Outpatient Foley Catheter Compared to Usual Inpatient Care for Labor Induction
| Status: | Terminated |
|---|---|
| Conditions: | Women's Studies |
| Therapuetic Areas: | Reproductive |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 6/17/2017 |
| Start Date: | September 2015 |
| End Date: | June 8, 2017 |
Outpatient Foley Catheter Compared to Usual Inpatient Care for Cervical Ripening: a Randomized Controlled Trial
Induction of labor, or causing labor to start before it otherwise starts spontaneously, is
sometimes necessary as pregnancy progresses to ensure the safety of both mother and infant.
Labor induction often begins with cervical ripening, in which various methods are used to
prepare the cervix for contractions and labor. Cervical ripening is beneficial and decreases
the need for cesarean section; however, it can be a lengthy process. By tradition, pregnant
women are admitted to the hospital at the start of this process and remain inpatient until
after the baby is born.
There is increasing interest in allowing the mother to return to her own home during the
very first part of this process. She may be more satisfied in a more comfortable environment
with her family. Growing scientific evidence supports use of the Foley catheter as an
approach to outpatient cervical ripening. The Foley catheter is a safe, effective method
that is already used often in the inpatient setting. It does not cause increased health
risks for either mother or baby. Previous research studies have shown that it is just as
safe and effective when women return to their own homes with a Foley catheter and that women
spend less time in the hospital before delivery. More information is needed before this
becomes a standard of care. This research study will allow pregnant women to return home for
the first night of their labor induction with a Foley catheter in place. In the morning they
will return to the hospital and stay until after delivery. They will be compared to a group
of women who remain in the hospital for their entire labor induction. The benefits to going
home during labor induction may include increasing maternal satisfaction and optimizing the
use of resources in the hospital.
sometimes necessary as pregnancy progresses to ensure the safety of both mother and infant.
Labor induction often begins with cervical ripening, in which various methods are used to
prepare the cervix for contractions and labor. Cervical ripening is beneficial and decreases
the need for cesarean section; however, it can be a lengthy process. By tradition, pregnant
women are admitted to the hospital at the start of this process and remain inpatient until
after the baby is born.
There is increasing interest in allowing the mother to return to her own home during the
very first part of this process. She may be more satisfied in a more comfortable environment
with her family. Growing scientific evidence supports use of the Foley catheter as an
approach to outpatient cervical ripening. The Foley catheter is a safe, effective method
that is already used often in the inpatient setting. It does not cause increased health
risks for either mother or baby. Previous research studies have shown that it is just as
safe and effective when women return to their own homes with a Foley catheter and that women
spend less time in the hospital before delivery. More information is needed before this
becomes a standard of care. This research study will allow pregnant women to return home for
the first night of their labor induction with a Foley catheter in place. In the morning they
will return to the hospital and stay until after delivery. They will be compared to a group
of women who remain in the hospital for their entire labor induction. The benefits to going
home during labor induction may include increasing maternal satisfaction and optimizing the
use of resources in the hospital.
This is a randomized controlled trial. The intervention group is comprised of low risk
pregnant women who will have a Foley catheter placed followed by dismissal home with return
in the morning for continuation of the labor induction process. The control group consists
of women who will remain inpatient during the entire cervical ripening phase followed by
continuation of the labor induction process in the inpatient setting.
Low risk pregnant women at term will be enrolled in clinic after their providers have
recommended induction of labor for a specific indication. They will be educated about
induction of labor, the Foley catheter, and the proposed research study. If they would like
to participate, they will be consented in the clinic. Computer-generated randomization will
occur on the morning of the planned induction, and the patients will be contacted by phone
to inform them of their assigned group. The randomization will be stratified by parity and
BMI.
Outpatient Foley catheter group:
If the patient is randomized to the intervention group (outpatient Foley), she will undergo
the following. She will present to the Family Birth Center in the evening at 1900. She will
undergo a nonstress test (NST), an ultrasound for fetal presentation and amniotic fluid
index, and a cervical exam with calculation of a Bishop score. The patient will be asked if
she is having regular, painful contractions, decreased fetal movement, vaginal bleeding,
leakage of fluid from the vagina concerning for rupture of membranes, or fevers or chills. A
Foley catheter will be placed if the following criteria have been met: the nonstress test is
reactive and reassuring (without the presence of ≥ 3 variable decelerations in a 20 minute
period, late-appearing decelerations, or any deceleration lasting ≥1 minute), the fetal
presentation is cephalic, the amniotic fluid index is 5 centimeters or more, the Bishop
score is <6, the cervical dilation is <3 cm, and she has no other clinical characteristics
that exclude her from the trial as described in the inclusion/exclusion criteria. A 30
French Foley will be placed either digitally or with speculum assistance. It will be
inflated with 60 cc of normal saline and taped to the patient's inner thigh. The fetal heart
rate tracing will be monitored for 1 hour after Foley placement. The patient will be sent
home if the following criteria are met: the fetal heart rate tracing is reactive and
category I; there is no evidence of rupture of membranes, spontaneous labor, or vaginal
bleeding more than spotting; and no other exclusion criteria are present. Before discharge,
the patient may receive pharmacologic pain relief in the form of one dose of acetaminophen
and/or fentanyl.
