Unfavorable Cervix for Induction of LaborNCT00604487
Induction of Labor in Patients With Unfavorable Cervical Conditions
A study testing ARD (Atad Ripener Device), AID (Atad double balloon Instillation Device) and folly catheter in people with Unfavorable Cervix for Induction of Labor, run by Hillel Yaffe Medical Center at 1 site in Israel.
Trial summary
Artificial ripening of the cervix and induction of labor remain as one of the therapeutic challenges in Obstetrics. The method widely used, the intravenous administration of Oxytocin, is associated with prolonged induction periods, a significant failure rate, and considerable patient discomfort. 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
- Unfavorable Cervix for Induction of Labor
- What is being tested?
- ARD (Atad Ripener Device), AID (Atad double balloon Instillation Device) and folly catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2008to Jan 2011
- Phase
- Interventional
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients 15 years of age or older.
- Diagnosed to be pregnant with an indication for induction of labor.
- Having a Bishop score of 4 points or less.
- Diagnosed as having a singleton pregnancy in a vertex presentation, with intact membranes, and no significant regular uterine contraction at gestational age of >28 weeks.
- Willingness to comply with the protocol for the duration of the study.
- Have signed an informed consent.
Who cannot join
- Any contraindication for a vaginal delivery (i.e. placenta previa, non vertex presentation).
- Ruptured membranes.
- Previous cesarean section or any uterine scar.
- Documented labor.
- Suspected fetal distress necessitating immediate intervention.
- Proven malignancy of the cervix.
- Active inflammatory or purulent condition of the lower genital tract.
Trial locations and contacts
1 site in 1 country.
About this study
Artificial ripening of the cervix and induction of labor remain as one of the therapeutic challenges in Obstetrics. The method widely used, the intravenous administration of Oxytocin, is associated with prolonged induction periods, a significant failure rate, and considerable patient discomfort. Therefore, over the years, a variety of locally applied pharmacological and physical ripening agents were evaluated. Currently, the commonly utilised local ripening agent is a Prostaglandin (PG) preparation. Although PG is being applied vaginally or extra-amniotically, systemic absorption of this agent is common, sometimes resulting in uterine hypertonicity, nausea and vomiting. In addition, both induction methods are associated with the initiation of uterine contractions, sometimes lasting for prolonged periods. Therefore a preferred induction method may be a mechanical one which will lead to cervical ripening without causing uterine contractions. Furthermore, there are additional potential advantages of mechanical methods compared to pharmacologic methods such as, ease of storage, low cost and less side effects. A folly catheter, inserted through the cervix, combined with continuous extra-amniotic NS instillation is being used for this purpose for many years. However this method although effective may cause uncomfortable traction of the balloon to the women's leg. Furthermore, dripping of saline through the cervix and vagina, occasionally occurs, may be annoying, and may be confused with rupture of membrane. We have recently introduced a newly developed balloon device (Atad Ripener Device), which was designed with one balloon located at the distal end of the device (the uterine balloon, U), while the other balloon is located 1.5 cm proximal to the first one (the cervicovaginal balloon, CV). Both balloons are expandable with Saline. The balloon inflated in the vagina provides the traction action and seals the cervix from saline leakage. Another balloon the AID (Atad double balloon Instillation Device) is identical to the ARD but has an additional long tip for instillation of normal to the extra-amniotic space. To the best of our knowledge, no comparison was performed between the use of the double balloon ripener device and folly catheter for induction of labor. Furthermore, there are no published data regarding the use of the double balloon instillation device (AID) combined with continuous extra-amniotic NS instillation. This study is designed to compare the efficacy, safety and side effects of mechanical methods of cervical ripening and labor induction by the double balloon device (ARD), the double balloon instillation device (AID) combined with continuous extra-amniotic instillation of normal saline and the folly catheter combined with continuous extra-amniotic normal saline instillation. The study aims at the accrual of 300 women (100 randomised in each arm).
- Being tested
- ARD (Atad Ripener Device), AID (Atad double balloon Instillation Device), folly catheter
- Keywords
- induction, cervix, balloon, Bishop
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ARD (Atad Ripener Device)Device
Atad double balloon ripener device
AID (Atad double balloon Instillation Device)Device
Double balloon instillation device and continuous extra-amniotic instillation of NS 50 Ml/hour
folly catheterDevice
folly catheter (40 ml NS in the balloon) and continuous extra-amniotic instillation of NS 50 Ml/hour
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Insertion of the Atad double balloon ripener device (100 ml NS in each balloon). Receives: Device: ARD (Atad Ripener Device) |
| 2 | Active comparator | Insertion of the double balloon instillation device (100 ml NS in each balloon) and continuous extra-amniotic instillation of NS 50 Ml/hour Receives: Device: AID (Atad double balloon Instillation Device) |
| 3 | Active comparator | Insertion of the folly catheter (40 ml NS in the balloon) and continuous extra-amniotic instillation of NS 50 Ml/hour Receives: Device: folly catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate and compare the efficacy of the Atad Ripening Device (ARD), of the double balloon instillation device (AID) with concomitant continuous extra-amniotic NS instillation - 50 Ml/hour and of the folly catheter combined with continuous extra-a
Measured: 2 years
Secondary outcomes (3)
To assess the safety of the induction methods.
