Induced Vaginal DeliveryNCT05798728
Outpatient Transcervical Balloon For Induction of Labor
A study testing Outpatient transcervical foley balloon and Inpatient Vaginal Misoprostol in people with Induced Vaginal Delivery and Induced; Birth, run by Hurley Medical Center at 1 site in United States.
Trial summary
The goal of this randomized control trial is to compare outpatient transcervical foley balloon to inpatient vaginal misoprostol in pregnant women for cervical ripening. The main questions it aims to answer are: 1. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Induced Vaginal Delivery, Induced; Birth
- What is being tested?
- Outpatient transcervical foley balloon and Inpatient Vaginal Misoprostol
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jun 2022to 1 Oct 2023
- 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 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Term singleton pregnancy (37 weeks of gestation or greater)
- Bishop score less than 6 and a maximum cervical dilation of 2 cm
- Cephalic presentation
Who cannot join
- Rupture of membranes
- Regular uterine contractions (3 or more contractions per 10 minutes)
- History of prior uterine surgery (cesarean delivery or myomectomy)
- Multiples gestations
- Malpresentation
- Nonreassuring fetal heart tracing (category 3 or persistent category 2)
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- Fetal demise
- Anomalous fetus
- Any contraindication to vaginal delivery
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Hurley Medical Center
Flint, Michigan, 48503
Barouyr Ajemian, MD, bajemia1@hurleymc.com
About this study
Official title: Outpatient Transcervical Balloon: Does it Shorten the Hospital Stay for Induction of Labor? Randomized Control Trial
The goal of this randomized control trial is to compare outpatient transcervical foley balloon to inpatient vaginal misoprostol in pregnant women for cervical ripening. The main questions it aims to answer are:
- Does outpatient transcervical foley balloon decreased the time from admission to delivery compared to inpatient vaginal misoprostol
- Does outpatient transcervical foley balloon will increase risk of c-section during induction of labor compared to inpatient vaginal misoprostol
Participants will be randomized to either the outpatient transcervical foley balloon group or to the inpatient intravaginal misoprostol group. The researchers will compare if outpatient transcervical foley balloon decreases the tie from hospital admission to delivery of the baby.
Read the detailed description
This is a prospective randomized unblinded control trial. Consented patients will have a cervical exam performed in the clinic to confirm that the bishop score is less than 6. Once this and the inclusion criteria are met, the participant will be randomized to either the outpatient transcervical foley arm or the vaginal misoprostol arm. Each pregnant woman will undergo the intervention stated in the numbered envelope which will be distributed based on their order of inclusion in the study. Due to the nature of the procedure, blinding could not be done.
Participants randomized to the transcervical foley group will be scheduled an appointment in the clinic the day before their scheduled induction day for the final screen and foley placement. On the other hand, participants randomized to the vaginal misoprostol group will be admitted to the labor and delivery unit on the day of their scheduled induction. All participants will undergo a cervical examination before the assigned intervention to verify their eligibility status. Those who do not meet the eligibility criteria, will be excluded. Both transcervical foley and vaginal misoprostol are standard of care for induction of labor at Hurley Medical Center. Thus, there would be no additional cost to the patient. The only difference in the study is the setting in which the transcervical foley is placed, i.e. in the obstetrics clinic as an outpatient.
Oxytocin will be initiated in all patients who did not have at least three regular contractions in 10 minutes. Continuous fetal heart rate monitoring and uterine activity monitoring will be performed in all patients. Amniotomy will be performed during the course of labor at the discretion of the health care provider and epidural anesthesia will be administered per the patient's request.
- Conditions
- Induced Vaginal Delivery, Induced; Birth
- Being tested
- Outpatient transcervical foley balloon, Inpatient Vaginal Misoprostol
- Keywords
- Misoprostol, Cytotec, Cervical ripening, Outpatient, Inpatient, Transcervical foley balloon, Mechanical dilation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Outpatient transcervical foley balloonProcedure or surgery
These participants will receive a 16-French Foley catheter which will be placed by a physician present in the clinic. The balloon will be inflated with 40 mL of sterile water, and the catheter will then be gently withdrawn so that the balloon applies pressure against the internal os. The catheter will then be taped to the inner thigh.
