Françoise Maillard

Previous induced abortions and the risk of very preterm delivery: results of the EPIPAGE study

Objectives  To evaluate the risk of very preterm birth (22–32 weeks of gestation) associated with previous induced abortion according to the complications leading to very preterm delivery in singletons.

Comparison of antihypertensive efficacy and perinatal safety of labetalol and methyldopa in the treatment of hypertension in pregnancy: a randomized controlled trial

Summary. Labetalol was compared with methyldopa in a randomized controlled trial involving 176 pregnant women with mild to moderate hypertension. Diastolic blood pressure below 86 mmHg was obtained in a similar proportion of women given labetalol or methyldopa. Intrauterine death occurred in four women treated with methyldopa, and the one neonatal death on day 1 occurred in the labetalol group. The average birthweight and the proportion of preterm or small‐for‐gestational‐age babies were similar in both groups. Heart rate, blood pressure, blood glucose, respiratory rate, and Silverman score of the babies did not differ between the two treatment groups, whether the comparison was made for all the infants, or only for those that were preterm or small‐for‐gestational‐age. These data indicate that maternal betablockade with labetalol is as safe as methyldopa for the fetus and the newborn.

Multicenter study on the clinical value of fetal pulse oximetry

OBJECTIVE Our purpose was to compare the predictive value of intrapartum fetal pulse oximetry with that of fetal blood analysis for an abnormal neonatal outcome in case of an abnormal fetal heart rate. STUDY DESIGN A prospective multicenter observational study was conducted from June 1994 to November 1995. Fetal oxygen saturation was continuously recorded with a Nellcor N-400 fetal pulse oximeter in case of an abnormal fetal heart rate during labor. Simultaneous readings of fetal oxygen saturation and fetal blood analysis obtained before birth (i.e., either at full dilatation or before cesarean section when indicated) were compared with the neonatal status. The criteria for an abnormal neonatal outcome were (1) an umbilical arterial blood pH < or = 7.15 and (2) a combined variable including 5-minute Apgar score < or = 7, umbilical arterial pH < or = 7.15, secondary respiratory distress, transfer in a neonatal care unit, or neonatal death. RESULTS At a 7.20 threshold for fetal scalp pH and 30% for fetal oxygen saturation (i.e., the 10th percentile in the study population), the predictive value of fetal pulse oximetry was similar to that of fetal blood analysis for an arterial umbilical pH < or = 7.15 and for an abnormal neonatal outcome (positive predictive value 56% vs 55%, negative predictive value 81% vs 82%, sensitivity 29% vs 35%, and specificity 93% vs 91%, respectively). The receiver-operator characteristic curve showed similar performance of either technique for cutoff values < or = 7.20 for fetal blood pH and < or = 30% for fetal oxygen saturation, whereas fetal pulse oximetry became superior at higher thresholds. CONCLUSION The predictive value of intrapartum fetal pulse oximetry can be favorably compared with that of fetal blood analysis. Randomized controlled management trials can now be performed to assess potential clinical benefits of this new tool.

Multicenter study on the clinical value of fetal pulse oximetry: I. Methodologic evaluation☆☆☆★

OBJECTIVE Our purpose was to evaluate the feasibility of intrapartum fetal pulse oximetry, the distribution of fetal oxygen saturation values, and the relationship with the neonatal outcome in a population with an abnormal fetal heart rate. STUDY DESIGN A prospective multicenter observational study was performed from June 1994 to November 1995. Fetal oxygen saturation was continuously recorded with use of a Nellcor N-400 fetal pulse oximeter in case of an abnormal fetal heart rate during labor. Simultaneous readings of fetal oxygen saturation and fetal blood analysis were obtained at inclusion and before birth. Feasibility, adverse effects, distribution of fetal oxygen saturation values, and relationship with neonatal outcome were assessed. RESULTS One hundred seventy-four patients were included. From 172 attempted sensor placements, the procedure was impossible in three cases and fetal oxygen saturation values were obtained in 164 cases (95.3%). Physicians considered sensor placement an easier task than an attempt at fetal blood analysis (easy in 87.5% vs 78.9% for fetal blood analysis, p = 0.03). The mean reliable signal time (+/- SD) was 64.7% +/- 32% during the first stage. There were no serious adverse effects in the study population. The mean fetal oxygen saturation during the first stage of labor was 42.2% +/- 8.0% (10th to 90th percentile range 30% to 53%). Fetal oxygen saturation was significantly correlated with scalp pH (r = 0.29, p = 0.01) but not with neonatal umbilical artery pH or gas values. There was a significant association between low fetal oxygen saturation (< 30%) and poor neonatal condition. CONCLUSION The feasibility of fetal pulse oximetry is satisfactory in clinical practice. It is easy to use and provides a fair rate of recorded values, even in a population with suspicion of fetal distress. A low fetal oxygen saturation is significantly associated with an abnormal neonatal outcome.

