Clinical trial NCT02546193: Outpatient Foley Catheter Compared to Usual Inpatient Care for Labor Induction
Official title: Outpatient Foley Catheter Compared to Usual Inpatient Care for Cervical Ripening: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Pregnancy
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2015-09-10
Enrollment: 39
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: This study began as a randomized controlled trial, but due to difficulty enrolling and high screen-failure rates, was modified to a prospective study design allowing participants to choose the arm they wished to participate in at the time of providing informed consent. The intervention group (both designs) was 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 (both designs) 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. For the RCT design, a computer-generated randomization would 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 was randomized or chose the intervention group (outpatient Foley), she underwent 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 was randomized or chose 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 was asked to complete a survey before leaving the hospital describing her experience and satisfaction with the cervical ripening process (both study designs. 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.

Eligibility criteria: 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

Primary outcomes:
measure: Pre-delivery Hospitalization Time
timeFrame: Delivery, approximately 16 to 30 hours after admission
Secondary outcomes:
measure: Mean Score on Maternal Satisfaction Survey
timeFrame: Discharge from the hospital, approximately 2-3 days after delivery
measure: Number of Participants Per Method of Induction Used
timeFrame: End of the third stage of labor, approximately 16 hours after admission
measure: Mean Dose of Medication for Pain Relief
timeFrame: End of the third stage of labor, approximately 16 hours after admission
measure: Mean Time of Delivery
timeFrame: End of the third stage of labor, approximately 16 to 30 hours after admission
measure: Number of Participants With Normal Spontaneous Vaginal Delivery
timeFrame: End of the third stage of labor, approximately 16 hours after admission
measure: Mean Estimated Blood Loss at Delivery
timeFrame: End of the third stage of labor, approximately 16 hours after admission
measure: Number of Participants With Intrapartum Complications
timeFrame: Final postpartum visit, approximately 42 days after delivery
measure: Number of Participants With Postpartum Complications
timeFrame: Final postpartum visit, approximately 42 days after delivery
measure: Mean Readmission Rate
timeFrame: Final postpartum visit, approximately 42 days after delivery
measure: Number of Infants Per Gender
timeFrame: Neonatal discharge from the hospital, approximately 2-3 days after delivery
measure: Mean Birth Weight
timeFrame: Neonatal discharge from the hospital, approximately 2-3 days after delivery
measure: Mean APGAR Scores
timeFrame: Neonatal discharge from the hospital, approximately 2-3 days after delivery
measure: Mean Umbilical Cord Blood Gases
timeFrame: Neonatal discharge from the hospital, approximately 2-3 days after delivery
measure: Number of Infants With Neonatal Morbidity or Mortality, Categorized by Reason.
timeFrame: Neonatal discharge from the hospital, approximately 2-3 days after delivery
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Vanessa E Torbenson, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jozwiak M, Bloemenkamp KW, Kelly AJ, Mol BW, Irion O, Boulvain M. Mechanical methods for induction of labour. Cochrane Database Syst Rev. 2012 Mar 14;(3):CD001233. doi: 10.1002/14651858.CD001233.pub2.
citation: Sciscione AC, Muench M, Pollock M, Jenkins TM, Tildon-Burton J, Colmorgen GH. Transcervical Foley catheter for preinduction cervical ripening in an outpatient versus inpatient setting. Obstet Gynecol. 2001 Nov;98(5 Pt 1):751-6. doi: 10.1016/s0029-7844(01)01579-4.
citation: Henry A, Madan A, Reid R, Tracy SK, Austin K, Welsh A, Challis D. Outpatient Foley catheter versus inpatient prostaglandin E2 gel for induction of labour: a randomised trial. BMC Pregnancy Childbirth. 2013 Jan 29;13:25. doi: 10.1186/1471-2393-13-25.
citation: Alfirevic Z, Gyte GM, Nogueira Pileggi V, Plachcinski R, Osoti AO, Finucane EM. Home versus inpatient induction of labour for improving birth outcomes. Cochrane Database Syst Rev. 2020 Aug 27;8(8):CD007372. doi: 10.1002/14651858.CD007372.pub4.