Word catheter and marsupialisation in women with a cyst or abscess of the Bartholin gland (WoMan-trial): a randomised clinical trial.

OBJECTIVE: To compare recurrence of a cyst or abscess of the Bartholin gland after surgical treatment using a Word catheter or marsupialisation. DESIGN: Multicentre, open-label, randomised controlled trial. SETTING: Eighteen hospitals in the Netherlands and one hospital in England. POPULATION: Women with a symptomatic cyst or abscess of the Bartholin gland. METHODS: Women were randomised to treatment with Word catheter or marsupialisation. MAIN OUTCOME MEASURES: The primary outcome was recurrence of the cyst or abscess within 1 year of treatment. The secondary outcomes included pain during and after treatment (measured on a 10-point scale), use of analgesics, and time from diagnosis to treatment. Analysis was by intention-to-treat. To assess whether marsupialisation would reduce the recurrence rate by 5% (from 20 to 15%) we needed to include 160 women (alpha error 0.05, beta error 0.2). RESULTS: One hundred and sixty-one women were randomly allocated to treatment by Word catheter (n = 82) or marsupialisation (n = 79) between August 2010 and May 2014. Baseline characteristics were comparable. Recurrence occurred in 10 women (12%) allocated to Word catheter versus eight women (10%) allocated to marsupialisation: relative risk (RR) 1.1, 95% confidence interval (CI) 0.64-1.91; P = 0.70. Pain scores after treatment were also comparable. In the first 24 hours after treatment, 33% used analgesics in the Word catheter group versus 74% in the marsupialisation group (P < 0.001). Time from diagnosis to treatment was 1 hour for placement of Word catheter versus 4 hours for marsupialisation (P = 0.001). CONCLUSIONS: In women with an abscess or cyst of the Bartholin gland, treatment with Word catheter and marsupialisation results in comparable recurrence rates. TWEETABLE ABSTRACT: Comparable recurrence rates for treatment of Bartholinic abscess/cyst with Word catheter and marsupialisation.

[Sudden loss of consciousness during labour]. / Plotselinge bewusteloosheid tijdens de bevalling.

This case describes a 36-year-old woman, gravida 4 para 2 at 41 weeks and 3 days gestation, who appeared unconscious during labour for 75 minutes. After excluding physical disorders, it transpired that she was having a conversion disorder. A patient with a decreased level of consciousness in childbirth must be assessed using the ABCDE method, positioned in left lateral tilt to prevent inferior vena cava compression. After stabilization of the vital functions and establishing the patient's history, physical examination and laboratory tests are components of the initial clinical assessment. Neurological examination should focus on brainstem and bihemispheric pathology. If indicated, a brain CT, EEG and ECG should be performed. The diagnosis 'conversion disorder' can be supported by neurological examination, since the pattern of deficits usually does not conform to known anatomic pathways. In 37% of the cases, conversion disorder is preceded by physical stress or trauma. The prevalence in pregnant women is unknown. The first-line treatment is patient education.

Schwangerschafts protein 1 (SP1) adds little to the age-related detection of fetal Down syndrome in the first trimester of pregnancy.

Schwangerschafts Protein 1 (SP1), being a placental protein appearing in the maternal circulation early in pregnancy, has been investigated as a potential marker for Down syndrome in the first trimester. Our study compared SP1 levels in 15 pregnancies with a Down syndrome fetus and 97 matched controls. Although the median MoM in Down syndrome pregnancies (0.49) was lower than in controls, its use as a marker added very little to the detection rate above the maternal age alone.

Acute maternal alcohol consumption disrupts behavioral state organization in the near-term fetus.

