Antibiotics for amniotic-fluid colonization by Ureaplasma and/or Mycoplasma spp. to prevent preterm birth: A randomized trial.

OBJECTIVE: To assess whether antibiotics used for treatment in asymptomatic second-trimester women positive for Mycoplasma or Ureaplasma spp. detected by amniotic-fluid PCR prevents preterm delivery. DESIGN: A randomized, double-blind, placebo-controlled trial. SETTING: 10 maternal fetal medicine centers in France. POPULATION: Women with a singleton pregnancy who underwent amniocentesis between 16 and 20 weeks' gestation (weeks) for Down syndrome screening. A sample of 238 women with PCR-positive findings per treatment group was needed to show a 50% reduction in the preterm delivery rate. METHODS: Amniotic fluid was tested. Women with positive findings on real-time PCR of amniotic fluid for Mycoplasma hominis, Mycoplasma genitalium, Ureaplasma urealyticum and Ureaplasma parvum were randomized to receive josamycin or placebo. Amniotic fluid was also tested for 16S PCR. MAIN OUTCOME MEASURES: The primary outcome was delivery before 37 weeks. RESULTS: In total, 1043 women underwent amniotic-fluid screening with specific PCR detection between July 2008 and July 2011: PCR detection failed in 27 (2.6%), and 20 (1.9%) underwent termination of pregnancy. Among the 1016 women with PCR results, 980 had available data for the primary outcome (delivery before 37 weeks) and 29 (3.0%) were positive for Ureaplasma and/or Mycoplasma spp. Because of the low rate of women with PCR-positive findings, the trial was stopped prematurely. In total, 19 women were randomized to receive placebo (n = 8) or josamycin (n = 11) and their characteristics were comparable, as was the rate of preterm delivery and secondary outcomes. In comparing all PCR-positive and -negative women regardless of treatment, PCR positivity for Ureaplasma and/or Mycoplasma spp. was not associated with any adverse pregnancy or neonatal outcome. Amniotic-fluid screening by 16S PCR showed no other bacterial colonization associated with preterm birth. CONCLUSIONS: Because of a low amniotic fluid colonization rate, the trial was interrupted. Maternal amniotic-fluid colonization by Mycoplasma and/or Ureaplasma spp. at 16-20 weeks in asymptomatic women is rare and not associated with adverse pregnancy outcomes. TRIAL REGISTRATION: ClinicalTrials.gov NCT00718705.

Undiagnosed abnormal postpartum blood loss: Incidence and risk factors.

BACKGROUND: We aimed to evaluate the incidence of undiagnosed abnormal postpartum blood loss (UPPBL) after vaginal delivery, identify the risk factors and compare them to those of postpartum haemorrhage (PPH). METHOD: The study population included women who participated in a randomized controlled trial of women with singleton low-risk pregnancy who delivered vaginally after 35 weeks' gestation (n = 3917). Clinical PPH was defined as postpartum blood loss ≥ 500 mL measured by using a collector bag and UPPBL was defined by a peripartum change in haemoglobin ≥ 2 g/dL in the absence of clinical PPH. Risk factors were assessed by multivariate multinomial logistic regression. RESULTS: The incidence of UPPBL and PPH was 11.2% and 11.0% of vaginal deliveries, respectively. The median peripartum change in Hb level was comparable between UPPBL and PPH groups (2.5 g/dL interquartile range [2.2-3.0] and 2.4 g/dL IQR [1.5-3.3]). Risk factors specifically associated with UPPBL were Asian geographical origin (adjusted OR [aOR] 2.3, 95% confidence interval [CI] 1.2-4.2; p = 0.009), previous caesarean section (aOR 3.4, 2.1-5.5; p<0.001) and episiotomy (aOR 2.6, 1.8-3.6; p<0.001). Risk factors for both UPPBL and PPH were primiparity, long duration of labour, instrumental delivery and retained placenta. CONCLUSION: Undiagnosed abnormal postpartum blood loss is frequent among women giving birth vaginally and has specific risk factors. The clinical importance of this entity needs further confirmation, and the benefit of systematic or targeted prevention strategies needs to be assessed.

