Prediction of large-for-gestational-age infant by fetal growth charts and hemoglobin A1c level in pregnancy complicated by pregestational diabetes.

OBJECTIVES: To compare the ability of three fetal growth charts (Fetal Medicine Foundation (FMF), Hadlock and National Institutes of Child Health and Human Development (NICHD) race/ethnicity-specific) to predict large-for-gestational age (LGA) at birth in pregnant individuals with pregestational diabetes, and to determine whether inclusion of hemoglobin A1c (HbA1c) level improves the predictive performance of the growth charts. METHODS: This was a retrospective analysis of individuals with Type-1 or Type-2 diabetes with a singleton pregnancy that resulted in a non-anomalous live birth. Fetal biometry was performed between 28 + 0 and 36 + 6 weeks of gestation. The primary exposure was suspected LGA, defined as estimated fetal weight ≥ 90th percentile using the Hadlock (Formula C), FMF and NICHD growth charts. The primary outcome was LGA at birth, defined as birth weight ≥ 90th percentile, using 2017 USA natality reference data. The performance of the three growth charts to predict LGA at birth, alone and in combination with HbA1c as a continuous measure, was assessed using the area under the receiver-operating-characteristics curve (AUC), sensitivity, specificity, positive predictive value and negative predictive value. RESULTS: Of 358 assessed pregnant individuals with pregestational diabetes (34% with Type 1 and 66% with Type 2), 147 (41%) had a LGA infant at birth. Suspected LGA was identified in 123 (34.4%) by the Hadlock, 152 (42.5%) by the FMF and 152 (42.5%) by the NICHD growth chart. The FMF growth chart had the highest sensitivity (77% vs 69% (NICHD) vs 63% (Hadlock)) and the Hadlock growth chart had the highest specificity (86% vs 76% (NICHD) and 82% (FMF)) for predicting LGA at birth. The FMF growth chart had a significantly higher AUC (0.79 (95% CI, 0.74-0.84)) for LGA at birth compared with the NICHD (AUC, 0.72 (95% CI, 0.68-0.77); P < 0.001) and Hadlock (AUC, 0.75 (95% CI, 0.70-0.79); P < 0.01) growth charts. Prediction of LGA improved for all three growth charts with the inclusion of HbA1c measurement in comparison to each growth chart alone (P < 0.001 for all); the FMF growth chart remained more predictive of LGA at birth (AUC, 0.85 (95% CI, 0.81-0.90)) compared with the NICHD (AUC, 0.79 (95% CI, 0.73-0.84)) and Hadlock (AUC, 0.81 (95% CI, 0.76-0.86)) growth charts. CONCLUSIONS: The FMF fetal growth chart had the best predictive performance for LGA at birth in comparison with the Hadlock and NICHD race/ethnicity-specific growth charts in pregnant individuals with pregestational diabetes. Inclusion of HbA1c improved further the prediction of LGA for all three charts. © 2022 The Authors. Ultrasound in Obstetrics & Gynecology published by John Wiley & Sons Ltd on behalf of International Society of Ultrasound in Obstetrics and Gynecology.

Cardiometabolic health after first pregnancy: Associations with social determinants of health. A nuMoM2b-HHS study.

Study objective: This study sought to evaluate the associations between social determinants of health (SDOH) at the time of first pregnancy and subsequent cardiometabolic health, defined as the development of metabolic syndrome. Design: nuMoM2b-HHS (Nulliparous Pregnancy Outcomes Study- Monitoring Mothers-to-Be-Heart Health Study) is an ongoing prospective cohort study. Setting: Eight academic medical centers enrolled and continue to follow participants. Participants: 4484 participants followed a mean of 3.2 years from the time of their first pregnancy. Interventions: N/a. Main outcome measure: Unadjusted and adjusted Poisson regression models with robust standard errors were used to obtain relative risks and 95% confidence intervals estimating the risk of metabolic syndrome for each baseline SDOH. In secondary analyses we examined the associations between SDOH and incident hypertension, obesity, and diabetes mellitus. Results: Metabolic syndrome developed in 13.6% of participants. Higher socioeconomic position at the time of pregnancy was associated with lower rates of metabolic syndrome [income > 200% poverty level aRR 0.55 (95% CI, 0.42-0.71), attainment of a bachelor's degree aRR 0.62 (0.46-0.84) or higher aRR 0.50 (0.35-0.71)], while being single [aRR 1.45 (95% CI, 1.18-1.77)] and having low health literacy were associated with a greater risk of metabolic syndrome [aRR 1.98 (95% CI, 1.28-3.07)]. Conclusions: Over a short interval following first pregnancy, participants accumulated high proportions of cardiovascular risk factors and metabolic syndrome, with some risk associated with SDOH. The impact of interventions addressing SDOH in pregnant people on cardiometabolic health should be tested as a means of reducing health inequities at the population level.

