Prediction of postnatal outcomes in fetuses with isolated congenital diaphragmatic hernias using different lung-to-head ratio measurements.

OBJECTIVES: The purpose of this study was to compare different methods for measuring the fetal lung area-to-head circumference ratio and to investigate their prediction of postpartum survival and the need for neonatal extracorporeal membrane oxygenation (ECMO) therapy in fetuses with isolated congenital diaphragmatic hernias. METHODS: This prospective study included 118 fetuses of at least 20 weeks' gestation with isolated left-sided congenital diaphragmatic hernias. The lung-to-head ratio was measured with 3 different methods (longest diameter, anteroposterior diameter, and tracing). To eliminate the influence of gestational age, the observed-to-expected lung-to-head ratio was calculated. Receiver operating characteristic (ROC) curves were calculated for the statistical prediction of survival and need for ECMO therapy by the observed-to-expected lung-to-head ratio measured with the different methods. RESULTS: For survival and ECMO necessity 118 and 102 cases (16 neonates were not eligible for ECMO) were assessed, respectively. For prediction of postpartum survival and ECMO necessity, the areas under the ROC curves and 95% confidence intervals showed very similar results for the 3 methods for prediction of survival (tracing, 0.8445 [0.7553-0.9336]; longest diameter, 0.8248 [0.7360-0.9136]; and anteroposterior diameter, 0.8002 [0.7075-0.8928]) and for ECMO necessity (tracing, 0.7344 [0.6297-0.8391]; longest diameter, 0.7128 [0.6027-0.8228]; and anteroposterior diameter, 0.7212 [0.6142-0.8281]). Comparisons between the areas under the ROC curves showed that the tracing method was superior to the anteroposterior diameter method in predicting postpartum survival (P = .0300). CONCLUSIONS: Lung-to-head ratio and observed-to-expected lung-to-head ratio measurements were shown to accurately predict postnatal survival and the need for ECMO therapy in fetuses with left-sided congenital diaphragmatic hernias. Tracing the limits of the lungs seems to be the favorable method for calculating the fetal lung area.

New formulas for calculating the lung-to-head ratio in healthy fetuses between 20 and 40 weeks' gestation.

OBJECTIVES: The purpose of this study was to develop new formulas for the expected fetal lung area-to-head circumference ratio in normal singleton pregnancies between 20 and 40 weeks' gestation. METHODS: The lung-to-head ratio and complete fetal biometric parameters of 126 fetuses between 20 and 40 weeks' gestation were prospectively measured. The lung-to-head ratio was measured by 3 different methods (longest diameter, anteroposterior diameter, and tracing). Formulas for predicting right and left lung-to-head ratios with regard to gestational age and biometric parameters were derived by stepwise regression analysis. RESULTS: New formulas for calculating right and left lung-to-head ratios by each measurement method were derived. The formulas included gestational age only and no biometric parameters. CONCLUSIONS: The new formulas for estimating the expected lung-to-head ratio by the 3 different methods in normal singleton pregnancies up to 40 weeks' gestation may help improve the prognostic power of observed-to-expected lung-to-head ratio assessment in fetuses with congenital diaphragmatic hernias.

Prediction of mortality and the need for neonatal extracorporeal membrane oxygenation therapy by 3-dimensional sonography and magnetic resonance imaging in fetuses with congenital diaphragmatic hernias.

