Short report: Post-operative wound infections after the gentle caesarean section.

OBJECTIVES: Worldwide, the caesarean section (CS) is the most performed type of surgery and numbers are still rising. The gentle CS has become a more common procedure as it allows the parents to experience birth. Early and continuous skin-to-skin contact between the mother and her newborn is pursued. Parents are not separated from their newborns and stay with their child in the operation theatre and recovery room. However, data are limited on the incidence of surgical site infections (SSI) after gentle CS. The aim of our study was to examine the risk of postoperative wound infections after gentle CS. Secondary outcomes included other maternal complications and neonatal outcomes. STUDY DESIGN: In this multicenter prospective cohort study, all women who underwent an elective gentle CS between January 2015 and January 2017 were eligible. Demographics, per procedural data, maternal complications and neonatal outcomes were collected. The follow-up lasted until six weeks post partum. RESULTS: Of the 243 performed CSs, two (0.8%) SSIs occurred; one superficial and one deep wound infection. One patient (0.4%) was readmitted for treatment of endometritis. In total, 20 (8.2%) maternal complications were identified. Median time to skin-to-skin contact was 3 minutes (IQR 2-4.25) with a median neonatal oxygen saturation 10 minutes after birth of 95% (IQR 92-98). Mean gestational age was 274 ±â€¯4.1 days (39 + 1 weeks) and mean neonatal pH was 7.28 (±SD 0.07). All children had Apgar scores >7 at 5 minutes after birth. Neonatal admission occurred in 19 cases (7.8%) and neonatal readmission in 10 cases (4.1%). CONCLUSION: The gentle CS seems to be a safe procedure for both mother and child and is not associated with an increased risk of surgical site infections or direct suboptimal neonatal outcomes. Therefore, more intensive mother-child interaction during CS is allowed.

Pharmacological pain relief and fear of childbirth in low risk women; secondary analysis of the RAVEL study.

BACKGROUND: Fear of childbirth may reduce the womens' pain tolerance during labour and may have impact on the mother-infant interaction. We aimed to assess (1) the association between fear of childbirth antepartum and subsequent request for pharmacological pain relief, and (2) the association between the used method of pain relief and experienced fear of childbirth as reported postpartum in low risk labouring women. METHODS: Secondary analysis of the RAVEL study, a randomised controlled trial comparing remifentanil patient controlled analgesia (PCA) and epidural analgesia to relieve labour pain. The RAVEL study included 409 pregnant women at low risk for obstetric complications at 18 midwifery practices and six hospitals in The Netherlands (NTR 3687). We measured fear of childbirth antepartum and experienced fear of childbirth reported postpartum, using the Wijma Delivery Expectancy/Experience Questionnaire. RESULTS: Women with fear of childbirth antepartum more frequently requested pain relief compared to women without fear of childbirth antepartum, but this association did not reach statistical significance (adjusted odds ratio (aOR2.0; 95% confidence interval (CI) 0.8-4.6). Women who received epidural analgesia more frequently reported fear of childbirth postpartum compared to women who did not receive epidural analgesia (aOR3.5; CI 1.5-8.2), while the association between remifentanil-PCA and fear of childbirth postpartum was not statistically significant (aOR1.7; CI 0.7-4.3). CONCLUSIONS: Women with fear of childbirth antepartum more frequently requested pain relief compared to women without fear of childbirth antepartum, but this association was not statistically significant. Women who received pharmacological pain relief more frequently reported that they had experienced fear of childbirth during labour compared to women who did not receive pain relief. Based on our data epidural analgesia with continuous infusion does not seem to be preferable over remifentanil-PCA as method of pain relief when considering fear of childbirth postpartum. TRIAL REGISTRATION: Netherlands Trial Register 3687 ; Register date: 5 Nov 2012.

[Practice variation in the application of remifentanil during labour; an overview of its application in Dutch hospitals]. / Praktijkvariatie in het gebruik van remifentanil tijdens de partus.

