PregnancyNCT04041687
Outpatient Cervical Ripening
An observational study of Pregnancy, run by Prisma Health-Upstate at 1 site in United States.
Trial summary
The process of labor induction can mean several hours or even days spent as an inpatient prior to delivery. These prolonged hospital admissions contribute to increased financial burden on both patients and hospital systems, dissatisfaction with induction length, and staffing concerns. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Pregnancy
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2019to 1 Mar 2020
- Phase
- Observational
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Low risk pregnant womenn
Who may be able to join
- Low risk, pregnant women seeking elective induction of labor after 39 weeks gestation
- Women without a medical indication for induction of labor.
- Multigravida or primigravida women who are scheduled for late term (postdates) induction will be included.
Who cannot join
- Previous cesarean section,
- Any contraindication to labor or vaginal delivery,
- A ny patients where misoprostol should be used with caution (IUGR, oligohydramnios)
- Bishop score > 6
- ruptured amnioticmembranes
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Outpatient Cervical Ripening with Misoprostol in Low-Risk Inductions After 39 Weeks Gestation: a Cost, Safety, and Satisfaction Analysis
The process of labor induction can mean several hours or even days spent as an inpatient prior to delivery. These prolonged hospital admissions contribute to increased financial burden on both patients and hospital systems, dissatisfaction with induction length, and staffing concerns. Several obstetric practices in the U.S. have already incorporated outpatient cervical ripening (the beginning of the induction process) into their regular practices. The investigators aim to determine if outpatient cervical ripening is a safe, non-inferior, and preferred option to the traditional inpatient induction process.
Read the detailed description
This study will attempt to assess whether outpatient cervical ripening with misoprostol, a synthetic PGE1 analog (Cytotec(R), Pfizer), is an effective and safe option for low-risk pregnant women at or after 39 weeks gestation with an unfavorable cervix. This study comes in the wake of the ARRIVE trial, which may reasonably increase the number of low-risk term inductions.
The process of labor induction, including cervical ripening, can take several hours or even days. This prolonged course contributes not only to long hospital stays and subsequently increased financial burden to both patients and healthcare systems, but also to patient and provider dissatisfaction with length of induction. Additionally, with the expected increase in elective inductions of primigravid women with unfavorable cervices as a result of the ARRIVE study, hospitals face the possibility of being at capacity on labor and delivery with inadequate staffing to ensure patient safety.
Traditionally, the process of cervical ripening begins after inpatient hospital admission. Several small studies have evaluated outpatient ripening with various agents including foley balloon catheters, PGE1 analogs such as misoprostol, and other prostaglandins. The American College of Obstetricians and Gynecologists has commented on the limited data available on outpatient cervical ripening safety and efficacy, noting that outpatient cervical ripening is "appropriate for carefully selected patients" in Practice Bulletin 107. Data have been reassuring as far as safety and efficacy based on several studies, but are limited due to small sample size, For example, a randomized, double-blind placebo-controlled study in 2009 found that outpatient oral misoprostol for late term pregnancies had a significantly shorter time from study entry to spontaneous labor and delivery. This study showed no difference in fetal or maternal morbidity, but was not powered to safety as there were only 44 subjects per group (10). Some institutions including OB/GYN groups at Beth Israel Deaconess Hospital, South Shore Hospital in MA, and Alaska Native medical center have incorporated outpatient ripening into their everyday practices, but little data on outcomes have been published from these sites.
The investigators aim to determine if outpatient cervical ripening is a safe, non-inferior option to the traditional inpatient cervical ripening. The investigators will evaluate whether outpatient ripening impacts patient satisfaction, patient/hospital costs, and adverse outcomes in our health system setting. Cervical ripening is standard care at other OB/GYN practices across the county and the investigators intend to apply this care pathway for patients. The investigator's goal is to ensure the safety of participants by carefully selecting low risk patients and providing necessary fetal monitoring before and after administration. The results of this study can be used to determine if outpatient cervical ripening can be incorporated in daily practices of OB/GYN providers at GHS.
- Conditions
- Pregnancy
- Keywords
- induction
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess outpatient cervical ripening protocol feasibility
length of induction misoprostol, a synthetic PGE1 analog (Cytotec®, Pfizer, New York), is an effective and safe option for low-risk pregnant women with an unfavorable cervix at or after 39 weeks gestation.
