydrogenase [LDH] >600 IU/L and/or haptoglobin 70 U/L and/or serum alanine aminotransferase [ALT] >70 U/L), and a low platelet count (<100 x 10(9)/L). Blood samples from patients with HELLP syndrome who were receiving either prednisolone or placebo were obtained before, during, and after a HELLP exacerbation in the antepartum period. Plasma levels of CRP, IL-1RA, IL-6, sIL-6R, IL-8, IL-10, TNF-alpha, and GSTA1-1 were determined. Samples from women with preeclampsia but without HELLP syndrome and from healthy pregnant women were included as controls. MAIN OUTCOME MEASURES: Plasma levels of CRP, IL-1RA, IL-6, sIL-6R, IL-8, IL-10, TNF-alpha, and GSTA1-1. RESULTS: During a HELLP exacerbation CRP, IL-6, IL-1Ra, and GSTA1-1 levels are significantly increased (p < 0.01). In the group of patients treated with prednisolone, significantly lower IL-6 levels were observed during a HELLP exacerbation, compared with patients who did not receive prednisolone (p < 0.01). CONCLUSION: HELLP syndrome is associated with an increased inflammatory response. Circulating IL-6 levels in HELLP syndrome are reduced during prednisolone administration, suggesting a stabilizing effect on the inflammatory endothelial process.

A randomised placebo-controlled trial of prolonged prednisolone administration to patients with HELLP syndrome remote from term.

OBJECTIVES: To evaluate the effect of prolonged administration of high-dose prednisolone on early onset HELLP (hemolysis, elevated liver enzymes, and low platelets) syndrome during expectant management. STUDY DESIGN: A randomized, double-blind trial was performed in 31 pregnant women with HELLP syndrome with an onset before 30 weeks gestation. Patients received either 50mg prednisolone or placebo intravenously twice a day. Primary outcome measures were the entry-to-delivery interval and the number of recurrent HELLP exacerbations in the antepartum period. RESULTS: Serious maternal morbidity was considerable, in particular in the placebo group where even on maternal occurred as a consequence of liver rupture. The mean entry-delivery interval did not differ between the prednisolone group (6.9 days) and the placebo group (8.0 days). However, patients in the prednisolone group had a significant lower risk of a recurrent HELLP exacerbation after the initial crisis had subsided, as compared to patients in the placebo group (HR 0.3, with 95% CI 0.3-0.9). Platelet count recovered faster in the prednisolone group as compared to the placebo group (mean 1.7 days versus 6.2 days, P<0.01). CONCLUSIONS: HELLP syndrome remote from term causes high risk for serious maternal morbidity and mortality. When expectant management is pursued in selected patients with a HELLP syndrome remote from term, prolonged administration of prednisolone reduces the risk of recurrent HELLP syndrome exacerbations.