OBJECTIVES: To compare different rotation angles for assessment of fetal lung volume by 3-dimensional (3D) sonography with magnetic resonance imaging (MRI) regarding prediction of mortality and the need for neonatal extracorporeal membrane oxygenation (ECMO) therapy in fetuses with congenital diaphragmatic hernias. METHODS: One hundred patients with fetal congenital diaphragmatic hernias between 22 and 39 weeks' gestation were examined by 3D sonography and MRI. Sonographic contralateral fetal lung volumes were assessed by the rotational technique (virtual organ computer-aided analysis) at 3 different rotation angles: 6°, 15°, and 30°. The MRI fetal lung volumes were calculated based on multiplanar T2-weighted MRI. To eliminate the influence of gestational age, the observed to expected contralateral fetal lung volume on sonography and the observed to expected fetal lung volume on MRI were calculated. Receiver operating characteristic (ROC) curves were calculated for the statistical prediction of survival and need for ECMO therapy by the observed to expected contralateral fetal lung volume (sonography) and observed to expected fetal lung volume (MRI). RESULTS: One hundred cases were assessed for survival and 89 for ECMO necessity (11 neonates were not eligible for ECMO). For prediction of postpartum survival and ECMO necessity, the areas under the ROC curves (AUCs) showed very similar results for MRI and 3D sonography: observed to expected fetal lung volume by MRI, 0.819 (95% confidence interval, 0.730-0.909) and 0.835 (0.748-0.922), respectively; 6° sonography, 0.765 (0.647-0.883) and 0.820 (0.734-0.905); 15° sonography, 0.784 (0.672-0.896) and 0.811 (0.719-0.903); and 30° sonography, 0.732 (0.609-0.855) and 0.772 (0.671-0.872). Comparisons between the AUCs revealed no statistical differences. CONCLUSIONS: We have shown the good prognostic value of 3D sonography in fetuses with congenital diaphragmatic hernias compared with MRI, particularly when using small rotation angles. Therefore, it can be an appropriate diagnostic tool when counseling patients for congenital diaphragmatic hernias.

Sex-specific differences in the concentration of tubular parameters in the amniotic fluid of second trimester fetuses.

OBJECTIVE: Renal dysplasia and obstructive uropathy are more common in males and are associated with an increased tubular loss of electrolytes. We aimed to compare the midtrimester concentration of tubular parameters in the prenatal period between healthy male and female fetuses. METHODS: Amniotic fluid was collected at 16 weeks of gestation at the time of genetic amniocentesis. The concentration of sodium, chloride, potassium, calcium, phosphate, magnesium, α1-microglobulin, creatinine and urea was determined in the amniotic fluid of 92 male and 108 female fetuses. RESULTS: The concentration of sodium, chloride and calcium was not significantly higher in male than in female fetuses. In contrast, the concentration of potassium (p=0.01), phosphate (p=0.04), magnesium (p=0.04) and α1-microglobulin (p=0.04) was significantly increased in the amniotic fluid of male fetuses. The concentration of electrolytes correlated to the concentration of creatinine, urea and α1-microglobulin. CONCLUSION: The concentration of specific tubular parameters in the amniotic fluid was higher in male compared with female fetuses. Whether this might point to sex-specific differences in tubular function in second trimester fetuses or reflect glomerular filtration or other interfering factors remains speculative.

Influence of different rotation angles in assessment of lung volumes by 3-dimensional sonography in comparison to magnetic resonance imaging in healthy fetuses.

OBJECTIVES: Three-dimensional (3D) sonographic volumetry is established in gynecology and obstetrics. Assessment of the fetal lung volume by magnetic resonance imaging (MRI) in congenital diaphragmatic hernias has become a routine examination. In vitro studies have shown a good correlation between 3D sonographic measurements and MRI. The aim of this study was to compare the lung volumes of healthy fetuses assessed by 3D sonography to MRI measurements and to investigate the impact of different rotation angles. METHODS: A total of 126 fetuses between 20 and 40 weeks' gestation were measured by 3D sonography, and 27 of them were also assessed by MRI. The sonographic volumes were calculated by the rotational technique (virtual organ computer-aided analysis) with rotation angles of 6° and 30°. To evaluate the accuracy of 3D sonographic volumetry, percentage error and absolute percentage error values were calculated using MRI volumes as reference points. Formulas to calculate total, right, and left fetal lung volumes according to gestational age and biometric parameters were derived by stepwise regression analysis. RESULTS: Three-dimensional sonographic volumetry showed a high correlation compared to MRI (6° angle, R(2) = 0.971; 30° angle, R(2) = 0.917) with no systematic error for the 6° angle. Moreover, using the 6° rotation angle, the median absolute percentage error was significantly lower compared to the 30° angle (P < .001). The new formulas to calculate total lung volume in healthy fetuses only included gestational age and no biometric parameters (R(2) = 0.853). CONCLUSIONS: Three-dimensional sonographic volumetry of lung volumes in healthy fetuses showed a good correlation with MRI. We recommend using an angle of 6° because it assessed the lung volume more accurately. The specifically designed equations help estimate lung volumes in healthy fetuses.

In vitro models of the fetal lung: comparison of lung volume measurements with 3-dimensional sonography and magnetic resonance imaging.

