Cervix; Insufficient Dilatation in LaborNCT01615107
Premature Rupture of Mambrane and Unfavourable Cervix
A study testing COOK RIPENENIG BALLOON+PITOCN, PITOCIN and double balloonand oxytocin in people with Cervix; Insufficient Dilatation in Labor, run by Hillel Yaffe Medical Center at 1 site in Israel.
Trial summary
The paucity of published data concerning the issue of mechanical labor induction in the setting of Term PROM has led us to undertake the present clinical trial. This study is designed to compare the efficacy and safety of the standard Oxytocin induction protocol with the double-balloon catheter device with concurrent… Read more about this study
- Who is it for?
- Ages 16 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cervix; Insufficient Dilatation in Labor
- What is being tested?
- COOK RIPENENIG BALLOON+PITOCN, PITOCIN and double balloonand oxytocin
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteIsrael
- Study dates
- Jul 2012to Jul 2014
- 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 16 to 50 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Diagnosed to be pregnant with PROM at > 34 week
- Found to have a Bishop score of 4 points or less.
- Diagnosed as having a singleto
- 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 deliver
- Regular uterine contractn
- Evidence of chorio-amonitis
- Previous cesarean section or presence of any uterine scar.
- Suspected placental abruption or presence of a significant hemorrhage.
- Non-reassuring fetal statu
Trial locations and contacts
1 site in 1 country.
Elad Mei-Dan, Dr contact
Israel1 site
Hillel Yaffe Medical Center
Hadera, 38101
HILLEL YAFFE MEDICAL CENTER
ELAD MEI-DAN, M.D.
About this study
Official title: Comparison Between the Use of Standard Oxytocin Induction Protocol and the Double-balloon Catheter Device With Concurrent Oxytocin
The paucity of published data concerning the issue of mechanical labor induction in the setting of Term PROM has led us to undertake the present clinical trial. This study is designed to compare the efficacy and safety of the standard Oxytocin induction protocol with the double-balloon catheter device with concurrent oxytocin administration in patients with Term PROM and unfavorable cervical conditions.
Read the detailed description
This will be a prospective randomised trial. Two hundred pregnant women with term PROM and an unfavourable cervix (Bishop Score ≤ 4) are expected to be entered into the study (see statistical analysis below).
All eligible women will be presented with the study protocol by a study coordinator. Women interested in participating will read and sign the informed consent. Subsequently, the following screening medical procedures will be completed: medical and gynecological history, physical and vaginal examination, ultrasonography to: (i) Confirm fetal vertex presentation, (ii) Exclude placenta previa and (iii) Assess cervical length and posterior cervical angle. (iv) Asses bio-physical profile score
A non-stress test will be performed in order to monitor:
- The fetal heart pattern for the presence or absence of decelerations and
- The presence of uterine contractions. All women will undergo a pelvic examination by a staff member to obtain an initial Bishop score.
If the patient will be determined eligible for study entry, and following the informed consent, randomisation into the following groups will take place:
GROUP 1: Oxytocin infusion alone (Standard Protocol). GROUP 2: insertion of the double balloon device and concurrent oxytocin administration.
GROUP 3: Expectant management
- Conditions
- Cervix; Insufficient Dilatation in Labor
- Being tested
- COOK RIPENENIG BALLOON+PITOCN, PITOCIN, double balloonand oxytocin, ballon and oxytocin, double balloonand and oxytocin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COOK RIPENENIG BALLOON+PITOCNDevice
Also called BALLOON+PITOCN
GROUP 2: insertion of the double balloon device and concurrent oxytocin administration.
PITOCINDrug
Also called Oxytocin infusion alone
: Oxytocin infusion alone (Standard Protocol
double balloonand oxytocinOther
Also called balloonand oxytocin
balloonand oxytocin
ballon and oxytocinOther
Also called balloon catheter device with concurrent oxytocin
double- balloon catheter device with concurrent oxytocin
double balloonand and oxytocinProcedure or surgery
Also called balloon catheter device with concurrent oxytocin
balloon catheter device with concurrent oxytocin
| Study group | Role | What they receive |
|---|---|---|
| GROUP 1: Oxytocin infusion alone | Experimental | GROUP 1: Oxytocin infusion alone Receives: Drug: PITOCIN |
| double balloonand oxytocin | Experimental | insertion of the double balloon and oxytocin Receives: Device: COOK RIPENENIG BALLOON+PITOCN; Other: double balloonand oxytocin; Other: ballon and oxytocin; Procedure: double balloonand and oxytocin |
What is being measured
The primary outcome is the main question the study is designed to answer.
