Foley Bulb Insertion by Blind Placement Versus Direct Visualization: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 372
- 试验地点
- 1
- 主要终点
- Infection
研究概览
简要总结
The investigators will compare, in a randomized clinical trial, two methods of placement (placement with a gloved hand vs. placement with a sterile speculum) of a Foley bulb transcervical dilator. The primary outcome is rate of infection.
详细描述
The target population for this study is women who present for scheduled induction of labor. If there is a decision by the obstetric team to place a transcervical Foley dilator for cervical ripen-ning, the obstetric team will notify the research team so that the patient may be screened for the study. If the patient consents to participation, written informed consent will be obtained by person-to-person contact. The PI, study coordinator, or a collaborator will be responsible for the in-formed consent. After informed consent is obtained, the patient will be randomized to the study group (digital placement) or the control group (placement with a sterile speculum).
The control group will undergo induction of labor by placement via sterile speculum of a 22-French transcervical Foley catheter. The cervix is visualized with a sterile vaginal speculum and cleaned with iodine or chlorhexidine. A Foley catheter is introduced into the cervix and the bal-loon is filled with 60 ml of sterile 0.9% NaCl. The Foley catheter will be left in place for at least 12 hours, and no longer than 24 hours. After placement standard intrapartum management of the patient will ensue.
The study group will undergo induction of labor by digital blind placement of a 22-French trans-cervical Foley catheter. A Foley catheter is introduced into the cervix using digits and hands wearing sterile gloves and the balloon is filled with 60 ml of sterile 0.9% NaCl. The Foley catheter will be left in place for at least 12 hours, and no longer than 24 hours. After placement standard intrapartum management of the patient will ensue.
If cervix remains unfavorable after extraction of the dilators (< 3cm and at most 60% effaced), a second Foley catheter will be used in this case for a maximum of 12 hrs. No crossover will be allowed. In other words, a second Foley bulb will be placed in the same manner as the first assignment arm.
In any attempts, if the Foley bulb is not able to be placed in either insertion technique , a prostaglandin agent for cervical ripening may be used and insertion of the mechanical dilator can be re-attempted at a later time, as is the standard of care at our institution. No cross over will be allowed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
The individual or individuals responsible for assessing outcome data will be blinded to group assignment.
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women between the ages of 18 and 50 years
- •Induction of labor
- •Plan for Foley bulb placement by the managing obstetrics team
排除标准
- •Patient unwilling or unable to provide consent
- •Fetal demise or major congenital anomaly
- •Immunosuppressed patients: i.e., taking systemic immunosuppressants or steroids (e.g. transplant patients; not including steroids for lung maturity), HIV with CD4<200, or other
- •Fever (>38°C) in the 48 hours prior to presentation for induction of labor
- •Use of anti-pyretic agent (i.e., acetaminophen) in the eight hours preceding admission for induction of labor
研究组 & 干预措施
Placement with gloved hand
The Foley bulb transcervical dilator will be placed blindly with a gloved hand.
干预措施: Method of placement of Foley bulb transcervical dilator (Procedure)
Placement with sterile speculum
The cervix will be directly visualized using a sterile speculum, and an instrument will be used to advance the Foley bulb transcervical dilator into the cervical os.
干预措施: Method of placement of Foley bulb transcervical dilator (Procedure)
结局指标
主要结局
Infection
时间窗: Labor to 30 days postpartum
Pooled maternal infection
次要结局
- Chorioamnionitis or "triple I"(From beginning of labor process until time of delivery)
- Maternal fever(From beginning of labor process to time of discharge, up to seven days)
- Request for pain relief(Within 30 minutes of placement procedure)
- Vaginal bleeding(Within 30 minutes of placement procedure)
- Endometritis(From time of delivery to 30 days postpartum)
- Artificial rupture of membranes(At time of placement of Foley bulb transcervical dilator)