Measured: 2 years
To assess the women's experience and satisfaction with the induction methods.
Measured: 2 years
To compare the different cervical scoring systems available for predicting a successful induction.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2008 (estimated)
- Study startJan 2008
- Primary completionJan 2011
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Unfavorable Cervix for Induction of LaborStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hillel Yaffe Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, elad mei-dan, Hillel Yaffe Medical Center
- Investigators
- Mordechai Hallak, M.D., Principal investigator, Department of Obstetrics & Gynecology, Hillel Yaffe Medical Center, Hadera
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00604487
- Sponsor's protocol ID
- inductionCTIL
- Other IDs
- no grant
- Status last verified
- Feb 2016
- First submitted
- 17 Jan 2008
- Last updated
- 22 Feb 2016
- Results posted
- No
- Data monitoring committee
- 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 36996264Anabusi S, Mei-Dan E, Hallak M, Walfisch A. Mechanical labor induction in the obese population: a secondary analysis of a prospective randomized trial. Arch Gynecol Obstet. 2016 Jan;293(1):75-80. doi: 10.1007/s00404-015-3765-3. Epub 2015 Jun 9.
PubMed 26054823Walfisch A, Mei-Dan E, Hallak M. Trans-cervical double balloon catheter with and without extra-amniotic saline infusion for cervical ripening: a prospective quasi-randomized trial. J Matern Fetal Neonatal Med. 2015 May;28(7):848-53. doi: 10.3109/14767058.2014.935328. Epub 2014 Jul 11.
PubMed 24939630Mei-Dan E, Walfisch A, Valencia C, Hallak M. Making cervical ripening EASI: a prospective controlled comparison of single versus double balloon catheters. J Matern Fetal Neonatal Med. 2014 Nov;27(17):1765-70. doi: 10.3109/14767058.2013.879704. Epub 2014 Feb 3.
PubMed 24397244
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Induction of Labor in Patients With Unfavorable Cervical Conditions
- ClinicalTrials.gov ID
- NCT00604487
- Acronym / sponsor ID
- inductionCTIL
- Keywords
- induction, cervix, balloon, Bishop
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Hillel Yaffe Medical CenterOther government
- Study start
- Jan 2008
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 30 Jan 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.
Artificial ripening of the cervix and induction of labor remain as one of the therapeutic challenges in Obstetrics. The method widely used, the intravenous administration of Oxytocin, is associated with prolonged induction periods, a significant failure rate, and considerable patient discomfort. Therefore, over the years, a variety of locally applied pharmacological and physical ripening agents were evaluated. Currently, the commonly utilised local ripening agent is a Prostaglandin (PG) preparation. Although PG is being applied vaginally or extra-amniotically, systemic absorption of this agent is common, sometimes resulting in uterine hypertonicity, nausea and vomiting. In addition, both induction methods are associated with the initiation of uterine contractions, sometimes lasting for prolonged periods. Therefore a preferred induction method may be a mechanical one which will lead to cervical ripening without causing uterine contractions. Furthermore, there are additional potential advantages of mechanical methods compared to pharmacologic methods such as, ease of storage, low cost and less side effects. A folly catheter, inserted through the cervix, combined with continuous extra-amniotic NS instillation is being used for this purpose for many years. However this method although effective may cause uncomfortable traction of the balloon to the women's leg. Furthermore, dripping of saline through the cervix and vagina, occasionally occurs, may be annoying, and may be confused with rupture of membrane. We have recently introduced a newly developed balloon device (Atad Ripener Device), which was designed with one balloon located at the distal end of the device (the uterine balloon, U), while the other balloon is located 1.5 cm proximal to the first one (the cervicovaginal balloon, CV). Both balloons are expandable with Saline. The balloon inflated in the vagina provides the traction action and seals the cervix from saline leakage. Another balloon the AID (Atad double balloon Instillation Device) is identical to the ARD but has an additional long tip for instillation of normal to the extra-amniotic space. To the best of our knowledge, no comparison was performed between the use of the double balloon ripener device and folly catheter for induction of labor. Furthermore, there are no published data regarding the use of the double balloon instillation device (AID) combined with continuous extra-amniotic NS instillation. This study is designed to compare the efficacy, safety and side effects of mechanical methods of cervical ripening and labor induction by the double balloon device (ARD), the double balloon instillation device (AID) combined with continuous extra-amniotic instillation of normal saline and the folly catheter combined with continuous extra-amniotic normal saline instillation. The study aims at the accrual of 300 women (100 randomised in each arm).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Device: ARD (Atad Ripener Device)Insertion of the Atad double balloon ripener device (100 ml NS in each balloon). |
| 2 | Active comparator | Device: AID (Atad double balloon Instillation Device)Insertion of the double balloon instillation device (100 ml NS in each balloon) and continuous extra-amniotic instillation of NS 50 Ml/hour |
| 3 | Active comparator | Device: folly catheterInsertion of the folly catheter (40 ml NS in the balloon) and continuous extra-amniotic instillation of NS 50 Ml/hour |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients 15 years of age or older.
