The Patient-Centered Outcomes Research Institute (PCORI) commissioned, via the Agency for Healthcare Research and Quality (AHRQ), a systematic evidence review on outpatient cervical ripening (CR). This update fulfills a requirement of PCORI’s authorizing mandate, which is “to engage in evidence synthesis, in order to make information from comparative clinical effectiveness research available to patients and providers so that they can make better-informed health care decisions.”
Women routinely undergo CR as the first, often lengthy step in the process of labor induction. CR usually includes administration of pharmacologic (prostaglandins) or mechanical (balloon catheter) agents that soften, efface, or dilate the cervix in order to prepare for vaginal delivery. Outpatient CR has been adopted in Canada and the United Kingdom and is being discussed as an option in the United States. Purported advantages of outpatient CR include a shorter hospital stay for the mother, thereby reducing the resource and space burden of the delivery wards and an improved patient experience. Consequently, implementation of outpatient CR in the United States may be advantageous provided it is safe.
The American College of Obstetrics & Gynecology (ACOG) has identified outpatient cervical ripening as an important topic for guideline development. The proposed systematic review will integrate information on the effectiveness and harms of outpatient CR and related patient preferences and inform ACOG’s clinical practice guidelines on the topic. In addition, the review seeks to understand the options available to monitor fetal wellbeing in the outpatient setting and to understand which CR methods are appropriate for women experiencing fetal demise.
With input from clinical experts and stakeholders, the following questions have been determined.
- What are the effectiveness and potential harms of CR in the outpatient compared to the inpatient setting?
- What are the comparative effectiveness and potential harms of different methods of CR evaluated in the outpatient setting (balloon catheter, prostaglandins, etc.)?
- What evidence informs preference for or tolerability of different methods of CR in the outpatient setting or outpatient compared to the inpatient setting?
- What are the effectiveness and potential harms of available methods for fetal surveillance in pregnant women undergoing CR with prostaglandins in the inpatient and outpatient setting?
- What are the effectiveness and potential harms of CR among women presenting with fetal demise in the late second or third trimester, in the inpatient and outpatient setting?