Measured: one year
Assess outpatient cervical ripening protocol feasibility
unplanned/unanticipated admissions
Measured: one year
Assess outpatient cervical ripening protocol feasibility
Rate of change in Bishop score
Measured: one year
Assess outpatient cervical ripening protocol feasibility
number of misoprostol doses required
Measured: one year
Assess outpatient cervical ripening protocol feasibility
number of cervical checks performed
Measured: one year
Assess outpatient cervical ripening protocol feasibility
rates of chorioamnionitis or endometritis
Measured: one year
Assess outpatient cervical ripening protocol feasibility
fetal or neonatal complications
Measured: one year
Assess outpatient cervical ripening protocol feasibility
other maternal complications of induction or delivery
Measured: one year
Assess outpatient cervical ripening protocol feasibility
apgar scores
Measured: one year
Assess outpatient cervical ripening protocol feasibility
route of delivery - vaginal delivery with or without assistance, cesarean section and indication
Measured: one year
Assess outpatient cervical ripening protocol feasibility
satisfaction - patient and provider, via survey (labor agentry questionnaire) for outpatient group
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2019
- Study start1 Jun 2019
- Primary completion1 Mar 2020
- Study completion1 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prisma Health-Upstate
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lauren Demosthenes, MD, Principal investigator, Prisma Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04041687
- Sponsor's protocol ID
- pro00084666
- Status last verified
- Oct 2024
- First submitted
- 26 Jul 2019
- Last updated
- 30 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outpatient Cervical Ripening with Misoprostol in Low-Risk Inductions After 39 Weeks Gestation: a Cost, Safety, and Satisfaction Analysis
- ClinicalTrials.gov ID
- NCT04041687
- Acronym / sponsor ID
- pro00084666
- Conditions
- Pregnancy
- Keywords
- induction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Prisma Health-UpstateUniversity, hospital or other
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 1 Mar 2020 (actual)
- Study completion
- 1 Mar 2020 (actual)
- First posted
- 1 Aug 2019 (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 process of labor induction can mean several hours or even days spent as an inpatient prior to delivery. These prolonged hospital admissions contribute to increased financial burden on both patients and hospital systems, dissatisfaction with induction length, and staffing concerns. Several obstetric practices in the U.S. have already incorporated outpatient cervical ripening (the beginning of the induction process) into their regular practices. The investigators aim to determine if outpatient cervical ripening is a safe, non-inferior, and preferred option to the traditional inpatient induction process.
Detailed description
This study will attempt to assess whether outpatient cervical ripening with misoprostol, a synthetic PGE1 analog (Cytotec(R), Pfizer), is an effective and safe option for low-risk pregnant women at or after 39 weeks gestation with an unfavorable cervix. This study comes in the wake of the ARRIVE trial, which may reasonably increase the number of low-risk term inductions.
The process of labor induction, including cervical ripening, can take several hours or even days. This prolonged course contributes not only to long hospital stays and subsequently increased financial burden to both patients and healthcare systems, but also to patient and provider dissatisfaction with length of induction. Additionally, with the expected increase in elective inductions of primigravid women with unfavorable cervices as a result of the ARRIVE study, hospitals face the possibility of being at capacity on labor and delivery with inadequate staffing to ensure patient safety.
Traditionally, the process of cervical ripening begins after inpatient hospital admission. Several small studies have evaluated outpatient ripening with various agents including foley balloon catheters, PGE1 analogs such as misoprostol, and other prostaglandins. The American College of Obstetricians and Gynecologists has commented on the limited data available on outpatient cervical ripening safety and efficacy, noting that outpatient cervical ripening is "appropriate for carefully selected patients" in Practice Bulletin 107. Data have been reassuring as far as safety and efficacy based on several studies, but are limited due to small sample size, For example, a randomized, double-blind placebo-controlled study in 2009 found that outpatient oral misoprostol for late term pregnancies had a significantly shorter time from study entry to spontaneous labor and delivery. This study showed no difference in fetal or maternal morbidity, but was not powered to safety as there were only 44 subjects per group (10). Some institutions including OB/GYN groups at Beth Israel Deaconess Hospital, South Shore Hospital in MA, and Alaska Native medical center have incorporated outpatient ripening into their everyday practices, but little data on outcomes have been published from these sites.
