Maternal Diabetes and Intrapartum Fetal Electrocardiogram.

OBJECTIVE: Fetal electrocardiogram (ECG) ST changes are associated with fetal cardiac hypoxia. Our objective was to evaluate ST changes by maternal diabetic status and stage of labor. METHODS: This was a secondary analysis of a multicentered randomized-controlled trial in which laboring patients with singleton gestations underwent fetal ECG scalp electrode placement and were randomly assigned to masked or unmasked ST-segment readings. Our primary outcome was the frequency of fetal ECG tracings with ST changes by the stage of labor. ECG tracings were categorized into mutually exclusive groups (ST depression, ST elevation without ST depression, or no ST changes). We compared participants with DM, gestational diabetes mellitus (GDM), and no DM. RESULTS: Of the 5,436 eligible individuals in the first stage of labor (95 with pregestational DM and 370 with GDM), 4,427 progressed to the second stage. ST depression occurred more frequently in the first stage of labor in participants with pregestational DM (15%, adjusted odds ratio [aOR] 2.20, 95% confidence interval [CI] 1.14-4.24) and with GDM (9.5%, aOR 1.51, 95% CI 1.02-2.25) as compared with participants without DM (5.7%). The frequency of ST elevation was similar in participants with pregestational DM (33%, aOR 0.79, 95% CI 0.48-1.30) and GDM (33.2%, aOR 0.91, 95% CI 0.71-1.17) as compared with those without DM (34.2%). In the second stage, ST depression did not occur in participants with pregestational DM (0%) and occurred more frequently in participants with GDM (3.5%, aOR 2.01, 95% CI 1.02-3.98) as compared with those without DM (2.0%). ST elevation occurred more frequently in participants with pregestational DM (30%, aOR 1.81, 95% CI 1.02-3.22) but not with GDM (19.0%, aOR 1.06, 95% CI 0.77-1.47) as compared with those without DM (17.8%). CONCLUSION: ST changes in fetal ECG occur more frequently in fetuses of diabetic mothers during labor. CLINICALTRIALS: gov number, NCT01131260. PRECIS: ST changes in fetal ECG, a marker of fetal cardiac hypoxia, occur more frequently in fetuses of diabetic parturients. KEY POINTS: · Fetal hypertrophic cardiomyopathy (HCM) and cardiac dysfunction occur frequently among fetuses of diabetic patients.. · Fetal ECG changes such as ST elevation and depression reflect cardiac hypoxia.. · Fetuses of diabetic patients demonstrate a higher prevalence of fetal ECG tracings with ST changes..

Intrapartum Fetal Electrocardiogram in Small- and Large-for-Gestational Age Fetuses.

OBJECTIVE: This study aimed to evaluate whether intrapartum fetal electrocardiogram (ECG) tracings with ST-elevation or depression occur more frequently in each stage of labor in small-for-gestational age (SGA) or large-for-gestational age (LGA), as compared with appropriate-for-gestational age (AGA) fetuses. STUDY DESIGN: We conducted a secondary analysis of a large, multicenter trial in which laboring patients underwent fetal ECG waveform-analysis. We excluded participants with diabetes mellitus and major fetal anomalies. Birth weight was categorized as SGA (<10th percentile), LGA (>90th percentile), or AGA (10-90th percentile) by using a gender and race/ethnicity specific nomogram. In adjusted analyses, the frequency of ECG tracings with ST-depression or ST-elevation without depression was compared according to birthweight categories and labor stage. RESULTS: Our study included 4,971 laboring patients in the first stage and 4,074 in the second stage. During the first stage of labor, there were no differences in the frequency of ST-depression in SGA fetuses compared with AGA fetuses (6.7 vs. 5.5%; adjusted odds ratio [aOR]: 1.41, 95% confidence interval [CI]: 0.93-2.13), or in ST-elevation without depression (35.8 vs. 34.1%; aOR: 1.17, 95% CI: 0.94-1.46). During the second stage, there were no differences in the frequency of ST-depression in SGA fetuses compared with AGA fetuses (1.6 vs. 2.0%; aOR: 0.69, 95% CI: 0.27-1.73), or in ST-elevation without depression (16.2 vs. 18.1%; aOR: 0.90, 95% CI: 0.67-1.22). During the first stage of labor, there were no differences in the frequency of ST-depression in LGA fetuses compared with AGA fetuses (6.3 vs. 5.5%; aOR: 0.97, 95% CI: 0.60-1.57), or in ST-elevation without depression (33.1 vs. 34.1%; aOR: 0.80, 95% CI: 0.62-1.03); during the second stage of labor, the frequency of ST-depression in LGA compared with AGA fetuses (2.5 vs. 2.0%, aOR: 1.36, 95% CI: 0.61-3.03), and in ST-elevation without depression (15.5 vs. 18.1%; aOR: 0.83, 95% CI: 0.58-1.18) were similar as well. CONCLUSION: The frequency of intrapartum fetal ECG tracings with ST-events is similar among SGA, AGA, and LGA fetuses. KEY POINTS: · SGA and LGA neonates are at increased risk of cardiac dysfunction.. · Fetal ECG has been used to evaluate fetal response to hypoxia.. · Fetal ST-elevation and ST-depression occur during hypoxia.. · Frequency of intrapartum ST-events is similar among SGA, AGA and LGA fetuses..

