Induction of Labor in Women With Unfavorable Cervix: Randomized Controlled Trial Comparing Outpatient to Inpatient Cervical Ripening Using Dilapan-S® (HOMECARE)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 338
- 试验地点
- 3
- 主要终点
- Number of Participants With Hospital Stay Longer Than 48 Hours
研究概览
简要总结
The target population for our study is women who present for induction of labor. If there is a decision by the obstetrical team to place a mechanical dilator for cervical ripening, the obstetrical team will notify the research staff so that the patient may be screened for the study. If the subject is eligible for the trial, written informed consent will be obtained by person-to-person contact. The PI, study coordinator, or a collaborator will be responsible for the informed consent procedure. After informed consent is obtained and Dilapan-S is placed, the patient will be randomized to the Outpatient or the Inpatient group.
详细描述
Group Assigned to Outpatient Cervical Ripening After Dilapan-S® placement, subject will be monitored for at least 30 minutes. If no contraindications, such as tachysystole, active vaginal bleeding, rupture of membranes or nonreassuring fetal testing (defined as minimal or absent variability, abnormal baseline, or presence of decelerations) evidence of labor, or other serious medical conditions deemed by the clinical staff or the attending physician to preclude outpatient cervical ripening develop after insertion, the subjects will be randomized. After randomization subject will record the pain she experienced during insertion in the patient's survey (see Appendix 3). Those subjects randomized to outpatient ripening will be given the option to either return home or to stay in a hotel if transportation is an issue. The cost for the hotel will be covered by the study budget. Subjects will be allowed to ambulate, shower and perform regular activity during that period. "Nothing per vagina" will be allowed (incl. intercourse, tampons etc.).
Group Assigned to Inpatient Cervical Ripening Subjects randomized to inpatient management will be admitted to L&D unit and standard clinical protocol will be initiated for cervical ripening and labor induction. During the period of 12 hours of cervical ripening subject is to remain "nothing per os" (NPO), "nothing per vagina" and undergo continuous fetal heart rate monitoring. No other interventions are to occur during this period of 12 hours, unless clinically indicated.
Labor Induction and Labor Management of the subject after the initial 12 hours of pre-induction or following the earlier removal or spontaneous expulsion of the dilator will be the same for both groups and at the discretion of the clinical team. Additional ripening (mechanical or prostaglandins) and/or oxytocin may or may not be needed. If needed, duration, type and dose of additional ripening agents and oxytocin will be documented.
Routine intrapartum care will be provided and relevant data collected by the subject's managing obstetrical team.
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 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Pregnant woman whose plan of care is induction of labor
- •Maternal age between 18 and 45 years
- •Understanding and capable to sign informed consent
- •Singleton pregnancy
- •Gestational age ≥ 37 0/7 weeks (based on a sure last menstrual period or a first trimester dating ultrasound)
- •Live fetus in cephalic presentation
- •Intact membranes
- •Pelvic exam (sterile vaginal exam) of less than or equal to 3cm and at most 60% effaced
排除标准
- •Active labor
- •Active genital herpes
- •Chorioamnionitis
- •Transfundal uterine or cervical surgery
- •Previous cesarean delivery
- •Non-reassuring fetal status
- •Need for continuous maternal or fetal monitoring during ripening
- •Contraindication for vaginal delivery
- •Active vaginal bleeding
- •Abnormal placental location or adherence (placenta previa or unresolved low lying placenta)
- •Estimated fetal weight > 5000 g (non diabetic) or > 4500 g (diabetic)
- •Intrauterine growth restriction (estimated fetal weight <10 percentile)
- •Oligohydramnios (amniotic fluid index < 5cm or deep vertical pocket of < 2 cm)
- •Fetal anomaly
- •Need for inpatient care (e.g. hypertension, insulin-dependent diabetes)
- •Poor or no access to a telephone and cannot be placed in the hotel
- •Absence of support person ( no adult accompanying the subject during outpatient cervical ripening period)
结局指标
主要结局
Number of Participants With Hospital Stay Longer Than 48 Hours
时间窗: 72 hours or discharge home time, whichever occurs first
Rate of hospital stay longer than 48 hours (from admission to discharge)
次要结局
- Number of Participants With Cesarean Delivery(1-4 days)
- Number of Participants With Vaginal Deliveries - 24 Hours(24 hours)
- Number of Participants With Vaginal Deliveries 2-4 Days(2-4 days)
- Number of Participants With Operative Vaginal Delivery(1-4 days)
- Change in Bishop Score From Insertion of Device to Extraction(12 hours)
- Time From Hospital Admission to Active Stage of Labor(1-2 days)