[Maternal serum screening for congenital abnormalities and Down syndrome in Sønderjylland County. Eight years of experience]. / Maternel serumscreening for medfødte misdannelser og Downs syndrome i Sønderjyllands Amt. Otte års erfaringer.

From January 1991 to December 1998 second-trimester maternal serum screening (Doubletest and Tripletest) for malformations and Down syndrome has been offered to pregnant women younger than 35 years of age living in Sønderjyllands county, Denmark. Follow-up of all cases of chromosome abnormalities and severe foetal malformations identified pre- or postnatally has been carried out. A total of 17,023 women were screened. Sixty-eight percent (17/25) of Down Syndrome pregnancies were detected. Three percent of the screened women were offered an amniocentesis due to a calculated risk of DS greater than 1:400 at birth. The positive predictive value was 1:30. For the three-year period 1996-1998 (Tripletest) the results were more promising: 91% (10/11) were detected, 3.9% were offered an amniocentesis, the positive predictive value was 1:21. In the eight-year period 80% (8/10) of the spina bifida cases were detected, all the cases (6/6) of anencephaly and 75% (6/8) of abdominal wall defects. One point six percent of the screened women were offered an amniocentesis due to high risk of a neural tube defect. The results confirm that second trimester maternal serum screening is a reliable method for determining the risk of severe foetal malformations and Down syndrome.

Cytogenetic analysis of 2928 CVS samples and 1075 amniocenteses from randomized studies.

We report cytogenetic results from a randomized Danish chorionic villus sampling (CVS) and amniocentesis (AC) study including 2928 placental and 1075 amniotic fluid specimens processed in the same laboratory. The results are presented in groups comparing CVS with amniocentesis and transabdominal (TA) CVS with transcervical (TC) CVS as randomized. More abnormalities and more ambiguous diagnostic problems were found in placental tissues than in amniotic cells. There were no diagnostic errors and no incorrect sex predictions. Mosaicism was detected in 1 per cent of all cases of CVS (discordancies included). When confirmation studies were done, 90 per cent were found to be confined to the placenta. Eight cases (0.7 per cent) of mosaicism/pseudomosaicism were seen in amniotic fluid specimens, and two cases of five with confirmation studies were confirmed in the fetus. The rate of mosaicism/pseudomosaicism in CVS and AC specimens differed (p < 0.05). The rate of pseudomosaicism in cultures of villi and amniotic fluid cells was 0.5 and 0.6 per cent, respectively. Single-cell aneuploidy was observed in 1.8 per cent of villi and 1.4 per cent of amniotic fluid cell specimens. Maternal cell contamination (MCC) was seen more often after TC sampling (4.5 per cent) compared with TA sampling (1.5 per cent), but posed no problems in interpretation. Compared with the processing of cultured specimens, the short-term method of preparation of villi in our laboratory doubled the technicians' workload. For practical and economic reasons we have ceased the routine use of short-term preparations.

[Randomized comparison of transabdominal, transcervical chorionic villi sampling and amniocentesis]. / Randomiseret sammenligning af transabdominal, transcervikal chorion villus biopsi og amniocentese.

The transabdominal chorionic villus sampling method was compared with the transcervical route and second trimester amniocentesis in a 3-winged randomised trial. Examination of 45 epidemiological variables showed the three procedure groups to be comparable at enrollment. In 3079 women at low genetic risk, we compared transabdominal with transcervical chorionic villus sampling and amniocentesis. The total fetal loss was 10.9%, 6.3% and 6.4% in the transcervical, transabdominal chorionic villus sampling groups and the amniocentesis group, respectively (p < 0.001). The two CVS procedures were compared in 2882 low and high genetic risk women with cytogenetically normal fetuses. Rates of unintended post-procedure loss were 3.7% and 7.7% for transabdominal CVS and transcervical CVS, respectively (p < 0.001), difference in rates 4.0%, 95% C.I. +2.3% to +5.8%. By a priori ultrasound scanning, more transcervical than transabdominal procedures (p < 0.001) were considered to be inaccessible for sampling. Our data indicate that transabdominal allows freer access to the placental site than transcervical sampling and is easier to adapt to than transcervical CVS. Women run comparable risks with transabdominal CVS and amniocentesis. Given the results of our study, transabdominal procedures remain the first choice for prenatal diagnosis and, since in our hands transcervical sampling entails an increased fetal risk, we have abandoned transcervical CVS in our two study centres.

Randomised comparison of amniocentesis and transabdominal and transcervical chorionic villus sampling.