The investigators aim to determine if outpatient cervical ripening is a safe, non-inferior option to the traditional inpatient cervical ripening. The investigators will evaluate whether outpatient ripening impacts patient satisfaction, patient/hospital costs, and adverse outcomes in our health system setting. Cervical ripening is standard care at other OB/GYN practices across the county and the investigators intend to apply this care pathway for patients. The investigator's goal is to ensure the safety of participants by carefully selecting low risk patients and providing necessary fetal monitoring before and after administration. The results of this study can be used to determine if outpatient cervical ripening can be incorporated in daily practices of OB/GYN providers at GHS.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Low risk pregnant womenn
Key inclusion criteria (3 listed)
- Low risk, pregnant women seeking elective induction of labor after 39 weeks gestation
- Women without a medical indication for induction of labor.
- Multigravida or primigravida women who are scheduled for late term (postdates) induction will be included.
Key exclusion criteria (5 listed)
- Previous cesarean section,
- Any contraindication to labor or vaginal delivery,
- A ny patients where misoprostol should be used with caution (IUGR, oligohydramnios)
- Bishop score > 6
- ruptured amnioticmembranes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Assess outpatient cervical ripening protocol feasibility
Time frame: one year
length of induction misoprostol, a synthetic PGE1 analog (Cytotec®, Pfizer, New York), is an effective and safe option for low-risk pregnant women with an unfavorable cervix at or after 39 weeks gestation.
Assess outpatient cervical ripening protocol feasibility
Time frame: one year
unplanned/unanticipated admissions
Assess outpatient cervical ripening protocol feasibility
Time frame: one year
Rate of change in Bishop score
Assess outpatient cervical ripening protocol feasibility
Time frame: one year
number of misoprostol doses required
Assess outpatient cervical ripening protocol feasibility
Time frame: one year
number of cervical checks performed
Assess outpatient cervical ripening protocol feasibility
Time frame: one year
rates of chorioamnionitis or endometritis
Assess outpatient cervical ripening protocol feasibility
Time frame: one year
fetal or neonatal complications
Assess outpatient cervical ripening protocol feasibility
Time frame: one year
other maternal complications of induction or delivery
Assess outpatient cervical ripening protocol feasibility
Time frame: one year
apgar scores
Assess outpatient cervical ripening protocol feasibility
Time frame: one year
route of delivery - vaginal delivery with or without assistance, cesarean section and indication
Assess outpatient cervical ripening protocol feasibility
Time frame: one year
satisfaction - patient and provider, via survey (labor agentry questionnaire) for outpatient group
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 30 Oct 2024.
- Individual participant dataSharing planned: No
Related trials for Pregnancy
Active, not recruitingPhase 1/2
A Beta-only IL-2 ImmunoTherapY Study
Advanced Solid Tumor, Unresectable Solid Tumor
Active, not recruitingPhase 2
Treating Muscle-invasive Bladder Cancer With A Non-surgical Method Consisting of Anti-PD-1 Therapy and Chemoradiation
Muscle-Invasive Bladder Carcinoma, Programmed Cell Death Protein 1 Inhibitor
Not yet recruiting
Ultrasound-Guided Radiofrequency Ablation for Focal Adenomyosis
Adenomyosis, Adenomyoma of Uterus
RecruitingPhase 2
Neurovascular Regulation During Exercise in Humans With Chronic Kidney Disease: Sympatholysis in CKD
Chronic Kidney Disease
Not yet recruiting
Combined Versus Multicomponent Training in People With Chronic Kidney Disease Stages 3a and 3b
Chronic Kidney Disease Stage 3A, Chronic Kidney Disease Stage 3B
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.
Lauren Demosthenes, MD principal investigator
Prisma Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy, run by Prisma Health-Upstate 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 5 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 30 Oct 2024. 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?
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?
Assess outpatient cervical ripening protocol feasibility (time frame: one year). The study lists 11 primary outcomes in all. 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 30 Oct 2024.