A core outcome set for pre-eclampsia research: an international consensus development study.

OBJECTIVE: To develop a core outcome set for pre-eclampsia. DESIGN: Consensus development study. SETTING: International. POPULATION: Two hundred and eight-one healthcare professionals, 41 researchers and 110 patients, representing 56 countries, participated. METHODS: Modified Delphi method and Modified Nominal Group Technique. RESULTS: A long-list of 116 potential core outcomes was developed by combining the outcomes reported in 79 pre-eclampsia trials with those derived from thematic analysis of 30 in-depth interviews of women with lived experience of pre-eclampsia. Forty-seven consensus outcomes were identified from the Delphi process following which 14 maternal and eight offspring core outcomes were agreed at the consensus development meeting. Maternal core outcomes: death, eclampsia, stroke, cortical blindness, retinal detachment, pulmonary oedema, acute kidney injury, liver haematoma or rupture, abruption, postpartum haemorrhage, raised liver enzymes, low platelets, admission to intensive care required, and intubation and ventilation. Offspring core outcomes: stillbirth, gestational age at delivery, birthweight, small-for-gestational-age, neonatal mortality, seizures, admission to neonatal unit required and respiratory support. CONCLUSIONS: The core outcome set for pre-eclampsia should underpin future randomised trials and systematic reviews. Such implementation should ensure that future research holds the necessary reach and relevance to inform clinical practice, enhance women's care and improve the outcomes of pregnant women and their babies. TWEETABLE ABSTRACT: 281 healthcare professionals, 41 researchers and 110 women have developed #preeclampsia core outcomes @HOPEoutcomes @jamesmnduffy. [Correction added on 29 June 2020, after first online publication: the order has been corrected.].

Cervical funneling or intra-amniotic debris and preterm birth in nulliparous women with midtrimester cervical length less than 30 mm.

OBJECTIVE: To evaluate whether the presence of cervical funneling or intra-amniotic debris identified in the second trimester is associated with a higher rate of preterm birth (PTB) in asymptomatic nulliparous pregnant women with a midtrimester cervical length (CL) less than 30 mm (i.e. below the 10th percentile). METHODS: This was a secondary cohort analysis of data from a multicenter trial in nulliparous women between 16 and 22 weeks' gestation with a singleton gestation and CL less than 30 mm on transvaginal ultrasound, randomized to treatment with either 17-alpha-hydroxyprogesterone caproate or placebo. Sonographers were centrally certified in CL measurement, as well as in identification of intra-amniotic debris and cervical funneling. Univariable and multivariable analysis was performed to assess the associations of cervical funneling and intra-amniotic debris with PTB. RESULTS: Of the 657 women randomized, 112 (17%) had cervical funneling only, 33 (5%) had intra-amniotic debris only and 45 (7%) had both on second-trimester ultrasound. Women with either of these findings had a shorter median CL than those without (21.0 mm vs 26.4 mm; P < 0.001). PTB prior to 37 weeks was more likely in women with cervical funneling (37% vs 21%; odds ratio (OR), 2.2 (95% CI, 1.5-3.3)) or intra-amniotic debris (35% vs 23%; OR, 1.7 (95% CI, 1.1-2.9)). Results were similar for PTB before 34 and before 32 weeks' gestation. After multivariable adjustment that included CL, PTB < 34 and < 32 weeks continued to be associated with the presence of intra-amniotic debris (adjusted OR (aOR), 1.85 (95% CI, 1.00-3.44) and aOR, 2.78 (95% CI, 1.42-5.45), respectively), but not cervical funneling (aOR, 1.17 (95% CI, 0.63-2.17) and aOR, 1.45 (95% CI, 0.71-2.96), respectively). CONCLUSIONS: Among asymptomatic nulliparous women with midtrimester CL less than 30 mm, the presence of intra-amniotic debris, but not cervical funneling, is associated with an increased risk for PTB before 34 and 32 weeks' gestation, independently of CL. Copyright © 2017 ISUOG. Published by John Wiley & Sons Ltd.

