NCT04248660

Brief 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
750

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

January 28, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 30, 2020

Completed
Last Updated

January 30, 2020

Status Verified

January 1, 2020

Enrollment Period

4 years

First QC Date

January 28, 2020

Last Update Submit

January 28, 2020

Conditions

Pregnancy Related

Keywords

Uterine artery dopplertype of deliveryobstetric outcomes

Outcome Measures

Primary Outcomes (4)

  • 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)

    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)

    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)

    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)

    10 months

Study Arms (1)

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

Interventions

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.

Uterine artery doppler measurements

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability 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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kanuni Sultan Süleyman Training and Research Hospital

Istanbul, 33404, Turkey (Türkiye)

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator, Pınar kadirogullari, M.D, Department of Obstetrics and Gynecology

Study Record Dates

First Submitted

January 28, 2020

First Posted

January 30, 2020

Study Start

January 1, 2016

Primary Completion

January 1, 2020

Study Completion

January 1, 2020

Last Updated

January 30, 2020

Record last verified: 2020-01

Locations

TU(1)