Patient Satisfaction During Outpatient Versus Inpatient Foley Catheter Induction of Labor
| Status: | Recruiting |
|---|---|
| Conditions: | Women's Studies |
| Therapuetic Areas: | Reproductive |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/17/2018 |
| Start Date: | November 2016 |
| End Date: | December 2019 |
| Contact: | Robert C Johnston, MD |
| Email: | rcjohnst@uci.edu |
| Phone: | 805 901 3562 |
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.
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.
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.
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.
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
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