OPHthalmic artEry DoppLer Evaluation After 37 Weeks of Gestation and Intrapartum Fetal Adverse Outcomes (the OPHELIA Study)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 1,477
- 主要终点
- Occurrence of in-labor cesarean delivery due to fetal hypoxic stress, assessed in relation to maternal ophthalmic artery Doppler indices measured before induction of labor.
研究概览
简要总结
The ophthalmic artery Doppler has been recently proposed as a potential "soft marker" for placental insufficiency in retrospective and observational studies, with similar clinical significance with respect to Uterine Artery (UA) Doppler evaluation and it is currently being investigated as an adjunctive clinical instrument to predict pre-eclampsia (PE) occurrence. Placental insufficiency strictly correlates with intrapartum fetal adverse outcomes and a concomitant induction of labor, alone, may further increase the hypoxic stress on the fetus during labor. This can be reflected by cardiotocographic alterations during labor, ultimately leading to emergency cesarean deliveries or instrumental vaginal deliveries.
Despite great advancements in understanding various maternal-fetal pathologies, the investigators are still not able to properly detect fetuses that are at higher risk for intrapartum compromise among those receiving an induction of labor. Therefore, the aim of this prospective study is to investigate any potential association between altered ophthalmic artery Doppler PSV ratio measured before labor induction in at-term, pregnant patients with intra-partum fetal compromise. Furthermore, the investigators aim to also measure an additional parameter that is the optic nerve sheath diameter (ONSD) - an indirect measure of intracranial pressure - before and after the second stage of labour, with the aim of studying its physiology during and after delivery.
详细描述
The ophthalmic artery (OA) Doppler has been recently proposed as a potential "soft marker" for placental insufficiency in retrospective and observational studies, with similar clinical significance with respect to Uterine Artery (UA) Doppler evaluation. It has been investigated in small-for-gestational-age (SGA) or fetal-growth-restricted (FGR) fetuses, as well as in low-risk pregnancies and at various gestational ages during pregnancy, showing to be predictive of impaired placentation, and, consequently, of pre-eclampsia occurrence.
The OA is the first branch of the internal carotid artery and its Doppler velocity waveform has two systolic peaks. The first systolic wave (PSV1) is created by cardiac systole, with the opening of the aortic valve and ejection of blood into the aorta, whilst the second systolic wave (PSV2) is a reflective wave formed by the systolic pulse wave reaching smaller, higher resistance arterioles and being reflected back towards the heart. At the level of the aortic arch, a fraction is diverted cranially to the cerebral circulation as a forward wave to create PSV2. In this way, PSV2 is most influenced by peripheral arterial compliance and resistance, whilst PSV1 is more affected by cardiac output. Therefore, an increase in the ratio of PSV2 to PSV1 (PSV ratio) could represent an increase in peripheral vascular resistance and/or a reduction in cardiac output, which are both indirect signs of placental dysfunction. The latter can be manifested during labor with well-established cardiotocographic patterns and induction of labor, alone, may enhance the intrapartum hypoxic stress on the fetus.
Furthermore, another parameter that is currently understudy is the Optic Nerve Sheath Diameter (ONSD). Recent evidence suggests that ONSD increases in pre-eclamptic patients, possibly reflecting a transient increase in intracranial pressure. However, evidence is scarce regarding its physiologic changes during and after labour. In understanding the potential mechanisms behind intrapartum fetal compromise in gravid, at-term patients undergoing labor induction, the hypothesis is that placental dysfunction, albeit not necessarily clinically manifest earlier in pregnancy, may play a role in fetal compromise during labor, especially in pregnancies undergoing induction of labor. Hence, investigating potential associations between a "soft marker" of placental insufficiency as Ophthalmic artery Doppler PSV ratio alterations and intrapartum fetal compromise would be paramount. Therefore the aim of this prospective interventional study is to investigate any association with altered OA PSV ratio and intrapartum fetal adverse outcomes in pregnant patients that reach term of pregnancy, undergoing induction of labor. In addition, the investigatos also aim to evaluate the ONSD before and after the second stage of labour in order to study its physiologic changes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years
- •Pregnant patients after 37 weeks of gestation undergoing induction of labor
- •Ability to provide written informed consent
排除标准
- •Age <18 years
- •Known fetal malformations
- •Known fetal genetic syndromes
- •Multiple pregnancy
- •Known maculopathies
- •Inability or unwillingness to provide written informed consent
研究组 & 干预措施
Ophthalmic Artery Doppler Assessment
Pregnant patients after 37 weeks of gestation undergoing induction of labor. Before labor induction, participants will undergo maternal ophthalmic artery Doppler assessment and measurement of optic nerve sheath diameter (ONSD). ONSD will be measured again after delivery. Maternal, intrapartum, and neonatal outcomes will be collected.
干预措施: Ophthalmic Artery Doppler (Diagnostic Test)
结局指标
主要结局
Occurrence of in-labor cesarean delivery due to fetal hypoxic stress, assessed in relation to maternal ophthalmic artery Doppler indices measured before induction of labor.
时间窗: From start of labor induction until delivery, up to 72 hours.
Occurrence of cesarean delivery during labor due to fetal hypoxic stress, evaluated in relation to maternal ophthalmic artery Doppler indices measured before induction of labor.
次要结局
- instrumental vaginal delivery for fetal hypoxic stress(From start of labor induction until delivery, up to 72 hours.)
- Cesarean delivery for any indication(From start of labor induction until delivery, up to 72 hours.)
- Cesarean delivery for clinical or subclinical chorioamnionitis(From start of labor induction until delivery, up to 72 hours.)
- Umbilical arterial pH <7.0(At delivery)
- 5-minute Apgar score <7(5 minutes after birth)
- Neonatal Intensive Care Unit admission(From birth until hospital discharge)
研究者
Ghi Tullio
Prof. Tullio Ghi, MD PhD
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
