The Early Amniocentesis Study: A Randomized Clinical Trial of Early Amniocentesis versus Midtrimester Amniocentesis
Bibliographic record
Abstract
OBJECTIVES: The primary purpose of this pilot study was to determine whether the safety of early amniocentesis (EA; 11 weeks to 12 weeks and 6 days) is similar to midtrimester amniocentesis (MA; 15 weeks to 16 weeks and 6 days). The secondary objectives were to determine the cytogenetic success and accuracy of EA compared with MA. METHODS: This prospective, randomized clinical trial compared continuous ultrasound-guided EA and MA (22-gauge needle) in patients at a late maternal age (> or = 35 years). The procedures were compared for safety, success and accuracy. RESULTS: Among the 683 women randomized and followed to pregnancy completion, there was a total of 27/344 (7.8%) and 25/339 (7.4%) fetal losses (spontaneous and induced abortions) in the EA and MA groups, respectively (difference 0.4%; CI -3.6 to 4.4%). The rate of postprocedure spontaneous fetal loss was 2.4% (8/330) in the EA group and 3.3% (10/299) in the MA group (NS). The procedure success rate at the first attempt was 97.6% in the EA group and 99.7% in the MA group. There were no diagnostic errors, and all but 2 EA cultures were successful (both repeated successfully). The perinatal outcome was similar in both groups. CONCLUSIONS: EA appears to be as safe and accurate as MA. A large multicentered, randomized trial is currently underway to verify these results.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.005 | 0.010 |
| Meta-epidemiology (narrow) | 0.002 | 0.001 |
| Meta-epidemiology (broad) | 0.004 | 0.002 |
| Bibliometrics | 0.001 | 0.000 |
| Science and technology studies | 0.000 | 0.002 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.002 | 0.001 |
| Research integrity | 0.003 | 0.004 |
| Insufficient payload (model declined to judge) | 0.008 | 0.001 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".