OBJECTIVE: To survey (a) the frequency of the use of patient-controlled analgesic remifentanil-PCA during labour in the Netherlands; (b) considerations by obstetricians whether or not to offer remifentanil-PCA; (c) target population for remifentanil-PCA and (d) the application of maternal monitoring. DESIGN: Descriptive survey. METHOD: A questionnaire was sent to all 81 Dutch hospitals with a labour ward. The following subjects were covered: (a) available methods for pharmacological pain relief; (b) considerations by obstetricians whether or not to offer remifentanil-PCA; (c) target population for remifentanil-PCA; (d) maternal monitoring and (e) the hospital's birth data for the year 2016. The hospital pharmacist was asked for the number of remifentanil dispensed in 2016-2017. RESULTS: The questionnaire was completed by 81 obstetricians (100% response rate). Remifentanil-PCA was available in 59 out of 81 (73%) of the hospitals with a mean use of 23% of the births (range 16-56%) in those units. In 34 (58%) of these hospitals, remifentanil-PCA is available for all women, and in 25 (42%) it was for a selected group of women. Most frequently mentioned considerations for offering remifentanil-PCA were 'a need for an alternative for epidural analgesia' and 'at the request of pregnant women' reported a respective 55 (93%) and 46 (78%) times. In hospitals where remifentanil-PCA was not offered, the following motives were given for this policy: 'epidural analgesia is the most effective method of pain relief during labour'; 'risk of serious maternal complications'; and 'sufficient monitoring during labour not feasible in delivery rooms'. CONCLUSION: A large variation between Dutch hospitals exists in the application of remifentanil-PCA during labour. In the majority of the hospitals, remifentanil-PCA is available for all women. The most common motives mentioned by obstetricians for its use are 'a need for an alternative for epidural analgesia' and 'at the request of pregnant women'.

[Remifentanil during labour; has its place in pain relief during labour been decided?] / Remifentanil tijdens de bevalling.

Patient-controlled analgesia using remifentanil (remifentanil PCA) has been used as a new form of pain relief during labour since soon after its release on the market. Reduction in pain scores lasts for 1 to 2 hours, and the analgesia is inferior to that of an epidural. Remifentanil PCA can be an alternative for epidural analgesia in cases where the woman cannot or does not want to receive epidural anaesthesia. In some hospitals in the Netherlands remifentanil PCA is being used on a large scale, possibly because of its less invasive character and for logistical reasons. The Netherlands RAVEL study comparing remifentanil with epidural analgesia showed greater satisfaction with pain relief in the epidural group. There is a high risk of hypoventilation during remifentanil PCA use, leading to desaturation; since desaturation can be a late consequence of hypoventilation, adequate monitoring of the woman is essential. It would be ideal to monitor the frequency and depth of ventilation along with peripheral saturation, and one-on-one care of the woman is advised.

Neonatal Safety of Elective Family-Centered Caesarean Sections: A Cohort Study.

BACKGROUND: Although little data are available concerning safety for newborns, family-centered caesarean sections (FCS) are increasingly implemented. With FCS mothers can see the delivery of their baby, followed by direct skin-to-skin contact. We evaluated the safety for newborns born with FCS in the Leiden University Medical Center (LUMC), where FCS was implemented in June 2014 for singleton pregnancies with a gestational age (GA) ≥38 weeks and without increased risks for respiratory morbidity. METHODS: The incidence of respiratory pathology, unplanned admission, and hypothermia in infants born after FCS in LUMC were retrospectively reviewed and compared with a historical cohort of standard elective cesarean sections (CS). RESULTS: From June 2014 to November 2015, 92 FCS were performed and compared to 71 standard CS in 2013. Incidence of respiratory morbidity, hypothermia, temperatures at arrival at the department, GA, and birth weight were comparable (ns). Unplanned admission occurred more often after FCS when compared to standard CS (21 vs 7%; p = 0.03), probably due to peripheral oxygen saturation (SpO2) monitoring. There was no increase in respiratory pathology (8 vs 6%, ns). One-third of the babies were separated from their mother during or after FCS. CONCLUSION: Unplanned neonatal admissions after elective CS increased after implementing FCS, without an increase in respiratory morbidity or hypothermia. SpO2 monitoring might have a contribution. Separation from the mother occurred often.

A retrospective study on persistent pain after childbirth in the Netherlands.

