Induction of Labor Affected Fetus / NewbornPhase 3NCT03806231
A Trial of Cervidil for Outpatient Pre-induction of Cervical Ripening
A Phase 3 study testing Outpatient Dinoprostone 10mg and Inpatient Dinoprostone 10 mg in people with Induction of Labor Affected Fetus / Newborn, run by Intermountain Health Care, Inc. at 1 site in United States.
Trial summary
Induction of labor is a frequently planned obstetric procedure. Induction for women with an unfavorable cervix (bishop score <6) increases the risk of cesarean section. This risk may be reduced by ripening or softening the cervix before the induction of labor. Read more about this study
- Who is it for?
- Ages 18 to 41 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Induction of Labor Affected Fetus / Newborn
- What is being tested?
- Outpatient Dinoprostone 10mg and Inpatient Dinoprostone 10 mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Aug 2019to 11 Apr 2020
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 41 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Accurate gestational age dating by Intermountain dating criteria placing the patient between 39 0/7 and 41 6/7 weeks gestational at time of cervical ripening
- Planning to undergo cervical ripening for induction of labor
- Participants must live <20 minutes away from the enrolling facility, or must stay < 20 minutes away.
- Pregnant women between the ages of 18 and 41 at the time of enrollment.
- Fetus in vertex position
Who cannot join
- Gestational age < 39 weeks or > 41 weeks and 6 days
- Hypertension (chronic, transitional, gestational, preeclampsia)
- Multiple gestation
- Intrauterine Growth Restriction
- Anticoagulant therapy or at high risk for thromboembolism
- Cardiac disease other than class I per American Heart Association (AHA)
Show all 18Show fewer
- Prior incision in the contractile portion of the uterus
- Placenta previa
- Oligohydramnios per American College of Obstetricians and Gynecologists (ACOG) criteria: AFI < 5 or deepest vertical pocket <= 2
- Polyhydramnios per ACOG criteria: Amniotic Fluid Index (AFI) >= 24
- Cervical dilation >= 3cm
- Known fetal anomaly that would require advanced neonatal care
- Pitocin-induction of labor is otherwise contraindicated
- Patient is receiving other uterotonics (e.g. oxytocin, Cytotec, etc.)
- Fetal distress
- Unexplained vaginal bleeding during the pregnancy
- Sensitivity to prostaglandin
- Evidence of or suspicion of marked cephalo-pelvic disproportion (per the Cervidil package insert revision 02/2016, Ferring Pharmaceuticals Inc. Parsippany, NJ)
Trial locations and contacts
1 site in 1 country.
United States1 site
Dixie Regional Medical Center
St. George, Utah, 84790
About this study
Official title: A Trial of Cervidil (Dinoprostone, Prostaglandin E2 (PGE2), Insert) for Outpatient Pre-induction of Cervical Ripening in Women at 39.0-41.6 Weeks Gestation
Induction of labor is a frequently planned obstetric procedure. Induction for women with an unfavorable cervix (bishop score <6) increases the risk of cesarean section. This risk may be reduced by ripening or softening the cervix before the induction of labor. This protocol outlines a randomized trial of 200 women evaluating the placement and use of Cervidil to the post vaginal fornix to soften the cervix in preparation for induction.
This trial is looking at inpatient vs outpatient pre-induction cervical ripening using Cervidil and the effects on (1) maternal and newborn outcomes including time of admission to delivery, (2) system healthcare cost, (3) cost to patient, and (4) patient satisfaction.
Read more
The investigators hypothesize when compared to patients admitted to the hospital for cervical ripening:
- From the time of admission, patients in the outpatient cervical ripening arm will progress to complete cervical dilation in less time.
- The total overall cost of care for the encounter will be reduced for the group in the outpatient cervical ripening arm.
- Patients in the outpatient cervical ripening arm will have more overall satisfaction.
- Being tested
- Outpatient Dinoprostone 10mg, Inpatient Dinoprostone 10 mg
- Keywords
- Cervical Ripening
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Outpatient Dinoprostone 10mgDrug
Also called Outpatient Cervidil
Dinoprostone (10 mg) is a vaginal insert approved to start and/or continue the ripening of the cervix in pregnant women who are at or near the time of delivery and in whom there is a medical reason for inducing (bringing on) labor. Women randomized to the outpatient cervical ripening group will be administered the drug prior to their induction and discharged after monitoring and physician approval. They will return for their schedule induction.
