Routine third-trimester ultrasound for the detection of small-for-gestational age in low-risk pregnancies (ROTTUS study): randomized controlled trial.

OBJECTIVE: To compare the proportion of small-for-gestational-age (SGA) infants detected by routine third-trimester ultrasound vs those detected by selective ultrasound based on serial symphysis-fundus height (SFH) measurements (standard care) in low-risk pregnancy. METHODS: This was an open-label randomized controlled trial conducted at a hospital in Kenya between May 2018 and February 2020. Low-risk pregnant women were randomly allocated (ratio of 1:1) to routine ultrasound for fetal growth assessment between 36 + 0 and 37 + 6 weeks' gestation (intervention group) or to standard care, which involved a selective growth scan on clinical suspicion of fetal growth abnormality based on serial SFH measurements (control group). During ultrasound examination, fetal growth was assessed by measurement of the abdominal circumference (AC), and AC < 10th centile was used to diagnose a SGA fetus. The main prespecified outcomes were the detection of neonatal SGA, defined as birth weight < 10th centile, and of severe neonatal SGA, defined as birth weight < 3rd centile. The predictive performance of routine third-trimester ultrasound and selective ultrasound based on serial SFH measurements was determined using receiver-operating-characteristics (ROC)-curve analysis. RESULTS: Of 566 women assessed for eligibility, 508 (89.8%) were randomized, of whom 253 were allocated to the intervention group and 255 to the control group. Thirty-six babies in the intervention group and 26 in the control group had a birth weight < 10th centile. The detection rate of SGA infants by routine third-trimester ultrasound vs that by standard care was 52.8% (19/36) vs 7.7% (2/26) (P < 0.001) and the specificity was 95.5% (191/200) and 97.9% (191/195), respectively (P = 0.08). The detection rate of severe SGA was 66.7% (12/18) by routine ultrasound vs 8.3% (1/12) by selective ultrasound based on SFH measurements (P < 0.001), with specificities of 91.7% (200/218) and 98.1% (205/209), respectively (P = 0.006). The area under the ROC curve of routine third-trimester ultrasound in prediction of SGA was significantly greater than that of selective ultrasound based on SFH measurements (0.92 (95% CI, 0.87-0.96) vs 0.68 (95% CI, 0.58-0.77); P < 0.001). CONCLUSIONS: In low-risk pregnancy, routine ultrasound performed between 36 + 0 and 37 + 6 weeks is superior to selective ultrasound based on serial SFH measurements for the detection of true SGA, with high specificity. © 2021 International Society of Ultrasound in Obstetrics and Gynecology.

International standards for fetal brain structures based on serial ultrasound measurements from Fetal Growth Longitudinal Study of INTERGROWTH-21st Project.

OBJECTIVE: To create prescriptive growth standards for five fetal brain structures, measured using ultrasound, in healthy, well-nourished women at low risk of impaired fetal growth and poor perinatal outcome, taking part in the Fetal Growth Longitudinal Study (FGLS) of the INTERGROWTH-21st Project. METHODS: This was a complementary analysis of a large, population-based, multicenter, longitudinal study. The sample analyzed was selected randomly from the overall FGLS population, ensuring an equal distribution among the eight diverse participating sites and of three-dimensional (3D) ultrasound volumes across pregnancy (range: 15-36 weeks' gestation). We measured, in planes reconstructed from 3D ultrasound volumes of the fetal head at different timepoints in pregnancy, the size of the parieto-occipital fissure (POF), Sylvian fissure (SF), anterior horn of the lateral ventricle, atrium of the posterior horn of the lateral ventricle (PV) and cisterna magna (CM). Fractional polynomials were used to construct the standards. Growth and development of the infants were assessed at 1 and 2 years of age to confirm their adequacy for constructing international standards. RESULTS: From the entire FGLS cohort of 4321 women, 451 (10.4%) were selected at random. After exclusions, 3D ultrasound volumes from 442 fetuses born without a congenital malformation were used to create the charts. The fetal brain structures of interest were identified in 90% of cases. All structures, except the PV, showed increasing size with gestational age, and the size of the POF, SF, PV and CM showed increasing variability. The 3rd , 5th , 50th , 95th and 97th smoothed centiles are presented. The 5th centiles for the POF and SF were 3.1 mm and 4.7 mm at 22 weeks' gestation and 4.6 mm and 9.9 mm at 32 weeks, respectively. The 95th centiles for the PV and CM were 8.5 mm and 7.5 mm at 22 weeks and 8.6 mm and 9.5 mm at 32 weeks, respectively. CONCLUSIONS: We have produced prescriptive size standards for fetal brain structures based on prospectively enrolled pregnancies at low risk of abnormal outcome. We recommend these as international standards for the assessment of measurements obtained using ultrasound from fetal brain structures. © 2020 Authors. Ultrasound in Obstetrics & Gynecology published by John Wiley & Sons Ltd on behalf of International Society of Ultrasound in Obstetrics and Gynecology.

