Cervical Length MeasurementNCT02916082
Cervical Length Pre-induction as a Tool to Predict Vaginal Birth
An observational study of Cervical Length Measurement and Pregnancy, Prolonged, run by Saint Thomas Hospital, Panama at 1 site in Panama.
Trial summary
To evaluate the value of measuring cervical length as a predictor of vaginal birth after induction of labor with prostaglandins in pregnancies with 41 weeks of gestation. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Cervical Length Measurement, Pregnancy, Prolonged
- What is being tested?
- Cervical length measurement
- Type of treatment
- Surgery or procedure
- How many people
- 200 participants
- Where
- 1 sitePanama
- Study dates
- Nov 2015to Aug 2016
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Pregnancies with a gestational age of 41 weeks or more.
Who may be able to join
- 41 weeks or more of gestational age
- Cervical length measured by a FMF certified physician
Who cannot join
- Any condition that could interfere with a possible vaginal birth (previous cesarean section, hypertensive disorders of pregnancies).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Use of Cervical Length Previous to the Use of Prostaglandins as a Tool to Predict Vaginal Birth in Pregnancies With > 41 Weeks Gestation.
To evaluate the value of measuring cervical length as a predictor of vaginal birth after induction of labor with prostaglandins in pregnancies with 41 weeks of gestation.
- Conditions
- Cervical Length Measurement, Pregnancy, Prolonged
- Being tested
- Cervical length measurement
- Keywords
- Cervical length, Prolonged pregnancy, Vaginal birth
- Medical subject headings
- Pregnancy, Prolonged
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cervical length measurementProcedure or surgery
Vaginal ultrasound to measure cervical length previous to use of prostaglandins.
| Study group | Role | What they receive |
|---|---|---|
| Prolonged pregnancy | Pregnancies with 41 weeks or more of gestation determined by a reliable last menstrual period or early fetal ultrasound. Receives: Procedure: Cervical length measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vaginal Birth
Number of vaginal births obtained after a measure of cervical length below 2,5 cms.
Measured: 72 hours
Secondary outcomes (1)
Induction to delivery time
Time (hours) between the application of a prostaglandin and termination of pregnancy (vaginal or cesarean).
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2016 (estimated)
- Study startNov 2015
- Primary completionJun 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical Length MeasurementStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saint Thomas Hospital, Panama
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Osvaldo A. Reyes T., Saint Thomas Hospital, Panama
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02916082
- Sponsor's protocol ID
- 2015-288V2
- Status last verified
- Sep 2016
- First submitted
- 25 Sep 2016
- Last updated
- 27 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Cervical Length Previous to the Use of Prostaglandins as a Tool to Predict Vaginal Birth in Pregnancies With > 41 Weeks Gestation.
- ClinicalTrials.gov ID
- NCT02916082
- Acronym / sponsor ID
- 2015-288V2
- Conditions
- Cervical Length Measurement, Pregnancy, Prolonged
- Keywords
- Cervical length, Prolonged pregnancy, Vaginal birth
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Saint Thomas Hospital, PanamaUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- Jun 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 27 Sep 2016 (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.
To evaluate the value of measuring cervical length as a predictor of vaginal birth after induction of labor with prostaglandins in pregnancies with 41 weeks of gestation.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prolonged pregnancy | – | Procedure: Cervical length measurementPregnancies with 41 weeks or more of gestation determined by a reliable last menstrual period or early fetal ultrasound. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Pregnancies with a gestational age of 41 weeks or more.
Key inclusion criteria (2 listed)
- 41 weeks or more of gestational age
- Cervical length measured by a FMF certified physician
Key exclusion criteria (1 listed)
- Any condition that could interfere with a possible vaginal birth (previous cesarean section, hypertensive disorders of pregnancies).
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 measurementVaginal ultrasound to measure cervical length previous to use of prostaglandins. | Procedure or surgery | Prolonged pregnancy |
Primary outcome
Vaginal Birth
Time frame: 72 hours
Number of vaginal births obtained after a measure of cervical length below 2,5 cms.
1 secondary outcome
Induction to delivery time
Time frame: 72 hours
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 27 Sep 2016.
Related trials for Cervical Length Measurement
Recruiting
Optimal Timing of Routine Cervical Length Measurements During Anatomy Survey
Cervical Insufficiency, Preterm Birth
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Cervical Length Measurement and Pregnancy, Prolonged, run by Saint Thomas Hospital, Panama at 1 site in Panama.
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 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: finished, as of the sponsor's last update on 27 Sep 2016. 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 Panama. 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?
Vaginal Birth (time frame: 72 hours). 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 27 Sep 2016.