Risk factors for chronic post-traumatic stress disorder development one year after vaginal delivery: a prospective, observational study.

Our study aimed to assess the prevalence of post-traumatic stress disorder (PTSD) after childbirth one year after vaginal delivery and to identify characteristics of women and deliveries associated with it. Questionnaires were mailed a year after delivery to 1103 women with prospectively collected delivery and postpartum data, including a question on day 2 assessing their experience of childbirth. PTSD was assessed a year later by the Impact of Event and Traumatic Event Scales; 22 women (4.2%, 95%CI 2.7-6.3%) met the PTSD diagnostic criteria and 30 (5.7%; 95%CI 3.9-8.0%) PTSD profile criteria. Factors associated with higher risk of PTSD profile were previous abortion (aOR 3.6, 95%CI 1.4-9.3), previous postpartum hemorrhage (Aor 5.3, 95%CI 1.3-21.4), and postpartum hemoglobin <9 g/dl (aOR 2.7, 95%CI 1.0-7.5). Among 56 women (10.3%) reporting bad childbirth memories at day 2 postpartum, 11 (21.1%) met PTSD diagnosis and 11 (21.1%) PTSD profile criteria a year later, compared with 11 (2.4%) (P < 0.001) and 18 (3.8%) (P < 0.001), respectively, of the 489 (87.7%) women with good memories. PTSD is not rare at one year after vaginal delivery in a low-risk population. A simple question at day 2 post partum may identify women most at risk of PTSD and help determine if early intervention is needed.

Predictive value of vaginal IL-6 and TNFα bedside tests repeated until delivery for the prediction of maternal-fetal infection in cases of premature rupture of membranes.

OBJECTIVE: Examine the predictive value for maternal-fetal infection of routine bedside tests detecting the proinflammatory cytokines, TNFα and IL-6, in the vaginal secretions of women with premature rupture of the membranes (PROM). STUDY DESIGN: This prospective two-center cohort study included all women hospitalized for PROM over a 2-year period. A bedside test assessed IL-6 and TNFα in vaginal secretions. Both centers routinely tested CRP and leukocytes, assaying both in maternal serum, and analyzed vaginal bacterial flora; all samples were repeated twice weekly until delivery. RESULTS: The study included 689 women. In cases of preterm PROM (PPROM) before 37 weeks (n=184), a vaginal sample positive for one or more bacteria was the only marker associated with early neonatal infection (OR 5.6, 95%CI; 2.0-15.7). Its sensitivity was 82% (95%CI; 62-94) and its specificity 56% (95%CI; 47-65). All positive markers of infection were associated with the occurrence of chorioamnionitis. In cases of PROM from 37 weeks onward (n=505), only CRP >5mg/dL was associated with early neonatal infection (OR=8.3, 95%CI; 1.1-65.4) or clinical chorioamnionitis (OR=6.8, 95%CI; 1.5-30.0). The sensitivity of CRP >5mg/dL was 91% (95%CI; 59-100) and its specificity 45% (95%CI; 40-51) for predicting early neonatal infection, and 89% (95%CI; 65-99) and 46% (95%CI; 41-51), respectively, for predicting clinical chorioamnionitis. CONCLUSION: The association of vaginal cytokines with maternal-fetal infection is weak and thus prevents their use as a good predictor of maternal-fetal infection. CRP and vaginal samples may be useful for identifying a group of women at low risk of infection.

Study protocol. TRAAP - TRAnexamic Acid for Preventing postpartum hemorrhage after vaginal delivery: a multicenter randomized, double-blind, placebo-controlled trial.

