Cervical RipeningNCT03111316
Foley Catheter Compared to the Foley Catheter Alone for Cervical Ripening
A study testing Cervidil 10 MG Vaginal Insert and Foley Catheter in people with Cervical Ripening and Induction of Labor, run by University of Oklahoma at 1 site in United States.
Trial summary
In term women presenting for labor induction, combined use of the controlled release dinoprostone vaginal insert and Foley catheter for cervical ripening will decrease the median time from induction to vaginal delivery by at least four hours compared to the Foley catheter alone. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Cervical Ripening, Induction of Labor
- What is being tested?
- Cervidil 10 MG Vaginal Insert and Foley Catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Apr 2017to 24 Jul 2020
- Phase
- Interventional
- 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 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Cervix ≤2 cm dilated; if 2 cm, <80% effaced
- Gestational age 37 weeks or more
- Singleton gestation
- Cephalic presentation
- Live fetus
Who cannot join
- Contractions more frequent than every 5 minutes
- Premature rupture of membranes
- Prior uterine incision
- Temperature 38C or higher
- Fetal anomalies
- Placenta previa
Show all 10Show fewer
- Suspected abruption or undiagnosed bleeding more than spotting
- Fetal heart rate tracing prior to enrollment with no more than minimal variability, late decelerations, or more than two variable decelerations
- HIV infection
- Allergy to either latex or dinoprostone
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
About this study
Official title: Combined Use of the Controlled Release Dinoprostone Insert and Foley Catheter Compared to the Foley Catheter Alone for Cervical Ripening and Labor Induction in Term Women: A Randomized Controlled Trial
In term women presenting for labor induction, combined use of the controlled release dinoprostone vaginal insert and Foley catheter for cervical ripening will decrease the median time from induction to vaginal delivery by at least four hours compared to the Foley catheter alone.
Read the detailed description
Those who provide informed consent will be allocated by an online randomization system either to placement of a transcervical Foley catheter and an intravaginal dinoprostone controlled release insert or a Foley catheter alone. Randomization will be stratified by parity (nulliparous or parous).
In both study groups, the balloon on the end of the Foley catheter will be inflated with 30 mL of sterile water, pulled back against the internal os of the cervix, and taped to the maternal thigh under minimal tension. Also in both groups, the Foley catheter will be removed if any of the following occurs: 1) expulsion, 2) fetal heart rate tracing mandating evaluation for membrane rupture and placement of internal monitors, 3) spontaneous membrane rupture, or 4) if 12 hours has elapsed since placement. The dinoprostone insert will be removed if: 1) the fetal heart rate tracing mandates evaluation for membrane rupture and placement of internal monitors, 2) tachysystole develops (more than 5 contractions per 10 minutes averaged over 30 minutes, 3) spontaneous membrane rupture, or 4) 12 hours has elapsed since placement. Though these are the criteria for insert removal, in keeping with the pragmatic design of this trial, the decision regarding removal will be left to the discretion of the attending physician.
Women will remain recumbent for 30 minutes after agent placement and, except for trips to the restroom, will undergo continuous monitoring of uterine contractions and fetal heart rate. Oxytocin, according to standard intravenous protocol, will be allowed only after removal of cervical ripening agent(s). After specified cervical ripening, labor management will be at the discretion of the attending obstetrician, in keeping with the pragmatic nature of the study design.
Antibiotics will be administered if indicated for prophylaxis against early-onset neonatal infection with group B streptococci or for treatment of chorioamnionitis. Cesarean delivery will be performed, per the discretion of the attending obstetrician, for standard maternal or fetal indications.
Medical records will be reviewed no less than 30 days after delivery. Demographic, intrapartum, and outcome data will be entered into a computerized database.
- Conditions
- Cervical Ripening, Induction of Labor
- Being tested
- Cervidil 10 MG Vaginal Insert, Foley Catheter
- Keywords
- Cervical Ripening, Induction of Labor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cervidil 10 MG Vaginal InsertDrug
Also called Dinoprostone
Dinoprostone vaginal insert is a thin, flat, polymeric slab which is rectangular in shape with rounded corners contained within the pouch of an off-white knitted polyester retrieval system, an integral part of which is a long tape. Each slab is buff colored, semitransparent and contains 10 mg of dinoprostone in a hydrogel insert. An integral part of the knitted polyester retrieval system is a long tape designed to aid retrieval at the end of the dosing interval or earlier if clinically indicated. The finished product is a controlled release formulation which has been found to release dinoprostone in vivo at a rate of approximately 0.3 mg/hr.
Foley CatheterDevice
The balloon on the end of the Foley catheter will be inflated with 30 mL of sterile water, pulled back against the internal os of the cervix, and taped to the maternal thigh under minimal tension.
| Study group | Role | What they receive |
|---|---|---|
| Foley Catheter & Dinoprostone Insert | Other | transcervical Foley catheter and an intravaginal dinoprostone controlled release insert Receives: Drug: Cervidil 10 MG Vaginal Insert; Device: Foley Catheter |
| Foley Catheter Alone | Other | a Foley catheter alone Receives: Device: Foley Catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Median Times From Placement of Foley Catheter to Vaginal Delivery
median time estimation for use of dinoprostone and foley catheter and foley catheter alone
Measured: 48 hours
Secondary outcomes (1)
To Evaluate the Proportion of Patients That Delivered by 12 Hours and Proportion of Patients Delivered by 24 Hours
To evaluate the proportion of patients that delivered vaginally by 12 hours and proportion of patients delivered vaginally by 24 hours.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2017
- Study start9 Apr 2017
- Primary completion5 Jan 2018
- Study completion24 Jul 2020
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 Cervical RipeningStudies of the same condition, open and under way.
