Preterm BirthNCT01340352
Is It Possible to Predict Pre Term Labor by Measuring Cervical Length in the Non-pregnant Uterus?
An observational study of Preterm Birth, run by HaEmek Medical Center, Israel at 1 site in Israel.
Trial summary
Working hypothesis and aims: To investigate the association between cervical length in non-pregnant women, and the risk of premature birth. The participants will be recruited from the HaEmek Medical Center delivery room registration. Women delivered between 24-37 pregnancy weeks will be allocated to the study group. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Preterm Birth
- How many people
- 62 participants
- Where
- 1 siteIsrael
- Study dates
- May 2011to Jan 2015
- 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 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Study population: HaEmek Medical Center delivery room.
Who may be able to join
- Nonpregnant women aged 18-40 years.
- Singelton last pregnancy.
- Last birth, spontaneous premature (24-37 week)
- Last birth at least 3 months ago.
Who cannot join
- Presence of uterine malformations.
- Sonographic pathologic findings.
- Technical failure (failed appropiate sonographic visualisation)
- Presence of fetal malformations ( in preterm delivery )
- Presence of comorbidities including diabetes, hypertension, collagen disease, thrombophilia
- Presence of risk factors for premature delivery (amniotic fluid infection,
- cervical surgical treatments - conization, polyhydramnios, etc.).
Trial locations and contacts
1 site in 1 country.
About this study
Working hypothesis and aims:
To investigate the association between cervical length in non-pregnant women, and the risk of premature birth.
The participants will be recruited from the HaEmek Medical Center delivery room registration. Women delivered between 24-37 pregnancy weeks will be allocated to the study group. The investigators will invite them 3 month or more after delivery to ultrasound examination of the cervical length. The participants in the control group will be the women whom term delivery follows by chronological manner to those in study group. Data of the cervucal length will be collected at the time of the examination.
Read the detailed description
Women will be invited to undergo an examination in Ultrasound Unit of Department of Obstetrics and Gynecology, HaEmek Medical Center.
Ultrasound examination will be performed using the Voluson E8 device, General Electric.
The cervical length,between the external and internal orifice will be measured using conventional technologies available including: Doppler, three dimensional and two dimensional ultrasound.
- Conditions
- Preterm Birth
- Medical subject headings
- Premature Birth
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 |
|---|---|---|
| study group: previous preterm labor | Not described | |
| control group:previous term delivery | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
length of the cervix in mm.
External orifice location is well-defined anatomically and easy for identification .Internal orifice location will be determined by the level of the uterine arteries at both sides of the cervix.
Measured: up to 20 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2011 (estimated)
- Study startMay 2011
- Primary completionMay 2012
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preterm BirthStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- HaEmek Medical Center, Israel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Etty Spiegel, HaEmek Medical Center, Israel
- Investigators
- Etty Daniel-Spiegel, MD, Principal investigator, haemek medical center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01340352
- Sponsor's protocol ID
- 0137-10-EMC
- Status last verified
- Jun 2015
- First submitted
- 20 Apr 2011
- Last updated
- 16 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is It Possible to Predict Pre Term Labor by Measuring Cervical Length in the Non-pregnant Uterus?
- ClinicalTrials.gov ID
- NCT01340352
- Acronym / sponsor ID
- 0137-10-EMC
- Conditions
- Preterm Birth
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- HaEmek Medical Center, IsraelUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- May 2012 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 22 Apr 2011 (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.
Working hypothesis and aims:
To investigate the association between cervical length in non-pregnant women, and the risk of premature birth.
The participants will be recruited from the HaEmek Medical Center delivery room registration. Women delivered between 24-37 pregnancy weeks will be allocated to the study group. The investigators will invite them 3 month or more after delivery to ultrasound examination of the cervical length. The participants in the control group will be the women whom term delivery follows by chronological manner to those in study group. Data of the cervucal length will be collected at the time of the examination.
Detailed description
Women will be invited to undergo an examination in Ultrasound Unit of Department of Obstetrics and Gynecology, HaEmek Medical Center.
Ultrasound examination will be performed using the Voluson E8 device, General Electric.
The cervical length,between the external and internal orifice will be measured using conventional technologies available including: Doppler, three dimensional and two dimensional ultrasound.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| study group: previous preterm labor | – | – |
| control group:previous term delivery | – | – |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- HaEmek Medical Center delivery room.
Key inclusion criteria (4 listed)
- Nonpregnant women aged 18-40 years.
- Singelton last pregnancy.
- Last birth, spontaneous premature (24-37 week)
- Last birth at least 3 months ago.
Key exclusion criteria (7 listed)
- Presence of uterine malformations.
- Sonographic pathologic findings.
- Technical failure (failed appropiate sonographic visualisation)
- Presence of fetal malformations ( in preterm delivery )
- Presence of comorbidities including diabetes, hypertension, collagen disease, thrombophilia
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
length of the cervix in mm.
Time frame: up to 20 month
External orifice location is well-defined anatomically and easy for identification .Internal orifice location will be determined by the level of the uterine arteries at both sides of the cervix.
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 16 Jun 2015.
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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.
Etty Daniel-Spiegel, MD principal investigator
haemek 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 Preterm Birth, run by HaEmek Medical Center, Israel 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 4 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 16 Jun 2015. 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?
length of the cervix in mm. (time frame: up to 20 month). 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 16 Jun 2015.