Disturbed sleep regulation is often observed in neonates of women who drank heavily during pregnancy. It is unknown if (and how) an occasional drink affects fetal sleeping behavior. In 28 near-term pregnant women we examined the effects on fetal behavioral state organization of two glasses of wine (0.25 g of ethanol/kg of maternal body weight). Simultaneous 2-h recordings of fetal heart rate and body, eye, and breathing movements were made on two successive days, once without alcohol exposure and once during maternal alcohol consumption. The study was standardized for time of day and fetal sleep state, i.e., the start of recording was either during quiet sleep (n = 16) or during active sleep (n = 12). Alcohol intake reduced fetal eye movements, disorganized behavioral state organization (rapid eye movement sleep was affected in particular), and suppressed fetal breathing activity almost completely. Modest maternal alcohol intake affects fetal behavioral state organization, which reflects an immediate effect on fetal brain function.

Maternal serum levels of free beta-hCG and PAPP-A in the first trimester of pregnancy are not associated with subsequent fetal growth retardation or preterm delivery.

The purpose of this case-control study was to examine the association of first-trimester concentrations of free beta-human chorionic gonadotropin (free beta-hCG) and pregnancy-associated plasma protein A (PAPP-A) in maternal serum with subsequent preterm delivery or small-for-gestational age (SGA) fetuses. We collected all the blood samples before chorionic villus sampling in the first trimester. Concentrations of free beta-hCG and PAPP-A were expressed in multiples of the median (MOM) for gestational age. We compared the levels of both analytes in 73 SGA pregnancies (birth weight below the fifth percentile) with those in 292 normal controls, who were matched for gestational age, maternal age, parity, maternal weight, and smoking habits. We also compared the levels in 87 pregnancies with a preterm delivery (delivery before 37 completed weeks) with those in 348 matched controls. The median concentrations of PAPP-A and free beta-hCG, expressed in MOMs, in the 73 SGA pregnancies were 0.83 and 0.95, respectively, compared with 0.98 and 1.01, respectively, in the 292 matched controls (P=0.08 and 0.19, respectively). In the 87 pregnancies with a preterm delivery, the median concentrations of PAPP-A and free beta-hCG were 0.98 and 0.94, respectively, compared with 0.99 and 0.99, respectively, in the 348 matched controls (P=0.82 and 0.10, respectively). In contrast with the maternal serum analytes used in second-trimester screening--alpha-fetoprotein and human chorionic gonadotropin--this study showed that concentrations of PAPP-A and free beta-hCG in the first trimester were not associated with subsequent fetal growth retardation or preterm delivery.

Women's opinions and the implications of first- versus second-trimester screening for fetal Down's syndrome.

Two groups of pregnant women were questioned regarding their opinions on serum screening for Down's syndrome in the first trimester of pregnancy. One group comprised 83 women attending our antenatal clinic who were questioned at the time of the existing second-trimester screening test. Seventy-six per cent of those who participated in the second-trimester screening programme would have preferred the test to have been in the first trimester, mainly because of the easier termination of pregnancy and/or the earlier reassurance provided. The remaining 24 per cent could see no advantage in the earlier time frame. Of the 49 women who had declined second-trimester screening, only two would have participated in screening had it been in the first trimester. The other group comprised those women attending our antenatal diagnosis clinic who were considering chorionic villus sampling (CVS). Forty-four per cent of these women would have allowed serum screening in the first trimester to influence their decision as to whether to undergo definitive prenatal diagnostic testing. In general, those women who made use of second-trimester serum screening would also do so in the first trimester. Those who declined the existing screening programme would also decline first-trimester screening. Many women currently deciding to undergo CVS would allow a first-trimester screening test to influence their decision.

The HELLP syndrome: its association with unexplained elevation of MSAFP and MShCG in the second trimester.

