Labor, PrematurePhase 4NCT00432250
The Use of Cervical Length to Reduce Hospital Stay in Women Admitted Because of Preterm Labor.
A Phase 4 study testing Cervical length ultrasound in people with Labor, Premature and Cervical Length, run by Hospital Clinic of Barcelona at 1 site in Spain.
Trial summary
The objective of this study was to investigate the effect of the use of sonographic cervical length (CL) on the hospital stay in women admitted because of preterm labor. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Labor, Premature, Cervical Length
- What is being tested?
- Cervical length ultrasound
- Type of treatment
- Surgery or procedure
- How many people
- 150 participants
- Where
- 1 siteSpain
- Study dates
- Jan 2002to Apr 2005
- Phase
- Phase 4
- 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
- Adult, Older adult
Who may be able to join
- Admitted because of preterm labor
- Not delivered after 24-48 h of admission
- Single pregnancy
- Intact membranes
- Gestational age between 24.0 and less tahn 36.0 weeks
- Bishop score < 6
Who cannot join
- Fetal death or malformation
- Signs of chorioamnionitis
- Non-reassuring fetal test
Trial locations and contacts
1 site in 1 country.
About this study
The objective of this study was to investigate the effect of the use of sonographic cervical length (CL) on the hospital stay in women admitted because of preterm labor.
Read the detailed description
Eligible women who agreed to participate in the study were randomized by means of a central randomization office into two groups:
CONTROL group: cervical length was measured but the result was blinded to the physician in charge and women was managed according to the standard protocol.
STUDY group: cervical length was measured and the result was reported to the physician in charge. If cervical length was of 25 mm or more, discharge in 12-24 h was recommended. If cervical length was less than 25 mm, decision on discharge was made following clinical criteria.
- Conditions
- Labor, Premature, Cervical Length
- Being tested
- Cervical length ultrasound
- Keywords
- Preterm labor, Cervical ultrasonography, Hospital stay
- Medical subject headings
- Obstetric Labor, Premature
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cervical length ultrasoundProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of hospital stay
Gestational age at delivery
Secondary outcomes (4)
Rate of hospital stay below 3 days
Interval admission-to-delivery < 7 days
Rate of preterm delivery before 37 weeks
Rate of preterm delivery before 34 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2007 (estimated)
- Study startJan 2002
- Study completionApr 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Labor, PrematureStudies of the same condition, open and under way.
- More trials run by Hospital Clinic of BarcelonaThe 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 4
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 150 participants
Sponsor and investigators
- Lead sponsor
- Hospital Clinic of Barcelona
- Sponsor type
- University, hospital or other
- Investigators
- Montse Palacio, Principal investigator, Hospital Clinic of BarcelonaVicenç Cararach, Principal investigator, Hospital Clínic of Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00432250
- Sponsor's protocol ID
- CLHSPTL
- Status last verified
- Feb 2007
- First submitted
- 6 Feb 2007
- Last updated
- 7 Feb 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Cervical Length to Reduce Hospital Stay in Women Admitted Because of Preterm Labor.
- ClinicalTrials.gov ID
- NCT00432250
- Acronym / sponsor ID
- CLHSPTL
- Conditions
- Labor, Premature, Cervical Length
- Keywords
- Preterm labor, Cervical ultrasonography, Hospital stay
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants
- Lead sponsor
- Hospital Clinic of BarcelonaUniversity, hospital or other
- Study start
- Jan 2002
- Study completion
- Apr 2005
- First posted
- 7 Feb 2007 (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 objective of this study was to investigate the effect of the use of sonographic cervical length (CL) on the hospital stay in women admitted because of preterm labor.
Detailed description
Eligible women who agreed to participate in the study were randomized by means of a central randomization office into two groups:
CONTROL group: cervical length was measured but the result was blinded to the physician in charge and women was managed according to the standard protocol.
STUDY group: cervical length was measured and the result was reported to the physician in charge. If cervical length was of 25 mm or more, discharge in 12-24 h was recommended. If cervical length was less than 25 mm, decision on discharge was made following clinical criteria.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Admitted because of preterm labor
- Not delivered after 24-48 h of admission
- Single pregnancy
- Intact membranes
- Gestational age between 24.0 and less tahn 36.0 weeks
Key exclusion criteria (3 listed)
- Fetal death or malformation
- Signs of chorioamnionitis
- Non-reassuring fetal test
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 |
|---|---|---|
| Cervical length ultrasound | Procedure or surgery | – |
Primary outcome
Length of hospital stay
Gestational age at delivery
4 secondary outcomes
Rate of hospital stay below 3 days
Interval admission-to-delivery < 7 days
Rate of preterm delivery before 37 weeks
Rate of preterm delivery before 34 weeks
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 7 Feb 2007.
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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.
Montse Palacio principal investigator
Hospital Clinic of Barcelona
Vicenç Cararach principal investigator
Hospital Clínic of Barcelona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Cervical length ultrasound in people with Labor, Premature and Cervical Length, run by Hospital Clinic of Barcelona at 1 site in Spain.
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 3 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 7 Feb 2007. 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 Spain. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 hospital stay. The study lists 2 primary outcomes in all. 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 7 Feb 2007.