A cluster-randomized trial to reduce major perinatal morbidity among women with one prior cesarean delivery in Québec (PRISMA trial): study protocol for a randomized controlled trial.

BACKGROUND: Rates of cesarean delivery are continuously increasing in industrialized countries, with repeated cesarean accounting for about a third of all cesareans. Women who have undergone a first cesarean are facing a difficult choice for their next pregnancy, i.e.: (1) to plan for a second cesarean delivery, associated with higher risk of maternal complications than vaginal delivery; or (b) to have a trial of labor (TOL) with the aim to achieve a vaginal birth after cesarean (VBAC) and to accept a significant, but rare, risk of uterine rupture and its related maternal and neonatal complications. The objective of this trial is to assess whether a multifaceted intervention would reduce the rate of major perinatal morbidity among women with one prior cesarean. METHODS/DESIGN: The study is a stratified, non-blinded, cluster-randomized, parallel-group trial of a multifaceted intervention. Hospitals in Quebec are the units of randomization and women are the units of analysis. As depicted in Figure 1, the study includes a 1-year pre-intervention period (baseline), a 5-month implementation period, and a 2-year intervention period. At the end of the baseline period, 20 hospitals will be allocated to the intervention group and 20 to the control group, using a randomization stratified by level of care. Medical records will be used to collect data before and during the intervention period. Primary outcome is the rate of a composite of major perinatal morbidities measured during the intervention period. Secondary outcomes include major and minor maternal morbidity; minor perinatal morbidity; and TOL and VBAC rate. The effect of the intervention will be assessed using the multivariable generalized-estimating-equations extension of logistic regression. The evaluation will include subgroup analyses for preterm and term birth, and a cost-effectiveness analysis. DISCUSSION: The intervention is designed to facilitate: (1) women's decision-making process, using a decision analysis tool (DAT), (2) an estimate of uterine rupture risk during TOL using ultrasound evaluation of low-uterine segment thickness, (3) an estimate of chance of TOL success, using a validated prediction tool, and (4) the implementation of best practices for intrapartum management. TRIAL REGISTRATION: Current Controlled Trials, ID: ISRCTN15346559 . Registered on 20 August 2015.

Variation in preterm birth rate and the role of short cervical length across two populations: a comparative cohort study.

OBJECTIVE: To examine variation in preterm birth (PTB) rates between nulliparous women from two different populations and to investigate the contribution of short cervical length to any observed variation. STUDY DESIGN: A comparative study between two cohorts of singleton nulliparous women from the Netherlands and Chicago, USA was performed. Women with a non-anomalous singleton pregnancy who underwent routine transvaginal cervical length measurement between 16+0 and 21+6 weeks of gestation with a known pregnancy outcome were selected. Fetuses with congenital anomalies, intrauterine fetal deaths and deliveries before 24+0 weeks were excluded. Total, spontaneous and iatrogenic PTB rates were calculated for both populations and compared with univariable and multivariable logistic regression. RESULTS: We included 3409 women from the Netherlands and 3334 women from Chicago. The median cervical length was slightly lower in the Netherlands compared with Chicago (42 vs 44 mm, P<0.0001), but the rate of cervical length of ⩽25 mm was comparable (0.9% vs 0.8%, P=0.69). The total rate of PTB prior to 37 weeks was comparable between locations (8.0% in the Netherlands vs 7.3% in Chicago, P=0.27) but PTB prior to 32 weeks was higher in the Netherlands (1.3% vs 0.5%, P=0.002). Multivariable regression revealed that women from the Netherlands, compared with women from Chicago, are at increased risk for spontaneous PTB between 24 and 27 weeks and between 28 and 31 weeks (adjusted odds ratio (aOR) 5.3, 95% confidence interval (CI) 1.5 to 19 and 3.1, 95% CI 1.2 to 8.3, respectively). In contrast, the number of late spontaneous PTB between 34 and 36 weeks did not differ between both populations (4.1% vs 4.3% aOR 1.1, 95% CI 0.87 to 1.5). CONCLUSIONS: Despite similar percentages of short cervix, there are marked differences in early PTB rates between the Netherlands and Chicago, possibly indicating different phenotypes of PTB. A high frequency of spontaneous early preterm birth is not always accompanied by an increase in the frequency of a short cervix.

