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No consensus exists for the best way to monitor and when to trigger delivery in mothers of babies with fetal growth restriction. We aimed to assess whether changes in the fetal ductus venosus Doppler waveform (DV) could be used as indications for delivery instead of cardiotocography short-term variation (STV). In this prospective, European multicentre, unblinded, randomised study, we included women with singleton fetuses at 26–32 weeks of gestation who had very preterm fetal growth restriction (ie, low abdominal circumference [<10th percentile] and a high umbilical artery Doppler pulsatility index [>95th percentile]). We randomly allocated women 1:1:1, with randomly sized blocks and stratified by participating centre and gestational age (<29 weeks vs ≥29 weeks), to three timing of delivery plans, which differed according to antenatal monitoring strategies: reduced cardiotocograph fetal heart rate STV (CTG STV), early DV changes (pulsatility index >95th percentile; DV p95), or late DV changes (A wave [the deflection within the venous waveform signifying atrial contraction] at or below baseline; DV no A). The primary outcome was survival without cerebral palsy or neurosensory impairment, or a Bayley III developmental score of less than 85, at 2 years of age. We assessed outcomes in surviving infants with known outcomes at 2 years. We did an intention to treat study for all participants for whom we had data. Safety outcomes were deaths in utero and neonatal deaths and were assessed in all randomly allocated women. This study is registered with ISRCTN, number 56204499. Between Jan 1, 2005 and Oct 1, 2010, 503 of 542 eligible women were randomly allocated to monitoring groups (166 to CTG STV, 167 to DV p95, and 170 to DV no A). The median gestational age at delivery was 30·7 weeks (IQR 29·1–32·1) and mean birthweight was 1019 g (SD 322). The proportion of infants surviving without neuroimpairment did not differ between the CTG STV (111 [77%] of 144 infants with known outcome), DV p95 (119 [84%] of 142), and DV no A (133 [85%] of 157) groups (ptrend=0·09). 12 fetuses (2%) died in utero and 27 (6%) neonatal deaths occurred. Of survivors, more infants where women were randomly assigned to delivery according to late ductus changes (133 [95%] of 140, 95%, 95% CI 90–98) were free of neuroimpairment when compared with those randomly assigned to CTG (111 [85%] of 131, 95% CI 78–90; p=0.005), but this was accompanied by a non-significant increase in perinatal and infant mortality. Although the difference in the proportion of infants surviving without neuroimpairment was non-significant at the primary endpoint, timing of delivery based on the study protocol using late changes in the DV waveform might produce an improvement in developmental outcomes at 2 years of age. ZonMw, The Netherlands and Dr Hans Ludwig Geisenhofer Foundation, Germany.

Continuous electronic fetal heart-rate monitoring is widely used during labour, and computerised interpretation could increase its usefulness. We aimed to establish whether the addition of decision-support software to assist in the interpretation of cardiotocographs affected the number of poor neonatal outcomes. In this unmasked randomised controlled trial, we recruited women in labour aged 16 years or older having continuous electronic fetal monitoring, with a singleton or twin pregnancy, and at 35 weeks' gestation or more at 24 maternity units in the UK and Ireland. They were randomly assigned (1:1) to decision support with the INFANT system or no decision support via a computer-generated stratified block randomisation schedule. The primary outcomes were poor neonatal outcome (intrapartum stillbirth or early neonatal death excluding lethal congenital anomalies, or neonatal encephalopathy, admission to the neonatal unit within 24 h for ≥48 h with evidence of feeding difficulties, respiratory illness, or encephalopathy with evidence of compromise at birth), and developmental assessment at age 2 years in a subset of surviving children. Analyses were done by intention to treat. This trial is completed and is registered with the ISRCTN Registry, number 98680152. Between Jan 6, 2010, and Aug 31, 2013, 47 062 women were randomly assigned (23 515 in the decision-support group and 23 547 in the no-decision-support group) and 46 042 were analysed (22 987 in the decision-support group and 23 055 in the no-decision-support group). We noted no difference in the incidence of poor neonatal outcome between the groups—172 (0·7%) babies in the decision-support group compared with 171 (0·7%) babies in the no-decision-support group (adjusted risk ratio 1·01, 95% CI 0·82–1·25). At 2 years, no significant differences were noted in terms of developmental assessment. Use of computerised interpretation of cardiotocographs in women who have continuous electronic fetal monitoring in labour does not improve clinical outcomes for mothers or babies. National Institute for Health Research.