Inpatient Dinoprostone 10 mgDrug
Also called Inpatient Cervidil
Dinoprostone (10 mg) is a vaginal insert approved to start and/or continue the ripening of the cervix in pregnant women who are at or near the time of delivery and in whom there is a medical reason for inducing (bringing on) labor. Women who are randomized to the inpatient cervical ripening group will be administered the drug prior to their induction and remain hospitalized.
| Study group | Role | What they receive |
|---|---|---|
| Outpatient Cervical Ripening | Experimental | Patients randomized to the outpatient cervical ripening arm will come in for a scheduled visit in Labor and Delivery prior to her scheduled induction. A research nurse will examine her and place the Cervidil insert into the posterior vaginal fornix. The patient will be monitored for 2 hours and sent home after a the following are present: (1) reactive non-stress test (NST) (2) category 1 tracing x 2 hours (3) no vaginal bleeding (4) normal maternal vital signes (5) intact bag of water (BOW) and (6) less than 1 contraction every 10 minutes at the time of discharge. The patient will remove the insert the following morning prior to her scheduled induction. Receives: Drug: Outpatient Dinoprostone 10mg |
| Inpatient Cervical Ripening | Active comparator | The patient will be admitted into the Labor and Delivery unit prior to her scheduled induction. A research nurse will examine her and place the Cervidil insert into the posterior vaginal fornix. The patient will be watched with continuous fetal monitoring for 2 hours. The patient remains hospitalized and the following morning the induction will be started per Intermountain Healthcare protocol. Receives: Drug: Inpatient Dinoprostone 10 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dilation Completion Time
Time of admission for induction to complete dilation.
Measured: Time of admission to completion of dilation (up to 48 hours)
Total Cost of Induction Charged to Patient
Total hospital charges to patient, as obtained by Intermountain Healthcare billing
Measured: Through study completion (up to 1 year)
Secondary outcomes (7)
Patient Satisfaction: Survey
Measured by patient satisfaction/pain/anxiety survey. Questions about patient satifisfaction, pain, and anxiety will have Likert scale responses that range from 2 to 10 choices. Each question will be evaluated independently between cases and controls.
Measured: Time of delivery to discharge (up to 96 hours)
Vaginal Delivery Rate
Number of patients enrolled who delivered vaginally
Measured: Through study completion (up to 1 year)
Operative Vaginal Delivery Rate
Number of patients enrolled who required an operative vaginal delivery
Measured: Through study completion (up to 1 year)
Cesarean Delivery Rate
Number of patients enrolled who had a c-section delivery
Measured: Through study completion (up to 1 year)
Start of Oxytocin Until Delivery
Length of time between patient receiving oxytocin and delivery
Measured: Time oxytocin is administered to time of delivery (up to 24 hours)
Time of Delivery Until Discharge
Length of time between delivery and discharge.
Measured: Time of delivery to discharge (up to 96 hours)
Time of Admission Until Discharge
Total length of time patient was hospitalized, from admission to Labor and Delivery until discharge
Measured: Time of admission to labor and delivery to discharge (up to 96 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2019
- Study start7 Aug 2019
- Primary completion5 Dec 2019
- Study completion11 Apr 2020
Why it stopped: Sponsor declined to provide further funding/product support.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Induction of Labor Affected Fetus / NewbornStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Intermountain Health Care, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- Ferring Pharmaceuticals
- Responsible party
- Sponsor
- Investigators
- John Nichols, DO, Principal investigator, Intermountain Health Care, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03806231
- Sponsor's protocol ID
- OutpatientCervidilTrial
- Status last verified
- Aug 2021
- First submitted
- 25 Oct 2018
- Last updated
- 5 Sep 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- 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 5 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Trial of Cervidil (Dinoprostone, Prostaglandin E2 (PGE2), Insert) for Outpatient Pre-induction of Cervical Ripening in Women at 39.0-41.6 Weeks Gestation
- ClinicalTrials.gov ID
- NCT03806231
- Acronym / sponsor ID
- OutpatientCervidilTrial
- Keywords
- Cervical Ripening
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor declined to provide further funding/product support.
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Intermountain Health Care, Inc.University, hospital or other
- Collaborators
- Ferring Pharmaceuticals
- Study start
- 7 Aug 2019 (actual)
- Primary completion
- 5 Dec 2019 (actual)
- Study completion
- 11 Apr 2020 (actual)
- First posted
- 16 Jan 2019 (actual)
- Results
- Posted 5 Sep 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Induction of labor is a frequently planned obstetric procedure. Induction for women with an unfavorable cervix (bishop score <6) increases the risk of cesarean section. This risk may be reduced by ripening or softening the cervix before the induction of labor. This protocol outlines a randomized trial of 200 women evaluating the placement and use of Cervidil to the post vaginal fornix to soften the cervix in preparation for induction.
This trial is looking at inpatient vs outpatient pre-induction cervical ripening using Cervidil and the effects on (1) maternal and newborn outcomes including time of admission to delivery, (2) system healthcare cost, (3) cost to patient, and (4) patient satisfaction.