Reported prevalence rates of persistent postpartum pain (PPP) range from less than 1% to almost 20%. The aim of this study was to examine the prevalence of PPP in a Dutch cohort and to evaluate a possible causal role for specific risk factors on the development of chronic pain after childbirth. A questionnaire was sent to 960 postpartum women approximately 2 years after delivery. Primary outcome was pain that arose from childbirth at follow-up, and secondary outcomes included quality of life (QoL) and Hospital Anxiety and Depression Scale scores. Tested risk factors included mode of labor analgesia, history of negative effect, history of chronic pain, delivery route, parity, and ethnicity. A total of 495 (51.6%) women participated. At a mean time of 2.3 postpartum years, 7.3% of women reported any pain and 6.1% reported significant pain related to the delivery. Compared to spontaneous delivery, cesarean delivery provided protection against persistent pain (odds ratio, 0.12; 95% CI, 0.01-0.63, P<0.05). None of the other risk factors, including remifentanil use for labor pain, were of influence on the prevalence of persistent pain. Women with PPP experienced greater negative effects and had lower QoL scores compared to women without pain. In this cohort of Dutch patients, PPP is a serious problem with a great impact on the physical and mental health of women.

Calculating Preference Weights for the Labor and Delivery Index: A Discrete Choice Experiment on Women's Birth Experiences.

OBJECTIVE: The aim of this study was to calculate preference weights for the Labor and Delivery Index (LADY-X) to make it suitable as a utility measure for perinatal care studies. METHODS: In an online discrete choice experiment, 18 pairs of hypothetical scenarios were presented to respondents, from which they had to choose a preferred option. The scenarios describe the birth experience in terms of the seven LADY-X attributes. A D-efficient discrete choice experiment design with priors based on a small sample (N = 110) was applied. Two samples were gathered, women who had recently given birth and subjects from the general population. Both samples were analyzed separately using a panel mixed logit (MMNL) model. Using the panel mixed multinomial logit (MMNL) model results and accounting for preference heterogeneity, we calculated the average preference weights for LADY-X attribute levels. These were transformed to represent a utility score between 0 and 1, with 0 representing the worst and 1 representing the best birth experience. RESULTS: In total, 1097 women who had recently given birth and 367 subjects from the general population participated. Greater value was placed on differences between bottom and middle attribute levels than on differences between middle and top levels. The attributes that resulted in larger utility increases than the other attributes were "feeling of safety" in the sample of women who had recently given birth and "feeling of safety" and "availability of professionals" in the general population sample. CONCLUSIONS: By using the derived preference weights, LADY-X has the potential to be used as a utility measure for perinatal (cost-) effectiveness studies.

Good reliability and validity for a new utility instrument measuring the birth experience, the Labor and Delivery Index.

OBJECTIVES: To validate the Labor and Delivery Index (LADY-X), a new delivery-specific utility measure. STUDY DESIGN AND SETTING: In a test-retest design, women were surveyed online, 6 to 8 weeks postpartum and again 1 to 2 weeks later. For reliability testing, we assessed the standard error of measurement (S.E.M.) and the intraclass correlation coefficient (ICC). For construct validity, we tested hypotheses on the association with comparison instruments (Mackey Childbirth Satisfaction Rating Scale and Wijma Delivery Experience Questionnaire), both on domain and total score levels. We assessed known-group differences using eight obstetrical indicators: method and place of birth, induction, transfer, control over pain medication, complications concerning mother and child, and experienced control. RESULTS: The questionnaire was completed by 308 women, 257 (83%) completed the retest. The distribution of LADY-X scores was skewed. The reliability was good, as the ICC exceeded 0.80 and the S.E.M. was 0.76. Requirements for good construct validity were fulfilled: all hypotheses for convergent and divergent validity were confirmed, and six of eight hypotheses for known-group differences were confirmed as all differences were statistically significant (P-values: <0.001-0.023), but for two tests, difference scores did not exceed the S.E.M. CONCLUSION: The LADY-X demonstrates good reliability and construct validity. Despite its skewed distribution, the LADY-X can discriminate between groups. With the preference weights available, the LADY-X might fulfill the need for a utility measure for cost-effectiveness studies for perinatal care interventions.

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.

A comprehensive representation of the birth-experience: identification and prioritization of birth-specific domains based on a mixed-method design.

