PregnancyNCT02210598
Outpatient Labor Induction With the Transcervical Foley Balloon
A study testing inpatient Foley balloon induction, outpatient Foley balloon induction and Oxytocin in people with Pregnancy and Labor; Forced or Induced, Affecting Fetus or Newborn, run by University of Southern California at 1 site in United States.
Trial summary
This study represents the first randomized trial comparing traditional inpatient induction with a transcervical foley catheter versus outpatient induction with immediate removal of a transcervical foley catheter. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pregnancy, Labor; Forced or Induced, Affecting Fetus or Newborn
- What is being tested?
- inpatient Foley balloon induction, outpatient Foley balloon induction and Oxytocin
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2014to Jan 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Viable Intrauterine Pregnancy
- Greater than or equal to 37 weeks gestation on date of induction
- Cephalic Presentation
- Medically indicated induction of labor
- AFI greater than or equal to 5
- Patient able to be contacted by phone and demonstrates an understanding of the return instructions
- Cervical Dilation 2cm or less
Who cannot join
- Placenta Previa/Low Lying Placenta
- Placenta accreta/increta/percreta
- Undiagnosed vaginal bleeding
- Preeclampsia or HELLP Syndrome
- Intrauterine Growth Restriction
- Rupture of Membranes
Show all 19Show fewer
- Prior cesarean section or transfundal uterine surgery
- Twin Gestation
- Fetal Anomaly
- Rh Isoimmunization
- Fetal Demise
- Uterine Tachysystole
- Less than 18 years of age
- HIV Infection
- Active herpes, hepatitis B or C infection
- Latex Allergy
- EFW>4000g
- Chorioamnionitis
- Non-English or Non-Spanish Speaking
Trial locations and contacts
1 site in 1 country.
Patrick M Mullin, MD contact
United States1 site, 1 recruiting
- Recruiting
Los Angeles County + University of Southern California Medical Center
Los Angeles, California, 90033
About this study
Official title: Outpatient Labor Induction With the Transcervical Foley Balloon: A Randomized Trial Comparing Outpatient Immediate Removal Foley Versus Standard Inpatient Foley Induction
This study represents the first randomized trial comparing traditional inpatient induction with a transcervical foley catheter versus outpatient induction with immediate removal of a transcervical foley catheter. The immediate removal technique allows the induction process to begin in the hospital setting, but allows the patient to go home without a foreign body in situ. The investigators hypothesize the outpatient group will spend less time hospitalized prior to discharge. Additionally, the investigators will explore the vaginal delivery rates and maternal/neonatal safety profiles between groups.
Read the detailed description
This is a randomized controlled trial.
Patients who are candidates for labor induction and meet inclusion criteria will be identified in the obstetrics clinic when they are being scheduled for induction of labor, or at a later clinic date. If they agree to participate, patients will be randomized and enrolled in the study at that time. Those who consent will be randomized into Group A (Experimental Group) and Group B (Control Group). No stratification criteria will be used.
Patients randomized to the control group will undergo induction of labor using the standard foley bulb and Pitocin method. Participants will be placed in the dorsal lithotomy position, an 18 French Foley catheter will be placed transcervically and its balloon filled with 60mL of sterile saline. One of two methods will be used to place the transcervical foley based on provider preference and determination of which method will offer the greatest chance for successful placement. Method A is placement of the foley "blindly" by palpation of the cervix. Method B utilizes direct visualization with sterile speculum placement. Method will be documented in the data collection forms. The catheter will be left in place and IV oxytocin will be started per protocol. The foley catheter will be removed after 12 hours if not spontaneously extruded.
Patients randomized to the experimental group will undergo outpatient induction of labor. Either of the above two described methods will be used to place an 18 French Foley catheter transcervically and its balloon filled with 60mL of sterile saline. The catheter will be deflated and removed within 10 minutes of placement. The patient will then undergo a non-stress test (NST). If the patient has a reactive NST with no late or variable decelerations or uterine tachysystole, the patient will be discharged home with clear return precautions and instructions to return to the triage area in 24 hours. When the patient returns to the hospital, a sterile vaginal exam will be done and Bishop score documented. The patient will then be admitted to L\&D for inpatient continuation of induction with IV oxytocin per protocol.
In accordance with the Friedman curve and current LAC+USC practice, primigravid participants will be given 20 hours of maximum Pitocin (22 mU/ min) to achieve active labor and multigravid participants will be given 14 hours before a failed induction is diagnosed. Cesarean delivery will be recommended for arrest of dilation, arrest of descent, or any obstetric indication as decided by the on-duty house staff. Finally, at patient request, intravenous or regional anesthesia will be made available at any time during the labor and delivery process.