BACKGROUND: Postpartum hemorrhage (PPH) is a major cause of maternal mortality, accounting for one quarter of all maternal deaths worldwide. Estimates of its incidence in the literature vary widely, from 3 % to 15 % of deliveries. Uterotonics after birth are the only intervention that has been shown to be effective in preventing PPH. Tranexamic acid (TXA), an antifibrinolytic agent, has been investigated as a potentially useful complement to uterotonics for prevention because it has been proved to reduce blood loss in elective surgery, bleeding in trauma patients, and menstrual blood loss. Randomized controlled trials for PPH prevention after cesarean (n = 10) and vaginal (n = 2) deliveries show that women who received TXA had significantly less postpartum blood loss without any increase in their rate of severe adverse effects. However, the quality of these trials was poor and they were not designed to test the effect of TXA on the reduction of PPH incidence. Large, adequately powered, multicenter randomized controlled trials are required before the widespread use of TXA to prevent PPH can be recommended. METHODS AND DESIGN: A multicenter, double-blind, randomized controlled trial will be performed. It will involve 4000 women in labor for a planned vaginal singleton delivery, at a term ≥ 35 weeks. Treatment (either TXA 1 g or placebo) will be administered intravenously just after birth. Prophylactic oxytocin will be administered to all women. The primary outcome will be the incidence of PPH, defined by blood loss ≥500 mL, measured with a graduated collector bag. This study will have 80 % power to show a 30 % reduction in the incidence of PPH, from 10.0 % to 7.0 %. DISCUSSION: In addition to prophylactic uterotonic administration, a complementary component of the management of third stage of labor acting on the coagulation process may be useful in preventing PPH. TXA is a promising candidate drug, inexpensive, easy to administer, and simple to add to the routine management of deliveries in hospitals. This large, adequately powered, multicenter, randomized placebo-controlled trial seeks to determine if the risk-benefit ratio favors the routine use of TXA after delivery to prevent PPH. TRIAL REGISTRATION: ClinicalTrials.gov NCT02302456 (November 17, 2014).

Cervical length in asymptomatic twin pregnancies: prospective multicenter comparison of predictive indicators.

UNLABELLED: Abstract Objective: To determine whether cervical shortening between 22 and 27 weeks predicts spontaneous preterm delivery before 34 weeks better than a single cervical length (CL) measurement at 22 or 27 weeks in asymptomatic twins. METHODS: Prospective 13-center study over a 2-year-period. CL was measured in 120 asymptomatic twin pregnancies. The area under the ROC curve was calculated for each parameter and the cutoff point providing the best diagnostic performance, sensitivity and specificity for predicting spontaneous delivery<34 weeks was defined too. RESULTS: About 13/116 women gave birth before 34 weeks. The three ROC curves differed significantly at the 0.05 level. The best cutoff points were CL≤35 mm at 22 weeks, CL≤25 mm at 27 weeks and cervical shortening≥20%. For equal sensitivity values for each, specificity for CL≤25 mm at 27 weeks was 87.5%, significantly better. CONCLUSIONS: The performance of cervical shortening for the prediction of preterm delivery of asymptomatic twins before 34 weeks does not differ from that of CL measurements at 22 or 27 weeks. The modest predictive value of CL at 22 weeks and of cervical shortening is an argument against recommending routine CL measurements.

Outpatient cervical ripening by nitric oxide donors for prolonged pregnancy: a randomized controlled trial.

OBJECTIVE: To assess whether outpatient cervical ripening at 41 0/7 weeks of gestation with the nitric oxide donor isosorbide mononitrate reduces cesarean delivery rates in nulliparous women with an unfavorable cervix. METHODS: We recruited nulliparous pregnant women with a Bishop score less than 6 in a randomized, multicenter, double-blind, placebo-controlled trial. Women received 40 mg vaginal isosorbide mononitrate or a placebo at 41 0/7, 41 2/7, and 41 4/7 weeks of gestation. They returned home between visits. At 41 5/7 weeks of gestation, for women who had not yet given birth, labor was induced with oxytocin or prostaglandins, depending on cervical status. We needed 685 women per group to detect a 25% reduction in the cesarean delivery rate, the primary outcome measure, from 25% in the placebo group to 18.75% in the isosorbide mononitrate group (1-ß=0.8, α=0.05, two-sided). RESULTS: The NOCETER (NO donors for reduction of CEsareans at TERm) trial was a negative study. The cesarean delivery rate was 27.3% (185/678) in the isosorbide mononitrate group and 27.2% (186/684) in the placebo group (relative risk 1.00, 95% confidence interval [CI] 0.84-1.19). None of the maternal secondary efficacy outcomes differed between groups. Side effects were more common among women receiving isosorbide mononitrate than in the placebo group (78.8% [534/678] compared with 27.9% [191/684], relative risk 2.82, 95% CI 2.49-3.20). Composite perinatal morbidity did not differ between groups. CONCLUSION: Outpatient cervical ripening with vaginal isosorbide mononitrate for prolonged pregnancy in nulliparous women does not reduce cesarean delivery rate. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, www.clinicaltrials.gov, NCT00930618.

