PDF(Pubmed)
Abstract：
OBJECTIVE: To update the Ghana PrenaBelt Trial\'s (GPT) primary outcome data with the latest fetal growth standard and reanalyse it. To estimate the posterior probability, under various clinically relevant prior probabilities, of maternal nightly positional therapy (PT) throughout the third-trimester having a beneficial effect on customised birth weight centile (CBWC) using Bayesian analyses.
METHODS: A reanalysis of a double-blind, sham-controlled, randomised clinical trial.
METHODS: A single, tertiary-level centre in Accra, Ghana.
METHODS: Two-hundred participants entered, 181 completed and 167 were included in the final analysis. Participants were Ghanaian, healthy, aged 18-35 years, with low-risk, singleton pregnancies in their third-trimester, with Body Mass Index<35 kg/m2 at the first antenatal appointment for the index pregnancy and without known fetal abnormalities, pregnancy complications or medical conditions complicating sleep.
METHODS: Participants were randomised to receive treatment with either a PT or sham-PT device.
METHODS: The primary outcome was the CBWC using the latest Perinatal Institute, Gestation-Related Optimal Weight calculator. Using Bayesian methods, posterior probabilities of achieving a greater than 0%, 5% and 10% benefit in CBWC with PT were estimated. There was no secondary outcome.
RESULTS: The median (IQR) CBWC was 42% (15-71) and 28% (9-52) in the PT and sham-PT groups, respectively (difference 8.4%; 95% CI -0.30 to 18.2; p=0.06). For achieving a >0%, >5% and >10% gain in CBWC with PT, the posterior probabilities were highly probable, probable and unlikely, respectively, given a range of prior probabilities reflecting varying degrees of pre-existing enthusiasm and scepticism.
CONCLUSIONS: Maternal nightly PT throughout the third-trimester did not have a statistically significant effect on CBWC on a frequentist analysis using the latest fetal growth standard. However, from a Bayesian analysis, clinicians can infer that PT is likely to benefit fetal growth but with a modest effect size.
BACKGROUND: NCT02379728.
METHODS: A reanalysis of a double-blind, sham-controlled, randomised clinical trial.
METHODS: A single, tertiary-level centre in Accra, Ghana.
METHODS: Two-hundred participants entered, 181 completed and 167 were included in the final analysis. Participants were Ghanaian, healthy, aged 18-35 years, with low-risk, singleton pregnancies in their third-trimester, with Body Mass Index<35 kg/m2 at the first antenatal appointment for the index pregnancy and without known fetal abnormalities, pregnancy complications or medical conditions complicating sleep.
METHODS: Participants were randomised to receive treatment with either a PT or sham-PT device.
METHODS: The primary outcome was the CBWC using the latest Perinatal Institute, Gestation-Related Optimal Weight calculator. Using Bayesian methods, posterior probabilities of achieving a greater than 0%, 5% and 10% benefit in CBWC with PT were estimated. There was no secondary outcome.
RESULTS: The median (IQR) CBWC was 42% (15-71) and 28% (9-52) in the PT and sham-PT groups, respectively (difference 8.4%; 95% CI -0.30 to 18.2; p=0.06). For achieving a >0%, >5% and >10% gain in CBWC with PT, the posterior probabilities were highly probable, probable and unlikely, respectively, given a range of prior probabilities reflecting varying degrees of pre-existing enthusiasm and scepticism.
CONCLUSIONS: Maternal nightly PT throughout the third-trimester did not have a statistically significant effect on CBWC on a frequentist analysis using the latest fetal growth standard. However, from a Bayesian analysis, clinicians can infer that PT is likely to benefit fetal growth but with a modest effect size.
BACKGROUND: NCT02379728.
摘要：
目的：用最新的胎儿生长标准更新加纳PrenaBelt试验(GPT)的主要结局数据并重新分析。估计后验概率,在各种临床相关的先验概率下，使用贝叶斯分析，在整个孕晚期的产妇夜间位置治疗（PT）对定制的出生体重百分位数（CBWC）具有有益的影响。
方法：对双盲，假控制，随机临床试验。
方法：单，阿克拉的三级中心，加纳。
方法：两百名参与者输入，181个完成，167个被包括在最终分析中。参与者是加纳人，健康,18-35岁,低风险,妊娠晚期的单胎妊娠,体重指数<35kg/m2在第一次产前预约指数妊娠，没有已知的胎儿异常，妊娠并发症或使睡眠复杂化的医疗条件。
方法：参与者随机接受PT或假PT装置治疗。
方法：主要结局是使用最新的围产期研究所进行的CBWC，与妊娠相关的最佳体重计算器。使用贝叶斯方法，实现大于0%的后验概率，估计有PT的CBWC的5％和10％的益处。没有次要结果。
结果：在PT和假PT组中，中位数（IQR）CBWC为42％（15-71）和28％（9-52），分别（差异8.4%；95%CI-0.30至18.2；p=0.06）。为了实现>0%，>5%和>10%的CBWC增益与PT，后验概率很可能，可能而且不太可能，分别,给定一系列先验概率，反映了不同程度的预先存在的热情和怀疑。
结论：在使用最新胎儿生长标准的频率分析中，整个孕晚期的母亲夜间PT对CBWC没有统计学上的显着影响。然而,根据贝叶斯分析，临床医生可以推断PT可能有利于胎儿生长,但效应大小适中.
背景：NCT02379728。
方法：对双盲，假控制，随机临床试验。
方法：单，阿克拉的三级中心，加纳。
方法：两百名参与者输入，181个完成，167个被包括在最终分析中。参与者是加纳人，健康,18-35岁,低风险,妊娠晚期的单胎妊娠,体重指数<35kg/m2在第一次产前预约指数妊娠，没有已知的胎儿异常，妊娠并发症或使睡眠复杂化的医疗条件。
方法：参与者随机接受PT或假PT装置治疗。
方法：主要结局是使用最新的围产期研究所进行的CBWC，与妊娠相关的最佳体重计算器。使用贝叶斯方法，实现大于0%的后验概率，估计有PT的CBWC的5％和10％的益处。没有次要结果。
结果：在PT和假PT组中，中位数（IQR）CBWC为42％（15-71）和28％（9-52），分别（差异8.4%；95%CI-0.30至18.2；p=0.06）。为了实现>0%，>5%和>10%的CBWC增益与PT，后验概率很可能，可能而且不太可能，分别,给定一系列先验概率，反映了不同程度的预先存在的热情和怀疑。
结论：在使用最新胎儿生长标准的频率分析中，整个孕晚期的母亲夜间PT对CBWC没有统计学上的显着影响。然而,根据贝叶斯分析，临床医生可以推断PT可能有利于胎儿生长,但效应大小适中.
背景：NCT02379728。
