Preterm LaborNCT01431885
Two Methods of Diagnosing Preterm Labor
A study testing Diagnosis by cervical length and fibronectin and Cervical change in people with Preterm Labor and Preterm Delivery, run by University of California, San Francisco at 1 site in United States.
Trial summary
Use of modern diagnostic tools e.g. fetal fibronectin and ultrasound measurement of cervical length to diagnose preterm labor can result in improved outcomes compared to traditional diagnosis based on digital examination to measure cervical change. Read more about this study
- Who is it for?
- Ages 16 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Preterm Labor, Preterm Delivery
- What is being tested?
- Diagnosis by cervical length and fibronectin and Cervical change
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 82 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2011to 13 Feb 2015
- 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 years and older
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- symptomatic complaints suggestive of preterm labor
- greater than 6 contractions per hour
Who cannot join
- multiple gestation
- rupture of amniotic membranes
- chorioamnionitis
- congenital malformations
- persistent vaginal bleeding
- abruptio placentae
Show all 12Show fewer
- placenta previa
- previously diagnosed short cervix < 2.5 cm
- cervical dilation > 3 cm
- cervical cerclage
- exposure to tocolytic drugs
- allergy or contraindication to nifedipine
Trial locations and contacts
1 site in 1 country.
United States1 site
Community Regional Medical Center
Fresno, California, 93701
About this study
Official title: Randomized Controlled Trial of Two Methods of Diagnosing Preterm Labor
Use of modern diagnostic tools e.g. fetal fibronectin and ultrasound measurement of cervical length to diagnose preterm labor can result in improved outcomes compared to traditional diagnosis based on digital examination to measure cervical change.
Read the detailed description
Symptomatic preterm labor patients will be randomized to diagnosis of preterm labor by serial digital examination versus an algorithm incorporating transvaginal ultrasound measurement of cervical length and vaginal fetal fibronectin.
- Conditions
- Preterm Labor, Preterm Delivery
- Being tested
- Diagnosis by cervical length and fibronectin, Cervical change
- Keywords
- fibronectin, cervical length
- Medical subject headings
- Obstetric Labor, Premature, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diagnosis by cervical length and fibronectinProcedure or surgery
Also called March of Dimes Preterm Labor Assessment Toolkit Algorithm B
Diagnosis will be made by MOD Algorithm B
Cervical changeProcedure or surgery
Also called None applicable
Diagnosis will be made by digital examination of cervical change
| Study group | Role | What they receive |
|---|---|---|
| PLAT | Active comparator | Diagnosis of preterm labor will be made by the March of Dimes Preterm Labor Assessment Toolkit Algorithm B, incorporating transvaginal ultrasound measurement of cervical length, and vaginal fetal fibronectin Receives: Procedure: Diagnosis by cervical length and fibronectin |
| Cervical Change | Placebo comparator | Diagnosis of preterm labor will be made by cervical change by digital examination Receives: Procedure: Cervical change |
What is being measured
The primary outcome is the main question the study is designed to answer.
Delivery prior to 37 weeks' gestation
Delivery of the baby prior to 37 weeks' gestation by any means and for any reason including spontaneous or indicated delivery for maternal or fetal complications
Measured: No longer than 18 weeks post randomization (at which time a pregnancy randomized at the earliest possible gestational age would be 42 weeks, generally the contemporary upper limit of the duration of pregnancy)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2011 (estimated)
- Study startAug 2011
- Primary completion13 Feb 2015
- Study completion13 Feb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preterm LaborStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Conrad R Chao, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01431885
- Sponsor's protocol ID
- 2010010
- Status last verified
- Jan 2020
- First submitted
- 24 Aug 2011
- Last updated
- 18 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of Two Methods of Diagnosing Preterm Labor
- ClinicalTrials.gov ID
- NCT01431885
- Acronym / sponsor ID
- 2010010
- Conditions
- Preterm Labor, Preterm Delivery
- Keywords
- fibronectin, cervical length
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- 13 Feb 2015 (actual)
- Study completion
- 13 Feb 2015 (actual)
- First posted
- 12 Sep 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.
Use of modern diagnostic tools e.g. fetal fibronectin and ultrasound measurement of cervical length to diagnose preterm labor can result in improved outcomes compared to traditional diagnosis based on digital examination to measure cervical change.
Detailed description
Symptomatic preterm labor patients will be randomized to diagnosis of preterm labor by serial digital examination versus an algorithm incorporating transvaginal ultrasound measurement of cervical length and vaginal fetal fibronectin.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PLAT | Active comparator | Procedure: Diagnosis by cervical length and fibronectinDiagnosis of preterm labor will be made by the March of Dimes Preterm Labor Assessment Toolkit Algorithm B, incorporating transvaginal ultrasound measurement of cervical length, and vaginal fetal fibronectin |
| Cervical Change | Placebo comparator | Procedure: Cervical changeDiagnosis of preterm labor will be made by cervical change by digital examination |
Who may qualify
- Ages
- 16 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- symptomatic complaints suggestive of preterm labor
- greater than 6 contractions per hour
Key exclusion criteria (12 listed)
- multiple gestation
- rupture of amniotic membranes
- chorioamnionitis
- congenital malformations
- persistent vaginal bleeding
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 |
|---|---|---|
| Diagnosis by cervical length and fibronectinAlso: March of Dimes Preterm Labor Assessment Toolkit Algorithm BDiagnosis will be made by MOD Algorithm B | Procedure or surgery | PLAT |
| Cervical changeAlso: None applicableDiagnosis will be made by digital examination of cervical change | Procedure or surgery | Cervical Change |
Primary outcome
Delivery prior to 37 weeks' gestation
Time frame: No longer than 18 weeks post randomization (at which time a pregnancy randomized at the earliest possible gestational age would be 42 weeks, generally the contemporary upper limit of the duration of pregnancy)
Delivery of the baby prior to 37 weeks' gestation by any means and for any reason including spontaneous or indicated delivery for maternal or fetal complications
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 18 Jan 2020.
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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.
Conrad R Chao, MD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diagnosis by cervical length and fibronectin and Cervical change in people with Preterm Labor and Preterm Delivery, run by University of California, San Francisco at 1 site in United States.
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 12 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 18 Jan 2020. 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 United States. 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. Some participants in this study may receive a placebo. 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?
Delivery prior to 37 weeks' gestation (time frame: No longer than 18 weeks post randomization (at which time a pregnancy randomized at the earliest possible gestational age would be 42 weeks, generally the contemporary upper limit of the duration of pregnancy)). 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 18 Jan 2020.