Effect of routine controlled cord traction as part of the active management of the third stage of labour on postpartum haemorrhage: multicentre randomised controlled trial (TRACOR).

OBJECTIVE: To assess the impact of controlled cord traction on the incidence of postpartum haemorrhage and other characteristics of the third stage of labour in a high resource setting. DESIGN: Randomised controlled trial. SETTING: Five university hospital maternity units in France. PARTICIPANTS: Women aged 18 or more with a singleton fetus at 35 or more weeks' gestation and planned vaginal delivery. INTERVENTIONS: Women were randomly assigned to management of the third stage of labour by controlled cord traction or standard placenta expulsion (awaiting spontaneous placental separation before facilitating expulsion). Women in both arms received prophylactic oxytocin just after birth. MAIN OUTCOME MEASURE: Incidence of postpartum haemorrhage ≥ 500 mL as measured in a collector bag. RESULTS: The incidence of postpartum haemorrhage did not differ between the controlled cord traction arm (9.8%, 196/2005) and standard placenta expulsion arm (10.3%, 206/2008): relative risk 0.95 (95% confidence interval 0.79 to 1.15). The need for manual removal of the placenta was significantly less frequent in the controlled cord traction arm (4.2%, 85/2033) compared with the standard placenta expulsion arm (6.1%, 123/2024): relative risk 0.69, 0.53 to 0.90); as was third stage of labour of more than 15 minutes (4.5%, 91/2030 and 14.3%, 289/2020, respectively): relative risk 0.31, 0.25 to 0.39. Women in the controlled cord traction arm reported a significantly lower intensity of pain and discomfort during the third stage than those in the standard placenta expulsion arm. No uterine inversion occurred in either arm. CONCLUSIONS: In a high resource setting, the use of controlled cord traction for the management of placenta expulsion had no significant effect on the incidence of postpartum haemorrhage and other markers of postpartum blood loss. Evidence to recommend routine controlled cord traction for the management of placenta expulsion to prevent postpartum haemorrhage is therefore lacking. TRIAL REGISTRATION: ClinicalTrials.gov NCT01044082.

Individual and organisational determinants associated with maintenance tocolysis in the management of preterm labour: a multilevel analysis.

BACKGROUND: Clinical guidelines do not recommend maintenance tocolysis for the management of preterm labour. The French national survey EVAPRIMA revealed it was administered to more than 50% of women hospitalised for preterm labour. Our aim was to identify the individual and organisational determinants associated with maintenance tocolysis. METHODS: The study was a secondary analysis of the prospective population-based EVAPRIMA study database. Population study included every women hospitalised for preterm labour and at risk of receiving maintenance tocolysis, over a one month period, in 99 randomly selected French maternity units. Main outcome was the prescription of maintenance tocolysis. The association between maintenance tocolysis and individual (maternal or obstetrical) and organisational determinants were evaluated with multilevel analysis. RESULTS: Of the 531 women included, 68.9% (95% CI 0.65-0.73) received maintenance tocolysis. The only individual factor associated with maintenance tocolysis was gestational age at admission; the rate of maintenance tocolysis was higher among women hospitalised before 32 weeks of gestation. The significantly different rates between maternity units demonstrated the existence of a maternity unit effect. Maintenance tocolysis was also associated with organisational determinants and was more frequent in level 1 (ORa = 6.54[2.21-19.40]) and level 2 maternity units (ORa = 3.68[1.28-10.59]), in units with less than 1500 deliveries/year (ORa = 5.27[4.43-19.44]), and in specific areas of France. CONCLUSION: A maternity unit effect, explained partly by the organisational characteristics of the units, plays a major role in the practice of maintenance tocolysis. Widespread dissemination of these results might improve adherence to clinical guidelines.

