Clinical trial NCT02975167: Patient Satisfaction During Outpatient Versus Inpatient Foley Catheter Induction of Labor
Official title: Patient Satisfaction During Outpatient Versus Inpatient Foley Catheter Induction of Labor
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Induction of Labor Affected Fetus / Newborn
Cervical Ripening
Patient Satisfaction
Keywords: Induction of labor
mechanical cervical ripening
patient satisfaction
outpatient
cost savings
Lead sponsor: MemorialCare Health System
Sponsor class: OTHER
First posted: 2016-11-29
Enrollment: 160
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Labor induction is one of the most common obstetric procedures performed in the U.S. In 2012, the last year for which data is available, 23.7% of all deliveries were the result of inductions. Labor induction first requires cervical ripening, which can be accomplished by several different methods. Vaginal or oral prostaglandins, extra amniotic saline infusion, osmotic dilators and transcervical Foley catheters are all widely used instruments for pre-induction cervical ripening. The ideal cervical ripening tool is safe for both mother and fetus, incurs low cost, does not require extensive monitoring, and causes minimal maternal discomfort. The Foley catheter has been found to be both safe and effective, but little is known about patient satisfaction with the device in an in-patient and out-patient setting. The proposed study will investigate patient satisfaction in a randomized controlled trial of in-patient versus out-patient use of Foley catheters.

Detailed description: Labor induction is one of the most common obstetric procedures performed in the U.S. In 2013, the last year for which data is available, 23.1% of all deliveries were the result of inductions. Labor induction often first requires cervical ripening, which can be accomplished by several different methods.

Pharmacologic cervical ripening approaches include vaginal or oral prostaglandin administration. Mechanical cervical ripening methods include osmotic dilators such as laminaria, and transcervical Foley catheters with or without extra amniotic saline infusion. The ideal cervical ripening tool is effective, safe for both mother and fetus, incurs low cost, does not require extensive monitoring, and causes minimal maternal discomfort.

Several recent meta-analyses have demonstrated both the safety and efficacy of the Foley catheter for pre-induction cervical ripening. When compared to prostaglandins, studies have shown that use of the transcervical Foley catheter for pre-induction cervical ripening results in either shortened or no statistically significant difference in vaginal delivery rates at 24 hours. No studies have demonstrated longer duration to vaginal delivery and cesarean delivery rates are equivalent. In addition, women with Foley catheters experience less uterine hyper-stimulation resulting in fetal heart rate changes as compared to those who receive prostaglandins. Other than one study suggesting increased risks of chorioamnionitis and neonatal infection, the vast majority of research suggests Foley catheters are overwhelming safe with little risk of severe maternal or neonatal morbidity.

Due to its safety profile and the ongoing desire to reduce healthcare costs, many institutions have initiated outpatient cervical ripening protocols. Studies suggest that outpatient cervical ripening with transcervical Foley catheter is both safe and effective. In addition, some studies demonstrate women who underwent outpatient cervical ripening spent less time in the hospital during their labor induction, sometimes resulting in significant cost savings at those institutions. The combination of safety, ease of use and cost savings potential make outpatient cervical ripening with a Foley catheter an appealing tool for both clinicians and patients. However, data on patient satisfaction with almost all methods of cervical ripening is sparse. Existing data on patient satisfaction of outpatient versus inpatient induction of labor stems from prior studies which used vaginal misoprostol gel or isosorbide mononitrate as induction agents. While one study suggests overall satisfaction with outpatient Foley catheter cervical ripening, a randomized controlled trial on this topic has yet to be performed.

Eligibility criteria: Inclusion Criteria:

* \> 18 yo
* Singleton pregnancy
* ≥ 39 weeks gestation
* Vertex presenting fetus

Exclusion Criteria:

* \< 18 years of age
* Maternal cardiac disease
* Class C diabetes mellitus or worse (as defined by the White classification system for diabetes in pregnancy)
* Gestational or chronic hypertension
* Active or history of venous thromboembolic disease requiring chemical anticoagulation
* Bleeding disorders
* History of placental abruption during current gestation
* Fetal anomalies
* Intrauterine growth restriction \< 5th percentile
* Prior uterine scar
* Vasa or placenta previa
* Active genital herpes
* Non-vertex fetal lie
* Amniotic fluid index (AFI) \< 5cm
* Multiple gestation
* (Pre)eclampsia
* Latex allergy

Primary outcomes:
measure: Patient satisfaction scores
timeFrame: Through study completion - expected to be one year
Secondary outcomes:
measure: Multiparous versus Nulliparous subjects
timeFrame: Through study completion - expected to be one year
Other outcomes:
Locations:
city: Long Beach
country: United States
facility: Miller Women's and Children's Hospital Long Beach
state: California
Study officials:
affiliation: Faculty
name: Vineet Shrivastava, MD
role: PRINCIPAL_INVESTIGATOR
References:
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