In this study, we examined the relationship between concentrations of maternal serum alpha-fetoprotein (MSAFP) and maternal serum human chorionic gonadotropin (MShCG) in the second trimester and the haemolysis, elevated liver enzymes, low platelet count (HELLP) syndrome. The concentrations of both serum markers, expressed in multiples of the median (MOM), in 16 women with the HELLP syndrome were compared with those in 10443 women without this syndrome who were screened for Down's syndrome and neural tube defects. All the women with a singleton pregnancy and a known pregnancy outcome were included in this study. At a cut-off level of 2.5 MOM, 37.5 per cent of the pregnancies with the HELLP syndrome had an elevated MShCG level, compared with 4.8 per cent in the whole population (P < 0.0001). 12.5 per cent of the women with the HELLP syndrome had an elevated MSAFP level, compared with 1.3 per cent in the whole population (P < 0.025). Women with a combined elevation of MSAFP and MShCG levels (0.3 per cent of the screened population) had a 47 time greater risk of developing the HELLP syndrome than the others (P < 0.01). The HELLP syndrome should be taken into account in the case of unexplained elevated levels of MShCG and MSAFP, especially in the rare event of combined elevation of both markers.

The association between hypertensive disorders of pregnancy and abnormal second-trimester maternal serum levels of hCG and alpha-fetoprotein.

OBJECTIVE: To examine the association between hypertensive disorders of pregnancy and second-trimester maternal serum alpha-fetoprotein (MSAFP) and hCG levels. METHODS: The proportions of abnormal second-trimester MSAFP and hCG levels in the serum samples from 65 women with true pregnancy-induced hypertension or preeclampsia (cases) were compared to the proportions of abnormal levels in all 1943 women without this disorder in the same cohort in a hospital setting. Maternal serum alpha-fetoprotein and hCG levels of the 65 cases also were compared to those of 325 completely uncomplicated matched control pregnancies, selected from the same cohort. Fisher exact test and Student t test were used for statistical analysis and P < .05 was considered statistically significant. RESULTS: An MSAFP level at least 2.5 multiples of the median (MoM) was found in two of 65 cases (3.1%) and in 27 of 1943 women (1.4%) in the rest of the cohort, a nonsignificant difference (relative risk [RR] = 2.2; P = .24). The statistical power to identify a significant difference for this RR was .27. An hCG level of at least 2.5 MoM was found in six cases (9.2%) and in 89 (4.6%) of women in the rest of the cohort, also a nonsignificant difference (RR = 2.0; P = .12). The statistical power to identify a significant difference for this RR was .38. The mean (+/-standard deviation) logarithms of the MSAFP and hCG MoMs in the 65 cases (0.039 +/- 0.191 and 0.048 +/- 0.265, respectively) were not significantly different from those in the 325 matched controls (0.006 +/- 0.148 and -0.010 +/- 0.244, respectively; P = .12 and .08, respectively). CONCLUSION: Although a weak association cannot be excluded, this study found no clinically important increase in risk of developing subsequent hypertensive disorders of pregnancy among women with abnormal second-trimester levels of MSAFP or hCG.

Maternal urinary beta-core hCG in chromosomally abnormal pregnancies in the first trimester.

We evaluated urinary beta-core human chorionic gonadotropin (beta-core hCG) in the detection of fetal Down's syndrome (DS) in the first trimester of pregnancy. Urine was collected prior to performing chorionic villous sampling (CVS) between 10 and 12 completed weeks from the last menstrual period. In the 9 months of the study, there were 15 chromosomal abnormalities detected by CVS: five trisomy 21, four monosomy X, two trisomy 18, and four cases of confined placental mosaicism (CPM). In these 15 aneuploid pregnancies, the levels of urinary beta-core hCG were expressed as multiples of the median (MOM) of the ratio of beta-core hCG/creatinine for gestational age. The MOMs of this ratio in each of the five DS pregnancies were 0.2, 0.5, 1.3, 1.4, and 1.7. No difference was found between fetuses with DS or any of the other chromosomal abnormalities tested and normal fetuses. Contrary to optimistic reports of urinary beta-core hCG in the second-trimester detection of fetal DS, our data suggest that this is not a useful screening test for DS in the first trimester of pregnancy.

Nuchal translucency cannot be used as a screening test for chromosomal abnormalities in the first trimester of pregnancy in a routine ultrasound practice.

