NCT07124130招募中4 期
Parenteral Lactated Ringer's Plus Dextrose 5% vs Lactated Ringer's in Labor: A Randomized Control Trial on Maternal and Neonatal Outcomes
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 158
- 试验地点
- 2
- 主要终点
- Time from Induction Start To Delivery
研究概览
简要总结
The goal of this clinical trial is to determine which of two types of standard intravenous (IV) fluids (a combination of 5% dextrose and Lactated Ringers solution and Lactated Ringers solution alone) has a better influence on labor when inducing labor in pregnant women. The main questions it aims to answer are:
- Does the use of 5% dextrose and Lactated Ringers lead to a shorter labor than the use of just Lactated Ringers?
- Does the use of 5% dextrose and Lactated Ringers increase the risk of neonatal hypoglycemia when compared to Lactated Ringers? Participants in this trial will be randomly assigned to one of two groups: a group that receives a solution of 5% dextrose and Lactated Ringers, and a group that receives Lactated Ringers alone. Researchers will compare the outcomes of the two groups to see which IV fluid is more effective.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
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
- •Nulliparous women
- •Age 18 years or older and able to provide informed consent
- •Singleton pregnancy at term
- •Induction of labor
- •Cephalic presentation
- •Unfavorable cervix (Bishop score ≤ 6)
排除标准
- •Age under 18 years
- •Involuntarily confined or detained
- •Considered as having diminished decision-making capacity
- •Spontaneous labor (cervical exam between 5-6 cm) with or without ruptured membraned
- •Favorable cervix (Bishop score >6)
- •Diabetes mellitus (both gestational and pre-gestational)
- •Structural renal disease
- •Acute or chronic kidney disease resulting in abnormal creatinine or proteinuria
- •Evidence of chorioamnionitis or non-reassuring fetal testing at the time of enrollment
- •Pyrexia (>38.0 degrees Celsius)
- •Stillbirth
- •Planned cesarean delivery
- •Women presenting with emergent circumstances for labor induction
研究组 & 干预措施
5% dextrose and Lactate Ringer
Active Comparator
Participants randomized to this arm will receive an intravenous solution of 5% dextrose and Lactate Ringer during labor.
干预措施: 5% Dextrose (D5) in Normal Saline (NS) (Drug)
5% dextrose and Lactate Ringer
Active Comparator
Participants randomized to this arm will receive an intravenous solution of 5% dextrose and Lactate Ringer during labor.
干预措施: Lactate Ringer (Drug)
Lactate Ringer only
Active Comparator
Participants randomized to this arm will receive an intravenous Lactate Ringer solution only.
干预措施: Lactate Ringer (Drug)
结局指标
主要结局
Time from Induction Start To Delivery
时间窗: From enrollment to the end of labor
次要结局
- Type of amniotomy(From enrollment until delivery)
- Mode of Delivery(From enrollment until delivery.)
- Indication for cesarean delivery(From enrollment until delivery.)
- Delivery within 12 hours of induction.(Time from induction until delivery.)
- Delivery within 24 hours of Induction(Time of induction to time of delivery.)
- Delivery within 36 hours of Induction(From time of induction to time of delivery.)
- Delivery within 48 hours of Induction(From time of induction to time of delivery.)
- Perineal Lacerations (Degree I-IV)(From time of enrollment to time of delivery.)
- Postpartum hemorrhage(Time of enrollment to time of delivery.)
- Blood Transfusion(From time of enrollment to hospital discharge (up to 42 days post-delivery).)
- Isolated maternal fever(From time of enrollment to hospital discharge (up to 42 days post-delivery).)
- Diagnosed Endometritis(From time of enrollment to hospital discharge (up to 42 days post-delivery).)
- Wound Separation/Infection(From time of enrollment to hospital discharge (up to 42 days post-delivery).)
- Intraamniotic Infection(From time of enrollment to hospital discharge (up to 42 days post-delivery).)
- Venous Thromboembolism (VTE)(From time of enrollment to hospital discharge (up to 42 days post-delivery).)
- Hysterectomy(From time of enrollment to hospital discharge (up to 42 days post-delivery).)
- Intensive Care Unit (ICU) Admission(From time of enrollment to ICU admission (up to 42 days post-delivery).)
- Maternal Death(From time of enrollment until maternal death (up to 42 days post-delivery).)
- Length of hospital stay(From time of hospital admission to time of hospital discharge (up to 50 days post-delivery).)
- Cord Prolapse(From time of enrollment to delivery.)
- Use of Terbutaline(From time of enrollment to delivery.)
- Placement of Intrauterine Pressure Catheter(From time of enrollment to delivery.)
- Epidural Use(From time of enrollment to delivery.)
- Neonatal 5- minute Apgar score <7(From time of delivery up to 1 day following delivery.)
- Neonatal Intensive Care Unit (NICU) Admission(From time of delivery to NICU admission. Includes the entire length of neonate's hospital stay, up to 1 year following delivery.)
- Neonatal Head Cooling Therapy(From time of delivery to time of hospital discharge. Includes the entire length of neonate's hospital stay, up to 1 year following delivery.)
- Neonatal Length of Stay (days)(From time of delivery to time of hospital discharge. Includes the entire length of neonate's hospital stay, up to 1 year following delivery.)
- Neonatal Severe Respiratory Distress Syndrome (RDS)(From time of delivery to hospital discharge. Includes the entire length of neonate's hospital stay, up to 1 year following delivery.)
- Neonatal outcome composite(From time of delivery to hospital discharge. Includes the entire length of neonate's hospital stay, up to 1 year following delivery.)
- Hypoxic-Ischemic Encephalopathy(From time of delivery to hospital discharge. Includes the entire length of neonate's hospital stay, up to 1 year following delivery.)
- Neonatal Intraventricular Hemorrhage (Grade 3 or 4)(From time of enrollment to hospital discharge. Includes the entire length of neonate's hospital stay, up to 1 year following delivery.)
- Arterial umbilical cord pH <7(From time of enrollment up to 1 day following delivery.)
- Diagnosed Neonatal Necrotizing Enterocolitis(From time of delivery to time of hospital discharge. Includes the entire length of neonate's hospital stay, up to 1 year following delivery.)
- NICU Stay >48 hours(From NICU admission to NICU discharge. Includes the entire length of neonate's hospital stay, up to 1 year following delivery.)
- Bishop Score: Cervical Dilation, Effacement, Station, Position, Consistency(From time of enrollment to time of induction up to 1 week.)
- Neonatal Sepsis (Culture-proven or Presumed)(From time of delivery to hospital discharge. Includes the entire length of neonate's hospital stay, up to 1 year following delivery.)
- Neonatal Blood Transfusion(From time of delivery to time of hospital discharge. Includes the entire length of neonate's hospital stay, up to 1 year following delivery.)
研究者
Tetsuya Kawakita, MD
Associate Professor
Eastern Virginia Medical School
研究点 (2)
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