Induced; BirthNCT03725397
Inpatient Versus Outpatient Foley Cervical Ripening Study
A study testing Outpatient and Inpatient in people with Induced; Birth, run by Yale University at 2 sites in United States.
Trial summary
To compare the efficacy and safety of cervical ripening with transcervical Foley catheter in inpatient vs outpatient setting Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Induced; Birth
- What is being tested?
- Outpatient and Inpatient
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 2 sitesUnited States
- Study dates
- 8 Jan 2019to 27 Jun 2022
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Indication for Induction of Labor is present
- Gestational age > 37 completed weeks with absence of comorbidities with an optimal dating (ultrasonography was performed before 22 weeks gestation)
- Singleton fetus in cephalic presentation confirmed with an ultrasound at the time of presentation for induction of labor
- Cervical exam with Bishop Score <6
- Intact membranes
- Normal vital signs (blood pressure < 140/90, normal body temperature) at the time of presentation for Induction of Labor and within the last 24 hours
- Maternal age ≥18 years of age
Who cannot join
- Any contraindication for vaginal birth by institutional policy
- Multiple gestation
- History of cesarean delivery
- Oligohydramnios/polyhydramnios/anhydramnios (MVP <2cm)
- Rupture of membranes
- Poorly controlled diabetes (Hgb A1C>8% and/or fingerstick glucose above target >50% of the time in the past week)
Show all 19Show fewer
- Poorly controlled chronic hypertension, gestational hypertension or preeclampsia (patient requiring IV antihypertensives within 4 hours of arrival)
- Vaginal bleeding
- Any conditions that require continuous electronic fetal monitoring either by institutional policy or provider determination (intrahepatic cholestasis of pregnancy, intrauterine growth restriction, abnormal non-stress test, others)
- Fetal anomaly with anticipated neonatal intensive care unit admission
- Fetal demise
- HIV infection, presence of genital herpetic lesion
- History of substance abuse during this pregnancy
- History of precipitous delivery (delivery <3hrs from onset of labor)
- Poor access to care (social, distance to hospital > 45 min, limited transportation)
- Poor social situation, history of domestic violence, untreated/uncontrolled psychiatric condition
- Inability to give informed consent, history of mental retardation
- Strong preference for inpatient management
- Inability to understand English or Spanish
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Yale New Haven Hospital- St. Raphael
New Haven, Connecticut, 06511
Yale New Haven Hospital, York Street Campus
New Haven, Connecticut, 06520
About this study
To compare the efficacy and safety of cervical ripening with transcervical Foley catheter in inpatient vs outpatient setting
Read the detailed description
The aim of the current study is to compare the efficacy and safety of cervical ripening with transcervical Foley catheter in inpatient vs outpatient setting in a diverse, urban population within the United States. We hypothesize that there will be no differences in time-to-delivery, failed induction rates, cesarean section rates, or maternal/neonatal morbidity and that there will be no differences in total length of stay (LOS), hours of sleep, active labor duration, and perceived satisfaction between groups.
- Conditions
- Induced; Birth
- Being tested
- Outpatient, Inpatient
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OutpatientBehavioural
The offered (studied) intervention will be allowing the women with a transcervical Foley catheter in place to spend the night at home.
InpatientBehavioural
Women with a transcervical Foley catheter to be admitted to the hospital overnight which has been a "standard of care".
| Study group | Role | What they receive |
|---|---|---|
| Outpatients with a transcervical Foley catheter | Experimental | Women with a transcervical Foley catheter in place that will spend the night at home. Receives: Behavioral: Outpatient |
| Inpatients with a transcervical Foley catheter | Active comparator | Women to be admitted to the hospital overnight which has been a "standard of care". Receives: Behavioral: Inpatient |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time of Foley catheter extrusion
Antepartum time of Foley catheter extrusion before patient being brought to labor
Measured: within 24 hours
Secondary outcomes (11)
Bishop score
Bishop scoring system used to consider having cervical ripening.Women with favorable cervices (BS 8 or more) are considered to have a cervix ripe and ready to proceed to induction. BS <6 are considered unripe, and therefore may benefit from additional ripening modalities
Measured: during labor
Total time in cervical ripening
Measure of total time in cervical ripening
Measured: from labor induction to delivery time
Total time slept during pre-induction
Total time slept during pre-induction
Measured: during labor
Total time in hospital
Total time in hospital
Measured: no max but an average of 3 days
Analgesia used during pre-induction
Analgesia used during pre-induction
Measured: within 24 hours before Pitocin initiation
Use of oxytocin
Pitocin is given as a continuous infusion and the dose is titrated according to the contraction pattern (goal max contractions but not hyperstimulation). We will calculate the total time of Pitocin infusion as well as total dose (rate of infusion x time).
