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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04141189
Other study ID # BezmialemVU fetal surveillance
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date November 15, 2019
Est. completion date November 15, 2020

Study information

Verified date February 2020
Source Bezmialem Vakif University
Contact taha takmaz, MD
Phone +902124531700
Email thtkmz@hotmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study will be undertaken to determine whether the frequency of fetal surveillance can be safely reduced from bi-weekly to weekly in the case of fetusus with intrauterine growth restriction.


Description:

In this prospective randomized study, the cases whose fetal weight predicted by ultrasonography (USG) between the 28th and 37th weeks of gestation are below 10percentile according to the World Health Organization (WHO) normograms. The cases will be divided into two groups as group 1:weekly and group 2:bi-weekly (twice-weekly) The cases will be evaluated by fetal Doppler, amniotic fluid volume, nonstress test (NST) and maternal preeclampsia tests.Maternal severe hypertension/preeclampsia, category 3 NST, oligohydramnios (after 37 weeks amniotic fluid index <5; after 34 weeks single deepest pocket <2 cm) ,pathological doppler (before 34 weeks reverse flow in an umbilical artery , after 34 weeks absent end-diastolic flow in an umbilical artery) in cases of birth decision will be taken. Cases without the above mentioned complications will be delivered between 38 weeks 3 days and 39 weeks.


Recruitment information / eligibility

Status Recruiting
Enrollment 206
Est. completion date November 15, 2020
Est. primary completion date October 15, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 40 Years
Eligibility Inclusion Criteria:

- 28-37 weeks pregnant women with estimated fetal weight below 10 percentile

- singlton pregnancy

Exclusion Criteria:

- maternal preeclampsia

- maternal systemic disease (pregestational diabetes, gestational diabetes mellitus a2, antiphospholipid antibody syndrome, chronic kidney disease)

- oligohydramnios (after 34 weeks amniotic fluid index <5; before 34 weeks single deepest pocket <2 cm)

- pathological doppler (high umbilical artery resistance index, absence of end-diastolic flow velocity in the umbilical artery, reverse flow in the umbilical artery, brain sparing effect in middle cerebral artery, abnormal ductus venosus flow)

Study Design


Intervention

Procedure:
weekly
fetal surveillance frequency
bi-weekly
fetal surveillance frequency

Locations

Country Name City State
Turkey Bezmialem Vakif University Hospital Istanbul

Sponsors (1)

Lead Sponsor Collaborator
Bezmialem Vakif University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Other gestational age at delivery gestational age at delivery as days (e.g. 261days) 24 hours
Other neonatal hospital stay duration of neonatal hospital stay (days) 3 months
Other acidosis fetal acidosis (normal cord-blood pH ranges from 7.14 to 7.4 during labor, values below 7.14 are considered to be acidosis) 24 hours
Other perinatal death The number of perinatal deaths. Perinatal death is a fetal death (stillbirth) or an early neonatal death (first 24 hours after birth) 3 months
Other cesarean delivery The number of births by cesarean section 24 hours
Primary neonatal hospital stay duration of neonatal hospital stay (days) 3 months
Secondary antenatal hospital stay duration of antenatal hospital stay (days) 3 months
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