The patient will be instructed to return to the Family Birth Center at 0700 the following
day. She will be given detailed verbal and written instructions of when to contact and
return to the Family Birth Center before the morning. She will be provided with the 24 hour
direct access line for the Family Birth Center to call with any questions or concerns. If
the Foley catheter is expulsed at home, she is to record the time of expulsion. She does not
need to return to the Family Birth Center earlier than planned due to expulsion.
When the patient returns in the morning, the induction will be continued at the discretion
of the providing obstetric team. The remainder of her care during the first, second, and
third stages of labor will be at the discretion of the providing team. The patient will have
continuous fetal monitoring. All patients' labor progress will be monitored using a
partogram. Cesarean delivery will not be performed for arrest of labor or failed induction
unless all criteria have been met as outlined by the Family Birth Center Workgroup protocol
made effective 6/2/14.
Inpatient usual care group:
If the patient is randomized to the control group (inpatient usual care), she will arrive to
the Family Birth Center at 1900 to undergo induction of labor. She will undergo a nonstress
test (NST), an ultrasound for fetal presentation and amniotic fluid index, and a cervical
exam with calculation of a Bishop score. The patient will be asked if she is having regular,
painful contractions, decreased fetal movement, vaginal bleeding, leakage of fluid from the
vagina concerning for rupture of membranes, or fevers or chills. She will be included or
excluded from the study based on the above information. Induction of labor may proceed at
the discretion of the providing obstetric team. Cervical ripening should be performed with
either 25 mcg vaginal misoprostol every 4 hours with a maximum of six doses or a 30 Fr Foley
catheter filled with 60 cc normal saline. The patient may need both methods during her
inpatient stay if her cervix is unfavorable. A Foley catheter will be favored during the
cervical ripening phase if there is tachysystole and/or a nonreassuring fetal heart tracing
precluding further misoprostol administration, provided the Bishop score is still <6. The
remainder of her care during the first, second, and third stages of labor will be at the
discretion of the providing team. All patients' labor progress will be monitored using a
partogram. Cesarean delivery will not be performed for arrest of labor or failed induction
unless all criteria have been met as outlined by the Family Birth Center Workgroup protocol
made effective 6/2/14.
Follow up
Each mother will be asked to complete a survey before leaving the hospital describing her
experience and satisfaction with the cervical ripening process. Primary and secondary
endpoints will be collected from neonatal and maternal charts through 42 days after the
patient's delivery or the date of the patient's final postpartum clinic visit, whichever
comes last.
pregnant women who will have a Foley catheter placed followed by dismissal home with return
in the morning for continuation of the labor induction process. The control group consists
of women who will remain inpatient during the entire cervical ripening phase followed by
continuation of the labor induction process in the inpatient setting.
Low risk pregnant women at term will be enrolled in clinic after their providers have
recommended induction of labor for a specific indication. They will be educated about
induction of labor, the Foley catheter, and the proposed research study. If they would like
to participate, they will be consented in the clinic. Computer-generated randomization will
occur on the morning of the planned induction, and the patients will be contacted by phone
to inform them of their assigned group. The randomization will be stratified by parity and
BMI.
Outpatient Foley catheter group:
If the patient is randomized to the intervention group (outpatient Foley), she will undergo
the following. She will present to the Family Birth Center in the evening at 1900. She will
undergo a nonstress test (NST), an ultrasound for fetal presentation and amniotic fluid
index, and a cervical exam with calculation of a Bishop score. The patient will be asked if
she is having regular, painful contractions, decreased fetal movement, vaginal bleeding,
leakage of fluid from the vagina concerning for rupture of membranes, or fevers or chills. A
Foley catheter will be placed if the following criteria have been met: the nonstress test is
reactive and reassuring (without the presence of ≥ 3 variable decelerations in a 20 minute
period, late-appearing decelerations, or any deceleration lasting ≥1 minute), the fetal
presentation is cephalic, the amniotic fluid index is 5 centimeters or more, the Bishop
score is <6, the cervical dilation is <3 cm, and she has no other clinical characteristics
that exclude her from the trial as described in the inclusion/exclusion criteria. A 30
French Foley will be placed either digitally or with speculum assistance. It will be
inflated with 60 cc of normal saline and taped to the patient's inner thigh. The fetal heart
rate tracing will be monitored for 1 hour after Foley placement. The patient will be sent
home if the following criteria are met: the fetal heart rate tracing is reactive and
category I; there is no evidence of rupture of membranes, spontaneous labor, or vaginal
bleeding more than spotting; and no other exclusion criteria are present. Before discharge,
the patient may receive pharmacologic pain relief in the form of one dose of acetaminophen
and/or fentanyl.
