PregnancyNCT00684606
Transcervical Foley Catheter With or Without Oxytocin for Induction of Labor
A study testing Oxytocin IV in people with Pregnancy and Induction of Labor, run by Sheba Medical Center at 1 site in Israel.
Trial summary
The purpose of the present study is to evaluate the possible benefit of concurrent IV Oxytocin infusion with trans cervical Foley catheter for pre-induction cervical ripening. Read more about this study
- Who is it for?
- Ages 15 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy, Induction of Labor
- What is being tested?
- Oxytocin IV
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteIsrael
- Study dates
- May 2008to May 2010
- 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 15 to 50 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Term pregnancy
- Medical indication for labor induction by transcervical Foley catheter
Who cannot join
- Preterm pregnancy
- Contraindication for induction of labor by transcervical Foley catheter or by IV Oxytocin:
- Uterine scar
- Multiple pregnancy
- PROM
- Grand-multiparity
Show all 10Show fewer
- Placenta previa or marginal placenta
- Spontaneous uterine contractions (more than 3 in 10 minutes)
- Vaginal bleeding
- Nonreassuring fetal heart rate
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Sheba medical center
Ramat Gan
Orit Moran, MD, 972-3-5302777, orit.moran@sheba.health.gov.il
Orit Moran, MD
About this study
Official title: Transcervical Foley Catheter With or Without IV Oxytocin Infusion for Induction of Labor: a Randomized Controlled Trial
The purpose of the present study is to evaluate the possible benefit of concurrent IV Oxytocin infusion with trans cervical Foley catheter for pre-induction cervical ripening.
Read the detailed description
Induction of labor in term pregnancy may be challenging, especially in patients with unfavorable cervical conditions. Numerous trails have presented evidence of the efficacy of the trans cervical Foley catheter for pre-induction cervical ripening.The purpose of the present study is to evaluate the possible benefit of concurrent IV Oxytocin infusion with trans cervical Foley catheter for pre-induction cervical ripening.
- Conditions
- Pregnancy, Induction of Labor
- Being tested
- Oxytocin IV
- Keywords
- Induction of Labor, Low Bishop Score, Transcervical Foley Catheter., IV Oxytocin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxytocin IVDrug
Also called Pitocin
5 miu/1000ml Glu/Saline
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Transcervical Foley catheter with IV Oxytocin Receives: Drug: Oxytocin IV |
| 2 | No intervention | Transcervical Foley catheter only |
What is being measured
The primary outcome is the main question the study is designed to answer.
The period of time needed for ripening the uterine cervix by Transcervical Foley catheter with or without IV Oxytocin infusion.
Measured: year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2008 (estimated)
- Study startMay 2008
- Primary completionMay 2010 (estimated)
- Study completionMay 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies of the same condition, open and under way.
- More trials run by Sheba 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Investigators
- Orit Moran, M.D., Principal investigator, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00684606
- Sponsor's protocol ID
- SHEBA-08-5164-OM-CTIL
- Status last verified
- Jun 2008
- First submitted
- 22 May 2008
- Last updated
- 19 Jun 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcervical Foley Catheter With or Without IV Oxytocin Infusion for Induction of Labor: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT00684606
- Acronym / sponsor ID
- SHEBA-08-5164-OM-CTIL
- Conditions
- Pregnancy, Induction of Labor
- Keywords
- Induction of Labor, Low Bishop Score, Transcervical Foley Catheter., IV Oxytocin
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- May 2008
- Primary completion
- May 2010 (estimated)
- Study completion
- May 2010 (estimated)
- First posted
- 26 May 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.
The purpose of the present study is to evaluate the possible benefit of concurrent IV Oxytocin infusion with trans cervical Foley catheter for pre-induction cervical ripening.
Detailed description
Induction of labor in term pregnancy may be challenging, especially in patients with unfavorable cervical conditions. Numerous trails have presented evidence of the efficacy of the trans cervical Foley catheter for pre-induction cervical ripening.The purpose of the present study is to evaluate the possible benefit of concurrent IV Oxytocin infusion with trans cervical Foley catheter for pre-induction cervical ripening.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Oxytocin IVTranscervical Foley catheter with IV Oxytocin |
| 2 | No intervention | –Transcervical Foley catheter only |
Who may qualify
- Ages
- 15 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Term pregnancy
- Medical indication for labor induction by transcervical Foley catheter
Key exclusion criteria (10 listed)
- Preterm pregnancy
- Contraindication for induction of labor by transcervical Foley catheter or by IV Oxytocin:
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 IVAlso: Pitocin5 miu/1000ml Glu/Saline | Drug | 1 |
Primary outcome
The period of time needed for ripening the uterine cervix by Transcervical Foley catheter with or without IV Oxytocin infusion.
Time frame: year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2008.
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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.
Orit Moran, M.D. principal investigator
Sheba 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 Oxytocin IV in people with Pregnancy and Induction of Labor, run by Sheba 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 2 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: status not confirmed, as of the sponsor's last update on 19 Jun 2008. 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 Orit Moran, MD (972-3-5302777, orit.moran@sheba.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The period of time needed for ripening the uterine cervix by Transcervical Foley catheter with or without IV Oxytocin infusion. (time frame: year). 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 19 Jun 2008.