Cord Clamping Level Above or Below Mother's Perineum
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 103
- 试验地点
- 2
- 主要终点
- Hematocrit Level
研究概览
简要总结
The purpose of this study is to determine if delayed cord clamping above the perineum has an effect on neonatal hematocrit when compared to delayed cord clamping below the perineum in pre-term spontaneous vaginal deliveries.
详细描述
This study will compare the difference in neonatal hematocrit with delayed cord clamping above vs. below the perineum, in infants who are born via pre-term spontaneous vaginal deliveries that are vigorous at delivery. Delayed cord clamping below the perineum is an accepted clinical practice in obstetrics and gynecology; however, delayed cord clamping above the perineum has not yet been studied in preterm infants. Delayed cord clamping above the perineum will provide the benefit of immediate skin-to-skin contact between the mother and her newborn.
Patients will have delayed cord clamping performed for 60-75 seconds either below the maternal perineum or while the infant is placed on the mother's abdomen. At approximately 24 hours after delivery (at the time of infant heel stick for routine, state-mandated screening tests), a small additional amount of blood will be collected to evaluate newborn hematocrit.
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
- 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
- •Singleton intrauterine pregnancies at least 30 weeks gestation but less than 37 weeks gestation
排除标准
- •Acute febrile illnesses or chronic medical problems such as hypertension, diabetes mellitus, renal disease, medically-managed seizure disorders
- •Pregnancy-related complications such as pre-eclampsia, intrauterine growth restriction, chromosomal/anatomical abnormalities, and placental abruption
- •Infants who are not anticipated to undergo spontaneous vaginal delivery
结局指标
主要结局
Hematocrit Level
时间窗: 24 hours after delivery
次要结局
- Number of Participants With Infants Who Were Admitted to the Neonatal Intensive Care Unit (NICU)(during the initial hospital stay (1-2 days))
- Number of Participants With Infants Who Received Blood Transfusion(during the initial hospital stay (1-2 days))
- Number of Participants With Infants Who Received Phototherapy(during the initial hospital stay (1-2 days))
- Apgar Score at 1 Minute(1 minute after birth)
- Apgar Score at 5 Minutes(5 minutes after birth)
研究者
Pamela Berens
Professor
The University of Texas Health Science Center, Houston