Progesterone for Prevention of Miscarriage and Preterm Birth in Women With First-Trimester Bleeding: PREEMPT Trial [A260]
Bibliographic record
Abstract
INTRODUCTION: First-trimester bleeding is associated with miscarriage and preterm birth, for which progesterone has been suggested to improve outcomes. Our study objective was to evaluate the effect of progesterone treatment throughout pregnancy on preventing miscarriage and preterm birth in pregnancies with first trimester bleeding. METHODS: This was a multicenter, double-blind, placebo-controlled, randomized trial comparing 200 mg micronized progesterone, vaginally administered nightly from presentation to 34 weeks of gestation, with an identically appearing placebo. Subjects with vaginal bleeding and live intrauterine pregnancy <14 weeks of gestation were eligible. Multifetal gestations, cervical insufficiency, recurrent pregnancy loss, or bleeding unrelated to placentation were excluded. Primary outcome was occurrence of live term pregnancy. Secondary outcomes included adverse maternal/newborn events and time to miscarriage or birth. Chi-square analyses compared proportions and Mann-Whitney tests compared time-to-event outcomes. RESULTS: A total of 549 patients were randomized, of whom 16 withdrew or were lost to follow-up, leaving 264 patients in the progesterone group and 269 patients in the placebo group. Baseline characteristics were comparable in both groups. The number of patients having a live term birth among those in the progesterone group was 197 (74.6%), compared with 190 (70.6%) in the placebo group (P=.30). Compared to the placebo group, those in the progesterone group had comparable risks of abortion <20 weeks (38 (14.4%) versus 43 (16.0%), P=.94), preterm birth (27 [10.2%] versus 33 [12.3%], P=.46), and stillbirth (2 [0.9%] versus 3 [1.3%], P=.65). There were no differences in adverse maternal or newborn outcomes, or in time-to-event for miscarriage or birth between the groups. CONCLUSION: Progesterone prescribed throughout pregnancy is not effective in preventing miscarriage or prematurity in subjects presenting with first-trimester vaginal bleeding in context of a live intrauterine pregnancy.
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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 | 0.000 | 0.001 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.001 | 0.001 |
| Insufficient payload (model declined to judge) | 0.003 | 0.000 |
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".