Pregnancy LossNCT04013035
Cervical Length on Pregnancy Termination
An observational study of Pregnancy Loss, run by Kanuni Sultan Suleyman Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Cervical length is used as a parameter to predict cervical insufficiency and onset of labor. However, its role in predicting abortion induction is unclear.To investigate the impact of cervical length measurement and fetal viability on second trimester pregnancy termination duration in nulliparous pregnant women. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Pregnancy Loss
- What is being tested?
- cervical length measurement
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2016to 1 Jun 2017
- 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 50 years
- Women only
- No healthy volunteers
- Adult
Study population: Nulliparous pregnant women at 13-26 weeks of gestation will be included in the study.
Who may be able to join
- -Nulliparous pregnant women at 13-26 weeks of gestation
Who cannot join
- Patients with multiple gestations,
- multiparous patients or
- patients that had uterine gynecologic surgery
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kanuni Sultan Süleyman Training and Research Hospital
Istanbul, 33404
About this study
Official title: The Impact of Fetal Viability and Cervical Length on Pregnancy Termination Outcomes in Nulliparous Second Trimester Pregnancies
Cervical length is used as a parameter to predict cervical insufficiency and onset of labor. However, its role in predicting abortion induction is unclear.To investigate the impact of cervical length measurement and fetal viability on second trimester pregnancy termination duration in nulliparous pregnant women.
Read the detailed description
Cervical length and fetal viability were evaluated prior to second trimester pregnancy termination due to various indications. nulliparous pregnant women through 13 and 26 gestational weeks in whom pregnancy termination was conducted within 72 hours after admission were included in the study. The subjects were grouped into two groups according to fetal viability.
- Conditions
- Pregnancy Loss
- Being tested
- cervical length measurement
- Keywords
- Cervix, Length, Viability, prostaglandin, Termination
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cervical length measurementProcedure or surgery
cervical length measurement at second trimester pregnancy termination in nulliparous pregnant women.
What is being measured
The primary outcome is the main question the study is designed to answer.
cervical length measurement
cervical length measurement at second trimester pregnancy termination in nulliparous pregnant women. The measurements will be saved as a number in cm.
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2019
- Study start1 Jan 2016
- Primary completion1 Jun 2017
- Study completion1 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy LossStudies 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
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pınar Kadirogulları, Kanuni Sultan Suleyman Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04013035
- Sponsor's protocol ID
- 2015.01.01
- Status last verified
- Jul 2019
- First submitted
- 7 Jul 2019
- Last updated
- 10 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Fetal Viability and Cervical Length on Pregnancy Termination Outcomes in Nulliparous Second Trimester Pregnancies
- ClinicalTrials.gov ID
- NCT04013035
- Acronym / sponsor ID
- 2015.01.01
- Conditions
- Pregnancy Loss
- Keywords
- Cervix, Length, Viability, prostaglandin, Termination
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 1 Jun 2017 (actual)
- Study completion
- 1 Jun 2017 (actual)
- First posted
- 9 Jul 2019 (actual)
- 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.
Cervical length is used as a parameter to predict cervical insufficiency and onset of labor. However, its role in predicting abortion induction is unclear.To investigate the impact of cervical length measurement and fetal viability on second trimester pregnancy termination duration in nulliparous pregnant women.
Detailed description
Cervical length and fetal viability were evaluated prior to second trimester pregnancy termination due to various indications. nulliparous pregnant women through 13 and 26 gestational weeks in whom pregnancy termination was conducted within 72 hours after admission were included in the study. The subjects were grouped into two groups according to fetal viability.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Nulliparous pregnant women at 13-26 weeks of gestation will be included in the study.
Key inclusion criteria (1 listed)
- -Nulliparous pregnant women at 13-26 weeks of gestation
Key exclusion criteria (3 listed)
- Patients with multiple gestations,
- multiparous patients or
- patients that had uterine gynecologic surgery
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 measurementcervical length measurement at second trimester pregnancy termination in nulliparous pregnant women. | Procedure or surgery | – |
Primary outcome
cervical length measurement
Time frame: 2 days
cervical length measurement at second trimester pregnancy termination in nulliparous pregnant women. The measurements will be saved as a number in cm.
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 10 Jul 2019.
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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.
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 Pregnancy Loss, run by Kanuni Sultan Suleyman Training and Research Hospital at 1 site in Turkey (Türkiye).
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 1 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 10 Jul 2019. 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 Turkey (Türkiye). 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?
cervical length measurement (time frame: 2 days). 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 10 Jul 2019.