Pregnancy RelatedNCT04248660
Uterine Artery Doppler and 11-14 / 20-22 Weeks of Gestation Pregnancy
An observational study of Pregnancy Related, run by Kanuni Sultan Suleyman Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Uterine artery doppler measurements will be made at 11-14 weeks and 20-22 weeks of gestation, and the classification of these measurements according to type of delivery; and to investigate the change in the effect of delivery type on uterine artery flows on obstetric outcomes (maternal, fetal, neonatal outcomes). Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Pregnancy Related
- What is being tested?
- uterine artery doppler measurement
- How many people
- 750 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2016to 1 Jan 2020
- 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 45 years
- Women only
- No healthy volunteers
- Adult
Study population: Patients who had uterine artery doppler measurements and delivered at 11-14 weeks and 20-22 weeks of pregnancy will be the study group. these patients; Doppler results will be classified according to pregnancy results, and the classification of these measurements according to type of delivery; and the effect of delivery on uterine artery flows on obstetric outcomes (maternal, fetal, neonatal outcomes) will be examined.
Who may be able to join
- Gestational age 11-14. applying to the outpatient clinic at week
- Single spontaneous pregnancy
- Having a first pregnancy (primigravid nullipar) or having given birth once (primipar) (first birth by vaginal route or cesarean)
- Result of previous pregnancy with live birth (term delivery without obstetric complication)
- No intrauterine growth restriction in the first pregnancy
- Women who gave birth by cesarean section were not placed due to caesarean indication due to placental location-invasion anomaly, maternal chronic disease (hypertension, diabetes, coronary artery disease, etc.), placental detachment.
Who cannot join
- Multiple pregnancies
- Pregnancies with assisted reproductive techniques
- Placental anomaly in previous pregnancy
- Maternal chronic hypertension, preeclampsia, history of diabetes
- Pregnant women who smoke
- The presence of fetal chromosomal or structural anomaly
Show all 9Show fewer
- two or more cesarean sections
- Having undergone non-cesarean surgery (myomectomy, septum or polyp resection ... etc)
- Presence of uterine structural anomaly
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: Comparison of Uterine Artery Doppler Measurements Performed at 11-14 and 20-22 Weeks of Gestation During Pregnancy According to Delivery Type and Number of Births and Investigation of the Effects on Obstetric Outcomes (Maternal, Fetal, Neonatal Results)
Uterine artery doppler measurements will be made at 11-14 weeks and 20-22 weeks of gestation, and the classification of these measurements according to type of delivery; and to investigate the change in the effect of delivery type on uterine artery flows on obstetric outcomes (maternal, fetal, neonatal outcomes).
Read the detailed description
The first and second trimester perinatal examination results performed by the same operator from pregnant women who have applied to the clinic since the first trimester are removed from the ViewPoint 6.0 server and database and their uterine artery doppler values (uterine artery PI and RI values, presence of uterine artery notch), placental location, gestational week of measurement, blood pressures, PAPP-A and hCG MoM values, obstetric results (type of birth, week, weight, ante-postpartum complications), data to be generated from other hospital records will be saved to the base
- Conditions
- Pregnancy Related
- Being tested
- uterine artery doppler measurement
- Keywords
- Uterine artery doppler, type of delivery, obstetric outcomes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
uterine artery doppler measurementOther
The effect of delivery type on changes in uterine blood flow will be investigated.
Doppler results groups will be defined according to the effect of deviations in uterine blood flow on neonatal and perinatal results.
| Study group | Role | What they receive |
|---|---|---|
| Uterine artery doppler measurements | Uterine artery doppler measurements will be made in the same patients at 11-14 weeks and 20-22 weeks of pregnancy.