A Randomized Trial of Intrapartum Fetal ECG ST-Segment Analysis.

BACKGROUND: It is unclear whether using fetal electrocardiographic (ECG) ST-segment analysis as an adjunct to conventional intrapartum electronic fetal heart-rate monitoring modifies intrapartum and neonatal outcomes. METHODS: We performed a multicenter trial in which women with a singleton fetus who were attempting vaginal delivery at more than 36 weeks of gestation and who had cervical dilation of 2 to 7 cm were randomly assigned to "open" or "masked" monitoring with fetal ST-segment analysis. The masked system functioned as a normal fetal heart-rate monitor. The open system displayed additional information for use when uncertain fetal heart-rate patterns were detected. The primary outcome was a composite of intrapartum fetal death, neonatal death, an Apgar score of 3 or less at 5 minutes, neonatal seizure, an umbilical-artery blood pH of 7.05 or less with a base deficit of 12 mmol per liter or more, intubation for ventilation at delivery, or neonatal encephalopathy. RESULTS: A total of 11,108 patients underwent randomization; 5532 were assigned to the open group, and 5576 to the masked group. The primary outcome occurred in 52 fetuses or neonates of women in the open group (0.9%) and 40 fetuses or neonates of women in the masked group (0.7%) (relative risk, 1.31; 95% confidence interval, 0.87 to 1.98; P=0.20). Among the individual components of the primary outcome, only the frequency of a 5-minute Apgar score of 3 or less differed significantly between neonates of women in the open group and those in the masked group (0.3% vs. 0.1%, P=0.02). There were no significant between-group differences in the rate of cesarean delivery (16.9% and 16.2%, respectively; P=0.30) or any operative delivery (22.8% and 22.0%, respectively; P=0.31). Adverse events were rare and occurred with similar frequency in the two groups. CONCLUSIONS: Fetal ECG ST-segment analysis used as an adjunct to conventional intrapartum electronic fetal heart-rate monitoring did not improve perinatal outcomes or decrease operative-delivery rates. (Funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development and Neoventa Medical; ClinicalTrials.gov number, NCT01131260.).

Intrapartum Resuscitation Interventions for Category II Fetal Heart Rate Tracings and Improvement to Category I.

OBJECTIVE: To evaluate intrapartum resuscitation interventions and improvement in category II fetal heart rate (FHR) tracings. METHODS: This secondary analysis of a randomized trial of intrapartum fetal electrocardiographic ST-segment analysis included all participants with category II FHR tracings undergoing intrauterine resuscitation: maternal oxygen, intravenous fluid bolus, amnioinfusion, or tocolytic administration. Fetal heart rate pattern-recognition software was used to confirm category II FHR tracings 30 minutes before intervention and to analyze the subsequent 60 minutes. The primary outcome was improvement to category I within 60 minutes. Secondary outcomes included FHR tracing improvement to category I 30-60 minutes after the intervention and composite neonatal outcome. RESULTS: Of 11,108 randomized participants, 2,251 (20.3%) had at least one qualifying intervention for category II FHR tracings: 63.7% improved to category I within 60 minutes and 50.5% improved at 30-60 minutes. Only 3.4% underwent cesarean delivery and 4.1% an operative vaginal delivery for nonreassuring fetal status within 60 minutes after the intervention. Oxygen administration was the most common intervention (75.4%). Among American College of Obstetricians and Gynecologists-defined subgroups that received oxygen, the absent FHR accelerations and absent-minimal FHR variability subgroup (n=332) was more likely to convert to category I within 60 minutes than the FHR accelerations or "moderate FHR variability" subgroup (n=1,919) (77.0% vs 63.0%, odds ratio [OR] 2.0, 95% CI 1.4-2.7). The incidence of composite neonatal adverse outcome for category II tracings was 2.9% (95% CI 2.2-3.7%) overall; 2.8% (95% CI 2.0-3.8%) for improvement to category I within 60 minutes (n=1,433); and 3.2% (95% CI 2.1-4.6%) for no improvement within 60 minutes (n=818). However, the group with improvement had 29% lower odds for higher level neonatal care (11.8% vs 15.9%, OR 0.71, 95% CI 0.55-0.91). CONCLUSION: Nearly two thirds of category II FHR tracings improved to category I within 60 minutes of intervention with a relatively low overall rate of the composite neonatal adverse outcome. FUNDING SOURCE: Funded in part by Neoventa Medical.

