Uterine balloon tamponade as an adjunct to misoprostol for the treatment of uncontrolled postpartum haemorrhage: a randomised controlled trial in Benin and Mali.

OBJECTIVE: To assess the effectiveness of low-cost uterine tamponade as an adjunct to misoprostol for the treatment of uncontrolled postpartum haemorrhage (PPH) in low-resource settings. DESIGN: Randomised controlled trial. SETTING: Seven healthcare facilities in Cotonou, Benin and Bamako, Mali. POPULATION: Women delivering vaginally who had clinically diagnosed PPH that was suspected to be due to uterine atony, who were unresponsive to oxytocin and who needed additional uterotonics. METHODS: Women were randomly assigned to receive uterine balloon tamponade with a condom-catheter device or no tamponade; both groups were also given intrarectal or sublingual misoprostol. MAIN OUTCOME MEASURE: Proportion of women with invasive surgery or who died before hospital discharge. RESULTS: The proportion of primary composite outcome did not differ significantly between the tamponade arm (16%; 9/57) and the standard second line treatment arm (7%; 4/59): relative risk 2.33 (95% CI 0.76 to 7.14, p=0.238). A significantly increased proportion of women with tamponade and misoprostol versus misoprostol alone had total blood loss more than 1000 mL: relative risk 1.52 (95% CI 1.15 to 2.00, p=0.01). Case fatality rate was higher in the tamponade group (10%; 6/57) than in the control group (2%; 1/59) (p=0.059). TRIAL REGISTRATION NUMBER: ISRCT Registry Number 01202389; Post-results.

Impact of accreditation training for residents on sonographic quality in gynecologic emergencies.

OBJECTIVES: To assess the impact of an educational intervention based on an original accreditation training program on the quality of emergency sonography performed by obstetrics and gynecology (Ob/Gyn) residents. METHODS: We conducted a prospective before-after study on residents who performed bedside standardized sonographic examinations as first-line investigations in patients seen at our gynecologic emergency department. In both periods, the residents followed a 1-hour class taught by a board-certified Ob/Gyn sonography expert (opinion leader) and received a written standardized imaging protocol. An accreditation training process was implemented for the new residents at the beginning of the second period: 5 complete sonographic examinations were required for each resident, and facilitated feedback from the opinion leader was performed using a dedicated sonographic quality score. During both periods, all consecutive sonograms were collected and stored. The primary outcome was the sonographic quality score. A mixed model for repeated measures was used to compare scores in both periods from 20 consecutive sonographic examinations performed by 5 residents who were different in each period. RESULTS: The mixed model analysis showed an increase in quality scores in the post-accreditation training compared to the pre-accreditation training period (estimated coefficient ± SD, 4.13 ± 0.51; t = 8.16). The sonographic examination order also had a significant effect in both periods (estimated coefficient ± SD, 0.11 ± 0.03; t = 3.99). CONCLUSIONS: An accreditation training process including facilitated feedback from a local opinion leader improved the quality of sonographic examinations performed by Ob/Gyn residents in women presenting to a gynecologic emergency department.

Routine ultrasound examination by OB/GYN residents increase the accuracy of diagnosis for emergency surgery in gynecology.

INTRODUCTION: Diagnostic accuracy of first-line sonographic evaluation by obstetrics/gynecology residents in determining the need for emergency surgery in women with acute pelvic pain is unknown. Aim of this study was to evaluate the diagnostic accuracy of routine ultrasound evaluation by obstetrics/gynecology residents, available 24 hours a day, in patients with acute pelvic pain. METHODS: A cross-sectional retrospective study included consecutive patients who underwent emergency laparoscopy for acute pelvic pain at a teaching hospital gynecologic emergency unit, between January 1, 2004, and December 31, 2006. The laparoscopic diagnosis was the reference standard. Gynecologic and nongynecologic conditions requiring immediate surgery to avoid severe morbidity or death were defined as surgical emergencies. In all patients, obstetrics/gynecology residents routinely performed clinical examination and standardized ultrasonography was routinely recorded. Sonograms were re-interpreted for the study, blinded to physical examination and laparoscopic findings, according to evidence-based predetermined criteria. Sensitivity, specificity, and likelihood ratios were computed for clinical data alone, sonographic data alone, and the combination of both. RESULTS: Emergency laparoscopy was performed in 234 patients, diagnosing 139 (59%) surgical emergencies. Clinical and sonographic examinations performed by the residents each independently predicted a need for emergency surgery. Combining both examinations was superior over each examination alone and had an acceptable false-negative rate of 1%. CONCLUSIONS: First-line combined clinical and sonographic examination by obstetrics/gynecology residents is effective in ruling out surgical emergencies in patients with acute pelvic pain.

