A Trial of Cervidil (Dinoprostone, Prostaglandin E2 (PGE2), Insert) for Outpatient Pre-induction of Cervical Ripening in Women at 39.0-41.6 Weeks Gestation
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Dilation Completion Time
研究概览
简要总结
Induction of labor is a frequently planned obstetric procedure. Induction for women with an unfavorable cervix (bishop score <6) increases the risk of cesarean section. This risk may be reduced by ripening or softening the cervix before the induction of labor. This protocol outlines a randomized trial of 200 women evaluating the placement and use of Cervidil to the post vaginal fornix to soften the cervix in preparation for induction.
This trial is looking at inpatient vs outpatient pre-induction cervical ripening using Cervidil and the effects on (1) maternal and newborn outcomes including time of admission to delivery, (2) system healthcare cost, (3) cost to patient, and (4) patient satisfaction.
The investigators hypothesize when compared to patients admitted to the hospital for cervical ripening:
- From the time of admission, patients in the outpatient cervical ripening arm will progress to complete cervical dilation in less time.
- The total overall cost of care for the encounter will be reduced for the group in the outpatient cervical ripening arm.
- Patients in the outpatient cervical ripening arm will have more overall satisfaction.
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
- None
入排标准
- 年龄范围
- 18 Years 至 41 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Accurate gestational age dating by Intermountain dating criteria placing the patient between 39 0/7 and 41 6/7 weeks gestational at time of cervical ripening
- •Planning to undergo cervical ripening for induction of labor
- •Participants must live <20 minutes away from the enrolling facility, or must stay < 20 minutes away.
- •Pregnant women between the ages of 18 and 41 at the time of enrollment.
- •Fetus in vertex position
排除标准
- •Gestational age < 39 weeks or > 41 weeks and 6 days
- •Hypertension (chronic, transitional, gestational, preeclampsia)
- •Multiple gestation
- •Intrauterine Growth Restriction
- •Anticoagulant therapy or at high risk for thromboembolism
- •Cardiac disease other than class I per American Heart Association (AHA)
- •Prior incision in the contractile portion of the uterus
- •Placenta previa
- •Oligohydramnios per American College of Obstetricians and Gynecologists (ACOG) criteria: AFI < 5 or deepest vertical pocket <= 2
- •Polyhydramnios per ACOG criteria: Amniotic Fluid Index (AFI) >= 24
- •Cervical dilation >= 3cm
- •Known fetal anomaly that would require advanced neonatal care
- •Pitocin-induction of labor is otherwise contraindicated
- •Patient is receiving other uterotonics (e.g. oxytocin, Cytotec, etc.)
- •Fetal distress
- •Unexplained vaginal bleeding during the pregnancy
- •Sensitivity to prostaglandin
- •Evidence of or suspicion of marked cephalo-pelvic disproportion (per the Cervidil package insert revision 02/2016, Ferring Pharmaceuticals Inc. Parsippany, NJ)
研究组 & 干预措施
Outpatient Cervical Ripening
Patients randomized to the outpatient cervical ripening arm will come in for a scheduled visit in Labor and Delivery prior to her scheduled induction. A research nurse will examine her and place the Cervidil insert into the posterior vaginal fornix. The patient will be monitored for 2 hours and sent home after a the following are present: (1) reactive non-stress test (NST) (2) category 1 tracing x 2 hours (3) no vaginal bleeding (4) normal maternal vital signes (5) intact bag of water (BOW) and (6) less than 1 contraction every 10 minutes at the time of discharge. The patient will remove the insert the following morning prior to her scheduled induction.
干预措施: Outpatient Dinoprostone 10mg (Drug)
Inpatient Cervical Ripening
The patient will be admitted into the Labor and Delivery unit prior to her scheduled induction. A research nurse will examine her and place the Cervidil insert into the posterior vaginal fornix. The patient will be watched with continuous fetal monitoring for 2 hours. The patient remains hospitalized and the following morning the induction will be started per Intermountain Healthcare protocol.
干预措施: Inpatient Dinoprostone 10 mg (Drug)
结局指标
主要结局
Dilation Completion Time
时间窗: Time of admission to completion of dilation (up to 48 hours)
Time of admission for induction to complete dilation.
Total Cost of Induction Charged to Patient
时间窗: Through study completion (up to 1 year)
Total hospital charges to patient, as obtained by Intermountain Healthcare billing
次要结局
- Start of Oxytocin Until Delivery(Time oxytocin is administered to time of delivery (up to 24 hours))
- Time of Delivery Until Discharge(Time of delivery to discharge (up to 96 hours))
- Time of Admission Until Discharge(Time of admission to labor and delivery to discharge (up to 96 hours))
- Patient Satisfaction: Survey(Time of delivery to discharge (up to 96 hours))
- Vaginal Delivery Rate(Through study completion (up to 1 year))
- Operative Vaginal Delivery Rate(Through study completion (up to 1 year))
- Cesarean Delivery Rate(Through study completion (up to 1 year))