BACKGROUND: In obstetrics, effectiveness and cost-effectiveness studies often present several specific outcomes with likely contradicting results and may not reflect what is important for women. A birth-specific outcome measure that combines the core domains into one utility score would solve this problem. The aim of this study was to investigate which domains are most relevant for women's overall experience of labor and birth and should be included in such a measure. METHODS: A sequential mixed-method design with three steps was applied. First, the domains were identified by literature review and online focus groups consisting of pregnant women, women who recently gave birth, and their partners. Second, in a prioritizing task, women who recently gave birth and professionals (midwives, gynecologists, and researchers) selected and ranked their top seven domains. Third, the domains that were most frequently selected and had the highest ranking scores determined the basis for a consensus discussion with experts, whereby the definitive list of domains was formed. RESULTS: In the first step, 34 birth-specific domains were identified, which cover domains regarding the caregivers, intrapersonal aspects of the mother, partner support, and contextual and medical aspects of birth. Based on the prioritizing task results (step 2) of 96 women and 89 professionals, this list was reduced to 14 most relevant domains. In a consensus discussion, the final seven domains were selected by combining several of the 14 remaining domains and giving priority to the domains indicated to be relevant by mothers. The seven definite domains were: 1) availability of competent health professionals; 2) health professionals' support; 3) provision of information; 4) health professionals' response to needs and requests; 5) feelings of safety; 6) worries about the child's health; and 7) experienced duration until the first contact with the child. CONCLUSIONS: The experienced availability and quality of received care, concerns about safety and the baby's health, and first contact with the baby are regarded as key aspects for a mother's overall birth experience. Therefore, these domains are considered to be the most crucial for inclusion in a birth-specific outcome measure.

Remifentanil patient controlled analgesia versus epidural analgesia in labour. A multicentre randomized controlled trial.

BACKGROUND: Pain relief during labour is a topic of major interest in the Netherlands. Epidural analgesia is considered to be the most effective method of pain relief and recommended as first choice. However its uptake by pregnant women is limited compared to other western countries, partly as a result of non-availability due to logistic problems. Remifentanil, a synthetic opioid, is very suitable for patient controlled analgesia. Recent studies show that epidural analgesia is superior to remifentanil patient controlled analgesia in terms of pain intensity score; however there was no difference in satisfaction with pain relief between both treatments. METHODS/DESIGN: The proposed study is a multicentre randomized controlled study that assesses the cost-effectiveness of remifentanil patient controlled analgesia compared to epidural analgesia. We hypothesize that remifentanil patient controlled analgesia is as effective in improving pain appreciation scores as epidural analgesia, with lower costs and easier achievement of 24 hours availability of pain relief for women in labour and efficient pain relief for those with a contraindication for epidural analgesia.Eligible women will be informed about the study and randomized before active labour has started. Women will be randomly allocated to a strategy based on epidural analgesia or on remifentanil patient controlled analgesia when they request pain relief during labour. Primary outcome is the pain appreciation score, i.e. satisfaction with pain relief.Secondary outcome parameters are costs, patient satisfaction, pain scores (pain-intensity), mode of delivery and maternal and neonatal side effects.The economic analysis will be performed from a short-term healthcare perspective. For both strategies the cost of perinatal care for mother and child, starting at the onset of labour and ending ten days after delivery, will be registered and compared. DISCUSSION: This study, considering cost effectiveness of remifentanil as first choice analgesia versus epidural analgesia, could strongly improve the care for 180.000 women, giving birth in the Netherlands yearly by giving them access to pain relief during labour, 24 hours a day. TRIAL REGISTRATION NUMBER: Dutch Trial Register NTR2551, http://www.trialregister.nl.

Feasibility of nonselective testing for hemoglobinopathies in early pregnancy in The Netherlands.

OBJECTIVE: To examine the feasibility of standardized hemoglobinopathy (HBP) carrier testing for pregnant women in The Netherlands in addition to the standard anemia screening. METHODS: We assessed the prevalence of HBP in women at the time of the first pregnancy visit using both a prospective cohort (N = 703) and a retrospective series of women selected at random (N = 588). For the purpose of analysis, the population was divided into a high risk and a low risk group for HBP based on maternal ethnicity. Screening for HBP utilized standard screening tests for anemia, with additional high performance liquid chromatography (Variant II); molecular analysis was performed by Gap-polymerase chain reaction (Gap-PCR) and if necessary, direct sequencing and multiplex ligation-dependent probe amplification (MLPA). Family history was reported or collected from the medical records. RESULTS: ß-Globin defects were found in 3.9% of the total population (50/1291). The frequency in the high risk population was 5.6% (37/656), compared with 1.2% (6/501) in the low risk group. In the prospective study we found 30 HBP carriers, leading to testing of 16 partners and identification of two couples at risk. One affected child was born. Mean gestational age at the screening was 11.3 weeks with a standard deviation (SD) of 5.8. CONCLUSION: We found that the prevalence of HBP carriers is high enough in our population to warrant HBP testing for the entire multiethnic population in early pregnancy at the time of anemia screening. This is feasible as most women had their booking early in their first trimester.