- Being tested
- inpatient Foley balloon induction, outpatient Foley balloon induction, Oxytocin
- Keywords
- labor, induced, catheter, oxytocin, Cesarean section
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
inpatient Foley balloon inductionDevice
Also called 18-French Bard catheter
The catheter will be left in place and IV oxytocin will be started per LAC+USC protocol. The foley catheter will be removed after 12 hours if not spontaneously extruded.
outpatient Foley balloon inductionDevice
Also called 18-French Bard catheter
The catheter will be deflated and removed within 10 minutes of placement. The patient will then undergo a non-stress test (NST). If the patient has a reactive NST with no late or variable decelerations or uterine tachysystole, the patient will be discharged home with clear return precautions and instructions to return to the triage area in 24 hours.
OxytocinDrug
When a patient randomized to the outpatient Foley Balloon induction group returns to the hospital, a sterile vaginal exam will be done and Bishop score documented. The patient will then be admitted to L\&D for inpatient continuation of induction with IV oxytocin per LAC+USC protocol.
Patients randomized to the inpatient Foley balloon induction group will have IV oxytocin initiated per LAC+USC protocol at the time of Foley balloon placement.
| Study group | Role | What they receive |
|---|---|---|
| inpatient Foley balloon induction | Active comparator | Inpatient Foley induction participants will be placed in the dorsal lithotomy position, a Foley catheter will be placed transcervically and its balloon filled with 60mL of sterile saline. One of two methods will be used to place the transcervical foley based on provider preference and determination of which method will offer the greatest chance for successful placement. Method A is placement of the foley "blindly" by palpation of the cervix. Method B utilizes direct visualization with sterile speculum placement. Method will be documented in the data collection forms. The catheter will be left in place and IV oxytocin will be started per LAC+USC protocol. The foley catheter will be removed after 12 hours if not spontaneously extruded. Receives: Device: inpatient Foley balloon induction; Drug: Oxytocin |
| outpatient Foley balloon induction | Experimental | Patients randomized to the experimental group will undergo outpatient Foley induction of labor. Either of the above two described methods will be used to place an 18 French Foley catheter transcervically and its balloon filled with 60mL of sterile saline. The catheter will be deflated and removed within 10 minutes of placement. The patient will then undergo a non-stress test (NST). If the patient has a reactive NST with no late or variable decelerations or uterine tachysystole, the patient will be discharged home with clear return precautions and instructions to return to the triage area in 24 hours. When the patient returns to the hospital, a sterile vaginal exam will be done and Bishop score documented. The patient will then be admitted to L\&D for inpatient continuation of induction with IV oxytocin per LAC+USC protocol. Receives: Device: outpatient Foley balloon induction; Drug: Oxytocin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of inpatient hospitalization (hours)
compare inpatient time as measured by time from admission to time to discharge between the control (standard transcervical foley balloon placement/inpatient procedure) and the experimental group (immediate removal transcervical foley balloon placement/outpatient procedure)
Measured: time from hospital admission to time to discharge, on average 96 hours
Secondary outcomes (8)
Duration of labor induction (hours)
Measured: time of initiation of labor induction to delivery, on average 24 hours
Cesarean section rate (percentage)
Measured: determined at time of delivery
Duration of oxytocin use during labor induction (hours)
Measured: time of initiation of oxytocin until it is discontinued, on average 18 hours
Rate of patients having prolonged fetal heart rate decelerations during labor induction (percentage)
Measured: from initiation of labor induction to delivery, on average 24 hours
Rate of patients developing chorioamnionitis during labor induction (percentage)
Measured: from initiation of induction until delivery, on average 24 hours
Rate of patients developing uterine tachysystole during labor induction (percentage)
Measured: from initiation of labor induction to delivery, on average 24 hours
Rate of infants admitted to NICU (percentage)
Measured: on average during the 24 hours following delivery
APGAR score
Measured: at 1 minute, 5 minutes, and 10 minutes after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2014 (estimated)
- Study startMar 2014
- Primary completionJan 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for PregnancyStudies of the same condition, open and under way.