Doppler results will be classified according to pregnancy results and primary results will be doppler findings. Receives: Other: uterine artery doppler measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Doppler results of 11-14 weeks of gestation in patients with previous cesarean section
uterine artery doppler values (uterine artery PI , presence of uterine artery notch)
Measured: 10 months
Doppler results of 11-14 weeks of gestation in those who gave birth beforehand
uterine artery doppler values (uterine artery PI , presence of uterine artery notch)
Measured: 10 months
Doppler results of 20-22 weeks of gestation in patients with previous cesarean section
uterine artery doppler values (uterine artery PI , presence of uterine artery notch)
Measured: 10 months
Doppler results of 20-22 weeks of gestation in those who gave birth beforehand
uterine artery doppler values (uterine artery PI , presence of uterine artery notch)
Measured: 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2020
- Study start1 Jan 2016
- Primary completion1 Jan 2020
- Study completion1 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy RelatedStudies 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
- Retrospective
- Enrolment
- 750 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
- NCT04248660
- Sponsor's protocol ID
- ATADEK-2020/00
- Status last verified
- Jan 2020
- First submitted
- 28 Jan 2020
- Last updated
- 30 Jan 2020
- 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 30 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Uterine Artery Doppler Measurements Performed at 11-14 and 20-22 Weeks of Gestation During Pregnancy According to Delivery Type and Number of Births and Investigation of the Effects on Obstetric Outcomes (Maternal, Fetal, Neonatal Results)
- ClinicalTrials.gov ID
- NCT04248660
- Acronym / sponsor ID
- ATADEK-2020/00
- Conditions
- Pregnancy Related
- Keywords
- Uterine artery doppler, type of delivery, obstetric outcomes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 750 participants (actual)
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 1 Jan 2020 (actual)
- Study completion
- 1 Jan 2020 (actual)
- First posted
- 30 Jan 2020 (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.
Uterine artery doppler measurements will be made at 11-14 weeks and 20-22 weeks of gestation, and the classification of these measurements according to type of delivery; and to investigate the change in the effect of delivery type on uterine artery flows on obstetric outcomes (maternal, fetal, neonatal outcomes).
Detailed description
The first and second trimester perinatal examination results performed by the same operator from pregnant women who have applied to the clinic since the first trimester are removed from the ViewPoint 6.0 server and database and their uterine artery doppler values (uterine artery PI and RI values, presence of uterine artery notch), placental location, gestational week of measurement, blood pressures, PAPP-A and hCG MoM values, obstetric results (type of birth, week, weight, ante-postpartum complications), data to be generated from other hospital records will be saved to the base
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Uterine artery doppler measurements | – | Other: uterine artery doppler measurementUterine artery doppler measurements will be made in the same patients at 11-14 weeks and 20-22 weeks of pregnancy. Doppler results will be classified according to pregnancy results and primary results will be doppler findings. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients who had uterine artery doppler measurements and delivered at 11-14 weeks and 20-22 weeks of pregnancy will be the study group. these patients; Doppler results will be classified according to pregnancy results, and the classification of these measurements according to type of delivery; and the effect of delivery on uterine artery flows on obstetric outcomes (maternal, fetal, neonatal outcomes) will be examined.
Key inclusion criteria (6 listed)
- Gestational age 11-14. applying to the outpatient clinic at week
- Single spontaneous pregnancy
- Having a first pregnancy (primigravid nullipar) or having given birth once (primipar) (first birth by vaginal route or cesarean)
- Result of previous pregnancy with live birth (term delivery without obstetric complication)
- No intrauterine growth restriction in the first pregnancy
Key exclusion criteria (9 listed)
- Multiple pregnancies
- Pregnancies with assisted reproductive techniques
- Placental anomaly in previous pregnancy
- Maternal chronic hypertension, preeclampsia, history of diabetes
- Pregnant women who smoke
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 |
|---|---|---|
| uterine artery doppler measurementThe effect of delivery type on changes in uterine blood flow will be investigated. Doppler results groups will be defined according to the effect of deviations in uterine blood flow on neonatal and perinatal results. | Other | Uterine artery doppler measurements |
Primary outcome
Doppler results of 11-14 weeks of gestation in patients with previous cesarean section
Time frame: 10 months
uterine artery doppler values (uterine artery PI , presence of uterine artery notch)
Doppler results of 11-14 weeks of gestation in those who gave birth beforehand
Time frame: 10 months
uterine artery doppler values (uterine artery PI , presence of uterine artery notch)
Doppler results of 20-22 weeks of gestation in patients with previous cesarean section
Time frame: 10 months
uterine artery doppler values (uterine artery PI , presence of uterine artery notch)
Doppler results of 20-22 weeks of gestation in those who gave birth beforehand
Time frame: 10 months
uterine artery doppler values (uterine artery PI , presence of uterine artery notch)
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 30 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.
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 Related, 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 6 inclusion and 9 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 30 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 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?
Doppler results of 11-14 weeks of gestation in patients with previous cesarean section (time frame: 10 months). The study lists 4 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 30 Jan 2020.