Background In Tanzania, 35% of pregnant women fail to complete four antenatal care (ANC) visits, increasing their risk for pregnancy-related complications, maternal mortality, and stillbirth. We evaluated the effectiveness of a Mobile Fetal Heart Monitor (Melody International Ltd, iCTG) device in improving pregnancy and childbirth outcomes in Tanzania. Methods We used a pragmatic, non-randomized clinical trial to evaluate the effectiveness of the 8-month implementation of iCTG. Pregnant women at 32 gestational age or above were monitored using iCTG in intervention facilities ( n  = 492), while control facilities ( n  = 271) continued standard care. The primary outcome was the completion of ≥ 4 ANC visits, with secondary outcomes including abnormal fetal heart rate (FHR) detection, birth method, institutional births, Apgar scores, and perinatal outcomes. Binary, multinomial, and Poisson regression models were used to determine the intervention effect. Results iCTG users were twice as likely to complete fewer than 4 ANC visits (OR: 2.5, 95% CI: 1.28–4.75, p  = 0.007). However, iCTG was associated with higher abnormal FHR detection rates (8.08, 95% CI: 2.51–26.02; p  < 0.001), increased risk of caesarean section ( p  < 0.001), reduced risk for Apgar scores < 7 at 5 min ( p  = 0.024) and fewer perinatal deaths ( p  = 0.003). There were no significant differences in newborn admission ( p  = 0.41) or institutional births ( p  = 0.26). Conclusion Implementing iCTG for antepartum FHR monitoring effectively detected abnormal FHR and was associated with improved newborn outcomes, highlighting its potential to improve perinatal outcomes in Tanzania. However, no effect was found on the number of ANC visits and institutional births. Further studies are needed to assess the effectiveness of iCTG in diverse populations and contexts and identify key factors for optimal implementation. Trial registration The study was registered in the University Hospital Medical Information Network (UMIN) Clinical Trial Registry (ID: UMIN000051932) on 18 August 2023. ( https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000058801 ).

AbstractObjectiveTo determine whether discontinuing oxytocin stimulation in the active phase of induced labour is associated with lower caesarean section rates.DesignInternational multicentre, double blind, randomised controlled trial.SettingNine hospitals in Denmark and one in the Netherlands between 8 April 2016 and 30 June 2020.Participants1200 women stimulated with intravenous oxytocin infusion during the latent phase of induced labour.InterventionWomen were randomly assigned to have their oxytocin stimulation discontinued or continued in the active phase of labour.Main outcome measureDelivery by caesarean section.ResultsA total of 607 women were assigned to discontinuation and 593 to continuation of the oxytocin infusion. The rates of caesarean section were 16.6% (n=101) in the discontinued group and 14.2% (n=84) in the continued group (relative risk 1.17, 95% confidence interval 0.90 to 1.53). In 94 parous women with no previous caesarean section, the caesarean section rate was 7.5% (11/147) in the discontinued group and 0.6% (1/155)in the continued group (relative risk 11.6, 1.15 to 88.7). Discontinuation was associated with longer duration of labour (median from randomisation to delivery 282 v 201 min; P<0.001), a reduced risk of hyperstimulation (20/546 (3.7%) v 70/541 (12.9%); P<0.001), and a reduced risk of fetal heart rate abnormalities (153/548 (27.9%) v 219/537 (40.8%); P<0.001) but rates of other adverse maternal and neonatal outcomes were similar between groups.ConclusionsIn a setting where monitoring of the fetal condition and the uterine contractions can be guaranteed, routine discontinuation of oxytocin stimulation may lead to a small increase in caesarean section rate but a significantly reduced risk of uterine hyperstimulation and abnormal fetal heart rate patterns.Trial registrationClinicalTrials.gov NCT02553226.

