Outpatient Foley Catheter Compared to Usual Inpatient Care for Labor Induction

NCT02546193 | Terminated Results

• 1 other identifier: 14-008988
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

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.

Conditions

Pregnancy

Outcome Measures

Primary Outcomes (1)

• Pre-delivery Hospitalization Time

  The time from when the patient is admitted to the hospital until she delivers her infant and placenta will be recorded. For the outpatient group, this will be measured by adding together the time that the patient spends in the Family Birth Center during Foley placement in the evening with the time she spends inpatient the next day during the rest of her induction until delivery.

  Delivery, approximately 16 to 30 hours after admission

Secondary Outcomes (14)

• Mean Score on Maternal Satisfaction Survey

  Discharge from the hospital, approximately 2-3 days after delivery

• Number of Participants Per Method of Induction Used

  End of the third stage of labor, approximately 16 hours after admission

• Mean Dose of Medication for Pain Relief

  End of the third stage of labor, approximately 16 hours after admission

• Mean Time of Delivery

  End of the third stage of labor, approximately 16 to 30 hours after admission

• Number of Participants With Normal Spontaneous Vaginal Delivery

  End of the third stage of labor, approximately 16 hours after admission

Study Arms (2)

Outpatient Foley catheter (Randomized & Prospective)

EXPERIMENTAL

This arm reflects enrolled women who were (A) randomized to the outpatient Foley catheter group (RCT design) or (B) chose the outpatient Foley catheter group (Modified Prospective study design). Participants underwent basic history review, fetal nonstress testing, ultrasound for presentation and amniotic fluid index, and cervical exams the evening before their scheduled induction in the Family Birth Center. A Foley catheter was placed for cervical ripening. After fetal monitoring, they were dismissed to home, to return to the Family Birth Center in the morning for continuation of their labor inductions in the inpatient setting.

Device: Foley catheter

Inpatient usual care (Randomized & Prospective)

ACTIVE COMPARATOR

This arm reflects enrolled women who were (A) randomized to the inpatient usual care group (RCT design) or (B) chose the inpatient usual care group (Modified Prospective study design). No participants in the modified Prospective study design were accrued due to screen failure. Participants presented to the Family Birth Center in the evening for their scheduled induction of labor. They underwent basic history review, fetal nonstress testing, ultrasound for presentation and amniotic fluid index, and cervical exam. Cervical ripening commenced with either a Foley catheter or vaginal misoprostol per the discretion of the managing obstetric team. They remained in the inpatient setting throughout their entire labor induction course.

Device: Foley catheter; Drug: Misoprostol

Interventions

Foley catheter DEVICE

The Foley catheter is a device used to achieve cervical ripening at the start of labor induction. It is a single balloon catheter placed transcervically by a provider, either digitally or using a speculum for visualization. The balloon is placed above the internal os but below the fetal head, amniotic membranes, and placenta and is inflated. In this study, it will be inflated with 60 cc of normal saline and taped to the patient's thigh for traction. Over several hours, the balloon gradually dilates the cervix. The catheter is typically expulsed when the cervix is 3-4 centimeters.

Inpatient usual care (Randomized & Prospective); Outpatient Foley catheter (Randomized & Prospective)

Misoprostol DRUG

Misoprostol is a prostaglandin E1 analogue that is used for cervical ripening during labor induction. A 25 microgram tablet is placed in the vagina by a provider. A new 25 mcg tablet can be used vaginally every 4 hours for up to 6 total doses.

Inpatient usual care (Randomized & Prospective)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• 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"
• Singleton gestation
• Cephalic presentation
• Amniotic fluid index greater than or equal to 5 centimeters
• Formal prenatal ultrasound documenting the absence of placenta previa
• Bishop score \<6 and cervical dilation \<3cm
• The woman is able to give appropriate consent and has undergone an informed consent process.
• Maternal age ≥ 18 years old at the time of consent.

You may not qualify if:

• New diagnosis requiring immediate hospitalization for monitoring (such as new onset hypertensive disease of pregnancy)
• Vaginal bleeding
• Active labor
• Premature rupture of membranes as determined by positive ferning and as supported by pooling of fluid in the vaginal vault.
• Uterine tachysystole (\>5 contractions in 10 minutes)
• Nonreassuring fetal heart tracing before or after Foley placement
• Chorioamnionitis or maternal fever
• Intrauterine fetal demise
• Contraindication to vaginal delivery, relative or absolute (i.e. transfundal uterine surgery)
• Abnormal placentation including a low lying placenta
• Prior cesarean delivery
• Intrauterine growth restriction (growth \<10th percentile by formal ultrasound)
• Known fetal anomaly
• Human immunodeficiency virus, Hepatitis C, or active herpes infection
• Maternal cardiopulmonary disease requiring cardiac monitoring during labor

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Publications (5)

• 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.

  PMID: 22419277 BACKGROUND

• 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.

  PMID: 11704164 BACKGROUND

• 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.

  PMID: 23356673 BACKGROUND

• de Vaan MD, Ten Eikelder ML, Jozwiak M, Palmer KR, Davies-Tuck M, Bloemenkamp KW, Mol BWJ, Boulvain M. Mechanical methods for induction of labour. Cochrane Database Syst Rev. 2023 Mar 30;3(3):CD001233. doi: 10.1002/14651858.CD001233.pub4.

  PMID: 36996264 DERIVED

• 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.

  PMID: 32852803 DERIVED

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Interventions

Misoprostol

Intervention Hierarchy (Ancestors)

Prostaglandins E, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors

Limitations and Caveats

No statistical analysis comparing the intervention to usual care was undertaken due to inability to achieve necessary sample size and power required to meaningfully assess the aims and detect statistical effect of the intervention.

Results Point of Contact

• Title: VanessaTorbenson, M.D.
• Organization: Mayo Clinic

torbenson.vanessa@mayo.edu

507-266-9873

Study Officials

• Vanessa E Torbenson, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Instructor in Obstetrics-Gynecology

Study Record Dates

• First Submitted: August 14, 2015
• First Posted: September 10, 2015
• Study Start: September 1, 2015
• Primary Completion: June 8, 2017
• Study Completion: June 8, 2017
• Last Updated: June 20, 2019
• Results First Posted: June 20, 2019

Record last verified: 2019-05

Locations

US (1)