We decided to assess the practicability of introducing nuchal translucency (NT) measurements as a screening programme for fetal Down's syndrome in the first trimester of pregnancy, within the population of women who receive ultrasound examinations in our department. Over a 1-year period, measurements were made in 923 fetuses at < or = 13 weeks' gestation. Fifty-two per cent of the mothers were 36 years or older or had a past history of a chromosomally abnormal fetus or child. Measurements were only successful 58 per cent of the time; this improved to 74 per cent if the fetus was > or = 10 weeks' gestation. Inter-observer variability did not cause a major problem. There were 36 fetuses with an NT > or = 3 mm. Two of these fetuses had a chromosomal abnormality (both trisomy 21). The translucency in these two cases was so large that they would have been detected and offered prenatal diagnosis even prior to this study. There was a total of ten aneuploidies in the study group. Only two of these fetuses were detected by this screening method; five had an NT measurement < 3 mm and in three fetuses (all trisomy 21), measurements were not successful. We outline the practical problems that could be expected by introducing ultrasound screening in a routine setting. Although the efficacy of the test in a research setting may seem good, the effectiveness in everyday usage appears much less impressive, making its uptake as a screening technique in a general ultrasound practice at this stage imprudent.

Placental mosaicism is associated with unexplained second-trimester elevation of MShCG levels, but not with elevation of MSAFP levels.

In this patient-control study, we examined the impact of placental mosaicism on the concentrations of maternal serum human chorionic gonadotropin (MShCG) and maternal serum alpha-fetoprotein (MSAFP) in the second trimester of pregnancy. Patient and control groups were selected from 2347 women with a singleton pregnancy, who underwent chorionic villous sampling in the first trimester and from whom second-trimester serum samples had been collected. The concentrations of both serum markers, expressed in multiples of the median (MOM), in 35 women with confined placental mosaicism (CPM) were compared with those in 70 controls with uncomplicated pregnancies. Elevated MSAFP or MShCG was defined as a concentration of > or = 2.0 MOM. Of the 35 pregnancies with CPM, none had an elevated MSAFP level, as opposed to two out of the 70 women (2.9 per cent) in the control group (P = NS). Nine women in the placental mosaicism group (26 per cent) had an MShCG level of > or = 2.0 MOM, compared with five in the control group (7.1 per cent; P = 0.0135). Nineteen women in the placental mosaicism group (54 per cent) were screen-positive for Down's syndrome (cut-off 1:250), compared with 17 women (24 per cent) in the control group (P = 0.0042; relative risk = 2.3). The three highest MShCG levels were found in pregnancies with CPM that involved trisomy 16; all these women delivered a small-for-gestational age (SGA) infant. CPM, especially with trisomy 16, is associated with elevated levels of MShCG, but not with elevated levels of MSAFP. It is an important cause of false-positive results in serum screening programmes for fetal Down's syndrome. It is possible that abnormal MShCG levels in pregnancies with CPM result from dysfunctional placenta, caused by chromosomally abnormal areas. We therefore recommend increased surveillance of pregnancies with unexplained elevated MShCG levels.

The relation between serum markers in the second trimester and placental pathology. A study on extremely small for gestational age fetuses.