Maternal Pulse Pressure and the Risk of Postepidural Complications: A Randomized Controlled Trial.

OBJECTIVE: To test the hypothesis that increasing the intravenous fluid bolus volume at the time of epidural placement in women with narrow pulse pressure would reduce postepidural fetal heart rate (FHR) abnormalities, hypotension, and resuscitative obstetric interventions. METHODS: We performed a single-center randomized controlled trial. Eligible participants were normotensive with a nonanomalous singleton gestation at or after 35 weeks and with a narrow pulse pressure (less than 45 mm Hg) on admission. Enrolled patients remained eligible for randomization at epidural request if they were within 6 hours of admission and the FHR remained category 1. Patients were allocated to a 500-mL (institutional standard) or 1,500-mL intravenous fluid bolus at epidural placement. A reference group with admission pulse pressure 50 mm Hg or greater was also evaluated. The primary outcome was a category 2 or 3 FHR pattern within 60 minutes after the epidural test dose. Evaluated secondary outcomes included maternal hypotension and composite resuscitative interventions to correct FHR abnormalities or hypotension. We calculated that 276 women (138/group) would provide 80% power to detect a relative 50% reduction in the occurrence of the primary outcome from 27% in the 500-mL group to 13.5% in the 1,500-mL group (two-sided α=0.05). RESULTS: From October 2015 to November 2016, 276 women were allocated to receive a 500-mL (n=139) or 1,500-mL (n=137) fluid bolus. One hundred thirty-eight women were evaluated in the reference group. Demographic, obstetric, and labor characteristics were similar between groups. The 1,500-mL group had significantly fewer postepidural FHR abnormalities (38.0% compared with 51.8%, relative risk 0.73, 95% CI 0.56-0.96, P=.02). Maternal systolic hypotension (10.2% compared with 34.5%, relative risk 0.30, 95% CI 0.17-0.51, P<.001) and composite postepidural interventions (18.3% compared with 44.2%, relative risk 0.42, 95% CI 0.28-0.62, P<.001) were also less frequent in the 1,500-mL group. Fetal heart rate abnormalities remained significantly less frequent in the reference group than among women with a narrow pulse pressure on admission for delivery. CONCLUSION: A 1,500-mL intravenous fluid bolus in women with a narrow pulse pressure decreases the risk of postepidural FHR abnormalities (number needed to treat=7), results in less frequent postepidural hypotension, and reduces the need for resuscitative interventions. Admission pulse pressure may be used to individualize intrapartum fluid management at the time of initiation of neuraxial labor analgesia. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT02565485.

Can hemoglobin A1c in early pregnancy predict adverse pregnancy outcomes in diabetic patients?

OBJECTIVE: To examine the association of elevated early pregnancy hemoglobin A1c (HbA1c) levels with adverse pregnancy outcomes in women with preexisting diabetes mellitus. STUDY DESIGN: Retrospective cohort study of 330 women with preexisting diabetes enrolled in a Diabetes in Pregnancy Program at an academic institution between 2003 and 2011 who had an early HbA1c determination. The frequencies of composite maternal adverse pregnancy outcomes (birth at<37 weeks, preeclampsia, and medically indicated birth <39 weeks), and composite fetal adverse pregnancy outcomes [shoulder dystocia, Apgar scores<7 at 5 minutes, small for gestational age (SGA), large for gestational age (LGA), and stillbirth] were compared between HbA1c categories (<6.5, 6.5-7.4, 7.5-8.4 and ≥ 8.5%). RESULTS: There was no statistically significant difference between composite adverse maternal pregnancy outcomes and composite adverse fetal pregnancy outcomes as well as other individual outcomes between different HbA1c categories. Of the vaginally delivered women in our cohort, the 37 patients with HbA1c levels of ≥ 8.5% had a significantly higher frequency of fetal shoulder dystocia than the 62 with HbA1c levels of < 8.5% (24.2 vs. 1.6%, P = 0.002). Neonates of patients with HbA1c ≥ 8.5% were more likely to have low five minute Apgar scores than neonates of patients with HbA1c < 8.5%, but this was of borderline statistical significance (7.4% vs. 0.5%, P = 0.05). CONCLUSION: In patients with preexisting diabetes mellitus, HbA1c levels of ≥ 8.5% during early pregnancy are not useful in predicting most adverse outcomes, although there may be an increased risk for shoulder dystocia.