OBJECTIVES: Three-dimensional (3D) sonography is an established volumetric method in gynecology and obstetrics. The aim of this study was to investigate the variability of 3D sonographic measurements and their accuracy in comparison with magnetic resonance imaging (MRI) for assessing fetal lung volume using in vitro lung models. METHODS: Twenty-three in vitro lung models with randomly defined volumes ranging from 1 to 60 mL were made from gelatin with plastic sheaths, manually molded into the shape of fetal lungs. The models were measured using 3D sonography and MRI. The 3D sonographic volumes were calculated using the rotational technique with angles of 6° and 30°. Multiplanar T2-weighted sequences were used for the MRI measurements. The percentage error and absolute percentage error were calculated for each method, and intraobserver and interobserver variability in 3D sonographic measurements was assessed with intraclass correlation coefficients (ICCs). Agreement between calculated and real volumes using the limits of agreement method was also evaluated. RESULTS: The ICCs for the rotation angles indicated very good intraobserver and interobserver variability (6°, 0.995 and 0.996; 30°, 0.997 and 0.985). No systematic errors were observed in the mean percentage errors for 3D sonographic measurements or MRI volumetry. The lowest median absolute percentage error (1.76) was obtained with MRI volumetry, significantly lower than the values for sonography (6°, 5.00; P < .001; 30°, 5.49; P < .001). There were no significant differences in absolute percentage errors between the rotation angles (P = .82) and no significant differences in limits of agreement between 3D sonography and MRI (6°, P = .76; 30°, P = .39). CONCLUSIONS: Three-dimensional sonographic volumetry was almost as accurate as MRI in this in vitro model and can be regarded as a good alternative method. Further research is needed to confirm these findings in vivo and to assess the prognostic value in fetuses with lung hypoplasia (eg, congenital diaphragmatic hernias).

Assessment of lung volume by 3-dimensional sonography and magnetic resonance imaging in fetuses with congenital diaphragmatic hernias.

OBJECTIVES: The purpose of this study was to evaluate the influence of different rotation angles in assessment of the contralateral lung volume by 3-dimensional (3D) sonography in comparison to magnetic resonance imaging (MRI) in fetuses with congenital diaphragmatic hernias. METHODS: A total of 126 measurements by 3D sonography and MRI were conducted in 81 patients between 18 and 39 weeks' gestation. The 3D sonographic volumes of the contralateral fetal lung were calculated by the rotational technique (virtual organ computer-aided analysis) with rotation angles of 6°, 15°, and 30°. Transverse multiplanar T2-weighted MRI was performed for the MRI measurements. To compare the accuracy of 3D sonographic volumetry using different rotation angles, MRI assessment was taken as the reference method, and percentage errors and limits of agreement were calculated for each angle. RESULTS: Three-dimensional sonographic volume measurements showed a high correlation with MRI (6° angle, R(2) = 0.86; 15° angle, R(2) = 0.78; 30° angle, R(2) = 0.68). The mean percentage error showed no systematic error. With regard to random error, the 6° step had significantly lower values than the larger angles 30° step (R = 0.472) and the narrowest limits of agreement. CONCLUSIONS: Especially when using a small rotation angle, assessment of the contralateral fetal lung volume by 3D sonography in congenital diaphragmatic hernias is a reliable alternative to MRI.

Associated malformations in congenital diaphragmatic hernia.

Congenital diaphragmatic hernia (CDH) is a severe neonatal anomaly. The aim of this study was to evaluate the frequency and types of malformations associated with CDH. The outcome was compared with that in newborns with CDH alone. The study included 362 fetuses and newborns at a single national center for CDH. Associated malformations and chromosomal aberrations were noted prenatally and postnatally. The neonatal outcome was assessed relative to the use of extracorporeal membrane oxygenation (ECMO) and the mortality rate. At least one associated malformation was diagnosed in 143 cases (39.5%). Altogether, 272 associated malformations were found. Only 50 (18.4%) anomalies were diagnosed antenatally. In 62 (17.1%) cases, 102 major malformations were found along with CDH, with a prenatal detection rate of 35.3%. The associated malformations were very heterogeneous, but cardiovascular malformations were the most common. Newborns with major anomalies, chromosomal aberrations, or syndromes additional to CDH had a significantly lower survival rate than newborns with an isolated CDH. Associated malformations did not affect the rate of ECMO treatment. Associated malformations in CDH are frequent and heterogeneous, and diligent and experienced antenatal and postnatal care is important.