IntroductionFollowing the detection of fetal growth restriction, there is no consensus about the criteria that should trigger delivery in the late preterm period. The consequences of inappropriate early or late delivery are potentially important yet practice varies widely around the world, with abnormal findings from fetal heart rate monitoring invariably leading to delivery. Indices derived from fetal cerebral Doppler examination may guide such decisions although there are few studies in this area. We propose a randomised, controlled trial to establish the optimum method of timing delivery between 32 weeks and 36 weeks 6 days of gestation. We hypothesise that delivery on evidence of cerebral blood flow redistribution reduces a composite of perinatal poor outcome, death and short-term hypoxia-related morbidity, with no worsening of neurodevelopmental outcome at 2 years.Methods and analysisWomen with non-anomalous singleton pregnancies 32+0 to 36+6 weeks of gestation in whom the estimated fetal weight or abdominal circumference is <10th percentile or has decreased by 50 percentiles since 18–32 weeks will be included for observational data collection. Participants will be randomised if cerebral blood flow redistribution is identified, based on umbilical to middle cerebral artery pulsatility index ratio values. Computerised cardiotocography (cCTG) must show normal fetal heart rate short term variation (≥4.5 msec) and absence of decelerations at randomisation. Randomisation will be 1:1 to immediate delivery or delayed delivery (based on cCTG abnormalities or other worsening fetal condition). The primary outcome is poor condition at birth and/or fetal or neonatal death and/or major neonatal morbidity, the secondary non-inferiority outcome is 2-year infant general health and neurodevelopmental outcome based on the Parent Report of Children’s Abilities-Revised questionnaire.Ethics and disseminationThe Study Coordination Centre has obtained approval from London-Riverside Research Ethics Committee (REC) and Health Regulatory Authority (HRA). Publication will be in line with NIHR Open Access policy.Trial registration numberMain sponsor: Imperial College London, Reference: 19QC5491. Funders: NIHR HTA, Reference: 127 976. Study coordination centre: Imperial College Healthcare NHS Trust, Du Cane Road, London, W12 0HS with Centre for Trials Research, College of Biomedical & Life Sciences, Cardiff University. IRAS Project ID: 266 400. REC reference: 20/LO/0031. ISRCTN registry: 76 016 200.

Background The Moyo device is an easy-to-use device that allows continuous electronic fetal heart rate monitoring (FHRM). We explored the acceptability of using the Moyo device for continuous intrapartum FHRM in Eastern Uganda. Methods Between November 2023 and August 2024, we introduced the Moyo device for continuous intrapartum FHRM among mothers with high-risk pregnancies at Mbale Regional Referral Hospital in Eastern Uganda. We then conducted 34 in-depth interviews with 14 health workers who had used the Moyo device for continuous FHRM and with 20 mothers on whom the Moyo device was used. Participants were purposively selected and interviewed using a semi-structured interview guide. The interviews were audio recorded and transcribed verbatim. We analyzed data using thematic content analysis in Atlas ti.9 software and presented our findings using Sekhon’s acceptability model. Results Participants perceived the Moyo device as a useful and an easy-to-use tool for intrapartum FHRM. Mothers felt involved in monitoring their babies’ condition, with the freedom to ambulate during labour. Moyo facilitated early detection of fetal distress, and triage of patients awaiting caesarean section in a very busy setting. The facilitators to its use were: adequate staff training, health education and counselling of mothers about the device, and tool attributes such as accuracy, reliability and being user friendly. The barriers included poor health worker attitudes, risk of cross-infection, short battery life and the device alarms that were perceived as disturbances. Conclusion The Moyo device was acceptable to both health workers and mothers, with perceived improvements in both obstetric outcomes and birth experience. When introducing the device, careful attention needs to be paid to the training of both staff and the laboring women. Potential success of large scale roll out is supported by participants’ positive attitudes toward the Moyo and high perceived effectiveness.