Image-scoring system for umbilical and uterine artery pulsed-wave Doppler ultrasound measurement.

OBJECTIVES: To develop an objective image-scoring system for pulsed-wave Doppler measurement of maternal uterine and fetal umbilical arteries, and evaluate how this compares with subjective assessment. METHODS: As an extension to the INTERGROWTH-21st Project, we developed a scoring system based on six predefined criteria for uterine and umbilical artery pulsed-wave Doppler measurements. Objective evaluation using the scoring system was compared with subjective assessment which consisted of classifying an image as simply acceptable or unacceptable. Based on sample size estimation, a total of 120 umbilical and uterine artery Doppler images were selected randomly from the INTERGROWTH-21st image database. Two independent reviewers evaluated all images in a blinded fashion, both subjectively and using the six-point scoring system. Percentage agreement and kappa statistic were compared between the two methods. RESULTS: The overall agreement between reviewers was higher for objective assessment using the scoring system (agreement, 85%; adjusted kappa, 0.70) than for subjective assessment (agreement, 70%; adjusted kappa, 0.47). For the six components of the scoring system, the level of agreement (adjusted kappa) was 0.97 for anatomical site, 0.88 for sweep speed, 0.77 for magnification, 0.68 for velocity scale, 0.68 for image clarity and 0.65 for angle of insonation. CONCLUSION: In quality assessment of umbilical and uterine artery pulsed-wave Doppler measurements, our proposed objective six-point image-scoring system is associated with greater reproducibility than is subjective assessment. We recommend this as the preferred method for quality control, auditing and teaching. Copyright © 2018 ISUOG. Published by John Wiley & Sons Ltd.

Quality control of ultrasound for fetal biometry: results from the INTERGROWTH-21st Project.

OBJECTIVE: To assess a comprehensive package of ultrasound quality control in the Fetal Growth Longitudinal Study of the INTERGROWTH-21st Project, a large multicenter study of fetal growth. METHODS: Quality control (QC) measures were performed for 20 313 ultrasound scan images obtained prospectively from 4321 fetuses at 14-41 weeks' gestation in eight geographical locations. At the time of each ultrasound examination, three fetal biometric variables (head circumference (HC), abdominal circumference (AC) and femur length (FL)) were measured in triplicate on separately generated images. All measurements were taken in a blinded fashion. QC had two elements: (1) qualitative QC: visual assessment by sonographers at each study site of their images based on specific criteria, with 10% of images being re-assessed at the Oxford-based Ultrasound Quality Unit (compared using an adjusted kappa statistic); and (2) quantitative QC: assessment of measurement data by comparing the first, second and third measurements (intraobserver variability), remeasurement of caliper replacement in 10% (interobserver variability), both by Bland-Altman plots and plotting frequency histograms of the SD of triplicate measurements and assessing how many were above or below 2 SD of the expected distribution. The system allowed the sonographers' performances to be monitored regularly. RESULTS: A high level of agreement between self- and external scoring was demonstrated for all measurements (κ = 0.99 (95% CI, 0.98-0.99) for HC, 0.98 (95% CI, 0.97-0.99) for AC and 0.96 (95% CI, 0.95-0.98) for FL). Intraobserver 95% limits of agreement (LoA) of ultrasound measures for HC, AC and FL were ± 3.3%, ± 5.6% and ± 6.2%, respectively; the corresponding values for interobserver LoA were ± 4.4%, ± 6.0% and ± 5.6%. The SD distribution of triplicate measurements for all biometric variables showed excessive variability for three of 31 sonographers, allowing prompt identification and retraining. CONCLUSIONS: Qualitative and quantitative QC monitoring was feasible and highly reproducible in a large multicenter research study, which facilitated the production of high-quality ultrasound images. We recommend that the QC system we developed is implemented in future research studies and clinical practice. Copyright © 2017 ISUOG. Published by John Wiley & Sons Ltd.

