Digital Versus Speculum Exams in Preterm Prelabor Rupture of Membranes: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 86
- 试验地点
- 1
- 主要终点
- Pregnancy latency
研究概览
简要总结
After preterm prelabor rupture of membranes (PPROM)[breaking of the amniotic sac prior to 37 weeks gestation in pregnancy], patients are recommended for inpatient admission and close monitoring for complications including preterm labor, intraamniotic infection (infection of the sac around the baby), and placental abruption (separation of the placenta from wall of the uterus). When evaluation of cervical dilation is clinically indicated, obstetricians traditionally perform sterile speculum exams due to concern for decrease in pregnancy latency (length of time between breaking the water and delivery) with sterile digital exams in retrospective studies. These studies are concerning, however, by the indications for the exams and are at risk for confounding by indication. This is a randomized, non-inferiority trial to examine if sterile digital versus speculum exams effect latency of pregnancy in patients with PPROM.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •22 weeks 0 days gestation to 33 weeks 5 days gestation
- •Clinical or laboratory confirmation of PPROM
- •At least 8 hours after rupture event
- •English speaking
- •Notably, for patients <25 weeks, approach for enrollment will be deferred until after the patient has discussed their desires for fetal resuscitation with the care team and are at a gestational age where they would desire this resuscitation.
排除标准
- •Contraindications to digital examination
- •COVID-19 positive on admission
结局指标
主要结局
Pregnancy latency
时间窗: up to 10 weeks
time from admission to delivery
次要结局
- Maternal sepsis(Within 2 weeks of delivery)
- Maternal intensive care unit (ICU) admission(Within 2 weeks of delivery)
- Composite neonatal morbidity(28 days of life)
- Need for respiratory support(28 days of life)
- Neonatal sepsis at >72 hours of life(28 days of life)
- Hypoxic ischemic encephalopathy(28 days of life)
- Patient satisfaction with exams(At delivery)
- Maternal chorioamnionitis(Prior to delivery)
- Endomyometritis(Within 2 weeks of delivery)
- Length of neonatal intensive care unit (NICU) admission(Up to 1 year)
- Neonatal death(During NICU admission, up to 1 year)
- Maternal wound infections(Within 2 weeks of delivery)
- Neonatal pneumonia(28 days of life)
- Neonatal sepsis at <72 hours of life(Within 72 hours of birth)
- Maternal death(Within 2 weeks postpartum)
- Neonatal intraventricular hemorrhage (IVH)(28 days of life)
- Necrotizing enterocolitis (NEC)(28 days of life)