Role of fetal abdominal circumference as a prognostic parameter of perinatal complications.

OBJECTIVE: To evaluate the potential of fetal abdominal circumference (AC) measurement as predictor of perinatal complications in term newborns. MATERIALS AND METHODS: This prospective study included 324 consecutive term pregnancies within a 6-month period between February and August 2009. Inclusion criteria were a singleton pregnancy with at least 37 weeks of gestation, vertex presentation, absence of structural or chromosomal disorders and complete ultrasound examination within 3 days of delivery. Patients with elective caesarean sections were excluded. Vaginal deliveries were assessed with regard to the impact of fetal AC on the mode of delivery, the neonatal outcome (pH, base excess, APGAR score at 5 min) and the incidence of perineal injuries. When appropriate, U tests and χ (2) tests were performed for group comparisons. RESULTS: Complete data were obtained for 258 patients. Sixty-six patients were excluded because they underwent elective caesarean section. Only 12 of the 30 fetuses with an AC ≥ 36.0 cm weighed more than 4,000 g. There was no significant difference in relation to incidence of surgical delivery (instrumental delivery, P = 0.754 and caesarean section, P = 0.405), the neonatal outcome (pH, P = 0.527; base excess, P = 0.146; APGAR score at 5 min, P = 0.552), and the occurrence of perineal injuries (2nd and 3rd degree, P = 0.951). CONCLUSION: The results of the study could not demonstrate a significant relationship between AC ≥ 36.0 cm and perinatal complications. For this, measuring the fetal AC is of no help in finding the correct clinical management.

Umbilical cord blood donation during caesarean section does not lead to increased maternal blood loss.

BACKGROUND: Umbilical cord blood haematopoietic stem cell donation (UCBD) has increased in recent years. While performing UCBD during caesarean section, suturing the uterotomy is delayed for a few minutes. The aim of our study was to analyse if this causes an increase in maternal blood loss. PATIENTS AND METHODS: In this retrospective study, we compared pre- and postpartal haemoglobin levels of 100 patients who delivered by caesarean, either with UCBD (study group) or without UCBD (control group). P-values < or = 0.05 were regarded as significant. RESULTS: The main clinical characteristics did not show any significant differences between the two groups. There was no significant difference of decrease in haemoglobin between the study group and the control group (p=0.747). CONCLUSION: UCBD during caesarean section does not lead to increased maternal blood loss. Objections to the safety of UCBD regarding increased maternal blood loss during caesarean section can be dispelled.

Comparison of different sonographic methods to determine fetal abdominal circumference.

PURPOSE: In modern obstetric management, accurate estimation of fetal weight is an important prognostic parameter of neonatal morbidity and mortality, and a valuable tool for determining further treatment. Fetal abdominal measurements, mostly abdominal circumference (AC), are not only included in the majority of commonly used weight equations, but also have the greatest impact on weight estimation. This therefore underlines the importance of accurate determination of the AC. The aim of our study was to evaluate which method for AC calculation is the most accurate one and thereby gives the best results for fetal weight estimation. MATERIALS AND METHODS: This prospective study included 239 term pregnancies. Inclusion criteria were a singleton pregnancy and ultrasound examination with complete fetal biometric parameters within 3 days of delivery, and absence of structural or chromosomal malformations. For calculation of the sonographic AC, three different methods were used. As a reference method, AC of the infant was determined immediately after birth. The accuracy of fetal weight estimation was determined for all of these methods of AC measurement using a commonly used weight equation. Differences were compared by using percentage error (PE), absolute percentage error (APE), limits of agreement (LOA) and cumulative distribution. RESULTS: The ellipse region-of-interest (ROI) method showed the best results of all sonographic methods. For estimating fetal weight, it had the lowest median APE of the sonographic methods and the lowest SD of the PE, as well as the narrowest LOA. Regarding the cumulative distribution, ellipse ROI technique included the most cases at all discrepancy levels (5, 10, 15, and 20%). CONCLUSION: Accurate measurement of fetal AC is important for good fetal weight estimation. The differences between the three techniques were small; however, there was a significant advantage when using the ellipse ROI method.

Chlamydia trachomatis infection as a risk factor for infertility among women in Ghana, West Africa.

