S. Schiermeier

Sensitivity and specificity of intrapartum computerised FIGO criteria for cardiotocography and fetal scalp pH during labour: multicentre, observational study

Objective  To identify sensitivity and specificity of computerised cardiotocography (CTG) analysis for fetal acidosis during delivery.

What is the "normal" fetal heart rate?

Aim. There is no consensus about the normal fetal heart rate. Current international guidelines recommend for the normal fetal heart rate (FHR) baseline different ranges of 110 to 150 beats per minute (bpm) or 110 to 160 bpm. We started with a precise definition of “normality” and performed a retrospective computerized analysis of electronically recorded FHR tracings. Methods. We analyzed all recorded cardiotocography tracings of singleton pregnancies in three German medical centers from 2000 to 2007 and identified 78,852 tracings of sufficient quality. For each tracing, the baseline FHR was extracted by eliminating accelerations/decelerations and averaging based on the “delayed moving windows” algorithm. After analyzing 40% of the dataset as “training set” from one hospital generating a hypothetical normal baseline range, evaluation of external validity on the other 60% of the data was performed using data from later years in the same hospital and externally using data from the two other hospitals. Results. Based on the training data set, the “best” FHR range was 115 or 120 to 160 bpm. Validation in all three data sets identified 120 to 160 bpm as the correct symmetric “normal range”. FHR decreases slightly during gestation. Conclusions. Normal ranges for FHR are 120 to 160 bpm. Many international guidelines define ranges of 110 to 160 bpm which seem to be safe in daily practice. However, further studies should confirm that such asymmetric alarm limits are safe, with a particular focus on the lower bound, and should give insights about how to show and further improve the usefulness of the widely used practice of CTG monitoring.

Comparison of non-invasive fetal electrocardiogram to Doppler cardiotocogram during the 1st stage of labor

Abstract Objective: We compared a non-invasive fetal electrocardiogram (fECG) to Doppler cardiotocogram (CTG) during the 1st stage of labor. Study design: This was a prospective observational study of non-invasive fECG using five abdominal electrodes and one Doppler ultrasound probe in 27 patients. Data were analyzed for reliability, clinical and statistical equivalence. Results: The fECG was similar to the traditional Doppler method. The fECG characterizes a fetal heart rate (FHR) trace in a similar way with regards to acceleration count, decelerations count and coincidence, variability and baseline. The FHR was overall correlated (Pearsons r=0.91). Conclusion: This non-invasive fECG presents an alternative, reliable and accurate assessment for fetal well-being during the 1st stage of labor.

Gender-Related Changes in Magnetocardiographically Determined Fetal Cardiac Time Intervals in Intrauterine Growth Retardation

Prenatal growth deficiencies as well as gender have been associated with cardiovascular disease in later life. It is also known that the duration of fetal cardiac time intervals (CTI) are dependent on fetal development. The aim of this work was to examine the relationship between fetal CTI in healthy and intrauterine growth retardation (IUGR) fetuses, taking gender into account. A total of 269 magnetocardiograms (MCG) were obtained in 47 healthy and 27 IUGR pregnancies. In each signal-averaged MCG, durations of CTI were determined. Age- and heart rate–corrected values were compared between normal and IUGR fetuses separately with respect to gender. Overall, there was an association between atrial and ventricular conduction times and estimated fetal body weight. In female fetuses, IUGR was associated with shorter P WAVE, PQ segment, PR interval, and QRS complex and longer STT and QT intervals. For males, this was so only for P wave, QRS complex, and STT interval. The shortening of conduction times in IUGR may be explained by reduced cardiac muscle mass associated with lower body weight. On the other hand, the gender-specific differences, particularly in the IUGR fetuses may be due to hormonal factors.