Measured: 3 days
Fever over 38 degrees C
Did the patient have a fever over 38 degrees C
Measured: within 7 days of Foley placement
Neonatal Intensive Care Unit (NICU)
Was the baby admitted to NICU
Measured: within 7 days of Foley placement
APGAR scores
Apgar score is a universal (international) scoring system. The 1-minute score determines how well the baby tolerated the birthing process. The 5-minute score tells the health care provider how well the baby is doing outside the mother's womb.
Measured: 1 minute of life
APGAR scores
Apgar score is a universal (international) scoring system. The 1-minute score determines how well the baby tolerated the birthing process. The 5-minute score tells the health care provider how well the baby is doing outside the mother's womb.
Measured: 5 minutes of life
Hospital charges
All patients will be charged. We are hoping to see lower charges for women in the Out Patient group.
Measured: within 30 days after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2018
- Study start8 Jan 2019
- Primary completion27 Jun 2022
- Study completion27 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Induced; BirthStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- two cohort double blinded clinical trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Katherine Kohari, MD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03725397
- Sponsor's protocol ID
- 2000022710
- Status last verified
- Feb 2023
- First submitted
- 22 Jun 2018
- Last updated
- 22 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 32852803
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inpatient Versus Outpatient Foley Cervical Ripening Study
- ClinicalTrials.gov ID
- NCT03725397
- Acronym / sponsor ID
- 2000022710
- Conditions
- Induced; Birth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- 8 Jan 2019 (actual)
- Primary completion
- 27 Jun 2022 (actual)
- Study completion
- 27 Jun 2022 (actual)
- First posted
- 31 Oct 2018 (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.
To compare the efficacy and safety of cervical ripening with transcervical Foley catheter in inpatient vs outpatient setting
Detailed description
The aim of the current study is to compare the efficacy and safety of cervical ripening with transcervical Foley catheter in inpatient vs outpatient setting in a diverse, urban population within the United States. We hypothesize that there will be no differences in time-to-delivery, failed induction rates, cesarean section rates, or maternal/neonatal morbidity and that there will be no differences in total length of stay (LOS), hours of sleep, active labor duration, and perceived satisfaction between groups.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- two cohort double blinded clinical trial
| Arm | Type | Receives |
|---|---|---|
| Outpatients with a transcervical Foley catheter | Experimental | Behavioral: OutpatientWomen with a transcervical Foley catheter in place that will spend the night at home. |
| Inpatients with a transcervical Foley catheter | Active comparator | Behavioral: InpatientWomen to be admitted to the hospital overnight which has been a "standard of care". |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Indication for Induction of Labor is present
- Gestational age > 37 completed weeks with absence of comorbidities with an optimal dating (ultrasonography was performed before 22 weeks gestation)
- Singleton fetus in cephalic presentation confirmed with an ultrasound at the time of presentation for induction of labor
- Cervical exam with Bishop Score <6
- Intact membranes
Key exclusion criteria (19 listed)
- Any contraindication for vaginal birth by institutional policy
- Multiple gestation
- History of cesarean delivery
- Oligohydramnios/polyhydramnios/anhydramnios (MVP <2cm)
- Rupture of membranes
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 |
|---|---|---|
| OutpatientThe offered (studied) intervention will be allowing the women with a transcervical Foley catheter in place to spend the night at home. | Behavioural | Outpatients with a transcervical Foley catheter |
| InpatientWomen with a transcervical Foley catheter to be admitted to the hospital overnight which has been a "standard of care". | Behavioural | Inpatients with a transcervical Foley catheter |
Primary outcome
Time of Foley catheter extrusion
Time frame: within 24 hours
Antepartum time of Foley catheter extrusion before patient being brought to labor
11 secondary outcomes
Bishop score
Time frame: during labor
Total time in cervical ripening
Time frame: from labor induction to delivery time
Total time slept during pre-induction
Time frame: during labor
Total time in hospital
Time frame: no max but an average of 3 days
Analgesia used during pre-induction
Time frame: within 24 hours before Pitocin initiation
Use of oxytocin
Time frame: 3 days
Fever over 38 degrees C
Time frame: within 7 days of Foley placement
Neonatal Intensive Care Unit (NICU)
Time frame: within 7 days of Foley placement
APGAR scores
Time frame: 1 minute of life
APGAR scores
Time frame: 5 minutes of life
Hospital charges
Time frame: within 30 days after discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2023.
- 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.
Katherine Kohari, MD principal investigator
Yale University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Outpatient and Inpatient in people with Induced; Birth, run by Yale University at 2 sites 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: finished, as of the sponsor's last update on 22 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time of Foley catheter extrusion (time frame: within 24 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 NCT03725397, which also lists 1 linked publication.
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 22 Feb 2023.