PregnancyNCT00342550
Cervical Volume by Three-Dimensional Ultrasound as a Predictor of Preterm Delivery
An observational study of Pregnancy and Preterm Birth, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 1 site in United States.
Trial summary
Preterm labor is a leading cause of perinatal morbidity and mortality. Several investigators have reported that ultrasound evaluation of the cervix can predict the risk of preterm delivery. Read more about this study
- Who is it for?
- Ages 15 years and older, women only
- Conditions the study is for
- Pregnancy, Preterm Birth, Cervical Length Measurement
- How many people
- 648 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Mar 1998to 1 May 2008
- 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 15 years and older
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Pregnant women attending Hutzel Women's clinic at Detroit Medical Center
Who may be able to join
- Singleton gestation;
- Estimated gestational age between 20 and 35 weeks gestation;
- 3 Intact membranes;
- 4. Signed informed consent for voluntary participation and serial endovaginal scans.
- Estimated gestational age between 16 and < 24 weeks gestation;
- Planned cerclage placement due to increased preterm labor risk (i.e., short cervix or dilated cervix);
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- Intact membranes;
- Signed informed consent for voluntary participation and serial endovaginal scans.
- Term gestation (greater than 37 weeks);
- Intact membranes;
- Cervical dilatation less than 2 cm;
- Signed informed consent for voluntary participation and serial endovaginal scans.
Who cannot join
- Absent fetal cardiac activity;
- Desire not to have vaginal ultrasound scans.
- Absent fetal cardiac activity;
- Desire not to have vaginal ultrasound scans.
- Absent fetal cardiac activity;
- Desire not to have vaginal ultrasound scans.
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- INCLUSION CRITERIA - PATIENTS UNDERGOING ELECTIVE INDUCTION OF LABOR:
- Term gestation (greater than 37 weeks);
- Intact membranes;
- Signed informed consent for voluntary participation and serial endovaginal scans.
- EXCLUSION CRITERIA - PATIENTS UNDERGOING ELECTIVE INDUCTION OF LABOR:
- Absent fetal cardiac activity;
- Desire not to have vaginal ultrasound scans.
Trial locations and contacts
1 site in 1 country.
About this study
Preterm labor is a leading cause of perinatal morbidity and mortality. Several investigators have reported that ultrasound evaluation of the cervix can predict the risk of preterm delivery. Three-dimensional ultrasound may provide additional information about how to best counsel parents about the chances of premature birth. This technology has the capability for accurate volume measurements of irregular structures that is superior to conventional ultrasound. Therefore, it is possible that three-dimensional ultrasound methods may better characterize cervical changes and the risk for preterm delivery.
Our protocol will attempt to identify prognostic indicators of adverse pregnancy outcome by three-dimensional ultrasound. A maximum of 680 pregnant women with the diagnosis of preterm labor will be prospectively studied to characterize cervical morphology and volume as predictors of preterm delivery risk. These results will be correlated with placental pathology and pregnancy outcome. We will also compare the performance of conventional two-dimensional endovaginal ultrasound with three-dimensional ultrasound findings. This information is expected to improve our understanding about the nature and timing of cervical volume changes in relation to pregnancy outcome.
Read the detailed description
Preterm labor is a leading cause of perinatal morbidity and mortality. Several investigators have reported that ultrasound evaluation of the cervix can predict the risk of preterm delivery. Three-dimensional ultrasound may provide additional information about how to best counsel parents about the chances of premature birth. This technology has the capability for accurate volume measurements of irregular structures that is superior to conventional ultrasound. Therefore, it is possible that three-dimensional ultrasound methods may better characterize cervical changes and the risk for preterm delivery.
Our protocol will attempt to identify prognostic indicators of adverse pregnancy outcome by three-dimensional ultrasound. A maximum of 680 pregnant women with the diagnosis of preterm labor will be prospectively studied to characterize cervical morphology and volume as predictors of preterm delivery risk. These results will be correlated with maternal and fetal biological markers, placental pathology and pregnancy outcome. We will also compare the performance of conventional two-dimensional endovaginal ultrasound with three-dimensional ultrasound findings. This information is expected to improve our understanding about the nature and timing of cervical volume changes in relation to pregnancy outcome.
- Conditions
- Pregnancy, Preterm Birth, Cervical Length Measurement
- Keywords
- Pregnancy, Preterm Birth, Pregnancy Complications, Natural History
- Medical subject headings
- Premature Birth, Pregnancy Complications
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 |
|---|---|---|
| Pregnant Women | Pregnant women aged 15 and older between 20 and 35 weeks with singleton gestation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Document cervical volume and funneling changes in women with preterm labor. Determine the relationship between cervical volume and funneling changes to the risk of preterm delivery.
