Cervical RipeningPhase 3NCT03138252
Study of the Effectiveness of Cervical Ripening Balloon With and Without Oxytocin
A Phase 3 study testing Oxytocin in people with Cervical Ripening and Induction of Labor, run by University Hospitals Cleveland Medical Center at 1 site in United States.
Trial summary
Study Purpose: The purpose of this study is to determine the optimal method for induction of labor in multiparous women who present with an unfavorable cervix. Hypothesis: Our hypothesis is that using oxytocin while the cervical ripening balloon is in place will result in more rapid labor courses, without increasing… 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
- Cervical Ripening, Induction of Labor, Multiparity
- What is being tested?
- Oxytocin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2014to Jul 2017
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age > 18 years
- Gestational age > 34 + 0/7 weeks
- Prior spontaneous vaginal delivery
- Clinical or U/S EFW of <4500 grams
- Singleton gestation
- Cervical dilation <2 cm
Who cannot join
- Any contraindication to cervical ripening balloon, pitocin, or vaginal delivery
- Placenta within 2 cm of cervical os
- Placental abruption, chorioamninoitis, or systemic infection prior to induction
- Rupture of membranes prior to induction ->1 prior C/S
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Controlled Trial: Cervical Ripening Balloon With and Without Oxytocin for Cervical Ripening in Multiparas
Study Purpose: The purpose of this study is to determine the optimal method for induction of labor in multiparous women who present with an unfavorable cervix.
Hypothesis: Our hypothesis is that using oxytocin while the cervical ripening balloon is in place will result in more rapid labor courses, without increasing morbidity or increasing the need for operative delivery.
- Conditions
- Cervical Ripening, Induction of Labor, Multiparity
- Being tested
- Oxytocin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxytocinDrug
| Study group | Role | What they receive |
|---|---|---|
| Cervical Ripening Balloon Alone | Active comparator | Multiparous women will begin cervical ripening with a cervical ripening balloon alone. After the balloon is expelled or removed, induction of labor will proceed with pitocin per standard protocol at MacDonald Women's Hospital. Receives: Drug: Oxytocin |
| Cervical Ripening Balloon + Oxytocin | Active comparator | Multiparous women will begin cervical ripening with a cervical ripening balloon and simultaneous oxytocin. After the balloon is expelled or removed, induction of labor will proceed with pitocin per standard protocol at MacDonald Women's Hospital. Receives: Drug: Oxytocin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time From Cervical Ripening to Delivery
Time from placement of cervical ripening balloon to delivery
Measured: Time to delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2017
- Study startNov 2014
- Primary completionJul 2017
- Study completionJul 2017
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.
- Other trials for Cervical RipeningStudies of the same condition, open and under way.
- More trials run by University Hospitals Cleveland Medical CenterThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospitals Cleveland Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03138252
- Sponsor's protocol ID
- CRB + Oxytocin
- Status last verified
- May 2022
- First submitted
- 3 May 2014
- Last updated
- 4 May 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial: Cervical Ripening Balloon With and Without Oxytocin for Cervical Ripening in Multiparas
- ClinicalTrials.gov ID
- NCT03138252
- Acronym / sponsor ID
- CRB + Oxytocin
- Conditions
- Cervical Ripening, Induction of Labor, Multiparity
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- University Hospitals Cleveland Medical CenterUniversity, hospital or other
- Study start
- Nov 2014 (actual)
- Primary completion
- Jul 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 3 May 2017 (actual)
- Results
- Posted 4 May 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study Purpose: The purpose of this study is to determine the optimal method for induction of labor in multiparous women who present with an unfavorable cervix.
Hypothesis: Our hypothesis is that using oxytocin while the cervical ripening balloon is in place will result in more rapid labor courses, without increasing morbidity or increasing the need for operative delivery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cervical Ripening Balloon Alone | Active comparator | Drug: OxytocinMultiparous women will begin cervical ripening with a cervical ripening balloon alone. After the balloon is expelled or removed, induction of labor will proceed with pitocin per standard protocol at MacDonald Women's Hospital. |
| Cervical Ripening Balloon + Oxytocin | Active comparator | Drug: OxytocinMultiparous women will begin cervical ripening with a cervical ripening balloon and simultaneous oxytocin. After the balloon is expelled or removed, induction of labor will proceed with pitocin per standard protocol at MacDonald Women's Hospital. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age > 18 years
- Gestational age > 34 + 0/7 weeks
- Prior spontaneous vaginal delivery
- Clinical or U/S EFW of <4500 grams
- Singleton gestation
Key exclusion criteria (4 listed)
- Any contraindication to cervical ripening balloon, pitocin, or vaginal delivery
- Placenta within 2 cm of cervical os
- Placental abruption, chorioamninoitis, or systemic infection prior to induction
- Rupture of membranes prior to induction ->1 prior C/S
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 |
|---|---|---|
| Oxytocin | Drug | Cervical Ripening Balloon + Oxytocin, Cervical Ripening Balloon Alone |
Primary outcome
Time From Cervical Ripening to Delivery
Time frame: Time to delivery
Time from placement of cervical ripening balloon to delivery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Oxytocin in people with Cervical Ripening and Induction of Labor, run by University Hospitals Cleveland 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 6 inclusion and 4 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 4 May 2022. 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 4 May 2022). 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?
Time From Cervical Ripening to Delivery (time frame: Time to delivery). 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 4 May 2022.