Small-for-gestational-age birth weight (CHAP safety outcome)
Whether a baby was born smaller than expected for the length of the pregnancy. CHAP used it to check that treating the mother did not slow the baby’s growth.
- Outcome
- In this atlas
Overview
Technical summary
CHAP primary safety outcome: a birth weight under the 10th percentile for the baby’s gestational age and sex, judged by the Duryea population standard. The recipient is the newborn; the mother received the treatment strategy. The paper counts the same denominators in two words: the Results say 128 of 1146 infants, and the Table 2 footnote says the complete-case safety analysis included 2270 patients, 1146 in the active-treatment group and 1124 in the control group. This record uses infants because the outcome is the newborn's birth weight and the Results name that unit. The trial enrolled women with a singleton fetus, so one infant corresponds to one patient.
Definition
A birth weight in the lowest tenth for the baby’s gestational age and sex (under the 10th percentile), judged by the Duryea population standard.
- Unit
- infants
Measured in
Studies in this atlas that report this outcome, by the claim each finding supports. Each finding keeps its own population, denominator and time window on the study page.
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Primary endpoint CHAP (Chronic Hypertension and Pregnancy) trial See the findings
Applies to Newborn- Infants born to the women in the trial who had birth-weight data: 1146 in the treated group and 1124 in the control group in the complete-case analysis. The infants were exposed through their mothers’ treatment; they were not treated themselves. The women enrolled before 23 weeks, and the gestational age at birth was not restricted by the source.
- Births at CHAP sites in the United States; the manuscript does not describe the birth setting.
- United States
- Newborn, birth weight measured at birth
- Gestational age Not reported
- Postnatal age 0 days to 0 days
In CHAP the mothers were treated, and the safety question was the baby’s growth. Babies born small for their gestational age (birth weight below the 10th percentile) numbered 128 of 1146 with data in the treated group (11.2%) and 117 of 1124 in the control group (10.4%). The adjusted risk ratio was 1.04 (95% CI 0.82 to 1.31). The interval includes no difference, so the trial did not show a clear change in this safety outcome.Limitations. The trial was powered to detect a relative difference of 35% or more in small-for-gestational-age birth weight, so a smaller increase cannot be ruled out. The percentages come from the 2270 patients with sufficient data (complete-case analysis of the safety outcome); the adjusted risk ratio comes from a multiple-imputation analysis of all 2408 patients (Table 2, N = 2408). Open-label design, one country. The recipient is the newborn, exposed through the mother’s treatment.
Record details
- Record id
maternal:outcome-chap-sga-below-10th-percentile- Content hash
2a067a7b38bfdb022421862ccd1c4fac38bcb1400b566dbf126d37dd159fe764