Inpatient Vaginal MisoprostolProcedure or surgery
These participants will receive 25 micrograms of Misoprostol (100- microgram tablet cut into fourths by the hospital pharmacist) inserted vaginally into the posterior fornix every 4 hours and repeated up to a maximum of six doses per our standard hospital protocol.
| Study group | Role | What they receive |
|---|---|---|
| Inpatient Vaginal Misoprostol | Active comparator | These participants will receive intravaginal Misoprostol in the inpatient setting per our standard hospital protocol for cervical ripening. Receives: Procedure: Inpatient Vaginal Misoprostol |
| Outpatient transcervical foley balloon | Experimental | These participants will receive a catheter which will be placed by a physician present in the clinic, however, patient are discharged home for 12 hours until their time of induction of labor. Receives: Procedure: Outpatient transcervical foley balloon |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time from hospital admission to delivery of the newborn
The primary outcome is to determine if there is a difference in the time from admission to delivery for those who receive transcervical foley balloon in the clinic the day before induction compared to those who get vaginal misoprostol in the hospital on the day of the induction
Measured: From hospital admission until delivery of the newborn
Secondary outcomes (18)
Chorioamnionitis/endometritis
Number of participants with fever, increased white blood cell count or foul smelling discharge in the outpatient transcervical foley group compared to that of in the intravaginal Misoprostol group
Measured: From hospital admission until 2 weeks postpartum
Cesarean delivery
Number of participants delivering via cesarean section in the outpatient transcervical foley group compared to that of in the inpatient intravaginal Misoprostol group
Measured: From hospital admission until delivery of the newborn
Postpartum hemorrhage
Number of participants with quantified blood loss greater than 1000ml in the outpatient transcervical foley group compared to that of in the inpatient intravaginal Misoprostol group
Measured: From hospital admission until 2 weeks postpartum
Delivery within 24 hours of hospital admission
To determine is if the delivery rate within 24 hours from hospital admission in the outpatient transcervical foley group is greater compared to the inpatient intravaginal Misoprostol group
Measured: From hospital admission until delivery of the newborn
Total hospital length of stay
To determine is if there is an increase risk of prolonged hospital stay in the outpatient transcervical foley group compared to the inpatient intravaginal Misoprostol group
Measured: From hospital admission until discharge, assessed up to a week
Hospital readmission within 30 days of discharge
To determine is if there is an increase risk of hospital readmission within 30 days of discharge in the outpatient transcervical foley group compared to the inpatient intravaginal Misoprostol group
Measured: From discharge until 30 days postpartum
Cervical examination at the time of admission
To determine if cervical dilation is more favorable for induction in the outpatient transcervical foley balloon compared to the inpatient intravaginal Misoprostol
Measured: Within the first hour of hospital admission
Unscheduled hospital admissions or unscheduled visits to our obstetric triage unit before the time of scheduled admission
To determine if outpatient transcervical foley balloon placement increases the unscheduled hospital admissions or unscheduled visits to our obstetric triage unit before the time of scheduled admission.
Measured: From date of outpatient transcervical foley balloon placement until time of scheduled admission, assessed up to 12 hours
Frequency of acetaminophen use after randomization but before hospital admission
To determine if outpatient transcervical foley balloon placement increases the frequency of acetaminophen use after randomization but before hospital admission
Measured: From time of outpatient transcervical foley balloon placement until hospital admission, assessed up to 12 hours
Spontaneous rupture of membranes between randomization and hospital admission
To determine if outpatient transcervical foley balloon placement increases spontaneous rupture of membranes between randomization and hospital admission
Measured: From time of transcervical foley balloon placement until spontaneous rupture of membranes, assessed up to 12 hours
Duration of oxytocin infusion (in min)
To determine if there is an increase in the duration of oxytocin infusion (in minutes) in the outpatient transcervical foley group compared to the inpatient intravaginal Misoprostol group
Measured: From hospital admission until delivery of the newborn
Maximum oxytocin rate infused (in milliunits/min)
To determine if there is an increase in the maximum oxytocin rate infused (in milliunits/min) in the outpatient transcervical foley group compared to the inpatient intravaginal Misoprostol group
Measured: From hospital admission until delivery of the newborn
Duration of neuraxial anesthesia use
To determine is if there is an increase in the duration of neuraxial anesthesia use in the outpatient transcervical foley group compared to the inpatient intravaginal Misoprostol group
Measured: From hospital admission until delivery of the newborn
Presence of heavy vaginal bleeding before delivery
To determine if outpatient transcervical foley balloon placement increases heavy vaginal bleeding before delivery
Measured: From outpatient transcervical foley balloon insertion until delivery of newborn
Meconium-stained amniotic fluid
To determine is if there is an increase in the rate of meconium-stained amniotic fluid in the outpatient transcervical foley group compared to the inpatient intravaginal Misoprostol group
Measured: From hospital admission until delivery of the newborn
Time from rupture of membranes to delivery
To determine is if there is an decreases the duration from rupture of membranes to delivery in the outpatient transcervical foley group compared to the inpatient intravaginal Misoprostol group
Measured: From time of rupture of membranes until delivery of the newborn
Highest maternal intrapartum temperature
To determine is if there is an increase in maternal intrapartum temperature in the outpatient transcervical foley group compared to the inpatient intravaginal Misoprostol group
Measured: From hospital admission until delivery of the newborn
Admission white blood cell count
To determine is if there is an increase in admission white blood cell count in the outpatient transcervical foley group compared to the inpatient intravaginal Misoprostol group
Measured: From hospital admission until delivery of the newborn
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2023
- Study start9 Jun 2022
- Primary completion9 Jun 2023 (estimated)
- Study completion1 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Induced Vaginal DeliveryStudies of the same condition, open and under way.
