Multiple PregnancyNCT00790504
Transperineal Ultrasound for the Female Pelvic Floor in Women With Multiple Gestation
An observational study of Multiple Pregnancy, run by Sheba Medical Center at 1 site in Israel.
Trial summary
This trial studies the effect of pregnancies of multiple gestations (i.e. twins, triplets etc.) on the female pelvic floor with regards to the pregnancy itself and labor and delivery mode, by using transperineal ultrasound. This will be compared with pregnancies with single fetuses. Read more about this study
- Who is it for?
- Ages 17 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Multiple Pregnancy
- How many people
- 0 participants
- Where
- 1 siteIsrael
- Study dates
- Nov 2008to Jan 2012
- Phase
- Observational
- 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 17 to 60 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Study population: Women with multiple gestations recruited from the prenatal care or high risk pregnancy units
Who may be able to join
- Women with multiple gestations
- Women with singleton gestation
- Able to understand the consent form
Who cannot join
- None specified
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Follow up of the Female Pelvic Floor in Multiple Gestation Using Transperineal Ultrasound
This trial studies the effect of pregnancies of multiple gestations (i.e. twins, triplets etc.) on the female pelvic floor with regards to the pregnancy itself and labor and delivery mode, by using transperineal ultrasound. This will be compared with pregnancies with single fetuses.
Read the detailed description
This trial studies the effect of pregnancies of multiple gestations (i.e. twins, triplets etc.) on the female pelvic floor with regards to the pregnancy itself and labor and delivery mode, by using transperineal ultrasound. This will be compared with pregnancies with single fetuses. See study protocol.
- Conditions
- Multiple Pregnancy
- Keywords
- Pelvic floor, Transperineal ultrasound, Multiple pregnancy, Singleton pregnancy, Female pelvic floor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 study group | Women with multiple gestations recruited from the prenatal care or high risk pregnancy units | |
| 2 control group | Women with singleton gestation recruited from the prenatal care or high risk pregnancy units |
What is being measured
The primary outcome is the main question the study is designed to answer.
Multiple gestation affects the pelvic floor more than singleton gestation
Measured: Until recruitment completion
Secondary outcomes (1)
The mode of delivery affects pelvic floor outcome
Measured: As above
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2008 (estimated)
- Study startNov 2008
- Primary completionJan 2012 (estimated)
- Study completionJan 2012
Why it stopped: Difficulty recruiting patient. Lack of research assistant.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Dr. Vered Eisenberg, Sheba Medical Center
- Investigators
- Vered H Eisenberg, MD MHA, Principal investigator, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00790504
- Sponsor's protocol ID
- SHEBA-08-5470-VE-CTIL
- Status last verified
- Apr 2017
- First submitted
- 11 Nov 2008
- Last updated
- 2 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Follow up of the Female Pelvic Floor in Multiple Gestation Using Transperineal Ultrasound
- ClinicalTrials.gov ID
- NCT00790504
- Acronym / sponsor ID
- SHEBA-08-5470-VE-CTIL
- Conditions
- Multiple Pregnancy
- Keywords
- Pelvic floor, Transperineal ultrasound, Multiple pregnancy, Singleton pregnancy, Female pelvic floor
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Difficulty recruiting patient. Lack of research assistant.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- Nov 2008
- Primary completion
- Jan 2012 (estimated)
- Study completion
- Jan 2012 (actual)
- First posted
- 13 Nov 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.
This trial studies the effect of pregnancies of multiple gestations (i.e. twins, triplets etc.) on the female pelvic floor with regards to the pregnancy itself and labor and delivery mode, by using transperineal ultrasound. This will be compared with pregnancies with single fetuses.
Detailed description
This trial studies the effect of pregnancies of multiple gestations (i.e. twins, triplets etc.) on the female pelvic floor with regards to the pregnancy itself and labor and delivery mode, by using transperineal ultrasound. This will be compared with pregnancies with single fetuses. See study protocol.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 study group | – | –Women with multiple gestations recruited from the prenatal care or high risk pregnancy units |
| 2 control group | – | –Women with singleton gestation recruited from the prenatal care or high risk pregnancy units |
Who may qualify
- Ages
- 17 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Women with multiple gestations recruited from the prenatal care or high risk pregnancy units
Key inclusion criteria (3 listed)
- Women with multiple gestations
- Women with singleton gestation
- Able to understand the consent form
Key exclusion criteria (1 listed)
- None specified
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Multiple gestation affects the pelvic floor more than singleton gestation
Time frame: Until recruitment completion
1 secondary outcome
The mode of delivery affects pelvic floor outcome
Time frame: As above
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2017.
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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.
Vered H Eisenberg, MD MHA 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?
An observational study of Multiple Pregnancy, 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 3 inclusion and 1 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: withdrawn, as of the sponsor's last update on 2 May 2017. 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 was withdrawn before enrolling participants, so there are no results.
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?
Multiple gestation affects the pelvic floor more than singleton gestation (time frame: Until recruitment completion). 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 2 May 2017.