Scientific basis for standardization of fetal head measurements by ultrasound: a reproducibility study.

OBJECTIVE: To compare the standard methods for ultrasound measurement of fetal head circumference (HC) and biparietal diameter (BPD) (outer-to-outer (BPDoo) vs outer-to-inner (BPDoi) caliper placement), and compare acquisition of these measurements in transthalamic (TT) vs transventricular (TV) planes. METHODS: This study utilized ultrasound images acquired from women participating in the Oxford arm of the INTERGROWTH-21(st) Project. In the first phase of the study, BPDoo and BPDoi were measured on stored images. In the second phase, real-time measurements of BPD, occipitofrontal diameter (OFD) and HC in TT and TV planes were obtained by pairs of sonographers. Reproducibility of measurements made by the same (intraobserver) and by different (interobserver) sonographers, as well as the reproducibility of caliper placement and measurements obtained in different planes, was assessed using Bland-Altman plots. RESULTS: In Phase I, we analyzed ultrasound images of 108 singleton fetuses. The mean intraobserver and interobserver differences were < 2% (1.34 mm) and the 95% limits of agreement were < 5% (3 mm) for both BPDoo and BPDoi. Neither method for measuring BPD showed consistently better reproducibility. In Phase II, we analyzed ultrasound images of 100 different singleton fetuses. The mean intraobserver and interobserver differences were < 1% (2.26 mm) and the 95% limits of agreement were < 8% (14.45 mm) for all fetal head measurements obtained in TV and TT planes. Neither plane for measuring fetal head showed consistently better reproducibility. Measurement of HC using the ellipse facility was as reproducible as HC calculated from BPD and OFD. OFD by itself was the least reproducible of all fetal head measurements. CONCLUSIONS: Measurements of BPDoi and BPDoo are equally reproducible; however, we believe BPDoo should be used in clinical practice as it allows fetal HC to be measured and compared with neonatal HC. For all head measurements, TV and TT planes provide equally reproducible values at any gestational age, and HC values are similar in both planes. Fetal head measurement in the TT plane is preferable as international standards in this plane are available; however, measurements in the TV plane can be plotted on the same standards. Copyright © 2016 ISUOG. Published by John Wiley & Sons Ltd.

Image-scoring system for crown-rump length measurement.

OBJECTIVE: To develop and evaluate an objective image-scoring system for crown-rump length (CRL) measurements and to determine how this compares with subjective assessment. METHODS: A total of 125 CRL ultrasound images were selected from the database of the International Fetal and Newborn Growth Consortium for the 21(st) Century study group. Two reviewers, who were blinded to the operators' and to each others' results, evaluated all images both subjectively and objectively. Subjective evaluation consisted of rating an image as acceptable or unacceptable, while objective evaluation was based on six criteria. Reviewer differences for both the subjective and objective evaluations were compared using percentage of agreement and adjusted kappa values. RESULTS: The distribution of individual scores and differences between subjective and objective evaluation for the two reviewers was similar. Overall agreement between the reviewers was higher for objective evaluation (95.2%; adjusted κ, 0.904), than for subjective evaluation (77.6%; adjusted κ, 0.552). There was a high level of agreement for horizontal position (κ = 0.951), magnification (κ = 0.919), visualization of crown and rump (κ = 0.806) and caliper placement (κ = 0.756), while agreement for mid-sagittal section (κ = 0.629) and neutral position (κ = 0.565) were moderate and poor, respectively. CONCLUSION: The proposed six-point scoring system for CRL image rating is more reproducible than is subjective evaluation and should be considered as a method of quality assessment and audit.

