Low-dose aspirin for preventing intrauterine growth restriction and pre-eclampsia in sickle cell pregnancy (PIPSICKLE): a randomised controlled trial (study protocol).
Low-dose aspirin for preventing intrauterine growth restriction and pre-eclampsia in sickle cell pregnancy (PIPSICKLE): a randomised controlled trial (study protocol).
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DOI：
10.1136/bmjopen-2020-047949
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发表时间：
2021-08-13
期刊：
影响因子：
2.9
通讯作者：
Ogunnaike BA
中科院分区：
文献类型：
--
作者：
Afolabi BB;Babah OA;Adeyemo TA;Odukoya OO;Ezeaka CV;Nwaiwu O;Oshodi YA;Ogunnaike BA
妊娠合并镰状细胞病伴随着许多并发症，包括子痫前期(PE)和胎儿宫内生长受限(IUGR)。此前，我们在镰状细胞妊娠妇女中发现前列环素/血栓素比值异常，这种情况也在患有PE和不明原因的IUGR的非镰状细胞妊娠中发现。小剂量阿司匹林(LDA)已被证明可以通过减少血管收缩因子血栓素，同时节省前列环素，从而降低高危女性PE和IUGR的发生率，从而有效地“纠正”这一比例。它已被发现用于妊娠是安全的，但尚未在镰状细胞妊娠中进行测试。我们假设LDA可以降低孕妇HbSS(HbSS)和HbSc(HBSC)的IUGR和PE的发生率。这是一项多点、双盲、随机对照试验，在尼日利亚拉各斯州对怀孕12周至16周至36周的每日剂量为100 mg的阿司匹林与安慰剂进行比较。476名符合条件的孕妇HbSS和HBSC将被连续招募，随机分配到任何一组，并从招募到分娩。主要结果将是在共生21出生体重图上出生体重低于胎龄10厘米的发生率，或流产或围产儿死亡的发生率。次要结果将包括PE、产妇死亡、早产、围产期死亡、危象数量、需要输血以及感染和胎盘早剥等并发症。分析将按治疗意向进行，主要治疗效果将通过相对风险量化，95%可信区间为5%显著水平。招募医院的健康研究和道德委员会以及国家健康研究和道德委员会已经批准了伦理方面的批准。研究结果将在会议上公布，并适当发表。PACTR202001787519553；预告。
Pregnancy in sickle cell disease is fraught with many complications including pre-eclampsia (PE) and intrauterine growth restriction (IUGR). Previously, we found an abnormality in prostacyclin–thromboxane ratio in sickle cell pregnant women, a situation that is also found in non-sickle pregnancies with PE and unexplained IUGR. Low-dose aspirin (LDA) has been shown to reduce the incidence of PE and IUGR in high-risk women by reducing the vasoconstrictor thromboxane while sparing prostacyclin, in effect ‘correcting’ the ratio. It has been found to be safe for use in pregnancy but has not been tested in sickle cell pregnancy. We hypothesise that LDA will reduce the incidence of IUGR and PE in pregnant haemoglobin SS (HbSS) and haemoglobin SC (HbSC) women. This is a multisite, double blind, randomised controlled trial, comparing a daily dose of 100 mg aspirin to placebo, from 12 to 16 weeks’ gestation until 36 weeks, in Lagos state, Nigeria. Four hundred and seventy-six eligible pregnant HbSS and HbSC women will be recruited consecutively, randomly assigned to either group and followed from recruitment until delivery. The primary outcome will be the incidence of birth weight below 10th centile for gestational age on INTERGROWTH 21 birth weight charts, or incidence of miscarriage or perinatal death. Secondary outcomes will include PE, maternal death, preterm delivery, perinatal death, number of crises, need for blood transfusion and complications such as infections and placental abruption. Analysis will be by intention to treat and the main treatment effects will be quantified by relative risk with 95% CI, at a 5% significance level. Ethical approval has been granted by the Health Research and Ethics committees of the recruiting hospitals and the National Health Research and Ethics Committee. Study findings will be presented at conferences and published appropriately. PACTR202001787519553; Pre-results.
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影响因子：
9.8
作者：
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通讯作者：
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DOI：
10.1016/j.bpobgyn.2009.01.007
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DOI：
10.1111/j.1600-0897.2010.00861.x
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2010-12
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American journal of reproductive immunology (New York, N.Y. : 1989)
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