- More trials run by University of OklahomaThe 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
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Collaborators
- Ferring Pharmaceuticals
- Responsible party
- Sponsor
- Investigators
- Rodney K Edwards, MD, Principal investigator, The University of Oklahoma Health Sciences Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03111316
- Sponsor's protocol ID
- Ferring
- Status last verified
- Mar 2021
- First submitted
- 13 Mar 2017
- Last updated
- 24 Mar 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
de 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 36996264
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Use of the Controlled Release Dinoprostone Insert and Foley Catheter Compared to the Foley Catheter Alone for Cervical Ripening and Labor Induction in Term Women: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03111316
- Acronym / sponsor ID
- Ferring
- Conditions
- Cervical Ripening, Induction of Labor
- Keywords
- Cervical Ripening, Induction of Labor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Collaborators
- Ferring Pharmaceuticals
- Study start
- 9 Apr 2017 (actual)
- Primary completion
- 5 Jan 2018 (actual)
- Study completion
- 24 Jul 2020 (actual)
- First posted
- 12 Apr 2017 (actual)
- Results
- Posted 3 May 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In term women presenting for labor induction, combined use of the controlled release dinoprostone vaginal insert and Foley catheter for cervical ripening will decrease the median time from induction to vaginal delivery by at least four hours compared to the Foley catheter alone.
Detailed description
Those who provide informed consent will be allocated by an online randomization system either to placement of a transcervical Foley catheter and an intravaginal dinoprostone controlled release insert or a Foley catheter alone. Randomization will be stratified by parity (nulliparous or parous).
In both study groups, the balloon on the end of the Foley catheter will be inflated with 30 mL of sterile water, pulled back against the internal os of the cervix, and taped to the maternal thigh under minimal tension. Also in both groups, the Foley catheter will be removed if any of the following occurs: 1) expulsion, 2) fetal heart rate tracing mandating evaluation for membrane rupture and placement of internal monitors, 3) spontaneous membrane rupture, or 4) if 12 hours has elapsed since placement. The dinoprostone insert will be removed if: 1) the fetal heart rate tracing mandates evaluation for membrane rupture and placement of internal monitors, 2) tachysystole develops (more than 5 contractions per 10 minutes averaged over 30 minutes, 3) spontaneous membrane rupture, or 4) 12 hours has elapsed since placement. Though these are the criteria for insert removal, in keeping with the pragmatic design of this trial, the decision regarding removal will be left to the discretion of the attending physician.
Women will remain recumbent for 30 minutes after agent placement and, except for trips to the restroom, will undergo continuous monitoring of uterine contractions and fetal heart rate. Oxytocin, according to standard intravenous protocol, will be allowed only after removal of cervical ripening agent(s). After specified cervical ripening, labor management will be at the discretion of the attending obstetrician, in keeping with the pragmatic nature of the study design.
Antibiotics will be administered if indicated for prophylaxis against early-onset neonatal infection with group B streptococci or for treatment of chorioamnionitis. Cesarean delivery will be performed, per the discretion of the attending obstetrician, for standard maternal or fetal indications.
Medical records will be reviewed no less than 30 days after delivery. Demographic, intrapartum, and outcome data will be entered into a computerized database.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Foley Catheter & Dinoprostone Insert | Other | Drug: Cervidil 10 MG Vaginal Insert, Device: Foley Cathetertranscervical Foley catheter and an intravaginal dinoprostone controlled release insert |
| Foley Catheter Alone | Other | Device: Foley Cathetera Foley catheter alone |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Cervix ≤2 cm dilated; if 2 cm, <80% effaced
- Gestational age 37 weeks or more
- Singleton gestation
- Cephalic presentation
- Live fetus
Key exclusion criteria (10 listed)
- Contractions more frequent than every 5 minutes
- Premature rupture of membranes
- Prior uterine incision
- Temperature 38C or higher
- Fetal anomalies
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 |
|---|---|---|
| Cervidil 10 MG Vaginal InsertAlso: DinoprostoneDinoprostone vaginal insert is a thin, flat, polymeric slab which is rectangular in shape with rounded corners contained within the pouch of an off-white knitted polyester retrieval system, an integral part of which is a long tape. Each slab is buff colored, semitransparent and contains 10 mg of dinoprostone in a hydrogel insert. An integral part of the knitted polyester retrieval system is a long tape designed to aid retrieval at the end of the dosing interval or earlier if clinically indicated. The finished product is a controlled release formulation which has been found to release dinoprostone in vivo at a rate of approximately 0.3 mg/hr. | Drug | Foley Catheter & Dinoprostone Insert |
| Foley CatheterThe balloon on the end of the Foley catheter will be inflated with 30 mL of sterile water, pulled back against the internal os of the cervix, and taped to the maternal thigh under minimal tension. | Device | Foley Catheter & Dinoprostone Insert, Foley Catheter Alone |
Primary outcome
The Median Times From Placement of Foley Catheter to Vaginal Delivery
Time frame: 48 hours
median time estimation for use of dinoprostone and foley catheter and foley catheter alone
1 secondary outcome
To Evaluate the Proportion of Patients That Delivered by 12 Hours and Proportion of Patients Delivered by 24 Hours
Time frame: 24 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
- 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.
Rodney K Edwards, MD principal investigator
The University of Oklahoma Health Sciences Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cervidil 10 MG Vaginal Insert and Foley Catheter in people with Cervical Ripening and Induction of Labor, run by University of Oklahoma 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 10 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 24 Mar 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 May 2019). 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?
The Median Times From Placement of Foley Catheter to Vaginal Delivery (time frame: 48 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 NCT03111316, 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 24 Mar 2021.