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

Completed

Conditions

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

Observational

Enrollment (Actual)

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

      • 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

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
Intervention / Treatment
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.

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

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.

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)

January 1, 2016

Primary Completion (Actual)

January 1, 2020

Study Completion (Actual)

January 1, 2020

Study Registration Dates

First Submitted

January 28, 2020

First Submitted That Met QC Criteria

January 28, 2020

First Posted (Actual)

January 30, 2020

Study Record Updates

Last Update Posted (Actual)

January 30, 2020

Last Update Submitted That Met QC Criteria

January 28, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Other Study ID 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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