OBJECTIVES: To examine whether in women who are delivered of an extremely small for gestational age infant, raised levels of second trimester maternal serum alpha-fetoprotein (MSAFP) or human chorionic gonadotrophin (MShCG) levels are related to the presence of placental pathology detected at birth. DESIGN: Retrospective cross-sectional study. SETTING: Department of Obstetrics and Gynaecology, Antenatal Diagnosis Unit, Groningen University Hospital, The Netherlands. PARTICIPANTS: Eighty-four women who were delivered of an extremely SGA infant (< 2.3rd centile) in whom the MSAFP and the MShCG levels were known and placental pathology reports were available (study group), and 8692 women in whom the MSAFP and MShCG levels were known and the pregnancy outcome was normal (control group). Pregnancies with congenital anomalies were excluded. Analyte levels were expressed in multiples of the median (MoM) for gestational age. Statistical analysis between groups was performed by ANOVA, after logarithmic transformation of the MoMs, to normalise their distribution. MAIN OUTCOME MEASURES: 1. The means of the MSAFP and MShCG concentrations in the study group with and without placental lesions were compared with those in the control population. 2. The means of the MSAFP and MShCG levels in the study group with placental lesions were compared with those in the study group without placental lesions. RESULTS: 1. Comparison of study groups with controls: in the study group without placental lesions, the mean log MSAFP MoM (0.062), as well as the mean log MShCG MoM (-0.033), was not significantly different (P = 0.11 and P = 0.68, respectively) from the mean analyte levels in the control population (0.002 and 0.006, respectively). The mean logs of these analytes in the study group with placental lesions (0.162 and 0.129, respectively) were significantly higher compared with the MSAFP and MShCG levels in the control population (P < 0.001 for both analytes). 2. Comparison of study groups with each other: the mean log of the MSAFP level of 0.162 in the group with placental lesions was significantly different from the mean of 0.062 of the study group without placental lesions (P < 0.025). The higher mean log MShCG MoM of 0.129 in the group with placental lesions was significantly different from the mean log MShCG MoM of -0.033 in the study group without placental lesions (P < 0.025). CONCLUSIONS: Raised levels of second trimester MSAFP and MShCG in women who are subsequently delivered of an extremely small for gestational age infant are related to the presence of pathological changes in the placenta, detectable at birth. It is speculated that these placental pathological changes, which frequently accompany small for gestational age pregnancies, have their origin in the second trimester, when the normal physiological changes of the placenta occur.

Abnormal levels of maternal serum human chorionic gonadotropin and alpha-fetoprotein in the second trimester: relation to fetal weight and preterm delivery.

The aim of this prospective descriptive cross-sectional study was to examine the clinical significance of abnormal maternal serum human chorionic gonadotropin (MShCG) and alpha-fetoprotein (MSAFP) in the second trimester of pregnancy. The study group comprised 8892 women with a singleton pregnancy, who were screened for a neural tube defect and Down's syndrome. Exclusion criteria were unknown pregnancy outcome, a congenital anomaly, delivery before 25 weeks of amenorrhoea, or known insulin-dependent diabetes. MSAFP and MShCG were determined between 15 and 20 weeks' amenorrhoea. An abnormal result was defined as (a) MSAFP or MShCG > or = 2.5 MOM, (b) MSAFP or MShCG < or = 0.5 MOM, and (c) MSAFP and MShCG > or = 2.5 MOM. Birth weight percentiles and the duration of amenorrhoea at the time of delivery were employed as outcome parameters. Of the women with an abnormally elevated MSAFP, 9.4 per cent had an extremely small-for-gestational age (SGA) infant (< 2.3rd percentile; P < 0.01, relative risk 4.5), 27.1 per cent had an SGA infant (< tenth percentile; P < 0.01, relative risk 2.7), and 14.3 per cent had an appropriate-for-gestational age (AGA) infant that was delivered preterm (< 259 days; P < 0.01, relative risk 2.4). In the cases where the MShCG level was elevated, 4.4 per cent had an extremely SGA infant (P < 0.01, relative risk 2.1) and 15.5 per cent had an SGA infant (P < 0.01, relative risk 1.5). No significant association was found between an elevated MShCG level and preterm delivery. Low MShCG was significantly associated with SGA infants (P < 0.01, relative risk 1.2) but not with extremely SGA or preterm deliveries. In the group whose MSAFP and MShCG levels were both elevated, 23.8 per cent delivered an extremely SGA infant (P < 0.01, relative risk 10.9), 38.1 per cent an SGA infant (P < 0.01, relative risk 3.7) and 47.6 per cent had a preterm delivery or an SGA infant (P < 0.01, relative risk 3.0). Isolated or combined elevation of the MSAFP and MShCG levels in the second trimester of pregnancy is an indication for extra vigilance during further prenatal care. This applies to a lesser extent to a low MShCG level.

