Effect of a Labor Induction Protocol on Vaginal Delivery Rate
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Percentage of Vaginal Deliveries
研究概览
简要总结
The goal of this study is to see if there is a better way to induce labor.
详细描述
This is quasi-experimental prospective cohort study with historical control to examine the efficacy of a new labor induction bundle. The prospective cohort will consist of all eligible nulliparous and multiparous patients admitted for induction; the historical control group will consist of all eligible nulliparous and multiparous patients admitted for induction between August 2019 and February 2020. Patients who are part of the prospective cohort who do not consent to the labor bundle due to personal or physician preferences will be included in secondary analyses as a contemporary control group, however the sample size of this group will not be determined in advance.
Objective
To assess if implementation of an evidence-based labor induction bundle will increase the rate of vaginal delivery within 24 hours.
Hypothesis
Implementation of a labor induction bundle would result in a 30% increase in the rate of vaginal delivery within 24 hours.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Singleton pregnancy
- •Cephalic presentation
- •Gestational age 36 weeks 6 days- 42 weeks 0 days at initiation of induction of labor
- •Age 18 and over
排除标准
- •Preterm (less than 36 weeks 6 days) at initiation of induction of labor
- •Non-cephalic presentation
- •Major fetal anomalies or intrauterine fetal death
- •Bishop score more than 6 at initiation of induction of labor
- •Any contraindication to any agents in the induction protocol (i.e. prior cesarean delivery or myomectomy, three or more contractions per ten minute period averaged over 30 minutes at the initiation of induction of labor, low lying placenta).
- •Any contraindication to vaginal delivery
- •Latex allergic
研究组 & 干预措施
Pregnant women
We are including only women who are age 18 or over, who have a single baby (not twins), with the baby's head down, and are between 36 weeks 6 days and 42 weeks 0 days of pregnancy.
干预措施: Cytotec (Drug)
Pregnant women
We are including only women who are age 18 or over, who have a single baby (not twins), with the baby's head down, and are between 36 weeks 6 days and 42 weeks 0 days of pregnancy.
干预措施: oxytocin (Drug)
Pregnant women
We are including only women who are age 18 or over, who have a single baby (not twins), with the baby's head down, and are between 36 weeks 6 days and 42 weeks 0 days of pregnancy.
干预措施: Cervical Foley Balloon (Device)
结局指标
主要结局
Percentage of Vaginal Deliveries
时间窗: Within 24 hours
Percent vaginal delivery within 24 hours of initiation of labor induction
次要结局
- Percent of vaginal delivery within 12 hours of initiating induction(Within 12 hours)
- Percent of deliveries (vaginal or cesarean) within 12 hours of initiating induction(Within 12 hours)
- Rate of vaginal delivery(Within 4 days)
- Rate of cesarean delivery(Within 4 days)
- Rate of operative vaginal delivery(Within 4 days)
- For patients undergoing cesarean delivery, rate of each indication for cesarean delivery(Within 4 days)
- Incidence of chorioamnionitis(Within 4 days)
- Number of vaginal exams(Within 4 days)
- Incidence of spontaneous internal version to non-cephalic presentation(Within 4 days)
- Incidence of umbilical cord prolapse(Within 4 days)
- Incidence of postpartum hemorrhage(Within 7 days)
- Percent of deliveries (vaginal or cesarean) within 24 hours of initiating induction(Within 24 hours)
- Incidence of transfusion of blood products(Within 7 days)
- Incidence of Neonatal 5-minute APGAR score <7(Within 4 days)
- Incidence of Umbilical cord pH < 7, <7.1, <7.2(Within 4 days)
- Incidence of Neonatal NICU admission(Within 7 days)
- Patient satisfaction with induction and delivery process measured on a scale of 1-10 - immediate(During delivery hospitalization)
- Incidence of shoulder dystocia(Within 4 days)
- Incidence of birth injuries (eg. brachial plexus injuries, musculoskeletal injuries, etc).(Within 7 days)
- Number of attending physicians managing induction of labor(Within 4 days)
- Number of attending-to-attending hand-off's(Within 4 days)
- Number of resident-to-resident team hand-off's(Within 4 days)
研究者
Peter S. Bernstein
Principal Investigator
Montefiore Medical Center