Spinal anesthesia often causes hypotension, with consequent risk to the fetus. The use of vasopressor agents has been highly recommended for the prevention of spinal anesthesia-induced hypotension during caesarean delivery. Many studies have shown that norepinephrine can provide more stable maternal hemodynamics than phenylephrine. We therefore tested the hypothesis that norepinephrine preserves fetal circulation better than phenylephrine when used to treat maternal hypotension consequent to spinal anesthesia. Prospective, randomized, double-blinded study. Operating room. We recruited 223 parturients with uncomplicated singleton pregnancies who were scheduled for elective caesarean section under combined spinal-epidural anesthesia. The patients received prophylactic intravenous infusion of either 0.08 μg/kg/min norepinephrine or 0.5 μg/kg/min phenylephrine for prevention of spinal anesthesia-induced hypotension. Changes in fetal heart rate and fetal cardiac output before and after spinal anesthesia were measured using noninvasive Doppler ultrasound. 90 subjects who received norepinephrine infusion and 93 subjects who received phenylephrine infusion were ultimately analyzed in the present study. The effects of norepinephrine and phenylephrine on the change of fetal heart rate and fetal cardiac output at 3 and 6 min after spinal block were similar. Although there was a statistically significant decrease in fetal cardiac output at 6 min after subarachnoid block initiation in both the norepinephrine group (mean difference 0.02 L/min; 95% CI, 0–0.04 L/min; P = 0.03) and the phenylephrine group (mean difference 0.02 L/min; 95% CI, 0–0.04 L/min; P = 0.02), it remained within the normal range. Prophylactic infusion of comparable doses of phenylephrine or norepinephrine has similar effects on fetal heart rate and cardiac output changes after spinal anesthesia. Neither phenylephrine nor norepinephrine has meaningful detrimental effects on fetal circulation or neonatal outcomes. •Prophylactic infusion of comparable doses of phenylephrine or norepinephrine has similar effects on fetal heart rate and cardiac output changes after spinal anesthesia.•Neither phenylephrine nor norepinephrine has meaningful detrimental effects on fetal circulation.

Background Newborns are at the greatest risk for dying during the intrapartum period, including labor and delivery, and the first day of life. Fetal heart rate monitoring (FHRM) and partogram use to track labor progress are evidence-based techniques that can help to identify maternal and fetal risk factors so that these can be addressed early. The objective of this study was to assess health worker adherence to protocols for FHRM and partogram use during the intrapartum period, and to assess the association between adherence and intrapartum stillbirth in a tertiary hospital of Nepal. Methods A case-referent study was conducted over a 15-month period. Cases included all intrapartum stillbirths, while 20 % of women with live births were randomly selected on admission to make up the referent population. The frequency of FHRM and the use of partogram were measured and their association to intrapartum stillbirth was assessed using logistic regression analysis. Results During the study period, 4,476 women with live births were enrolled as referents and 136 with intrapartum stillbirths as cases. FHRM every 30 min was only completed in one-fourth of the deliveries, and labor progress was monitored using a partogram in just over half. With decreasing frequency of FHRM, there was an increased risk of intrapartum stillbirth; FHRM at intervals of more than 30 min resulted in a four-fold risk increase for intrapartum stillbirth (aOR 4.17, 95 % CI 2.0–8.7), and the likelihood of intrapartum stillbirth increased seven times if FHRM was performed less than every hour or not at all (aOR 7.38, 95 % CI 3.5–15.4). Additionally, there was a three-fold increased risk of intrapartum stillbirth if the partogram was not used (aOR 3.31, 95 % CI 2.0–5.4). Conclusion The adherence to FHRM and partogram use was inadequate for monitoring intrapartum progress in a tertiary hospital of Nepal. There was an increased risk of intrapartum stillbirth when fetal heart rate was inadequately monitored and when the progress of labor was not monitored using a partogram. Further exploration is required in order to determine and understand the barriers to adherence; and further, to develop tools, techniques and interventions to prevent intrapartum stillbirth. Clinical trial registration ISRCTN97846009 .