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.

BACKGROUND: Accurate 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. METHODS: We 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. RESULTS: The 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. CONCLUSIONS: The 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.

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.

Selective use of fetal fibronectin detection after cervical length measurement to predict spontaneous preterm delivery in women with preterm labor.

OBJECTIVE: The purpose of this study was to determine whether selective use of fetal fibronectin detection after ultrasound measurement of cervical length predicts preterm delivery in symptomatic patients better than either indicator alone. STUDY DESIGN: This prospective blinded study performed both tests on 359 women hospitalized for preterm labor between 18 and 34 completed weeks' gestation. The primary outcome was preterm delivery before 35 weeks'gestation. RESULTS: Among the 359 women included, 48 (13.4%) delivered before 35 weeks' gestation. The sensitivity, specificity, and positive and negative predictive values of cervical length < or = 25 mm were 75%, 63%, 24%, and 94%, respectively, and of fetal fibronectin > or = 50 ng/mL, 63%, 81%, 33%, and 93%. Fetal fibronectin detection was significantly (P < .001) more specific than cervical length measurement. For selective use of fetal fibronectin detection after cervical length measurement, the test was considered positive if cervical length was < or = 15 mm or if cervical length was between 16 and 30 mm with fetal fibronectin > or = 50 ng/mL. The predictive values of this test were not significantly different from those of fetal fibronectin detection (67%, 81%, 36%, and 94%). This strategy could have avoided 200 fibronectin tests. CONCLUSION: Selective use of fetal fibronectin detection after cervical length measurement is more specific than cervical length and as effective as fetal fibronectin assays in the entire population of women in preterm labor for predicting preterm birth.

Detection of interleukin 6 mRNA by RT-PCR in vaginal secretions: association with preterm delivery and neonatal infection in women with preterm labour and intact membranes.

OBJECTIVE: To find a biological marker associated with preterm delivery or neonatal infection in pregnant women with preterm labour and intact membranes. STUDY DESIGN: Cervical secretions were collected from 286 women hospitalized for preterm labour with intact membranes at 24-34 weeks' gestation. The outcomes studied were delivery before 33 and 35 weeks' gestation, chorioamnionitis, and neonatal infection, and their association with the presence of IL-6 mRNA in cervical secretions as detected by RT-PCR. The other infectious markers tested were: bacterial vaginosis and fetal fibronectin in cervical secretions; serum CRP and white blood cell count. RESULTS: The vaginal secretions of 13 of 286 women (4.7%) contained IL-6 mRNA. The only other marker tested significantly associated with IL-6 mRNA+ was the presence of streptococcus in vaginal secretions (30.8% versus 9.4% in the IL-6+ and-groups, p = 0.03). Although the difference did not reach statistical significance (p<0.06 and 0.08, respectively), in women with IL-6 mRNA in cervical secretions we observed a tendency to give birth before 33 and 35 weeks more often than the population as a whole. This group was at higher risk of neonatal infection (38.5% versus 15.1%; p = 0.04). After adjustment for infectious risk factors, IL-6 remained significantly associated with neonatal infection (OR = 4.6, 95% CI [1.1-18.9]). The sensitivity of IL-6 mRNA for neonatal infection was 11.1%. The specificity was 96.7%. CONCLUSION: The detection of IL-6 mRNA by RT-PCR in vaginal secretions allows identification of a small group of women at high risk of neonatal infection, independently of other markers of infection.