REMINDER SYSTEMS FOR SELF UTERINE MASSAGE IN THE PREVENTION OF POSTPARTUM BLOOD LOSS.

BACKGROUND: Uterine massage may significantly reduce post partum blood loss and could be patient-driven. OBJECTIVE: To assess the effectiveness of an alarm reminder system for self uterine massage in the prevention of post partum blood loss. DESIGN: A random controlled trial. SETTING: Meru District Hospital, Kenya. SUBJECTS: One hundred and twenty seven (127) women were randomly assigned to a 15 minute alarm reminder system (71) and non-alarm (56) control arm during the fourth stage of labour. RESULTS: Uterine massage compliance was better in the alarm group compared to the non-alarm group (Average massage of seven and two in two hours respectively P-value <0.0001), however the difference in blood loss was not significant 45.6 ml (95% CI 43-46) vs 47.1 ml (95% CI 43-52)ml p-value 0.892. CONCLUSION: Uterine massage compliance is remarkably increased by the use of an alarm reminder.

Perspectives on the practice of vaginal birth after caesarean section in East Africa.

BACKGROUND: The increasing Caesarean section rates being observed in most facilities will ultimately result in a larger proportion of women with previous scar. Choices need to be made by both the patient and the health worker between attempted Vaginal Birth after Caesarean section (VBAC) and Elective Repeat Caesarean section (ERCS). Both practices are associated with perinatal risks and benefits that call for certain objectivity and prudence in decision making especially where resources are scarce. OBJECTIVE: To determine perceptions on the practice of vaginal birth after Caesarean section among maternity service providers in East Africa. DESIGN: A semi-qualitative cross sectional survey using self administered questionnaires. SETTING: The study was undertaken among delegates attending a regional Obstetrics and Gynaecology conference in Mombasa, Kenya. SUBJECT: Sixty three consenting delegates were interviewed RESULTS: A majority (69.8%) of the respondents were consultants and midwives working in government facilities. Fifty eight out of the 63 respondents offered VBAC in their institutions despite acknowledging sub-optimal antenatal preparation. The main concerns identified were; deficiencies in healthcare delivery systems, inadequate human resources, lack of unit guidelines, inappropriate maternal education and inappropriate foetal monitoring tools. CONCLUSION: The practice of vaginal birth after Caesarean section was perceived to be sub-optimal with many existing deficiencies that need urgent action to ensure the safety of mothers and newborns. We therefore recommend that unless these concerns raised by maternity providers are addressed then the practice of VBAC in the region should not be encouraged.

Laparoscopic management of an ovarian ectopic pregnancy: case report.

Ovarian pregnancy is a rare variant of ectopic gestation. The diagnosis is often made at surgery and requires histological confirmation. The condition has not been reported locally and its diagnosis is easily missed. A case of an ovarian ectopic pregnancy in a 41 year old para 1 + 1 with secondary infertility is reported. The patient presented with lower abdominal pain and vaginal bleeding at six weeks gestation with a serum B-hCG of 79.12 mlU/L. An ultrasound showed a complex left adnexal mass. She underwent a diagnostic and operative laparoscopy. A left oophorectomy was performed due to difficulty in achieving haemostasis.

Successful pregnancy outcome following laparoscopic myomectomy: case report.

