Study population
In this prospective blinded observational study we investigated the accuracy of clinical Leopold’s manoeuvres as compared to ultrasound measurements in fetal weight estimation, with the actual birth weight as the gold standard.
This is a prospective blinded analysis of a cohort of all consecutive women giving birth, including vertex and breech, singleton gestations who presented for labour ≥37 weeks from January 2016 to May 2017 at our department.
To avoid selection bias and perform a real live evaluation, we examined all consecutive women registered for delivery and ultimately delivered at ≥37 weeks. No preterm deliveries prior to 37 weeks are done at our department, but are sent antenatally to a secondary referral centre. Therefore, there are no data on preterm deliveries in our data set.
Cases of both spontaneous labour and induction of labour were included as well as planned (primary) and unplanned (secondary) caesarean sections (see Table
1). No fetal abnormalities were detected in our group of pregnant women.
Table 1
Patient characteristics
Maternal Age | 29.2 ± 5.0 | |
Primiparous | 269 | 49.5 |
Multiparous | 274 | 50.5 |
Mean gestational age at examination [Weeks ± SD in days] | 37 + 3/7 (262 d) ± 6.8d | |
Mean gestational age at time of delivery [weeks ± SD in days] | 39 + 2/7 (275 d) ± 8d | |
Mean actual birth weight [g] | 3382.9 ± 400.2 | |
Median time estimation to birth [in days ± SD] | 15.6 ± 8 | |
Mode of delivery |
Spontaneous vaginal delivery | 342 | 63.0 |
Operative vaginal delivery | 45 | 8.3 |
Caesarean section | 156 (100%) | 28.7 |
Planned/Primary | 57 (36.5%) | 10.5 |
Unplanned/Secondary (including failed induction of labour) | 99 (63.5%) | 18.2 |
Mean maternal BMI [kg/m2] | 23.9 ± 4.8 | |
BMI < 25 | 379 | 69.8 |
BMI 25–99 | 164 | 30.2 |
Spontaneous onset of labour | 429 | 79.0 |
Induced onset of labour | 114 | 21.0 |
Gestational diabetes | 29 | 5.3 |
Pre-existing diabetes | 2 | 0.4 |
Chronic or gestational hypertension | 9 | 1.7 |
Preeclampsia | 13 | 2.4 |
The results were documented systematically during and analysed after the study period. All data were analysed in anonymized form. We did not change the pre-existing routine examination.
Clinical setting and fetal weight estimation by ultrasound and Leopold’s manoeuvres
At our institution the standard of care consists of registering pregnant women for delivery around the 37th week of their pregnancy.
The clinical setting at registration for delivery is as follows: 1.) Patient’s history taken by examining midwife; 2.) Cardiotocography (CTG) for 30 min in pregnant women at risk; 3) basic obstetric vaginal and abdominal examination with Leopold’s manoeuvres by midwife and documentation of EFW (blinded to the physician (sonographer)); 4) ultrasound biometric measurements (GE© E6, 3.5-MHz abdominal transducer) of the fetus by the physician (one of six consultants or one of two residents) including EFW (blinded to the examining midwife) registered in a nationwide electronic documentary system (PIA/Viewpoint© by LB-Systems©); 5) pre-delivery discussion with the physician regarding possible risks and mode of delivery.
Both the midwife and the physician (sonographer) were blinded to the documentation of the weight of prior babies, and pregnant women were asked not to disclose this information to avoid bias.
Every Friday, after the last delivery registration appointment of the week, the measurements were released for comparison. If discrepancies were noticed (> 500 g), these pregnant women were asked to return for re-counselling. Decisions were then based on the ultrasound measurements and their interpretation by a consultant.
Calculation by the ultrasound machine and the PIA/Viewpoint© system is based on Hadlock’s formula [
10] including measurement of biparietal diameter (BPD), head circumference (HC), abdominal circumference (AC) and femur length (FL). The results are discussed in a shared decision-making process between the examiner and the mother/parents to plan the mode of delivery.
Fetal weight estimation by midwives using Leopold’s manoeuvres is provided as a point estimate rounded off to the nearest 100 g by the examining midwife.
All examiners, 13 midwives, six consultants and two residents had a level of professional experience of at least 3 years, as both residents were in their fourth and last year of residency. The range of experience among midwives was 5 years to up to 34 years (mean 16.6), among consultants and residents between four and 34 years (mean 11.8).
As previously mentioned, we did not change the pre-existing routine examination, and the midwives already performed Leopold’s manoeuvres as a non-invasive examination for fetal weight estimation before we started our study. The institutional review board (IRB) decision was obtained from the Tauernkliniken GmbH IRB before recruitment for the full trial began in December 2015 (Ref.nr. IRB TK 01_10/2015). All women gave verbal informed consent to participate, which was recorded in the patient’s records.
Maternal demographics as well as pregnancy and neonatal outcome information were extracted from electronic medical records (PIA/Viewpoint© by LB-Systems©).
In order to extrapolate EFW (Leopold and US) from the examination on the date of birth registration to the actual date of birth, we used the complementary percentile curve for the Austrian population (separately available for girls and boys) (Heim et al., unpublished data).
BMI was evaluated for its impact on clinical estimation of fetal weight. Maternal BMI was calculated from height (self-reported) and weight (measured) at the time of admission and was divided into sub-categories of < 25 kg/m2 and ≥ 25 kg/m2.
Gestational age at registration for delivery was evaluated in intervals of 37 to 39 6/7 weeks, 40 to 40 6/7 weeks, and ≥ 41 weeks.
The outcome was to compare overall absolute error, overall absolute percent error, absolute percent error > 10% and absolute percent error > 20% for weight estimation by ultrasound and by Leopold’s manoeuvres versus the actual birth weight as the given gold standard. The estimations and extrapolations were performed according to validated methods to the best of our knowledge. The median time between estimation and birth is shown in Table
1.
Statistical analysis
Baseline characteristics of the study cohort were reported using descriptive statistics.
We calculated the mean and standard deviation (SD) of maternal age (years), duration of pregnancy (weeks + 6/7 days), fetal weight at birth (grams), body mass index (BMI) (kg/m
2), parity, mode of delivery (spontaneous, vaginal operative, Caesarean section), induction of labour and maternal risk factors (gestational diabetes, hypertension, preeclampsia) for univariate descriptive analysis (“patient characteristics”). Absolute errors (equal to the absolute value of the difference between the estimate and the observed weight at birth date) in the estimates were calculated, reporting the mean and SD for the Leopold and the US estimates. It seemed to be practice-relevant to report the proportion of cases with an absolute error ≥ 500 g [
20]. Additionally, we report absolute percent errors (mean SD), absolute percent errors > 10% and absolute percent errors > 20%.
To test for differences in the absolute errors and the absolute percent errors between Leopold and ultrasound estimates we used the paired T test. For the proportion of absolute errors ≥500 g, absolute percent error > 10% and absolute percent error > 20% we used the McNemar test statistics for paired samples.
We conducted the above analysis separately for normal weight and for overweight pregnant women.
In order to investigate the effects of BMI on estimate errors, we performed a descriptive analysis as described above, namely separately for the two groups (using two sample tests instead of paired tests). We stratified the results for BMI for < 25 kg/m2 (normal weight) and ≥ 25 kg/m2 (overweight).
Normality test was applied first by visual inspection of the respective histograms and then formally by applying the Shapiro-Wilk Test.
All statistical analyses were performed using Stata/SE 13.1, Special Edition (College Station, TX, USA).