Racial/ethnic differences in weekend delivery after induction of labor.

OBJECTIVE: To determine whether the frequency induction of labor (IOL) varies by day of the week based on maternal race/ethnicity. STUDY DESIGN: Gravid women in the US from 2007 to 2010 were stratified into <34, 34 to 36, 37 to 38 and ⩾39 weeks. Multivariable analyses estimated the association between weekend delivery, race/ethnicity (categorized as non-Hispanic white, Hispanic white, black and 'other') and their interaction with induction. RESULT: After 34 weeks, induction was less likely on the weekend (P<0.01) and less likely in black, Hispanic or 'other' women relative to non-Hispanic whites (P<0.01). However, there was a significant positive interaction between race/ethnicity and weekend delivery (P<0.001). During the late preterm gestation, weekend IOL was greater in black women (odds ratio, 1.08). CONCLUSION: The difference in IOL by race/ethnicity increased with gestational age. This difference was least on the weekends.

The association of beta-2 adrenoceptor genotype with short-cervix mediated preterm birth: a case-control study.

OBJECTIVE: To determine whether ß2 -adrenoceptor (ß2 AR) genotype is associated with shortening of the cervix or with preterm birth (PTB) risk among women with a short cervix in the second trimester. DESIGN: A case-control ancillary study to a multicentre randomised controlled trial. SETTING: Fourteen participating centres of the Maternal-Fetal Medicine Units Network of the Eunice Kennedy Shriver National Institute of Child Health and Human Development. POPULATION: Four hundred thirty-nine women, including 315 with short cervix and 124 with normal cervical length. METHODS: Nulliparous women with cervical length <30 mm upon a 16-22-week transvaginal sonogram and controls frequency-matched for race/ethnicity with cervical lengths ≥40 mm were studied. ß2 AR genotype was determined at positions encoding for amino acid residues 16 and 27. MAIN OUTCOME MEASURES: Genotype distributions were compared between case and control groups. Within the short cervix group, pregnancy outcomes were compared by genotype, with a primary outcome of PTB <37 weeks. RESULTS: Genotype data were available at position 16 for 433 women and at position 27 for 437. Using a recessive model testing for association between short cervix and genotype, and adjusted for ethnicity, there was no statistical difference between cases and controls for Arg16 homozygosity (OR 0.7, 95% CI 0.4-1.3) or Gln27 homozygosity (OR 0.9, 95% CI 0.3-2.7). Among cases, Arg16 homozygosity was not associated with protection from PTB or spontaneous PTB. Gln27 homozygosity was not associated with PTB risk, although sample size was limited. CONCLUSIONS: ß2 AR genotype does not seem to be associated with short cervical length or with PTB following the second-trimester identification of a short cervix. Influences on PTB associated with ß2 AR genotype do not appear to involve a short cervix pathway.

Predicting successful intended vaginal delivery after previous caesarean section: external validation of two predictive models in a Dutch nationwide registration-based cohort with a high intended vaginal delivery rate.