- More trials run by University of Southern CaliforniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Patrick M Mullin, MD, University of Southern California
- Investigators
- Patrick M Mullin, MD, Study director, University of Southern CaliforniaYen Chan, MD, Principal investigator, University of Southern CaliforniaRichard Lee, MD, Study director, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02210598
- Sponsor's protocol ID
- HS-13-00740
- Status last verified
- Apr 2017
- First submitted
- 19 Mar 2014
- Last updated
- 19 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 11704164Kelly AJ, Alfirevic Z, Dowswell T. Outpatient versus inpatient induction of labour for improving birth outcomes. Cochrane Database Syst Rev. 2009 Apr 15;(2):CD007372. doi: 10.1002/14651858.CD007372.pub2.
PubMed 19370687Henry 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.
PubMed 23356673de 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.
PubMed 36996264Alfirevic 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.
PubMed 32852803
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outpatient Labor Induction With the Transcervical Foley Balloon: A Randomized Trial Comparing Outpatient Immediate Removal Foley Versus Standard Inpatient Foley Induction
- ClinicalTrials.gov ID
- NCT02210598
- Acronym / sponsor ID
- HS-13-00740
- Keywords
- labor, induced, catheter, oxytocin, Cesarean section
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Jan 2018 (estimated)
- First posted
- 6 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study represents the first randomized trial comparing traditional inpatient induction with a transcervical foley catheter versus outpatient induction with immediate removal of a transcervical foley catheter. The immediate removal technique allows the induction process to begin in the hospital setting, but allows the patient to go home without a foreign body in situ. The investigators hypothesize the outpatient group will spend less time hospitalized prior to discharge. Additionally, the investigators will explore the vaginal delivery rates and maternal/neonatal safety profiles between groups.
Detailed description
This is a randomized controlled trial.
Patients who are candidates for labor induction and meet inclusion criteria will be identified in the obstetrics clinic when they are being scheduled for induction of labor, or at a later clinic date. If they agree to participate, patients will be randomized and enrolled in the study at that time. Those who consent will be randomized into Group A (Experimental Group) and Group B (Control Group). No stratification criteria will be used.
Patients randomized to the control group will undergo induction of labor using the standard foley bulb and Pitocin method. Participants will be placed in the dorsal lithotomy position, an 18 French Foley catheter will be placed transcervically and its balloon filled with 60mL of sterile saline. One of two methods will be used to place the transcervical foley based on provider preference and determination of which method will offer the greatest chance for successful placement. Method A is placement of the foley "blindly" by palpation of the cervix. Method B utilizes direct visualization with sterile speculum placement. Method will be documented in the data collection forms. The catheter will be left in place and IV oxytocin will be started per protocol. The foley catheter will be removed after 12 hours if not spontaneously extruded.
Patients randomized to the experimental group will undergo outpatient induction of labor. Either of the above two described methods will be used to place an 18 French Foley catheter transcervically and its balloon filled with 60mL of sterile saline. The catheter will be deflated and removed within 10 minutes of placement. The patient will then undergo a non-stress test (NST). If the patient has a reactive NST with no late or variable decelerations or uterine tachysystole, the patient will be discharged home with clear return precautions and instructions to return to the triage area in 24 hours. When the patient returns to the hospital, a sterile vaginal exam will be done and Bishop score documented. The patient will then be admitted to L\&D for inpatient continuation of induction with IV oxytocin per protocol.
In accordance with the Friedman curve and current LAC+USC practice, primigravid participants will be given 20 hours of maximum Pitocin (22 mU/ min) to achieve active labor and multigravid participants will be given 14 hours before a failed induction is diagnosed. Cesarean delivery will be recommended for arrest of dilation, arrest of descent, or any obstetric indication as decided by the on-duty house staff. Finally, at patient request, intravenous or regional anesthesia will be made available at any time during the labor and delivery process.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| inpatient Foley balloon induction | Active comparator | Device: inpatient Foley balloon induction, Drug: OxytocinInpatient Foley induction participants will be placed in the dorsal lithotomy position, a Foley catheter will be placed transcervically and its balloon filled with 60mL of sterile saline. One of two methods will be used to place the transcervical foley based on provider preference and determination of which method will offer the greatest chance for successful placement. Method A is placement of the foley "blindly" by palpation of the cervix. Method B utilizes direct visualization with sterile speculum placement. Method will be documented in the data collection forms. The catheter will be left in place and IV oxytocin will be started per LAC+USC protocol. The foley catheter will be removed after 12 hours if not spontaneously extruded. |