Laparoscopic Pectopexy: A Prospective, Randomized, Comparative Clinical Trial of Standard Laparoscopic Sacral Colpocervicopexy with the New Laparoscopic Pectopexy—Postoperative Results and Intermediate-Term Follow-Up in a Pilot Study

PURPOSE The purpose of the study was to compare the outcome of laparoscopic sacral colpocervicopexy with laparoscopic pectopexy. Our aim was to show that the safety and effectiveness of the new technique is similar to the traditional technique. We expected differences regarding defecation disorders. PATIENTS AND METHODS We randomly assigned patients to two treatment groups: 44 in the pectopexy and 41 in the sacropexy group. If necessary, the operative procedures were planned in a so-called multicompartment setting regarding the different pelvic floor disorders. All defects were managed at the same time. Eighty-one patients were examined 12 to 37 months after treatment (mean follow-up 20.67 months). RESULTS The long-term follow-up (21.8 months for pectopexy and 19.5 months for sacropexy) showed a clear difference regarding de novo defecation disorders (0% in the pectopexy vs 19.5% in the sacropexy group). The incidence of de novo stress urinary incontinence was 4.8% (pectopexy) vs 4.9% (sacropexy). The incidence of rectoceles (9.5% vs 9.8%) was similar in both groups. No de novo lateral defect cystoceles were found after pectopexy, whereas 12.5% were found after sacropexy. The apical descensus relapse rates, 2.3% for pectopexy vs 9.8% for sacropexy, were not statistically significant. The occurrence of de novo anterior defect cystoceles and rectoceles revealed no significant differences. CONCLUSION Laparoscopic pectopexy is a novel method of vaginal prolapse therapy that offers clear practical advantages compared with laparoscopic sacropexy. Because laparoscopic pectopexy does not reduce the pelvic space, it results in a zero percentage of defecation disorders.

[Foetal electrocardiography (ECG) is an alternative to Doppler ultrasound cardiotocogram (CTG) for antenatal assessment of foetal well-being--preliminary results].

INTRODUCTION Computer analysing software is required for the assessment of CTGs because of the low sensitivity and high intra- and interobserver variability. The German Society of Gynaecology and Obstetrics advises the use of computer analysing CTG software. This study is aimed at evaluating the use of a new foetal ECG analysis system as an alternative to the traditional Doppler ultrasound CTGs in the setting of a university labour suite. MATERIALS AND METHODS 10 pregnant women beyond the 32 (nd) week of gestation, who were admitted to hospital and gave informed consent to this study, were connected to the foetal EKG monitor system Monica AN24. Patient satisfaction, maternal and foetal EKG detection rates and time required to connect the patient were evaluated. RESULTS 8 out of 10 women would prefer the Monica AN24 monitor system over the traditional Doppler ultrasound CTG. In total, the mean foetal ECG detection rate was 62.3 % (SD +/- 30.4) during the recorded time interval; at rest the detection rate was 75.3 % (SD +/- 33.2); during the night time (23.00 to 7.00) the detection rate was 78.3 % (SD +/- 25.4); and during night time and at rest the detection rate was 82.2 % (SD +/- 24.3). The mean recorded time interval was 6 h and 54 min (SD +/- 2 h and 43 min). In total, the maternal ECG detection rate was as high as 99.7 % (SD +/- 0.4). The mean time required for applying the Monica AN24 monitor system was 3.2 min (SD +/- 0.6). CONCLUSION The foetal ECG monitor system may be a good alternative to Doppler ultrasound CTGs. With the perspective to analyse in a beat to beat manner foetal EKG heart rates, this new monitor system should be superior to Doppler ultrasound CTGs, however further larger studies are needed to confirm this hypothesis.

Fetal electrocardiographic measurements in the assessment of fetal heart rate variability in the antepartum period

This study examines signal availability in fetal electrocardiogram (FECG) beat-to-beat acquisition and the accuracy of fetal heart rate variability (HRV) analysis in the clinical setting using a commercially available FECG monitor. Signal availability was examined in 130 FECG recordings of 0.3-17.5 h duration collected in 63 fetuses (25th-42nd week of gestation) under uncontrolled conditions. Identification of R-peaks demonstrated a signal loss of 30% ± 24% with 3.6 ± 1.7 signal gaps per minute. Median duration of the gaps within a recording was 1.8 ± 0.2 s. Per hour of recording, 1.8 ± 2.1 episodes of 5 min of uninterrupted data were found. Signal availability improved with gestational age and was poorer in women with high body-mass index. Fetal HRV between weeks 36-42 was examined on the basis of 5 min RR-interval episodes obtained under controlled quiet conditions in 55 FECG compared to 46 high quality fetal magnetocardiograms. There were no differences in RR-interval duration, its standard deviation and low frequency power. However, various measures of short-term HRV were significantly higher in the FECG data: root mean square of successive differences (10.0 ± 1.8 versus 6.6 ± 3.0 ms, p < 0.001, high frequency spectral power (24 ± 12 versus 13 ± 13 ms(2), p < 0.001) and approximate entropy (0.86 ± 0.16 versus 0.73 ± 0.24, p = 0.007). We conclude that, in spite of considerable signal loss, FECG recordings can accurately estimate heart rate and its overall variance. However, measures that quantify short-term beat-to-beat HRV will be compromised due to possible recurring inappropriate detection of single R-peaks.

