Cervical Ripening in the Outpatient Setting

Project Summary Title and Description

Title
Cervical Ripening in the Outpatient Setting
Description
Structured Abstract Objectives. To assess the comparative effectiveness and potential harms of cervical ripening in the outpatient setting (vs. inpatient, vs. other outpatient intervention) and of fetal surveillance when a prostaglandin is used for cervical ripening. Data sources. Electronic databases (Ovid® MEDLINE®, Embase®, CINAHL®, Cochrane Central Register of Controlled Trials, and Cochrane Database of Systematic Reviews) to July 2020; reference lists; and a Federal Register notice. Review methods. Using predefined criteria and dual review, we selected randomized controlled trials (RCTs) and cohort studies of cervical ripening comparing prostaglandins and mechanical methods in outpatient versus inpatient settings; one outpatient method versus another (including placebo or expectant management); and different methods/protocols for fetal surveillance in cervical ripening using prostaglandins. When data from similar study designs, populations, and outcomes were available, random effects using profile likelihood meta-analyses were conducted. Inconsistency (using I2) and small sample size bias (publication bias, if ≥10 studies) were assessed. Strength of evidence (SOE) was assessed. All review methods followed Agency for Healthcare Research and Quality Evidence-based Practice Center methods guidance. Results. We included 30 RCTs and 10 cohort studies (73% fair quality) involving 9,618 women. The evidence is most applicable to women aged 25 to 30 years with singleton, vertex presentation and low-risk pregnancies. No studies on fetal surveillance were found. The frequency of cesarean delivery (2 RCTs, 4 cohort studies) or suspected neonatal sepsis (2 RCTs) was not significantly different using outpatient versus inpatient dinoprostone for cervical ripening (SOE: low). In comparisons of outpatient versus inpatient single-balloon catheters (3 RCTs, 2 cohort studies), differences between groups on cesarean delivery, birth trauma (e.g., cephalohematoma), and uterine infection were small and not statistically significant (SOE: low), and while shoulder dystocia occurred less frequently in the outpatient group (1 RCT; 3% vs. 11%), the difference was not statistically significant (SOE: low). In comparing outpatient catheters and inpatient dinoprostone (1 double-balloon and 1 single-balloon RCT), the difference between groups for both cesarean delivery and postpartum hemorrhage was small and not statistically significant (SOE: low). Evidence on other outcomes in these comparisons and for misoprostol, double-balloon catheters, and hygroscopic dilators was insufficient to draw conclusions. In head to head comparisons in the outpatient setting, the frequency of cesarean delivery was not significantly different between 2.5 mg and 5 mg dinoprostone gel, or latex and silicone single-balloon catheters (1 RCT each, SOE: low). Differences between prostaglandins and placebo for cervical ripening were small and not significantly different for cesarean delivery (12 RCTs), shoulder dystocia (3 RCTs), or uterine infection (7 RCTs) (SOE: low). These findings did not change according to the specific prostaglandin, route of administration, study quality, or gestational age. Small, nonsignificant differences in the frequency of cesarean delivery (6 RCTs) and uterine infection (3 RCTs) were also found between dinoprostone and either membrane sweeping or expectant management (SOE: low). These findings did not change according to the specific prostaglandin or study quality. Evidence on other comparisons (e.g., single-balloon catheter vs. dinoprostone) or other outcomes was insufficient. For all comparisons, there was insufficient evidence on other important outcomes such as perinatal mortality and time from admission to vaginal birth. Limitations of the evidence include the quantity, quality, and sample sizes of trials for specific interventions, particularly rare harm outcomes. Conclusions. In women with low-risk pregnancies, the risk of cesarean delivery and fetal, neonatal, or maternal harms using either dinoprostone or single-balloon catheters was not significantly different for cervical ripening in the outpatient versus inpatient setting, and similar when compared with placebo, expectant management, or membrane sweeping in the outpatient setting. This evidence is low strength, and future studies are needed to confirm these findings.
Attribution
N/A
Authors of Report
N/A
Methodology description
Data sources. Electronic databases (Ovid® MEDLINE®, Embase®, CINAHL®, Cochrane Central Register of Controlled Trials, and Cochrane Database of Systematic Reviews) to July 2020; reference lists; and a Federal Register notice. Review methods. Using predefined criteria and dual review, we selected randomized controlled trials (RCTs) and cohort studies of cervical ripening comparing prostaglandins and mechanical methods in outpatient versus inpatient settings; one outpatient method versus another (including placebo or expectant management); and different methods/protocols for fetal surveillance in cervical ripening using prostaglandins. When data from similar study designs, populations, and outcomes were available, random effects using profile likelihood meta-analyses were conducted. Inconsistency (using I2) and small sample size bias (publication bias, if ≥10 studies) were assessed. Strength of evidence (SOE) was assessed. All review methods followed Agency for Healthcare Research and Quality Evidence-based Practice Center methods guidance.
PROSPERO
CRD42020167406
DOI
N/A
Notes
DOI: 10.23970/AHRQEPCCER238 PubMed: https://pubmed.ncbi.nlm.nih.gov/33818996/ The data of this project were entered retrospectively by uploading data to the project from other software and file format such as Excel or Word. Tables: Appendix E-1. Data Abstraction of Study Characteristics (https://srdr.s3.amazonaws.com/Appendix+E1+Data+Abstraction+of+Study+Characteristics.xlsx), Appendix E-2. Data Abstraction of Outcomes (https://srdr.s3.amazonaws.com/Appendix+E2+Data+Abstraction+of+Outcomes.xlsx), Appendix G. Risk of Bias Assessment (https://srdr.s3.amazonaws.com/Appendix+G+Risk+of+Bias+Assessment.xlsx)
Funding Source
Agency for Healthcare Research and Quality (AHRQ)