OBJECTIVE: To externally validate two models from the USA (entry-to-care [ETC] and close-to-delivery [CTD]) that predict successful intended vaginal birth after caesarean (VBAC) for the Dutch population. DESIGN: A nationwide registration-based cohort study. SETTING: Seventeen hospitals in the Netherlands. POPULATION: Seven hundred and sixty-three pregnant women, each with one previous caesarean section and a viable singleton cephalic pregnancy without a contraindication for an intended VBAC. METHODS: The ETC model comprises the variables maternal age, prepregnancy body mass index (BMI), ethnicity, previous vaginal delivery, previous VBAC and previous nonprogressive labour. The CTD model replaces prepregnancy BMI with third-trimester BMI and adds estimated gestational age at delivery, hypertensive disease of pregnancy, cervical examination and induction of labour. We included consecutive medical records of eligible women who delivered in 2010. For validation, individual probabilities of women who had an intended VBAC were calculated. MAIN OUTCOME MEASURES: Discriminative performance was assessed with the area under the curve (AUC) of the receiver operating characteristic and predictive performance was assessed with calibration plots and the Hosmer-Lemeshow (H-L) statistic. RESULTS: Five hundred and fifteen (67%) of the 763 women had an intended VBAC; 72% of these (371) had an actual VBAC. The AUCs of the ETC and CTD models were 68% (95% CI 63-72%) and 72% (95% CI 67-76%), respectively. The H-L statistic showed a P-value of 0.167 for the ETC model and P = 0.356 for the CTD model, indicating no lack of fit. CONCLUSION: External validation of two predictive models developed in the USA revealed an adequate performance within the Dutch population.

A qualitative analysis of parturients' perspectives on neuraxial labor analgesia.

BACKGROUND: The decision to use, or not use, neuraxial analgesia is complex and likely multi-factorial. The objectives of this study were to understand parturients' concerns about neuraxial analgesia, and the reasons for not anticipating the use of neuraxial analgesia using qualitative methodology. METHODS: English-speaking, term parturients, who had not requested or received labor analgesia, were recruited for this mixed-methods study. In addition to a quantitative survey, the results of which have been published elsewhere, women were asked open-ended questions regarding concerns about neuraxial analgesia and reasons for not anticipating its use. Answers were recorded verbatim and analyzed using qualitative methodology. RESULTS: Interviews were conducted with 509 women. Thirty-nine percent of patients expressed some concern about neuraxial analgesia. These concerns were thematically represented by misunderstandings about neuraxial analgesia, general fears about the procedure, and lack of trust in providers. Many of the concerns were misunderstandings that were not supported by the medical literature. Of the 129 patients who did not anticipate using neuraxial analgesia, 23% stated that this was because they desired a natural childbirth and/or control over their labor experience, whereas 46% cited concerns about the procedure and its complications as the basis for their decision. CONCLUSION: Many women who anticipate not using neuraxial analgesia may be basing their decision on an inaccurate understanding of the risks of the procedure. Improved patient education and counseling that target specific areas of concern may address these misunderstandings.

PIERS proteinuria: relationship with adverse maternal and perinatal outcome.

OBJECTIVE: To examine the ability of three different proteinuria assessment methods (urinary dipstick, spot urine protein:creatinine ratio [Pr/Cr], and 24-hour urine collection) to predict adverse pregnancy outcomes. METHODS: We performed a prospective multicentre cohort study, PIERS (Preeclampsia Integrated Estimate of RiSk), in seven academic tertiary maternity centres practising expectant management of preeclampsia remote from term in Canada, New Zealand, and Australia. Eligible women were those admitted with preeclampsia who had at least one antenatal proteinuria assessment by urinary dipstick, spot urine Pr/Cr ratio, and/or 24-hour urine collection. Proteinuria assessment was done either visually at the bedside (by dipstick) or by hospital clinical laboratories for spot urine Pr/Cr and 24-hour urine collection. We calculated receiver operating characteristic area under the curve (95% CI) for each proteinuria method and each of the combined adverse maternal outcomes (within 48 hours) or adverse perinatal outcomes (at any time). Models with AUC ≥ 0.70 were considered of interest. Analyses were run for all women who had each type of proteinuria assessment and for a cohort of women ("ALL measures") who had all three proteinuria assessments. RESULTS: More women were proteinuric by urinary dipstick (≥ 2+, 61.4%) than by spot urine Pr/Cr (≥ 30 g/mol, 50.4%) or 24-hour urine collection (≥ 0.3g/d, 34.7%). Each proteinuria measure evaluated had some discriminative power, and dipstick proteinuria (categorical) performed as well as other methods. No single method was predictive of adverse perinatal outcome. CONCLUSION: The measured amount of proteinuria should not be used in isolation for decision-making in women with preeclampsia. Dipstick proteinuria performs as well as other methods of assessing proteinuria for prediction of adverse events.