- Diagnosed to be pregnant with an indication for induction of labor.
- Having a Bishop score of 4 points or less.
- Diagnosed as having a singleton pregnancy in a vertex presentation, with intact membranes, and no significant regular uterine contraction at gestational age of >28 weeks.
- Willingness to comply with the protocol for the duration of the study.
Key exclusion criteria (7 listed)
- Any contraindication for a vaginal delivery (i.e. placenta previa, non vertex presentation).
- Ruptured membranes.
- Previous cesarean section or any uterine scar.
- Documented labor.
- Suspected fetal distress necessitating immediate intervention.
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 |
|---|---|---|
| ARD (Atad Ripener Device)Atad double balloon ripener device | Device | 1 |
| AID (Atad double balloon Instillation Device)Double balloon instillation device and continuous extra-amniotic instillation of NS 50 Ml/hour | Device | 2 |
| folly catheterfolly catheter (40 ml NS in the balloon) and continuous extra-amniotic instillation of NS 50 Ml/hour | Device | 3 |
Primary outcome
To evaluate and compare the efficacy of the Atad Ripening Device (ARD), of the double balloon instillation device (AID) with concomitant continuous extra-amniotic NS instillation - 50 Ml/hour and of the folly catheter combined with continuous extra-a
Time frame: 2 years
3 secondary outcomes
To assess the safety of the induction methods.
Time frame: 2 years
To assess the women's experience and satisfaction with the induction methods.
Time frame: 2 years
To compare the different cervical scoring systems available for predicting a successful induction.
Time frame: 2 years
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 22 Feb 2016.
- 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.
- Derived from this study: PubMed 26054823Anabusi S, Mei-Dan E, Hallak M, Walfisch A. Mechanical labor induction in the obese population: a secondary analysis of a prospective randomized trial. Arch Gynecol Obstet. 2016 Jan;293(1):75-80. doi: 10.1007/s00404-015-3765-3. Epub 2015 Jun 9.
- Derived from this study: PubMed 24939630Walfisch A, Mei-Dan E, Hallak M. Trans-cervical double balloon catheter with and without extra-amniotic saline infusion for cervical ripening: a prospective quasi-randomized trial. J Matern Fetal Neonatal Med. 2015 May;28(7):848-53. doi: 10.3109/14767058.2014.935328. Epub 2014 Jul 11.
- Derived from this study: PubMed 24397244Mei-Dan E, Walfisch A, Valencia C, Hallak M. Making cervical ripening EASI: a prospective controlled comparison of single versus double balloon catheters. J Matern Fetal Neonatal Med. 2014 Nov;27(17):1765-70. doi: 10.3109/14767058.2013.879704. Epub 2014 Feb 3.
Related trials for Unfavorable Cervix for Induction of Labor
RecruitingPhase 3
Oxytocin vs Prostaglandins for Labor Induction of Women With an Unfavorable Cervix After 24h of Cervical Ripening
Cervical Ripening, Unfavorable Cervix
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.
Mordechai Hallak, M.D. principal investigator
Department of Obstetrics & Gynecology, Hillel Yaffe Medical Center, Hadera
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ARD (Atad Ripener Device), AID (Atad double balloon Instillation Device) and folly catheter in people with Unfavorable Cervix for Induction of Labor, run by Hillel Yaffe 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 6 inclusion and 7 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 22 Feb 2016. 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. 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?
To evaluate and compare the efficacy of the Atad Ripening Device (ARD), of the double balloon instillation device (AID) with concomitant continuous extra-amniotic NS instillation - 50 Ml/hour and of the folly catheter combined with continuous extra-a (time frame: 2 years). 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 NCT00604487, which also lists 4 linked publications.
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 22 Feb 2016.