We have compared three methods of prenatal diagnosis in two large obstetric centres in Denmark. Women were randomly assigned transabdominal (TA) chorionic villus sampling (CVS), transcervical (TC) CVS, or second-trimester amniocentesis (AC); women at high genetic risk were randomised between the two CVS groups only. Analysis of 45 epidemiological variables showed the three procedure groups to be similar at enrollment. All women were followed up until completion of pregnancy. Among 3079 women at low genetic risk total fetal loss rates were 10.9% for TC CVS, 6.3% for TA CVS, and 6.4% for AC (p < 0.001). More women had bleeding after the procedure in the CVS groups (p < 0.001), whereas more amniotic fluid leakage (p < 0.001) was reported after AC. No uterine infections occurred in any group. No case of oromandibular-limb abnormality was seen in the CVS groups, but 1 child in the AC group had aplasia of the right hand. The two CVS approaches were compared among 2882 women at low and high genetic risk who were found to have cytogenetically normal fetuses. Rates of unintentional loss after the procedure were 7.7% for TC CVS and 3.7% for TA CVS (p < 0.001; 95% Cl of difference 2.3-5.8%). At baseline ultrasound scanning after establishment of optimum sampling conditions, more TC than TA procedures (p < 0.001) were judged not to be feasible. We found that TA CVS allows better access to the placental site than TC sampling, is an easier skill to acquire, and has the potential that more villi can be aspirated when needed. The risk of fetal loss is similar after TA CVS and AC. However, losses after AC are at a later stage and are therefore more distressing. TA procedures remain the first choice for prenatal diagnosis. Since, in our hands, TC sampling carries a greater risk to the fetus, we have abandoned TC CVS in our two study centres.

Sampling success and risk by transabdominal chorionic villus sampling, transcervical chorionic villus sampling and amniocentesis: a randomized study.

A total of 3347 women were randomized to either transabdominal chorionic villus sampling, transcervical chorionic villus sampling or amniocentesis. Unless induced or spontaneous abortion had occurred, they had all completed up to 28 weeks of pregnancy at the time of analysis. No significant difference was seen between total fetal loss in the transabdominal chorionic villus sampling group and the amniocentesis group (6.2% and 6.6%, respectively, SE difference 0.92%, p = 0.01). The total fetal loss in the transcervical group was 10.1%. When the number of failed procedures and those cases which were evaluated as infeasible for the assigned method, are compared, the overall sampling efficacy is less good transcervically than transabdominally. After pooling our data with data from the Canadian randomized study and the American non-randomized study, the difference in risk between transcervical chorionic villus sampling and amniocentesis was 2.1%, SE difference = 0.64%, p = 0.8.

[Surgical gynecologic laparoscopy. A description of instruments and a pelvis model]. / Operative gynaekologisk laparoskopi. Beskrivelse af instrumenter og et baekkenfantom.

A model pelvis for practising laparoscopic surgical skills is mentioned and a programme of training exercises is proposed. The technique and material for laparoscopic haemostasis are reviewed together with the relevant surgical instrumentarium. Possible indications are suggested.

Ritodrine in the treatment of preterm labor: second Danish Multicenter Study.

In a randomized trial intramuscular ritodrine followed by oral ritodrine treatment and bed rest was compared with placebo and bed rest in the treatment of 99 cases of preterm labor. The ritodrine treatment did not have a statistically significant effect on birth weight, gestational age, or the incidence of low birth weight. However, it did inhibit preterm labor in the initial stage, resulting in a gain of a few days to a few weeks in length of gestation. This gain may be valuable. Where necessary, advantage can be taken of it to transfer the mother before delivery to a more specialized hospital with a neonatal intensive care unit or to administer steroid treatment to promote fetal lung maturation. No serious side effects were recorded. The intramuscular route is recommended because large fluid infusions are avoided and treatment can easily be started before the patient is transported from home to hospital.

Relief from pain localized to the lower back in early labour. A double blind trial of ketocaine, a new, highly effective, local, cutaneous analgesic (A 2358, Ane-Pad), and placebo.

Pain localized to the lower back in the first stage of labour in 47 primiparous women was treated by epicutaneous application of ketocaine or placebo compresses. Twenty-three patients were treated with ketocaine compresses (Ane-Ped), and 24 patients with compresses soaked with isotonic saline. The pain relieving effect was almost the same in both treatment groups. Pain localized to the lower back was reduced in about 50% of the patients after one hour's application of ketocaine or placebo compresses. Supplementary analgesics had to be administered in about 60% of the patients in each group. No maternal or foetal systemic side effects related to the treatment were registered. Local erythema on the application area was only reported in the ketocaine group. The frequency of feeling of warmth during the application of compresses of ketocaine were high compared to the placebo group, 78% and 29% respectively.