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. DESIGN: Multicentre, case-control study (the French EPIPAGE study). SETTING: Regionally defined population of births in France. SAMPLE: The sample consisted of 1943 very preterm live-born singletons (< 33 weeks of gestation), 276 moderate preterm live-born singletons (33-34 weeks) and 618 unmatched full-term controls (39-40 weeks). METHODS: Data from the EPIPAGE study were analysed using polytomous logistic regression models to control for social and demographic characteristics, lifestyle habits during pregnancy and obstetric history. The main mechanisms of preterm delivery were classified as gestational hypertension, antepartum haemorrhage, fetal growth restriction, premature rupture of membranes, idiopathic preterm labor and other causes. MAIN OUTCOME MEASURES: Odds ratios for very preterm birth by gestational age and by pregnancy complications leading to preterm delivery associated with a history of induced abortion. RESULTS: Women with a history of induced abortion were at higher risk of very preterm delivery than those with no such history (OR + 1.5, 95% CI 1.1-2.0); the risk was even higher for extremely preterm deliveries (< 28 weeks). The association between previous induced abortion and very preterm delivery varied according to the main complications leading to very preterm delivery. A history of induced abortion was associated with an increased risk of premature rupture of the membranes, antepartum haemorrhage (not in association with hypertension) and idiopathic spontaneous preterm labour that occur at very small gestational ages (< 28 weeks). Conversely, no association was found between induced abortion and very preterm delivery due to hypertension. CONCLUSION: Previous induced abortion was associated with an increased risk of very preterm delivery. The strength of the association increased with decreasing gestational age.

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.

Cervical length and funneling at 22 and 27 weeks to predict spontaneous birth before 32 weeks in twin pregnancies: a French prospective multicenter study.

OBJECTIVE: Our aim was to determine the accuracy of cervical length and funneling of the internal os in the prediction of the spontaneous very preterm birth of twin pregnancies. STUDY DESIGN: In a prospective study at 13 centers, routine transvaginal ultrasound scanning was used to examine 251 women with twin pregnancies at 22 weeks of gestation and 215 women at 27 weeks of gestation; cervical length, spontaneous cervical funneling, and funneling after transfundal pressure were evaluated. Receiver operating characteristic curve analysis was used to determine the best cervical length for the prediction of spontaneous preterm birth before 32 and 35 weeks of gestation. We calculated the sensitivity, specificity, and predictive values for cervical length and for funneling. RESULTS: The median gestational age at delivery was 36 weeks in both populations. Of the population that was included at 22 weeks of gestation, 5.2% (13 women) gave birth spontaneously before 32 weeks of gestation, and 13.2% (33 women) gave birth spontaneously before 35 weeks of gestation; the median cervical length was 40 mm. The receiver operating characteristic curve showed no clear best cutoff point for cervical length. For spontaneous delivery before 32 and 35 weeks of gestation, the sensitivity of cervical length < or =30 mm was 46% and 27%, respectively; the specificity was 89% and 90%, respectively. The sensitivity of funneling was 54% and 33%, and its specificity 89% and 91%, respectively. After multivariate analysis, only funneling remained significant for delivery before both 32 and 35 weeks of gestation. Of the population that was included at 27 weeks, 3.3% (7 women) gave birth spontaneously before 32 weeks of gestation, and 12.4% (26 women) gave birth spontaneously before 35 weeks of gestation; the median cervical length was 35 mm. The receiver operating characteristic curve showed 25 mm to be the best cutoff point for cervical length. For spontaneous delivery before 32 and 35 weeks of gestation, the sensitivity of cervical length < or =25 mm was 100% and 54%, respectively, and the specificity was 84% and 87%, respectively. The sensitivity of funneling was 86% and 54%, and the specificity 78% and 82%, respectively. After multivariate analysis, both indicators remained significant for delivery before 35 weeks of gestation. Funneling after transfundal pressure at 22 or 27 weeks did not predict very preterm delivery. CONCLUSION: Cervical length and funneling both predict the very preterm birth of twins. Although cervical length is the predictor of choice at 27 weeks of gestation, at 22 weeks of gestation the diagnostic values of both parameters are close.