| outpatient Foley balloon induction | Experimental | Device: outpatient Foley balloon induction, Drug: OxytocinPatients randomized to the experimental group will undergo outpatient Foley induction of labor. Either of the above two described methods will be used to place an 18 French Foley catheter transcervically and its balloon filled with 60mL of sterile saline. The catheter will be deflated and removed within 10 minutes of placement. The patient will then undergo a non-stress test (NST). If the patient has a reactive NST with no late or variable decelerations or uterine tachysystole, the patient will be discharged home with clear return precautions and instructions to return to the triage area in 24 hours. When the patient returns to the hospital, a sterile vaginal exam will be done and Bishop score documented. The patient will then be admitted to L\&D for inpatient continuation of induction with IV oxytocin per LAC+USC protocol. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Viable Intrauterine Pregnancy
- Greater than or equal to 37 weeks gestation on date of induction
- Cephalic Presentation
- Medically indicated induction of labor
- AFI greater than or equal to 5
Key exclusion criteria (19 listed)
- Placenta Previa/Low Lying Placenta
- Placenta accreta/increta/percreta
- Undiagnosed vaginal bleeding
- Preeclampsia or HELLP Syndrome
- Intrauterine Growth Restriction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| inpatient Foley balloon inductionAlso: 18-French Bard catheterThe catheter will be left in place and IV oxytocin will be started per LAC+USC protocol. The foley catheter will be removed after 12 hours if not spontaneously extruded. | Device | inpatient Foley balloon induction |
| outpatient Foley balloon inductionAlso: 18-French Bard catheterThe catheter will be deflated and removed within 10 minutes of placement. The patient will then undergo a non-stress test (NST). If the patient has a reactive NST with no late or variable decelerations or uterine tachysystole, the patient will be discharged home with clear return precautions and instructions to return to the triage area in 24 hours. | Device | outpatient Foley balloon induction |
| OxytocinWhen a patient randomized to the outpatient Foley Balloon induction group returns to the hospital, a sterile vaginal exam will be done and Bishop score documented. The patient will then be admitted to L\&D for inpatient continuation of induction with IV oxytocin per LAC+USC protocol. Patients randomized to the inpatient Foley balloon induction group will have IV oxytocin initiated per LAC+USC protocol at the time of Foley balloon placement. | Drug | inpatient Foley balloon induction, outpatient Foley balloon induction |
Primary outcome
Duration of inpatient hospitalization (hours)
Time frame: time from hospital admission to time to discharge, on average 96 hours
compare inpatient time as measured by time from admission to time to discharge between the control (standard transcervical foley balloon placement/inpatient procedure) and the experimental group (immediate removal transcervical foley balloon placement/outpatient procedure)
8 secondary outcomes
Duration of labor induction (hours)
Time frame: time of initiation of labor induction to delivery, on average 24 hours
Cesarean section rate (percentage)
Time frame: determined at time of delivery
Duration of oxytocin use during labor induction (hours)
Time frame: time of initiation of oxytocin until it is discontinued, on average 18 hours
Rate of patients having prolonged fetal heart rate decelerations during labor induction (percentage)
Time frame: from initiation of labor induction to delivery, on average 24 hours
Rate of patients developing chorioamnionitis during labor induction (percentage)
Time frame: from initiation of induction until delivery, on average 24 hours
Rate of patients developing uterine tachysystole during labor induction (percentage)
Time frame: from initiation of labor induction to delivery, on average 24 hours
Rate of infants admitted to NICU (percentage)
Time frame: on average during the 24 hours following delivery
APGAR score
Time frame: at 1 minute, 5 minutes, and 10 minutes after delivery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2017.
- Results publication: PubMed 11704164Sciscione 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.
- Results publication: PubMed 19370687Kelly AJ, Alfirevic Z, Dowswell T. Outpatient versus inpatient induction of labour for improving birth outcomes. Cochrane Database Syst Rev. 2009 Apr 15;(2):CD007372. doi: 10.1002/14651858.CD007372.pub2.
- Results publication: PubMed 23356673Henry 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.
- Derived from this study: PubMed 36996264de 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.
- Derived from this study: PubMed 32852803Alfirevic 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patrick M Mullin, MD contact
Patrick M Mullin, MD study director
University of Southern California
Yen Chan, MD principal investigator
University of Southern California
Richard Lee, MD study director
University of Southern California
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing inpatient Foley balloon induction, outpatient Foley balloon induction and Oxytocin in people with Pregnancy and Labor; Forced or Induced, Affecting Fetus or Newborn, run by University of Southern California at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Patrick M Mullin, MD (pmullin@usc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of inpatient hospitalization (hours) (time frame: time from hospital admission to time to discharge, on average 96 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02210598, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2017.