PPROM/PROM to delivery interval
Time from rupture of mambrane to delivery
From hospitalization until delivery
Measured: 3year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2012 (estimated)
- Study startJul 2012
- Primary completionJul 2014 (estimated)
- Study completionJul 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cervix; Insufficient Dilatation in 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 (estimated)
Sponsor and investigators
- Lead sponsor
- Hillel Yaffe Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Elad Mei-Dan, DR, Principal investigator, Hillel Yaffe Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01615107
- Sponsor's protocol ID
- 0013-12-HYMC
- Status last verified
- Apr 2012
- First submitted
- 23 Apr 2012
- Last updated
- 8 Jun 2012
- 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 36996264
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between the Use of Standard Oxytocin Induction Protocol and the Double-balloon Catheter Device With Concurrent Oxytocin
- ClinicalTrials.gov ID
- NCT01615107
- Acronym / sponsor ID
- 0013-12-HYMC
- Conditions
- Cervix; Insufficient Dilatation in Labor
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Hillel Yaffe Medical CenterOther government
- Study start
- Jul 2012
- Primary completion
- Jul 2014 (estimated)
- Study completion
- Jul 2014 (estimated)
- First posted
- 8 Jun 2012 (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.
The paucity of published data concerning the issue of mechanical labor induction in the setting of Term PROM has led us to undertake the present clinical trial. This study is designed to compare the efficacy and safety of the standard Oxytocin induction protocol with the double-balloon catheter device with concurrent oxytocin administration in patients with Term PROM and unfavorable cervical conditions.
Detailed description
This will be a prospective randomised trial. Two hundred pregnant women with term PROM and an unfavourable cervix (Bishop Score ≤ 4) are expected to be entered into the study (see statistical analysis below).
All eligible women will be presented with the study protocol by a study coordinator. Women interested in participating will read and sign the informed consent. Subsequently, the following screening medical procedures will be completed: medical and gynecological history, physical and vaginal examination, ultrasonography to: (i) Confirm fetal vertex presentation, (ii) Exclude placenta previa and (iii) Assess cervical length and posterior cervical angle. (iv) Asses bio-physical profile score
A non-stress test will be performed in order to monitor:
- The fetal heart pattern for the presence or absence of decelerations and
- The presence of uterine contractions. All women will undergo a pelvic examination by a staff member to obtain an initial Bishop score.
If the patient will be determined eligible for study entry, and following the informed consent, randomisation into the following groups will take place:
GROUP 1: Oxytocin infusion alone (Standard Protocol). GROUP 2: insertion of the double balloon device and concurrent oxytocin administration.
GROUP 3: Expectant management
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GROUP 1: Oxytocin infusion alone | Experimental | Drug: PITOCINGROUP 1: Oxytocin infusion alone |
| double balloonand oxytocin | Experimental | Device: COOK RIPENENIG BALLOON+PITOCN, Other: double balloonand oxytocin, Other: ballon and oxytocin, Procedure: double balloonand and oxytocininsertion of the double balloon and oxytocin |
Who may qualify
- Ages
- 16 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Diagnosed to be pregnant with PROM at > 34 week
- Found to have a Bishop score of 4 points or less.
- Diagnosed as having a singleto
- Willingness to comply with the protocol for the duration of the study.
- Have signed an informed consent.
Key exclusion criteria (6 listed)
- Any contraindication for a vaginal deliver
- Regular uterine contractn
- Evidence of chorio-amonitis
- Previous cesarean section or presence of any uterine scar.
- Suspected placental abruption or presence of a significant hemorrhage.
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 |
|---|---|---|
| COOK RIPENENIG BALLOON+PITOCNAlso: BALLOON+PITOCNGROUP 2: insertion of the double balloon device and concurrent oxytocin administration. | Device | double balloonand oxytocin |
| PITOCINAlso: Oxytocin infusion alone: Oxytocin infusion alone (Standard Protocol | Drug | GROUP 1: Oxytocin infusion alone |
| double balloonand oxytocinAlso: balloonand oxytocinballoonand oxytocin | Other | double balloonand oxytocin |
| ballon and oxytocinAlso: balloon catheter device with concurrent oxytocindouble- balloon catheter device with concurrent oxytocin | Other | double balloonand oxytocin |
| double balloonand and oxytocinAlso: balloon catheter device with concurrent oxytocinballoon catheter device with concurrent oxytocin | Procedure or surgery | double balloonand oxytocin |
Primary outcome
PPROM/PROM to delivery interval
Time frame: 3year
Time from rupture of mambrane to delivery From hospitalization until delivery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2012.
- 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.
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.
Elad Mei-Dan, Dr contact
Elad Mei-Dan, DR principal investigator
Hillel Yaffe Medical 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 COOK RIPENENIG BALLOON+PITOCN, PITOCIN and double balloonand oxytocin in people with Cervix; Insufficient Dilatation in 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 5 inclusion and 6 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 8 Jun 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Elad Mei-Dan, Dr (972-4-6188243), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PPROM/PROM to delivery interval (time frame: 3year). 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 NCT01615107, 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 8 Jun 2012.