Perspectives on communication in labor and delivery: a focus group analysis.

OBJECTIVE: The objective of this study was to elicit and explore perceptions of barriers to optimal communication among clinicians on a labor and delivery unit, and to use this information to select and design approaches to improve communication. STUDY DESIGN: A qualitative research design using a focus group format was utilized. Attending and resident obstetricians and anesthesiologists, as well as staff nurses, pharmacists and unit secretaries participated in the focus groups, which were recorded and transcribed. Data were analyzed using a framework analysis approach. RESULT: In total, 18 focus groups with a total of 92 participants were conducted. Eight key themes emerged regarding specific barriers to effective communication among clinicians in the labor and delivery setting. The most prominent of these themes included issues with inter-departmental coordination, clinical accessibility (the ability to reach other clinicians), lack of a consistent approach for clinical documentation, and the involvement of multiple care providers. On the basis of these themes, multiple interventions were designed to enhance communication. CONCLUSION: Focus group methodology can be used to elicit a detailed description of communication practices of clinicians on a labor and delivery unit, permitting an exploration of specific barriers to communication and the identification of potential solutions to those barriers.

Obstetric morbidity associated with amniotic sheets.

OBJECTIVE: The objective of this study was to determine whether amniotic sheets are associated with an increase in obstetric and neonatal morbidity. METHODS: Using a cohort study design, we identified all women with amniotic sheets, detected by a second-trimester ultrasound examination at a university hospital over a 6-year period. All women who received an ultrasound examination during that time, without a diagnosis of amniotic sheets, were also identified, and two women from among this group were randomly selected as controls for each case. Maternal and neonatal data were abstracted from the medical records, and maternal and neonatal morbidity were compared between the two groups. RESULTS: One hundred and twenty-two women with pregnancies with a diagnosis of amniotic sheets were identified and compared to 244 women with pregnancies without a diagnosis of amniotic sheets. Composite obstetric morbidity was higher in women with amniotic sheets: 21.3% vs. 8.2% (relative risk (RR) 2.6; 95% CI, 1.5-4.5). Additionally, in women with amniotic sheets, neonates were more likely to be born with a birth weight of < 2500 g (RR 3.3; 95% CI, 1.8-6.4) and were more likely to be admitted to the neonatal intensive care unit (RR 2.3; 95% CI, 1.3-4.3). There were no perinatal deaths observed in either group. CONCLUSION: Amniotic sheets are associated with an increase in adverse obstetric outcomes.

A randomized controlled trial of the effect of combined spinal-epidural analgesia on the success of external cephalic version for breech presentation.

BACKGROUND: Improving the success of external cephalic version (ECV) for breech presentation may help avoid some cesarean deliveries. The results of randomized trials comparing the success of ECV with neuraxial analgesia compared to control are inconsistent. We hypothesized that combined spinal-epidural (CSE) analgesia would increase the success of ECV when compared with systemic opioid analgesia. METHODS: Parturients with singleton breech presentation (n=96) were randomized to receive CSE analgesia with bupivacaine 2.5mg and fentanyl 15 microg (CSE group) or intravenous fentanyl 50 microg (SYS group) before ECV attempt. The primary outcome was ECV success. RESULTS: The success rate of ECV was 47% with CSE and 31% in the SYS group (P=0.14). Subsequent vaginal delivery was 36% for CSE and 25% for SYS (P=0.27). Median [IQR] visual analog pain scores (0-100mm scale) were lower with CSE (3 [0-12]) compared to SYS analgesia (36 [16 to 54]) (P<0.005) and patient satisfaction (0-10 scale) was higher (CSE 10 [9 to 10] versus SYS 7 [4 to 9]) (P<0.005). There were no differences in fetal heart rate patterns, but median time to return to fetal heart rate reactivity after analgesia was shorter with CSE (13 [IQR 9-21] min) compared to the SYS group (39 [IQR 23-51] min) (P=0.02). CONCLUSIONS: There was no difference in the rate of successful ECV or vaginal delivery with CSE compared to intravenous fentanyl analgesia. Pain scores were lower and satisfaction higher with CSE analgesia, and median time to fetal heart rate reactivity was shorter in the CSE group.