[Serum screening for fetal Down syndrome in pregnant women with an indication for prenatal diagnosis because of age: fewer amniocenteses]. / Serumscreening op foetaal Down-syndroom bij zwangeren met een leeftijdsindicatie voor prenatale diagnostiek: minder amniocentesen.

OBJECTIVE: To examine the influence of maternal serum screening for foetal Down's syndrome (DS) on the number of amniocenteses in women with an indication for prenatal diagnosis because of age > or = 36 years. DESIGN: Longitudinal descriptive study. SETTING: Department of Obstetrics and Gynaecology, University Hospital Groningen. METHOD: Between October 1, 1990 and March 31, 1994, sera from 693 women, 36 years or older with a singleton pregnancy, were tested (alpha-foetoprotein and human chorionic gonadotrophin) to calculate the likelihood of their having a foetus with DS. RESULTS: 195 pregnant women (28%) were screen-positive (risk of having a foetus with DS > or = 1:250); 105 of these (54%) chose to have an amniocentesis. Of the remaining 498 (screen-negative) women, 22 (4%) chose to have an amniocentesis. All 7 cases of DS were in the screen-positive group. CONCLUSION: Maternal serum screening in women aged > or = 36 years can markedly reduce the number of invasive prenatal diagnostic procedures, with a minimal reduction in the detection of DS foetuses. It is advisable to offer this form of screening to all women in this age group.

Changes with time in fetal heart rate variation, movement incidences and haemodynamics in intrauterine growth retarded fetuses: a longitudinal approach to the assessment of fetal well being.

Fetal heart rate (FHR) variation, general movements (FGM), breathing movements (FBM) and haemodynamics were studied longitudinally in 19 intrauterine growth retarded fetuses, who eventually were delivered by caesarean section (CS) because of fetal distress, in order to determine changes occurring with time. The fetuses were studied for the last 10 days on average before delivery (range 2-14 days). During this period on average eight 1-h FHR records were made and three 1-h movement recordings. The FHR pattern was analyzed numerically; the incidence of FGM and FBM was quantified and expressed as percentage of time. Blood flow velocity waveforms were measured in the umbilical artery (n = 19) and in the internal carotid artery (n = 14). In 14 of 19 fetuses abnormal velocity wave forms were present from the beginning of the study onwards. FHR variation was initially just within or below the norm and fell further during the last 2 days before CS. FGM and FBM fell below the normal range later and in a lower rate of occurrence than FHR variation. FGM showed a more or less consistent fall in time, whereas FBM showed a wide range throughout the period of observation. The poorest outcome occurred in fetuses with reversed end-diastolic velocities and rapid fall in FHR variation. It is concluded that with progressive deterioration of the fetal condition abnormal velocity wave form patterns occur first; FHR variation is reduced subsequently and FGM and FBM are the last to become abnormal. Assessment of fetal activity may be of help in fetuses with a marginally reduced FHR variation, in which prolongation of pregnancy is considered desirable to allow further maturation in utero.

Growth and motor development in fetuses of women with type-1 diabetes. III. First trimester quantity of fetal movement patterns.

Delayed emergence of movement patterns and disturbances in the development of behavioural states are often observed in the fetuses of diabetic women. The developmental course of specific fetal movement patterns was studied in 20 women with type-1 diabetes during the first trimester of pregnancy. The aim was to investigate whether maternal diabetes also has an effect on the rate of occurrence and temporal patterning of fetal movements. Real-time ultrasound recordings with a duration of 1 h were made once a week between the 7th and 17th week postmenstrual age in order to quantify fetal movements. The data were compared to those obtained in a group of uncomplicated pregnancies. The developmental trends in the occurrence of movement patterns were similar to those in the control fetuses, with the exception of startles. Before the 9th week of gestation, fetal movements occurred less frequently; this was related to the quality of maternal glucose control. After 12 weeks, the overall incidence was higher than in the control group, due to an increase in the incidence of breathing movements. The rate of breathing movements was generally slower than in the control group.