The investigators hypothesize when compared to patients admitted to the hospital for cervical ripening:
- From the time of admission, patients in the outpatient cervical ripening arm will progress to complete cervical dilation in less time.
- The total overall cost of care for the encounter will be reduced for the group in the outpatient cervical ripening arm.
- Patients in the outpatient cervical ripening arm will have more overall satisfaction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Outpatient Cervical Ripening | Experimental | Drug: Outpatient Dinoprostone 10mgPatients randomized to the outpatient cervical ripening arm will come in for a scheduled visit in Labor and Delivery prior to her scheduled induction. A research nurse will examine her and place the Cervidil insert into the posterior vaginal fornix. The patient will be monitored for 2 hours and sent home after a the following are present: (1) reactive non-stress test (NST) (2) category 1 tracing x 2 hours (3) no vaginal bleeding (4) normal maternal vital signes (5) intact bag of water (BOW) and (6) less than 1 contraction every 10 minutes at the time of discharge. The patient will remove the insert the following morning prior to her scheduled induction. |
| Inpatient Cervical Ripening | Active comparator | Drug: Inpatient Dinoprostone 10 mgThe patient will be admitted into the Labor and Delivery unit prior to her scheduled induction. A research nurse will examine her and place the Cervidil insert into the posterior vaginal fornix. The patient will be watched with continuous fetal monitoring for 2 hours. The patient remains hospitalized and the following morning the induction will be started per Intermountain Healthcare protocol. |
Who may qualify
- Ages
- 18 to 41 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Accurate gestational age dating by Intermountain dating criteria placing the patient between 39 0/7 and 41 6/7 weeks gestational at time of cervical ripening
- Planning to undergo cervical ripening for induction of labor
- Participants must live <20 minutes away from the enrolling facility, or must stay < 20 minutes away.
- Pregnant women between the ages of 18 and 41 at the time of enrollment.
- Fetus in vertex position
Key exclusion criteria (18 listed)
- Gestational age < 39 weeks or > 41 weeks and 6 days
- Hypertension (chronic, transitional, gestational, preeclampsia)
- Multiple gestation
- Intrauterine Growth Restriction
- Anticoagulant therapy or at high risk for thromboembolism
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 Dinoprostone 10mgAlso: Outpatient CervidilDinoprostone (10 mg) is a vaginal insert approved to start and/or continue the ripening of the cervix in pregnant women who are at or near the time of delivery and in whom there is a medical reason for inducing (bringing on) labor. Women randomized to the outpatient cervical ripening group will be administered the drug prior to their induction and discharged after monitoring and physician approval. They will return for their schedule induction. | Drug | Outpatient Cervical Ripening |
| Inpatient Dinoprostone 10 mgAlso: Inpatient CervidilDinoprostone (10 mg) is a vaginal insert approved to start and/or continue the ripening of the cervix in pregnant women who are at or near the time of delivery and in whom there is a medical reason for inducing (bringing on) labor. Women who are randomized to the inpatient cervical ripening group will be administered the drug prior to their induction and remain hospitalized. | Drug | Inpatient Cervical Ripening |
Primary outcome
Dilation Completion Time
Time frame: Time of admission to completion of dilation (up to 48 hours)
Time of admission for induction to complete dilation.
Total Cost of Induction Charged to Patient
Time frame: Through study completion (up to 1 year)
Total hospital charges to patient, as obtained by Intermountain Healthcare billing
7 secondary outcomes
Patient Satisfaction: Survey
Time frame: Time of delivery to discharge (up to 96 hours)
Vaginal Delivery Rate
Time frame: Through study completion (up to 1 year)
Operative Vaginal Delivery Rate
Time frame: Through study completion (up to 1 year)
Cesarean Delivery Rate
Time frame: Through study completion (up to 1 year)
Start of Oxytocin Until Delivery
Time frame: Time oxytocin is administered to time of delivery (up to 24 hours)
Time of Delivery Until Discharge
Time frame: Time of delivery to discharge (up to 96 hours)
Time of Admission Until Discharge
Time frame: Time of admission to labor and delivery to discharge (up to 96 hours)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
- Individual participant dataSharing planned: No
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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.
John Nichols, DO principal investigator
Intermountain Health Care, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Outpatient Dinoprostone 10mg and Inpatient Dinoprostone 10 mg in people with Induction of Labor Affected Fetus / Newborn, run by Intermountain Health Care, Inc. 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 5 inclusion and 18 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: stopped early, as of the sponsor's last update on 5 Sep 2021. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Sep 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Dilation Completion Time (time frame: Time of admission to completion of dilation (up to 48 hours)). The study lists 2 primary outcomes in all. 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 NCT03806231, 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 5 Sep 2021.