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

Not Applicable

• Conditions: Intrauterine Growth Restriction; Fetal Surveillance
• Interventions: Procedure: weekly; Procedure: bi-weekly

• Registration Number: NCT04141189
• Lead Sponsor: Bezmialem Vakif University

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2019-10-22
• Study First Submitted QC: 2019-10-24
• Study First Posted: 2019-10-28
• Study Start: 2019-11-15
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-11
• Last Update Posted: 2020-02-12
• Primary Completion: 2020-10-15
• Study Completion: 2020-11-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 206

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
weekly	weekly	weekly fetal surveillance
bi-weekly (twice-weekly)	bi-weekly	bi-weekly fetal surveillance

Primary Outcome Measures

Name	Time	Method
neonatal hospital stay	3 months	duration of neonatal hospital stay (days)

Secondary Outcome Measures

Name	Time	Method
antenatal hospital stay	3 months	duration of antenatal hospital stay (days)

Trial Locations

Locations (1)

Bezmialem Vakıf University Hospital; 🇹🇷 Istanbul, Turkey