OBJECTIVE: The use of cordocentesis in the diagnostic evaluation of patients with preterm labor is controversial. The objective of this study was to assess the risks and review the ethical issues of performing cordocenteses for the evaluation of fetuses in preterm labor. STUDY DESIGN: 399 patients in preterm labor underwent amniocentesis for the evaluation of the microbiologic state of the amniotic cavity. Among these, cordocentesis was performed in 142 patients. The duration of pregnancy, proportion of undelivered pregnancies and other indicators of adverse pregnancy outcome were compared between the two groups. Survival analysis and non-parametric tests were used in the analysis. RESULTS: Demographic and clinical variables at admission were similar in both study groups. No difference in outcome were observed between patients managed with amniocentesis vs. those managed with amniocentesis+ cordocentesis; 1) median post-procedural duration of pregnancy; 19 vs. 20.6 days; 2) proportion of preterm delivery within 24, 48, 72 hours and 7 days: 20.6% vs. 13.1%, 24.5% vs. 21.5%, 26.9% vs. 23.4% and 33.3% vs. 32.7%, respectively; 3) preterm delivery defined anyway as <32, <34, or <37 weeks; 3) rate of C/section: 12.5% vs. 13.4%; 4) rate of neonatal complications and perinatal deaths (6.2% vs. 2.1%). The Office of Protection from Research Risks (OPRR) requires that research projects be conducted with IRB approval, informed consent and careful evaluation of the risks and benefits. Several IRBs approved this study before its execution. Post-hoc ethical analysis also found that this study complies with the regulations to protect human subjects from research risks. CONCLUSION: No evidence for an increase in the rate of complications was found in patients managed with amniocentesis + cordocentesis vs. those managed with amniocentesis alone. Further studies are required to determine if prenatal detection of fetal sepsis by fetal blood analysis improves perinatal outcome.
|Journal||Acta Diabetologica Latina|
|Issue number||1 PART II|
|State||Published - 1 Dec 1997|
ASJC Scopus subject areas
- Internal Medicine
- Endocrinology, Diabetes and Metabolism