Bacterial vaginosis: prevalence and predictive value for premature delivery and neonatal infection in women with preterm labour and intact membranes

OBJECTIVES Assess the predictive values of bacterial vaginosis (BV) for preterm delivery (PD) and neonatal infection and compare them with standard markers of infection among women with preterm labour (PL). STUDY DESIGN Prospective blinded study in a tertiary referral centre in Paris. Women hospitalised for PL with intact membranes at a term between 24 and 34 weeks were included. Vaginal fluid, collected at inclusion was Gram-stained, scored, and interpreted according to Nugents criteria. RESULTS Out of 354 women tested, 254 had normal flora (72.3%), 76 intermediate (21.7%) and 24 BV (6.8%). A history of spontaneous miscarriage after 14 weeks was the only risk factor significantly associated with BV. BV was not significantly associated with PD<35 weeks or neonatal infection. Very preterm delivery (before 33 weeks) was significantly associated with the flora grade (P=0.02): women with normal, intermediate and abnormal flora, respectively had 27 (10.6%), 14 (18.4%) and 6 (25.0%) births before 33 weeks. Of the markers tested, the highest risk of very preterm delivery was associated with BV (odds ratio 2.95, 95% CI (1.1-0.8.1)) and CRP>20mg/dl (4.23 95% CI (1.8-9.7)). Predictive value of BV for preterm birth before 33 weeks were: sensitivity 12.8%, specificity 95.0%, positive predictive value 35.3%, and negative predictive value 84.3%. CONCLUSIONS The frequency of BV and its association with PD are probably very variable and must be interpreted differently from one population to another. While we found an association between BV results and delivery before 33 weeks, the predictive value of BV was disappointing. Although these findings reinforce the importance of a useful marker of subclinical infection, the usefulness of testing for BV in women with PL has not been demonstrated.

Maternal markers for detecting early-onset neonatal infection and chorioamnionitis in cases of premature rupture of membranes at or after 34 weeks of gestation: a two-center prospective study

BackgroundAccurate prediction of infection, including maternal chorioamnionitis and early-onset neonatal infection, remains a critical challenge in cases of preterm rupture of membranes and may influence obstetrical management. The aim of our study was to investigate the predictive value for early-onset neonatal infection and maternal histological and clinical chorioamnionitis of maternal biological markers in routine use at or after 34 weeks of gestation in women with premature rupture of membranes.MethodsWe conducted a two-center prospective study of all women admitted for premature rupture of membranes at or after 34 weeks of gestation. The association of C-reactive protein, white blood cell count, vaginal sample bacteriological results, and a prediction model at admission, for early-onset neonatal infection and maternal chorioamnionitis were analyzed by comparing areas under the receiver operating characteristic curves and specificity.ResultsThe study included 399 women. In all, 4.3% of the newborns had an early-onset neonatal infection and 5.3% of the women had clinical chorioamnionitis. Histological chorioamnionitis was detected on 10.8% of 297 placentas tested. White blood cell counts and C-reactive protein concentrations were significantly associated with early-onset neonatal infection and included in a prediction model. The area under the receiver operating characteristic curve of this model was 0.82 (95% CI [0.72, 0.92]) and of C-reactive protein, 0.80 (95% CI [0.68, 0.92]) (p = 1.0). Specificity was significantly higher for C-reactive protein than for the prediction model (48% and 43% respectively, p < 0.05). C-reactive protein was associated with clinical and histological chorioamnionitis, with areas under the receiver operating characteristic curve of 0.61 (95% CI [0.48, 0.74]) and 0.62 (95% CI [0.47, 0.74]), respectively.ConclusionsThe concentration of C-reactive protein at admission for premature rupture of membranes is the most accurate infectious marker for prediction of early-onset neonatal infection in routine use with a sensitivity > 90%. A useful next step would be a randomized prospective study of management strategy comparing CRP at admission with active management to assess whether this more individualized care is a safe alternative strategy in women with premature rupture of membranes at or after 34 weeks.

Prédiction de l’infection maternofœtale en cas de rupture prématurée des membranes par les marqueurs sériques maternels

Premature rupture of membranes is a common situation in obstetrics that links the amniotic cavity and the bacterial cervicovaginal flora. The main risk in case of preterm premature rupture of membranes is the occurrence of an amniochorial infection, which increases neonatal morbidity and mortality. One main purpose in cases of preterm premature rupture of membranes is to identify infection early to adapt the clinical care. Among the marker used in practice, CRP has a sensitivity between 56% and 86% and specificity between 55% and 82% for predicting clinical chorioamnionitis. These values are respectively 21% to 56% and 76% to 95% for the prediction of early neonatal infection. The white blood cell count, also used in routine, has a poor predictive value of clinical chorioamnionitis although a high specificity when the threshold is of 16 giga/l. Among the pro-inflammatory cytokines, interleukin-6 has been the most studied. Its predictive value for chorioamnionitis or neonatal infection is higher but its clinical usefulness is limited by the various threshold used in the studies and the lack of routine measure. Procalcitonin appears to have low predictive values for detecting amniochorial infection but has finally been little studied. Ways to improve prediction of infection in cases of premature rupture of membranes are either looking for new markers or the analysis of local markers (vaginal secretions and amniotic fluid).