Laparoscopic myomectomy is now widely used as an alternative to laparotomy in the management of symptomatic uterine fibroids. The advantages of this minimal access approach outweigh those of the open techniques. The pregnancy outcomes between the two methods have been studied and are comparable, but there still exists a lot of scepticism locally concerning this. It is against this background that we present a 31 year old nulliparous lady who had a two year history of primary infertility secondary to multiple uterine fibroids, the largest being fundal and measuring 6.6cm. She underwent a successful laparoscopic myomectomy in November, 2006 and conceived spontaneously in February 2007. Her antenatal follow up was uneventful. She delivered a live male, 2,650 grams by Caesarean section in October, 2007 and had an unremarkable peuperium. With the availability of proper equipment, instruments, and adequately developing skills, laparoscopic myomectomy is feasible locally and with proper patient selection could result in favourable outcome as it is elsewhere.

Caesarian section rates and perinatal outcome at the Aga Khan University Hospital, Nairobi.

BACKGROUND: There has been a persistent rise in the rate of Caesarean sections over the years. Whether this rise is the cause of the decline in infant mortality and improved neonatal outcome still remains debatable. OBJECTIVE: To compare the Caesarian section rate and the perinatal outcome at the Aga Khan University Hospital for the years 2001 and 2004. DESIGN: Retrospective study. SETTING: The Aga Khan University Hospital, Nairobi. MAIN OUTCOME MEASURES: The total Caesarian section rates, their indication and the perinatal outcome. RESULTS: The overall Caesarian section rate was 20.4% in 1996, 25.9% in 2001 and 38.1% in 2004. The rate among patients managed by their private obstetricians was 27.1% in 1996, 30.8% in 2001 and 41.7% in 2004. Whilst among general patients, it was 14.7%, 21.5% and 34.5% over the same period. The main indication for emergency Caesarian section was foetal distress, while that for elective Caesarian section was a previous uterine scar. The overall perinatal mortality rate improved from 25.2 per 1,000 births in 2001 to 14.0 per 1,000 births in 2004 (P< 0.001, 95%CL 8.58-30.62). The early neonatal mortality rate was 12.8 per 1,000 live births in 2001 compared to 10.8 per 1,000 live births in 2004 (p=0.08, 95%CI 9.84-13.76). CONCLUSION: There has been a significant increase in Caesarian section rate over the years. Being a referral unit dealing with many high-risk patients some of whom are supervised elsewhere and with a significant ratio of private patients, the high rate of Caesarean section at the Aga Khan University Hospital is expected. The rise could also be due to early detection of foetal compromise and improved diagnostic facilities leading to timely intervention. However, there has been a significant improvement in the neonatal outcome over the same period of time. Whether this is an effect of the high Caesarean section rate is debatable and calls for further research to correlate the two.

Comparison of the prevalence and characteristics of inpatient adverse events using medical records review and incident reporting.

BACKGROUND: Information on adverse events (AEs) in hospitalised patients in developing countries is scanty. OBJECTIVE: To compare the magnitude and characteristics of inpatient AEs in a tertiary, not-for-profit healthcare facility in Kenya, using medical records review and incident reporting. METHODS: Estimation of prevalence was done using incidents reported in 2010 from a random sample of medical records for hospital admissions. Nurse reviewers used 18 screening criteria, followed by physician reviewers to confirm occurrence. An AE was defined as an unexpected clinical event (UE) associated with death, disability or prolonged hospitalisation not explained by the disease condition. The kappa statistic was used to estimate inter-rater agreement, and analysis was done using logistic regression. RESULTS: The study identified 53 UEs from 2 000 randomly selected medical records and 33 reported UEs from 23 026 admissions in the index year. The prevalences of AEs from medical records review and incident reports were 1.4% (95% confidence interval (CI) 0.9 - 2.0) and 0.03% (95% CI 0.012 - 0.063), respectively. Compared with incident reporting, review of medical records identified more disability (13.2% v. 0%; p=0.03) and prolonged hospital stays (43.4% v. 18.2%; p=0.02). CONCLUSIONS: Review of medical records is preferable to incident reporting in determining the prevalence of AEs in health facilities with limited inpatient quality improvement experience. Further research is needed to determine whether staff education and a positive culture change through promotion of non-punitive UE reporting or a combination of approaches would improve the comprehensiveness of AE reporting.