- 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
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hurley Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Atinuke Akinpeloye, Hurley Medical Center
- Investigators
- Atinuke Akinpeloye, MD, Principal investigator, Hurley Medical Canter
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05798728
- Sponsor's protocol ID
- 1914347
- Status last verified
- Mar 2023
- First submitted
- 7 Mar 2023
- Last updated
- 5 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outpatient Transcervical Balloon: Does it Shorten the Hospital Stay for Induction of Labor? Randomized Control Trial
- ClinicalTrials.gov ID
- NCT05798728
- Acronym / sponsor ID
- 1914347
- Conditions
- Induced Vaginal Delivery, Induced; Birth
- Keywords
- Misoprostol, Cytotec, Cervical ripening, Outpatient, Inpatient, Transcervical foley balloon, Mechanical dilation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Hurley Medical CenterUniversity, hospital or other
- Study start
- 9 Jun 2022 (actual)
- Primary completion
- 9 Jun 2023 (estimated)
- Study completion
- 1 Oct 2023 (estimated)
- First posted
- 5 Apr 2023 (actual)
- 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.
The goal of this randomized control trial is to compare outpatient transcervical foley balloon to inpatient vaginal misoprostol in pregnant women for cervical ripening. The main questions it aims to answer are:
- Does outpatient transcervical foley balloon decreased the time from admission to delivery compared to inpatient vaginal misoprostol
- Does outpatient transcervical foley balloon will increase risk of c-section during induction of labor compared to inpatient vaginal misoprostol
Participants will be randomized to either the outpatient transcervical foley balloon group or to the inpatient intravaginal misoprostol group. The researchers will compare if outpatient transcervical foley balloon decreases the tie from hospital admission to delivery of the baby.
Detailed description
This is a prospective randomized unblinded control trial. Consented patients will have a cervical exam performed in the clinic to confirm that the bishop score is less than 6. Once this and the inclusion criteria are met, the participant will be randomized to either the outpatient transcervical foley arm or the vaginal misoprostol arm. Each pregnant woman will undergo the intervention stated in the numbered envelope which will be distributed based on their order of inclusion in the study. Due to the nature of the procedure, blinding could not be done.
Participants randomized to the transcervical foley group will be scheduled an appointment in the clinic the day before their scheduled induction day for the final screen and foley placement. On the other hand, participants randomized to the vaginal misoprostol group will be admitted to the labor and delivery unit on the day of their scheduled induction. All participants will undergo a cervical examination before the assigned intervention to verify their eligibility status. Those who do not meet the eligibility criteria, will be excluded. Both transcervical foley and vaginal misoprostol are standard of care for induction of labor at Hurley Medical Center. Thus, there would be no additional cost to the patient. The only difference in the study is the setting in which the transcervical foley is placed, i.e. in the obstetrics clinic as an outpatient.