Predictive value of pulse oximetry and fetal scalp blood pH in the case of meconium-stained amniotic fluid

OBJECTIVE To compare the predictive value of intrapartum fetal pulse oximetry to that of fetal scalp blood pH for an abnormal neonatal outcome in the case of thick meconium. STUDY DESIGN A prospective multicenter observational study was performed from June 1994 to November 1995. Fetal oxygen saturation was monitored using a Nellcor N-400 fetal pulse oximeter in case of abnormal FHR. The last readings of fetal oxygen saturation and fetal scalp blood pH before birth were used to assess the ability of both techniques to predict an abnormal neonatal status. RESULTS At a 30% cutoff, the negative predictive value of fetal oxygen saturation was not altered in case of meconium when compared to clear amniotic fluid (79 and 83%, respectively). Fetal scalp blood pH at a 7.20 threshold had a poor negative predictive value in case of meconium when compared to clear amniotic fluid (56% versus 88%, respectively). The receiver operator characteristic curve showed similar performance of fetal scalp blood pH and pulse oximetry in cases with clear amniotic fluid. In cases with meconium, the performance of fetal scalp blood pH was poor, whereas that of pulse oximetry remained unchanged. In three cases with meconium below the vocal cords, a drop in fetal oxygen saturation was observed during labor whereas fetal scalp blood pH remained within normal values. CONCLUSION The predictive value of fetal scalp blood pH is poor in case of meconium, whereas the predictive value of pulse oximetry seems to be unchanged in this situation.

Mesure de la longueur du col de l’utérus par voie endovaginale : technique et principales applications

Cervical length measurement by transvaginal ultrasound is commonly used to assess the risk of preterm birth (PTB) and refine the clinical management in cases of preterm labor (PTL). The transvaginal route is considered to be the reference for the measurement of the uterine cervix. Cervical length measurement has a good diagnostic value irrespective of the clinical context or past history associated with an increased risk of PTB. In case of PTL, the measurement of the cervical length by ultrasonography allows to reduce the number of hospitalizations, and to focus on the women who really need a treatment. In case of twin pregnancy, systematic systematic measurement of cervical length at 20-25 weeks gestation is not recommended because of the lack of therapeutic applications. In cases of high risk of PTB (PTB history, conization, uterine exposure to DES, etc.), selecting a group at high risk for PTB by a systematic cervical length measurement at 20-25 weeks gestation could be useful to select women for whom treatment with progesterone would be most beneficial. In this group, a follow-up of the cervical length since 16 weeks gestation may also be useful to indicate a cerclage if the cervical length is less than 15mm. In the general population, cervical length measurement may be useful during the second trimester of pregnancy in so far as a treatment by progesterone in cases of short cervix (<or=15mm) may be beneficial.

Prediction of clinical infection in women with preterm labour with intact membranes: a score based on ultrasonographic, clinical and biological markers.

OBJECTIVE To predict maternal and neonatal clinical infection at admission in women hospitalized for preterm labour (PTL) with intact membranes. STUDY DESIGN Prospective study of 371 women hospitalized for preterm labour with intact membranes. The primary outcome was clinical infection, defined by clinical chorioamnionitis at delivery or early-onset neonatal infection. RESULTS Clinical infection was identified in 21 cases (5.7%) and was associated with earlier gestational age at admission for PTL, elevated maternal C-reactive protein (CRP) and white blood cell count (WBC), shorter cervical length, and a cervical funnelling on ultrasound. We used ROC curves to determine the cut-off values that minimized the number of false positives and false negatives. The cut-off points chosen were 30 weeks for gestational age at admission, 25 mm for cervical length, 8 mg/l for CRP and 12,000 c/mm(3) for WBC. Each of these variables was assigned a weight on the basis of the adjusted odds ratios in a clinical infection risk score (CIRS). We set a threshold corresponding to a specificity close to 90%, and calculated the positive and negative predictive values and likelihood ratios of each marker and of the CIRS. The CIRS had a sensitivity of 61.9%, while the sensitivity of the other markers ranged from 19.0% to 42.9%. Internal cross-validation was used to estimate the performance of the CIRS in new subjects. The diagnostic values found remained close to the initial values. CONCLUSION A clinical infection risk score built from data known at admission for preterm labour helps to identify women and newborns at high risk of clinical infection.