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

Pregnancy Related Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04248660
• Other study ID #: ATADEK-2020/00
• Status: Completed
• Start date: January 1, 2016
• Est. completion date: January 1, 2020

Study information

• Verified date: January 2020
• Source: Kanuni Sultan Suleyman Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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).

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 750
• Est. completion date: January 1, 2020
• Est. primary completion date: January 1, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Pregnancy Related

Intervention

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.

Locations

Country	Name	City	State
Turkey	Kanuni Sultan Süleyman Training and Research Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Kanuni Sultan Suleyman Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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