The German Version of the ‘ICIQ Vaginal Symptoms Questionnaire’ (German ICIQ-VS): An Instrument Validation Study

Introduction: No validated questionnaire that evaluates vaginal symptoms is currently available in the German language. Here, we report the translation and validation process of the German ICIQ-VS. Subjects: Pilot study: 10 patients without any specific disease. Main study: 58 patients (cases) suffering from genital descensus higher than grade 1 pelvic organ prolapse quantification (POPQ) and 51 patients (controls) without vaginal affections. Methods: To establish a cultural-adaptive equivalent in German, recommendations from Guillemin et al. [J Clin Epidemiol 1993;46:1417–1432] were carefully followed. Participants of the main study were asked to fill in the questionnaire at three time points [baseline (T1), 7 days later (T2) and 1 year later (T3)]. Reliability, validity and sensitivity to change were evaluated. Results: In our pilot study, all questionnaire items were correctly interpreted and answered. In the main study, no changes from the original format were observed after translation and cultural adaptation. For the cases, internal consistency was acceptable (Cronbach’s alpha 0.72–0.79) and test-retest reliability was moderate to near-perfect for single items (weighted kappa 0.67–0.94). Sensitivity to change and content validity were excellent. Construct validity revealed statistically significant differences between groups. Conclusion: The ICIQ-VS has successfully been translated and validated into the German language.

Power morcellation inside a secure endobag: a pilot study

Abstract Introduction: Unprotected power morcellation can lead to a spread of previously undiagnosed malignancy. We present a new containment bag with two closable trocar insertion sites to reduce this risk. This pilot study was designed to assess the feasibility of this device under everyday conditions. Material and methods: The containment bag was used in ten laparoscopic supracervical hysterectomies. We evaluated time requirement for bag insertion into the abdominal cavity and in-bag morcellation. A 2000 ml polyurethane morcellation bag was used for all interventions. All surgeries were carried out in a three-trocar setting. Results: We carried out ten supracervical hysterectomies. No intraoperative complications and no bag ruptures occurred. The meantime requirement to insert the bag and prepare the specimen for morcellation was 10.5 min (range, 7–19 min). The mean specimen weight was 191.9 g (range, 32–710 g). Mean morcellation time was 10.5 min (range, 3–28 min), mean weight of remaining tissue and fluid in the bag after morcellation was 12.1 g (range, 7–19 g). Conclusions: The presented data demonstrate that the endobag can be successfully applied in the clinical routine. Further studies are required to evaluate additional characteristics, such as individual learning curve and time requirements.

Intrapartum ST segment analyses (STAN) using simultaneous invasive and non-invasive fetal electrocardiography: a report of 6 cases.

The objective of this study was to analyze ST segment analyses (STAN) using simultaneous traditional - gold standard invasive (fetal scalp electrode) and newly available non-invasive abdominal fetal electrocardiography (fECG) during delivery.This was a prospective observational study of non-invasive fetal ECG using 5 abdominally sited electrodes (Monica AN24) against the traditional fetal scalp electrodes (STAN S31) on 6 patients. Data were analyzed when the STAN S31 found the baseline and when there was a baseline rise.Successful fECG signal acquisition was achieved in 6/6 (100%) patients. Using the non-invasive fECG, P and QRS waves were seen in all cases, and T waves in 3/6 (50%). ST segment analysis analysis was possible in 6/6 (100%) and 3/6 (50%) using invasive and non-invasive fECG, respectively.This study demonstrates that ST segment analysis is feasible using invasive and non-invasive fECG. Further studies are warranted to confirm the preliminary results and improve ECG morphology of non-invasive fECG.