Uterine Artery Doppler and 11-14 / 20-22 Weeks of Gestation Pregnancy

January 28, 2020 updated by: Pınar Kadirogulları, Kanuni Sultan Suleyman Training and Research Hospital

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
750

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey, 33404
        • Kanuni Sultan Suleyman Training and Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

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.

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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
  • two or more cesarean sections
  • Having undergone non-cesarean surgery (myomectomy, septum or polyp resection ... etc)
  • Presence of uterine structural anomaly

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Other: uterine artery doppler measurement

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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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)
10 months
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)
10 months
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)
10 months
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)
10 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Kanuni Sultan Suleyman Training and Research Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 28, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 28, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 30, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 30, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 28, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ATADEK-2020/00

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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