In developing countries, data about the prevalence of genital Chlamydia trachomatis infections and their sequelae, especially tubal infertility, is scarce. A prospective case-control study was performed enrolling 439 Ghanaian women. The case group included 191 patients with primary or secondary infertility. The control group consisted of 248 healthy pregnant women. First-void urine samples were investigated by PCR, and serum specimens were tested for C. trachomatis-specific IgG and IgA antibodies. Demographic and behavioral information were gathered for statistical analysis. The PCR prevalence of C. trachomatis was relatively low and did not differ significantly among both groups (2.4 versus 1.6%). In contrast, significantly higher prevalences of specific IgG (39% versus 19%) and IgA (14% versus 3%) antibodies were found among infertile women. The adjusted odds ratios were 2.1 and 2.8, respectively. Our data suggest that previous C. trachomatis infections may contribute to infertility in Ghanaian women.

Gender-specific weight estimation of fetuses between 2,501 and 3,999 g--new regression formulae.

OBJECTIVE: To develop new gender-specific regression formulae to estimate fetal weight focusing on a particular weight range from 2,501 to 3,999 g. METHODS: 3,254 singleton pregnancies were included to generate new regression formulae for female and male fetuses, and to evaluate their accuracy. RESULTS: In comparison with commonly used formulae, the new gender-specific and weight-range-specific method of fetal weight estimation provided greater accuracy. The mean absolute error was less than 7%. CONCLUSIONS: When properly used, the new formulae can improve the accuracy of weight estimations in fetuses between 2,501 and 3,999 g.

Increased accuracy of fetal weight estimation with a gender-specific weight formula.

OBJECTIVE: To test whether Schild's sex-specific formula for estimating fetal weight is more accurate than commonly used regression formulae. METHODS: The gender-specific formula and 10 widely used equations were evaluated in a group of 989 pregnancies. Each fetus underwent ultrasound examination with complete biometric parameters within 7 days before delivery. RESULTS: Over the whole weight range and in the subgroup of newborns with a birth weight between 2,500 and 3,999 g, the sex-specific weight formula from Schild demonstrated the best level of accuracy. For infants with a birth weight of less than 2,500 g as well as for macrosomic newborns, the gender-specific formula did not improve fetal weight estimation. CONCLUSION: In pregnancies where fetal gender is known, Schild's regression formula should be used when fetal weight lies within the range of 2,500-3,999 g.

Finding the most accurate method to measure head circumference for fetal weight estimation.

OBJECTIVE: Accurate measurement of fetal head biometry is important for fetal weight estimation (FWE) and is therefore an important prognostic parameter for neonatal morbidity and mortality and a valuable tool for determining the further obstetric management. Measurement of the head circumference (HC) in particular is employed in many commonly used weight equations. The aim of the present study was to find the most accurate method to measure head circumference for fetal weight estimation. STUDY DESIGN: This prospective study included 481 term pregnancies. Inclusion criteria were a singleton pregnancy and ultrasound examination with complete fetal biometric parameters within 3 days of delivery, and an absence of structural or chromosomal malformations. Different methods were used for ultrasound measurement of the HC (ellipse-traced, ellipse-calculated, and circle-calculated). As a reference method, HC was also determined using a measuring tape immediately after birth. FWE was carried out with Hadlock formulas, including either HC or biparietal diameter (BPD), and differences were compared using percentage error (PE), absolute percentage error (APE), limits of agreement (LOA), and cumulative distribution. RESULTS: The ellipse-traced method showed the best results for FWE among all of the ultrasound methods assessed. It had the lowest median APE and the narrowest LOA. With regard to the cumulative distribution, it included the largest number of cases at a discrepancy level of ±10%. The accuracy of BPD was similar to that of the ellipse-traced method when it was used instead of HC for weight estimation. CONCLUSION: Differences between the three techniques for calculating HC were small but significant. For clinical use, the ellipse-traced method should be recommended. However, when BPD is used instead of HC for FWE, the accuracy is similar to that of the ellipse-traced method. The BPD might therefore be a good alternative to head measurements in estimating fetal weight.

Women's acceptance of a double-balloon device as an additional method for inducing labour.

