Amniocentesis Information about benefits, limitations and risks I, , born on____________________________, declare that I would like an amniocentesis to be performed for the purpose of a genetic analysis. The prenatal chromosomal diagnosis and, if indicated, biochemical examinations and/or genetic analyses of the samples shall be carried out in this cytogenetic laboratory or another genetic laboratory. I have been informed that fetal chromosomal defects such as Down’s syndrome, i.e. trisomy 21 (“mongolism” in colloquial language), can be detected by amniocentesis with a high degree of certainty (approx. 99.8%), and that spina bifida (”open back”) can be identified in over 98% of cases by determination of the so-called alphafetoprotein in the amniotic fluid. Regarding the puncture, the following points were explained to me in detail: 1. 2. 3. 4. 5. 6. It is performed from the 15th week of pregnancy (14 + 0) by means of a thin needle inserted through the abdominal wall. The puncture constitutes a low risk to the pregnant woman and the fetus. In rare cases complications in the form of amniotic fluid leak (0.3%) and miscarriage may occur (risk below 0.35%). I have also been informed that very rare complications such as maternal infections and fetal injury may occur. If such complications arise, please contact your doctor or, if you cannot reach him/her, contact us or a hospital. In exceptional cases, for example due to an unfavourable position of the fetus, the puncture may have to be postponed for about one to two weeks. In case of multiple pregnancy a puncture of all the amniotic cavities will be attempted in order to allow the examination of all fetuses. A normal chromosome set does not exclude congenital malformations (such as cleft lip with cleft upper jaw and palate, heart defects etc) or diseases. Ultrasonography before the 16th week of pregnancy is not as significant as the diagnostic screening for malformations in the 20th or 21st week of pregnancy. I have separately been informed about this screening in particular. Regarding the laboratory values, the following points were explained to me: 1. 2. 3. Cell cultivation may fail in very rare cases and a second puncture may be necessary. Delays may be caused by slow cell growth, or by findings requiring further staining procedures or the evaluation of a larger number of cell division patterns. In very rare cases the chromosome analysis may leave the clinical significance of diagnostic findings open, especially when tissue analysis reveals a so-called chromosomal mosaicism (normal cells are found next to cells showing a chromosome set change). Microscopic analysis may fail to detect the smallest structural changes in one or several chromosomes. Other structural chromosome changes require the analysis of parental chromosomes or further additional staining in order to understand their clinical significance. We will inform you about the necessity of performing these additional examinations. The advantages and disadvantages of a prenatal analysis of amniotic fluid were clearly explained to me. I have been given the opportunity to ask questions relating to all the points contained in this form, and I understand that the birth of a healthy child cannot be guaranteed. I have the opportunity to have a rapid chromosome analysis (FISH/PCR test) performed, which will deliver a significant result within one to two days. (Costs for this examination are not covered by the statutory health insurance). _ Yes, I would like a rapid chromosome analysis to be performed and I will bear the costs myself. For data protection reasons: I agree that my partner________________________________may be informed about the examination results yes no the sex of the child yes no Date Signature _____________________________________ Please do not hesitate to contact us if you have any further questions. Altonaer Str. 61 ¦ 20357 Hamburg ¦ Fon: 040/43 29 26 0 ¦ Fax: 040 /43 29 26 20 mail: info@praenatalzentrum.de ¦ www.praenatalzentrum.de