Data analysis is ongoing
Measured: Ongoing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2006 (estimated)
- Study start11 Mar 1998
- Primary completion1 May 2008
- Study completion1 May 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PregnancyStudies 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
- 648 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Roberto Romero, M.D., Principal investigator, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00342550
- Sponsor's protocol ID
- 999998016
- Other IDs
- OH98-CH-N016
- Status last verified
- Feb 2023
- First submitted
- 19 Jun 2006
- Last updated
- 24 Feb 2023
- Results posted
- No
Publications
Ayers JW, DeGrood RM, Compton AA, Barclay M, Ansbacher R. Sonographic evaluation of cervical length in pregnancy: diagnosis and management of preterm cervical effacement in patients at risk for premature delivery. Obstet Gynecol. 1988 Jun;71(6 Pt 1):939-44.
PubMed 3285274
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cervical Volume by Three-Dimensional Ultrasound as a Predictor of Preterm Delivery
- ClinicalTrials.gov ID
- NCT00342550
- Acronym / sponsor ID
- 999998016
- Conditions
- Pregnancy, Preterm Birth, Cervical Length Measurement
- Keywords
- Pregnancy, Preterm Birth, Pregnancy Complications, Natural History
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 648 participants (actual)
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)US National Institutes of Health
- Study start
- 11 Mar 1998 (actual)
- Primary completion
- 1 May 2008 (actual)
- Study completion
- 1 May 2008 (actual)
- First posted
- 21 Jun 2006 (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.
Preterm labor is a leading cause of perinatal morbidity and mortality. Several investigators have reported that ultrasound evaluation of the cervix can predict the risk of preterm delivery. Three-dimensional ultrasound may provide additional information about how to best counsel parents about the chances of premature birth. This technology has the capability for accurate volume measurements of irregular structures that is superior to conventional ultrasound. Therefore, it is possible that three-dimensional ultrasound methods may better characterize cervical changes and the risk for preterm delivery.
Our protocol will attempt to identify prognostic indicators of adverse pregnancy outcome by three-dimensional ultrasound. A maximum of 680 pregnant women with the diagnosis of preterm labor will be prospectively studied to characterize cervical morphology and volume as predictors of preterm delivery risk. These results will be correlated with placental pathology and pregnancy outcome. We will also compare the performance of conventional two-dimensional endovaginal ultrasound with three-dimensional ultrasound findings. This information is expected to improve our understanding about the nature and timing of cervical volume changes in relation to pregnancy outcome.
Detailed description
Preterm labor is a leading cause of perinatal morbidity and mortality. Several investigators have reported that ultrasound evaluation of the cervix can predict the risk of preterm delivery. Three-dimensional ultrasound may provide additional information about how to best counsel parents about the chances of premature birth. This technology has the capability for accurate volume measurements of irregular structures that is superior to conventional ultrasound. Therefore, it is possible that three-dimensional ultrasound methods may better characterize cervical changes and the risk for preterm delivery.
Our protocol will attempt to identify prognostic indicators of adverse pregnancy outcome by three-dimensional ultrasound. A maximum of 680 pregnant women with the diagnosis of preterm labor will be prospectively studied to characterize cervical morphology and volume as predictors of preterm delivery risk. These results will be correlated with maternal and fetal biological markers, placental pathology and pregnancy outcome. We will also compare the performance of conventional two-dimensional endovaginal ultrasound with three-dimensional ultrasound findings. This information is expected to improve our understanding about the nature and timing of cervical volume changes in relation to pregnancy outcome.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pregnant Women | – | –Pregnant women aged 15 and older between 20 and 35 weeks with singleton gestation |
Who may qualify
- Ages
- 15 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Pregnant women attending Hutzel Women's clinic at Detroit Medical Center
Key inclusion criteria (12 listed)
- 3 Intact membranes;
- 4. Signed informed consent for voluntary participation and serial endovaginal scans.
- Estimated gestational age between 16 and < 24 weeks gestation;
- Planned cerclage placement due to increased preterm labor risk (i.e., short cervix or dilated cervix);
- Intact membranes;
Key exclusion criteria (13 listed)
- Absent fetal cardiac activity;
- Desire not to have vaginal ultrasound scans.
- Absent fetal cardiac activity;
- Desire not to have vaginal ultrasound scans.
- Absent fetal cardiac activity;
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
Document cervical volume and funneling changes in women with preterm labor. Determine the relationship between cervical volume and funneling changes to the risk of preterm delivery.
Time frame: Ongoing
Data analysis is ongoing
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 24 Feb 2023.
- Background: PubMed 3285274Ayers JW, DeGrood RM, Compton AA, Barclay M, Ansbacher R. Sonographic evaluation of cervical length in pregnancy: diagnosis and management of preterm cervical effacement in patients at risk for premature delivery. Obstet Gynecol. 1988 Jun;71(6 Pt 1):939-44.
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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.
Roberto Romero, M.D. principal investigator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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 Pregnancy and Preterm Birth, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) 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 12 inclusion and 13 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 24 Feb 2023. 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. 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?
Document cervical volume and funneling changes in women with preterm labor. Determine the relationship between cervical volume and funneling changes to the risk of preterm delivery. (time frame: Ongoing). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00342550, which also lists 1 linked publication.
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 24 Feb 2023.