Cervical RipeningPhase 3NCT00815542
Induction of Labor in Oligohydramnios
A Phase 3 study testing double balloon catheter and prostaglandins E2 in people with Cervical Ripening, run by Meir Medical Center at 1 site in Israel.
Trial summary
When oligohydramnion - decreased amniotic fluid, is diagnosed at term pregnancies, the common practice is to induce labor. Whenever the cervix is not ripened, there are several methods to ripen the cervix, two of which are: mechanical, using a double balloon catheter and pharmacological, with prostaglandins. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cervical Ripening
- What is being tested?
- double balloon catheter and prostaglandins E2
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- Jun 2012to Jun 2012
- Phase
- Phase 3
- 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 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- singleton pregnancy
- normal pregnancy, well dated, at term
- un ripened cervix
Who cannot join
- previous cesarean section
- multiple pregnancy
- intra uterine growth restricted fetus
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Induction of Labor in Oligohydramnios - A Comparison Between Two Modes of Cervical Ripening for Patients With Oligohydramnios at Term
When oligohydramnion - decreased amniotic fluid, is diagnosed at term pregnancies, the common practice is to induce labor. Whenever the cervix is not ripened, there are several methods to ripen the cervix, two of which are: mechanical, using a double balloon catheter and pharmacological, with prostaglandins. The aim of the study is to compare those two methods of cervical ripening for patients with significant oligohydramnion at term.
The study will be a prospective randomised trial.
- Conditions
- Cervical Ripening
- Being tested
- double balloon catheter, prostaglandins E2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
double balloon catheterDevice
cervical ripening using double balloon catheter
prostaglandins E2Drug
prostaglandins E2 - Intravaginal Propess for 24 hours
| Study group | Role | What they receive |
|---|---|---|
| double balloon catheter | Active comparator | Cervical ripening by double balloon catheter Receives: Device: double balloon catheter |
| prostaglandins E2 | Placebo comparator | cervical ripening using prostaglandins E2 Receives: Drug: prostaglandins E2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time from ripening to active labor and to delivery, rates of cesarean section, rates of nonreassuring fetal heart rate during induction of labor.
Measured: during induction of labor, delivery and early post partum
Secondary outcomes (1)
patients satisfaction
Measured: induction of labor, delivery and early postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2008 (estimated)
- Study startJun 2012
- Primary completionJun 2012 (estimated)
- Study completionJun 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical RipeningStudies 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meir Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tal Biron - Shental, MD, Principal investigator, Meir Medical Center, Kfar Saba, Israel, Affiliated to Tel Aviv University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00815542
- Sponsor's protocol ID
- 034-2011-MMC
- Status last verified
- Mar 2012
- First submitted
- 25 Dec 2008
- Last updated
- 23 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Induction of Labor in Oligohydramnios - A Comparison Between Two Modes of Cervical Ripening for Patients With Oligohydramnios at Term
- ClinicalTrials.gov ID
- NCT00815542
- Acronym / sponsor ID
- 034-2011-MMC
- Conditions
- Cervical Ripening
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Meir Medical CenterUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Jun 2012 (estimated)
- Study completion
- Jun 2012 (estimated)
- First posted
- 30 Dec 2008 (estimated)
- 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.
When oligohydramnion - decreased amniotic fluid, is diagnosed at term pregnancies, the common practice is to induce labor. Whenever the cervix is not ripened, there are several methods to ripen the cervix, two of which are: mechanical, using a double balloon catheter and pharmacological, with prostaglandins. The aim of the study is to compare those two methods of cervical ripening for patients with significant oligohydramnion at term.
The study will be a prospective randomised trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| double balloon catheter | Active comparator | Device: double balloon catheterCervical ripening by double balloon catheter |
| prostaglandins E2 | Placebo comparator | Drug: prostaglandins E2cervical ripening using prostaglandins E2 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- singleton pregnancy
- normal pregnancy, well dated, at term
- un ripened cervix
Key exclusion criteria (3 listed)
- previous cesarean section
- multiple pregnancy
- intra uterine growth restricted fetus
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 |
|---|---|---|
| double balloon cathetercervical ripening using double balloon catheter | Device | double balloon catheter |
| prostaglandins E2prostaglandins E2 - Intravaginal Propess for 24 hours | Drug | prostaglandins E2 |
Primary outcome
Time from ripening to active labor and to delivery, rates of cesarean section, rates of nonreassuring fetal heart rate during induction of labor.
Time frame: during induction of labor, delivery and early post partum
1 secondary outcome
patients satisfaction
Time frame: induction of labor, delivery and early postpartum
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2012.
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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.
Tal Biron - Shental, MD principal investigator
Meir Medical Center, Kfar Saba, Israel, Affiliated to Tel Aviv University
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 double balloon catheter and prostaglandins E2 in people with Cervical Ripening, run by Meir Medical Center at 1 site in Israel.
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 3 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: status not confirmed, as of the sponsor's last update on 23 Mar 2012. 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 Israel. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tal Biron - Shental, MD (972-577-482716, Biront@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time from ripening to active labor and to delivery, rates of cesarean section, rates of nonreassuring fetal heart rate during induction of labor. (time frame: during induction of labor, delivery and early post partum). 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 23 Mar 2012.