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

Bezmialem Vakif University

Status: Unknown

Conditions: Intrauterine Growth Restriction; Fetal Surveillance

Treatments: Procedure: weekly; Procedure: bi-weekly

Study type: Interventional

Funder types: Other

Identifiers

NCT04141189

BezmialemVU fetal surveillance

Details and patient eligibility

About

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.

Full 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.

Enrollment: 206 estimated patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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206 participants in 2 patient groups

weekly

Experimental group

Description:

weekly fetal surveillance

Treatment:

Procedure: weekly

bi-weekly (twice-weekly)

Active Comparator group

Description:

bi-weekly fetal surveillance

Treatment:

Procedure: bi-weekly