Oxytocin will be initiated in all patients who did not have at least three regular contractions in 10 minutes. Continuous fetal heart rate monitoring and uterine activity monitoring will be performed in all patients. Amniotomy will be performed during the course of labor at the discretion of the health care provider and epidural anesthesia will be administered per the patient's request.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Inpatient Vaginal Misoprostol | Active comparator | Procedure: Inpatient Vaginal MisoprostolThese participants will receive intravaginal Misoprostol in the inpatient setting per our standard hospital protocol for cervical ripening. |
| Outpatient transcervical foley balloon | Experimental | Procedure: Outpatient transcervical foley balloonThese participants will receive a catheter which will be placed by a physician present in the clinic, however, patient are discharged home for 12 hours until their time of induction of labor. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Term singleton pregnancy (37 weeks of gestation or greater)
- Bishop score less than 6 and a maximum cervical dilation of 2 cm
- Cephalic presentation
Key exclusion criteria (9 listed)
- Rupture of membranes
- Regular uterine contractions (3 or more contractions per 10 minutes)
- History of prior uterine surgery (cesarean delivery or myomectomy)
- Multiples gestations
- Malpresentation
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 |
|---|---|---|
| Outpatient transcervical foley balloonThese participants will receive a 16-French Foley catheter which will be placed by a physician present in the clinic. The balloon will be inflated with 40 mL of sterile water, and the catheter will then be gently withdrawn so that the balloon applies pressure against the internal os. The catheter will then be taped to the inner thigh. | Procedure or surgery | Outpatient transcervical foley balloon |
| Inpatient Vaginal MisoprostolThese participants will receive 25 micrograms of Misoprostol (100- microgram tablet cut into fourths by the hospital pharmacist) inserted vaginally into the posterior fornix every 4 hours and repeated up to a maximum of six doses per our standard hospital protocol. | Procedure or surgery | Inpatient Vaginal Misoprostol |
Primary outcome
Time from hospital admission to delivery of the newborn
Time frame: From hospital admission until delivery of the newborn
The primary outcome is to determine if there is a difference in the time from admission to delivery for those who receive transcervical foley balloon in the clinic the day before induction compared to those who get vaginal misoprostol in the hospital on the day of the induction
18 secondary outcomes
Chorioamnionitis/endometritis
Time frame: From hospital admission until 2 weeks postpartum
Cesarean delivery
Time frame: From hospital admission until delivery of the newborn
Postpartum hemorrhage
Time frame: From hospital admission until 2 weeks postpartum
Delivery within 24 hours of hospital admission
Time frame: From hospital admission until delivery of the newborn
Total hospital length of stay
Time frame: From hospital admission until discharge, assessed up to a week
Hospital readmission within 30 days of discharge
Time frame: From discharge until 30 days postpartum
Cervical examination at the time of admission
Time frame: Within the first hour of hospital admission
Unscheduled hospital admissions or unscheduled visits to our obstetric triage unit before the time of scheduled admission
Time frame: From date of outpatient transcervical foley balloon placement until time of scheduled admission, assessed up to 12 hours
Frequency of acetaminophen use after randomization but before hospital admission
Time frame: From time of outpatient transcervical foley balloon placement until hospital admission, assessed up to 12 hours
Spontaneous rupture of membranes between randomization and hospital admission
Time frame: From time of transcervical foley balloon placement until spontaneous rupture of membranes, assessed up to 12 hours
Duration of oxytocin infusion (in min)
Time frame: From hospital admission until delivery of the newborn
Maximum oxytocin rate infused (in milliunits/min)
Time frame: From hospital admission until delivery of the newborn
Duration of neuraxial anesthesia use
Time frame: From hospital admission until delivery of the newborn
Presence of heavy vaginal bleeding before delivery
Time frame: From outpatient transcervical foley balloon insertion until delivery of newborn
Meconium-stained amniotic fluid
Time frame: From hospital admission until delivery of the newborn
Time from rupture of membranes to delivery
Time frame: From time of rupture of membranes until delivery of the newborn
Highest maternal intrapartum temperature
Time frame: From hospital admission until delivery of the newborn
Admission white blood cell count
Time frame: From hospital admission until delivery of the newborn
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2023.
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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.
Atinuke Akinpeloye, MD principal investigator
Hurley Medical Canter
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Outpatient transcervical foley balloon and Inpatient Vaginal Misoprostol in people with Induced Vaginal Delivery and Induced; Birth, run by Hurley Medical Center 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 3 inclusion and 9 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 5 Apr 2023. 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 Barouyr Ajemian, MD (810-262-6862, bajemia1@hurleymc.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time from hospital admission to delivery of the newborn (time frame: From hospital admission until delivery of the newborn). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Apr 2023.