Trends in the rate of invasive procedures after the addition of the intrauterine tamponade test to a protocol for management of severe postpartum hemorrhage.

OBJECTIVE: The purpose of this study was to investigate changes in invasive procedure rates after the addition of intrauterine balloon tamponade as an initial second-line therapy to our protocol for the management of severe postpartum hemorrhage. STUDY DESIGN: We compared the outcomes of all patients with postpartum hemorrhage that was unresponsive to prostaglandin during 2 equal periods, before (first period) and after (second period) the introduction of a balloon tamponade protocol. RESULTS: During the second period, 43 women had uterine tamponade with a Bakri balloon as their initial second-line therapy (after vaginal delivery, 31; after caesarean delivery, 12). The global success rate was 86% (37/43 women). Among patients who delivered vaginally, the rates of arterial embolization (8.2% vs 2.3% in the first and second period; P = .006; odds ratio, 0.26; 95% confidence interval, 0.09-0.72) and conservative surgical procedures (5.1% vs 1.4%, in the first and second period; P = .029; odds ratio, 0.26; 95% confidence interval, 0.07-0.95) were significantly lower after the uterine tamponade test was added to our protocol. CONCLUSION: Intrauterine balloon tamponade is an attractive adjunctive strategy for the achievement of hemostasis in intractable hemorrhages and prevention of the need for invasive procedures.

Prenatal BACs-on-Beads™: the prospective experience of five prenatal diagnosis laboratories.

OBJECTIVE: We previously reported on the validation of Prenatal BACs-on-Beads™ on retrospectively selected and prospective prenatal samples. This bead-based multiplex assay detects chromosome 13, 18, 21 and X/Y aneuploidies and the nine most frequent microdeletion syndromes. We demonstrated that Prenatal BACs-on-Beads(TM) is a new-generation, prenatal screening tool. Here, we describe the experience of five European prenatal diagnosis laboratories concerning the ongoing use of Prenatal BACs-on-Beads™ . METHODS: Some 1653 samples were analyzed. All results were confirmed by conventional karyotyping or another appropriate technique. All indications for invasive prenatal diagnosis were included. Amniotic fluid and chorionic villus samples were analyzed in equivalent proportions. RESULTS: The failure rate was 3.3% and the overall abnormality detection rate was ~1/10. Eighty-five percent of the detected abnormalities were common aneuploidies. Eleven microdeletions and duplications were identified, thus giving an overall yield for microdeletion and microduplication detection of 1/145. Compared with QF-PCR, Prenatal BACs-on-Beads™ provides an additional detection rate of ~1/250 for low-risk pregnancies. The false positive and negative rates were both <1%. CONCLUSION: When associated with conventional karyotyping, the Prenatal BACs-on-Beads™ assay combines a short turnaround time (typical of rapid aneuploidy detection tests) with valuable detection of the most frequent microdeletion syndromes that cannot be detected in cytogenetic analyses.

Hemoperitoneum assessment in ectopic pregnancy.

OBJECTIVE: To identify routine clinical, ultrasound, and biologic criteria to assess the volume of hemoperitoneum in women with ectopic pregnancy (EP). METHODS: Except for patients with hemodynamic shock, all women assigned to surgical laparoscopic treatment for confirmed EP at Poissy Saint Germain en Laye Hospital between January 2004 and December 2007 were included in the study. The patients underwent abdominal and digital pelvic examination, and standardized ultrasonography. Ordered logistic regression analysis was performed to select criteria associated with an increase in hemoperitoneum. The diagnostic accuracy of each variable was then calculated for different hemoperitoneum cut-off values. RESULTS: The study included 215 patients. Pelvic pain of 4 or above on a numeric rating scale (odds ratio [OR], 2.3; 95% confidence interval [CI], 1.3-4.1), abdominal guarding or rebound tenderness (OR, 4.6; 95% CI, 2.0-10.8), hemoglobin under 10 g/dL (OR, 12.2; 95% CI, 4.2-35.8), presence of fluid at transvaginal ultrasound (OR, 3.6; 95% CI, 1.4-9.2), and fluid in Morison pouch at abdominal ultrasound (OR, 5.6; 95% CI, 2.0-15.9) were found to be independently associated with hemoperitoneum. CONCLUSION: Both clinical examination and standardized ultrasonography were found to be useful for accurate evaluation of hemoperitoneum in patients presenting with EP.

Williams-Beuren syndrome: the prenatal phenotype.

Using prenatal BACs-on-Beads technology, the first prenatal case of Williams-Beuren syndrome (WBS) was diagnosed. In light of this result, an ultrasound scan confirmed the presence of well-characterized features of WBS. This case report emphasizes the fact that new genomic technologies will generate prenatal information and provide helpful additional information.

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.