Comparison of Follow-up Protocols in Terms of Fetal, Neonatal and Maternal Results in Intrauterine Growth Retardation

NCT ID: NCT04141189

Last Updated: 2020-02-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

206 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-15

Study Completion Date

2020-11-15

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Fetal Surveillance Intrauterine Growth Restriction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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weekly

weekly fetal surveillance

Group Type EXPERIMENTAL

weekly

Intervention Type PROCEDURE

fetal surveillance frequency

bi-weekly (twice-weekly)

bi-weekly fetal surveillance

Group Type ACTIVE_COMPARATOR

bi-weekly

Intervention Type PROCEDURE

fetal surveillance frequency

Interventions

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weekly

fetal surveillance frequency

Intervention Type PROCEDURE

bi-weekly

fetal surveillance frequency

Intervention Type PROCEDURE

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Bezmialem Vakif University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Bezmialem Vakıf University Hospital

Istanbul, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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taha takmaz, MD

Role: CONTACT

+902124531700

serdar kutuk, MD

Role: CONTACT

+902124531700

Facility Contacts

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Taha Takmaz, MD

Role: primary

+905548707340

Other Identifiers

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BezmialemVU fetal surveillance

Identifier Type: -

Identifier Source: org_study_id

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