The patient will be instructed to return to the Family Birth Center at 0700 the following
day. She will be given detailed verbal and written instructions of when to contact and
return to the Family Birth Center before the morning. She will be provided with the 24 hour
direct access line for the Family Birth Center to call with any questions or concerns. If
the Foley catheter is expulsed at home, she is to record the time of expulsion. She does not
need to return to the Family Birth Center earlier than planned due to expulsion.
When the patient returns in the morning, the induction will be continued at the discretion
of the providing obstetric team. The remainder of her care during the first, second, and
third stages of labor will be at the discretion of the providing team. The patient will have
continuous fetal monitoring. All patients' labor progress will be monitored using a
partogram. Cesarean delivery will not be performed for arrest of labor or failed induction
unless all criteria have been met as outlined by the Family Birth Center Workgroup protocol
made effective 6/2/14.
Inpatient usual care group:
If the patient is randomized to the control group (inpatient usual care), she will arrive to
the Family Birth Center at 1900 to undergo induction of labor. She will undergo a nonstress
test (NST), an ultrasound for fetal presentation and amniotic fluid index, and a cervical
exam with calculation of a Bishop score. The patient will be asked if she is having regular,
painful contractions, decreased fetal movement, vaginal bleeding, leakage of fluid from the
vagina concerning for rupture of membranes, or fevers or chills. She will be included or
excluded from the study based on the above information. Induction of labor may proceed at
the discretion of the providing obstetric team. Cervical ripening should be performed with
either 25 mcg vaginal misoprostol every 4 hours with a maximum of six doses or a 30 Fr Foley
catheter filled with 60 cc normal saline. The patient may need both methods during her
inpatient stay if her cervix is unfavorable. A Foley catheter will be favored during the
cervical ripening phase if there is tachysystole and/or a nonreassuring fetal heart tracing
precluding further misoprostol administration, provided the Bishop score is still <6. The
remainder of her care during the first, second, and third stages of labor will be at the
discretion of the providing team. All patients' labor progress will be monitored using a
partogram. Cesarean delivery will not be performed for arrest of labor or failed induction
unless all criteria have been met as outlined by the Family Birth Center Workgroup protocol
made effective 6/2/14.
Follow up
Each mother will be asked to complete a survey before leaving the hospital describing her
experience and satisfaction with the cervical ripening process. Primary and secondary
endpoints will be collected from neonatal and maternal charts through 42 days after the
patient's delivery or the date of the patient's final postpartum clinic visit, whichever
comes last.
Inclusion Criteria
1. Pregnant women at ≥37 weeks gestation by reliable dating criteria as determined by
the American College of Obstetricians and Gynecologists (i.e. gestational age
supported by one of the following: ultrasound prior to 20 weeks of gestation, fetal
heart tones auscultated by Doppler for 30+ weeks, or documented serum or urine
pregnancy test 36+ weeks ago)
2. Scheduled induction of labor with indication and timing supported by the Family Birth
Center induction of labor guideline entitled "Induction of labor: Indications and
Timing"
3. Singleton gestation
4. Cephalic presentation
5. Amniotic fluid index greater than or equal to 5 centimeters
6. Formal prenatal ultrasound documenting the absence of placenta previa
7. Bishop score <6 and cervical dilation <3cm
8. The woman is able to give appropriate consent and has undergone an informed consent
process.
9. Maternal age ≥ 18 years old at the time of consent.
Exclusion Criteria
1. New diagnosis requiring immediate hospitalization for monitoring (such as new onset
hypertensive disease of pregnancy)
2. Vaginal bleeding
3. Active labor
4. Premature rupture of membranes as determined by positive ferning and as supported by
pooling of fluid in the vaginal vault.
5. Uterine tachysystole (>5 contractions in 10 minutes)
6. Nonreassuring fetal heart tracing before or after Foley placement
7. Chorioamnionitis or maternal fever
8. Intrauterine fetal demise
9. Contraindication to vaginal delivery, relative or absolute (i.e. transfundal uterine
surgery)
10. Abnormal placentation including a low lying placenta
11. Prior cesarean delivery
12. Intrauterine growth restriction (growth <10th percentile by formal ultrasound)
13. Known fetal anomaly
14. Human immunodeficiency virus, Hepatitis C, or active herpes infection
15. Maternal cardiopulmonary disease requiring cardiac monitoring during labor
16. Pregestational diabetes
17. Rh isoimmunization
18. Non-English speaking
19. Distance from the hospital over 60 minutes by car, unreliable communication via
telephone, or unreliable transportation
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