Background While the effectiveness of cardiotocography in reducing neonatal morbidity is still debated, it remains the primary method for assessing fetal well-being during labor. Evaluating how accurately professionals interpret cardiotocography signals is essential for its effective use. The objective was to evaluate the accuracy of fetal hypoxia prediction by practitioners through the interpretation of cardiotocography signals and clinical variables during labor. Material and methods We conducted a cross-sectional online survey, involving 120 obstetric healthcare providers from several countries. One hundred cases, including fifty cases of fetal hypoxia, were randomly assigned to participants who were invited to predict the fetal outcome (binary criterion of pH with a threshold of 7.15) based on the cardiotocography signals and clinical variables. After describing the participants, we calculated (with a 95% confidence interval) the success rate, sensitivity and specificity to predict the fetal outcome for the whole population and according to pH ranges, professional groups and number of years of experience. Interobserver agreement and reliability were evaluated using the proportion of agreement and Cohen’s kappa respectively. Results The overall ability to predict a pH level below 7.15 yielded a success rate of 0.58 (95% CI 0.56-0.60), a sensitivity of 0.58 (95% CI 0.56-0.60) and a specificity of 0.63 (95% CI 0.61-0.65). No significant difference in the success rates was observed with respect to profession and number of years of experience. The success rate was higher for the cases with a pH level below 7.05 (0.69) and above 7.20 (0.66) compared to those falling between 7.05 and 7.20 (0.48). The proportion of agreement between participants was good (0.82), with an overall kappa coefficient indicating substantial reliability (0.63). Conclusions The use of an online tool enabled us to collect a large amount of data to analyze how practitioners interpret cardiotocography data during labor. Despite a good level of agreement and reliability among practitioners, the overall accuracy is poor, particularly for cases with a neonatal pH between 7.05 and 7.20. Factors such as profession and experience level do not present notable impact on the accuracy of the annotations. The implementation and use of a computerized cardiotocography analysis software has the potential to enhance the accuracy to detect fetal hypoxia, especially for ambiguous cardiotocography tracings.

Background The clinical diagnosis of late Fetal Growth Restriction (FGR) involves the integration of Doppler ultrasound data and Fetal Heart Rate (FHR) monitoring through computer assisted computerized cardiotocography (cCTG). The aim of the study was to evaluate the diagnostic power of combined Doppler and cCTG parameters by contrasting late FGR –and healthy controls. Methods The study was conducted from January 2018 to May 2020. Only pregnant women who had the last Doppler measurement obtained within 1 week before delivery and cCTG performed within 24 h before delivery were included in the study. Two hundred forty-nine pregnant women fulfilling the inclusion criteria were enrolled in the study; 95 were confirmed as late FGR and 154 were included in the control group. Results Among the extracted cCTG parameters, Delta Index, Short Term Variability (STV), Long Term Variability (LTV), Acceleration and Deceleration Phase Rectified Slope (APRS, DPRS) values were lower in the late FGR participants compared to the control group. In the FGR cohort, Delta, STV, APRS, and DPRS were found different when stratifying by MCA_PI (MCA_PI <5th centile or > 5th centile). STV and DPRS were the only parameters to be found different when stratifying by (UA_PI >95th centile or UA_PI <95th centile). Additionally, we measured the predictive power of cCTG parameters toward the identification of associated Doppler measures using figures of merit extracted from ROC curves. The AUC of ROC curves were accurate for STV (0,70), Delta (0,68), APRS (0,65) and DPRS (0,71) when UA_PI values were > 95th centile while, the accuracy attributable to the prediction of MCA_PI was 0.76, 0.77, 0.73, and 0.76 for STV, Delta, APRS, and DPRS, respectively. An association of UA_PI>95th centile and MCA_PI<5th centile with higher risk for NICU admission, was observed, while CPR < 5th centile resulted not associated with any perinatal outcome. Values of STV, Delta, APRS, DPRS were significantly lower for FGR neonates admitted to NICU, compared with the uncomplicated FGR cohort. Conclusions The results of this study show the contribution of advanced cCTG parameters and fetal Doppler to the identification of late FGR and the association of those parameters with the risk for NICU admission. Trial registration Retrospectively registered.