Key Questions

1. Key Question 1: How do the effectiveness and harms of cervical ripening using prostaglandins compare in the outpatient vs. inpatient setting? 1a: How do effectiveness and harms vary by choice of prostaglandin? 1b: Do effectiveness and harms vary by important patient characteristics (such as gestational age, parity, uncomplicated pregnancy, prior cesarean delivery, etc.)?
2. Key Question 2: How do the effectiveness and harms of cervical ripening using mechanical methods (e.g., balloon catheters) compare in the outpatient vs. inpatient setting? 2a: How do effectiveness and harms vary by choice of mechanical method in the inpatient versus the outpatient setting? 2b: Do effectiveness and harms vary by important patient characteristics (such as gestational age, parity, uncomplicated pregnancy, prior cesarean delivery, etc.)?
3. Key Question 3: How do the effectiveness and harms of cervical ripening in the outpatient setting vary by method of cervical ripening compared with each other, placebo or expectant management? 3a: Do effectiveness and harms vary by important patient characteristics (such as gestational age, parity, uncomplicated pregnancy, prior cesarean delivery, etc.)?
4. Key Question 4: How do the effectiveness and harms of different methods and protocols for fetal surveillance compare with each other or with no monitoring in pregnant women undergoing cervical ripening with prostaglandins? 4a. Do effectiveness and harms vary by important patient characteristics (such as gestational age, parity, uncomplicated pregnancy, prior cesarean delivery, etc.)?

Associated Extraction Forms

Associated Studies (each link opens a new tab)

TitleAuthorsYear
A prospective study of induction of labor with prostaglandin vaginal gel: ambulatory versus in-patient administration.1999
Vaginal misoprostol for cervical ripening at term: comparison of outpatient vs. inpatient administration.2005
Observational Study of Neonatal Safety for Outpatient Labour Induction Priming with Dinoprostone Vaginal Insert.2017
A cost-minimization analysis of intracervical prostaglandin E2 for cervical ripening in an outpatient versus inpatient setting.-- Not Found --
Dinoprostone vaginal insert for labour induction: a comparison of outpatient and inpatient settings.2009
Home cervical ripening with dinoprostone gel in nulliparous women with singleton pregnancies.2014
A randomized controlled trial of outpatient versus inpatient labour induction with vaginal controlled-release prostaglandin-E2: effectiveness and satisfaction.2003
A randomised controlled trial of outpatient compared with inpatient cervical ripening with prostaglandin E₂ (OPRA study).2015
Induction of labour using prostaglandin E2020
Outpatient Foley catheter versus inpatient prostaglandin E2 gel for induction of labour: a randomised trial.2013
Foley catheter induction of labor as an outpatient procedure.2016
Outpatient Foley Catheter for Induction of Labor in Parous Women: A Randomized Controlled Trial.2018
Effectiveness and infectious morbidity of outpatient cervical ripening with a Foley catheter.2004
Outpatient versus inpatient cervix priming with Foley catheter: A randomized trial.2017
Transcervical Foley catheter for preinduction cervical ripening in an outpatient versus inpatient setting.2001
Ambulatory cervical ripening in term pregnancy.1999
A comparison of inpatient with outpatient balloon catheter cervical ripening: a pilot randomized controlled trial.2015
Retrospective Comparison of PGE2020
Intracervical prostaglandin in postdate pregnancy. A randomized trial.1990
Outpatient management of the uncomplicated postdate pregnancy with intravaginal prostaglandin E2 gel and membrane stripping.-- Not Found --
Outpatient oral misoprostol for prolonged pregnancies: a pilot investigation.2009
A comparison of oral and intracervical prostaglandin E2 for ripening of the unfavourable cervix prior to induction of labour.1988
Vaginally administered misoprostol for outpatient cervical ripening in pregnancies complicated by diabetes mellitus.2001
Use of misoprostol on an outpatient basis for postdate pregnancy.2005
Outpatient cervical ripening with prostaglandin E2 and estradiol.2002
Antepartum cervical ripening: applying prostaglandin E2 gel in conjunction with scheduled nonstress tests in postdate pregnancies.1998
Membrane sweeping versus dinoprostone vaginal insert in the management of pregnancies beyond 41 weeks with an unfavorable cervix.1999
Management of pregnancies beyond forty-one weeks' gestation with an unfavorable cervix.1998
Foley catheter silicone versus latex for term outpatient induction of labour: A randomised trial.2019
Prostaglandin E2 cervical ripening without subsequent induction of labor.1999
Misoprostol outpatient cervical ripening without subsequent induction of labor: a randomized trial.2004
Outpatient misoprostol compared with dinoprostone gel for preinduction cervical ripening: a randomized controlled trial.2005
Outpatient misoprostol cervical ripening without subsequent induction of labor to prevent post-term pregnancy.2005
Randomised trial of outpatient induction of labor with vaginal PGE2 at 40-41 weeks of gestation versus expectant management.1996
Randomized double-blind placebo controlled study of preinduction cervical priming with 25 µg of misoprostol in the outpatient setting to prevent formal induction of labour.2017
Weekly administration of prostaglandin E2 gel compared with expectant management in women with previous cesareans. Prepidil Gel Study Group.1999
Patient-administered outpatient intravaginal prostaglandin E2 suppositories in post-date pregnancies: a double-blind, randomized, placebo-controlled study.1994
Sequential outpatient application of intravaginal prostaglandin E2 gel in the management of postdates pregnancies.1991
Double-blind comparison of 2.5 and 5.0 mg of prostaglandin E2 gel for preinduction cervical ripening.1996
Outpatient cervical ripening with intravaginal misoprostol.2000

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