OBJECTIVE: A wide variety of pharmacological and mechanical methods (e.g. balloon devices) are available for inducing labour, but little information is available about the way in which women regard balloon devices. The aim of this study was to investigate women's acceptance of and satisfaction with the induction of labour by administration of oral misoprostol and the combination of that with a double-balloon device. STUDY DESIGN: The study included 122 women with term pregnancies who required induction of labour between August 2009 and November 2010. They all participated in a randomized controlled trial to test different ways of inducing labour and were randomly assigned either to a 'study group' (with a combination of oral misoprostol and a double-balloon catheter) or a 'control group' (with oral misoprostol alone). After childbirth, a standardized questionnaire was given to all of the women for them to complete before discharge. In addition to assessing the induction of labour and their level of satisfaction with regard to delivery, the birth experience was objectively evaluated using the German-language version of Salmon's Item List (SIL-Ger). For statistical analysis, the chi-squared test, Fisher's exact test, the binomial test, the t-test, or the Mann-Whitney U-test for independent samples were used as appropriate. A significance level of 5% was chosen. RESULTS: Seventy-eight questionnaires were included in the analysis. The women were not bothered either by the placement of the double-balloon device (P=0.017) or by the presence of the catheter (P=0.002). In comparison with the control group, women in the study group would consider their method in a subsequent pregnancy and would recommend it to others more often (P=0.040). The SIL-Ger score showed a positive birth experience in both groups, with a significantly better score in the study group (87.7 ± 15.8 vs 79.3 ± 17.3 in the control group; P=0.030). The multivariate analysis identified three factors influencing the SIL-Ger score: satisfaction with childbirth (P<0.001), involvement in decision-making after childbirth (P=0.041), and the method of labour induction (combination of oral misoprostol and double-balloon catheter vs oral misoprostol alone; P=0.005). CONCLUSION: The women were satisfied with the induction of labour using oral misoprostol and the combination of that with a double-balloon catheter. The double-balloon catheter was accepted by the women, and surprisingly was found to have a positive impact on the birth experience.

Influence of gender on mortality and need for extracorporeal membrane oxygenation in neonates with congenital diaphragmatic hernia.

AIM: To evaluate the influence of gender in neonates with congenital diaphragmatic hernia (CDH) on survival and to assess the necessity of extracorporeal membrane oxygenation (ECMO) therapy. PATIENTS AND METHODS: All parturients with newborns suffering from CDH were included. A total of 425 infants with CDH were analyzed. The primary outcome parameters evaluated were the necessity of ECMO and the survival. Secondary outcome parameters were the mode of delivery, the arterial umbilical cord pH value, the Apgar score, and the postpartum day of death. Cases with incomplete data were excluded. RESULTS: An analysis of the gender distribution of neonates in our study revealed that more males (n=248) than females (n=177) suffered from CDH. This represented a male versus female gender ratio of 58.4% to 41.6%, a significantly different ratio from that for neonates without CDH (p=0.003). Comparing both groups, statistical analysis showed no significant differences in mode of delivery, arterial umbilical cord blood pH, Apgar score, or CDH-relevant parameters of postpartum survival, including the need for ECMO therapy. CONCLUSION: CDH occurred significantly more frequently in male newborns. However, there were no significant differences in postnatal survival nor in the necessity of ECMO therapy.

Combination of misoprostol and mechanical dilation for induction of labour: a randomized controlled trial.

OBJECTIVE: To evaluate a combination of oral misoprostol (OM) and mechanical dilation of the cervix to improve efficacy in inducing labour. STUDY DESIGN: This prospective, randomized study included 122 term pregnancies with an indication for induced labour. Each woman was randomly assigned to one of two groups. In the study group, a combination of OM and mechanical dilation with a double-balloon catheter for cervical ripening was used. In the control group, only OM was administered. The primary outcome measure was the rate of failure to induce labour, defined as no vaginal delivery within 48h. RESULTS: In the study group, the rate of failure to induce labour was significantly lower in comparison with the control group (9.3% vs. 21.2%; P=0.007). The median times for inducing labour were 15.3h in the study group and 20.8h in the control group (P=0.158). There were no significant differences between the two groups with regard to other outcome parameters. As there were no failures of induced labour among women with premature rupture of membranes, the study results were also evaluated after excluding these cases. Among those women without rupture of membranes, the median times for induction were 15.8h in the study group and 32.6h in the control group (P=0.024). The rates of failure to induce labour were 10.8% vs. 28.2% (P=0.002). CONCLUSION: A combination of OM and a double-balloon catheter improves the efficacy of labour induction in term pregnancies, particularly in women without premature rupture of the membranes.