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

Comparison of Follow-up Protocols in Terms of Fetal, Neonatal and Maternal Results in Intrauterine Growth Retardation: a Randomised Controlled Trial

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.

Study Overview

• Status: Unknown
• Conditions: Intrauterine Growth Restriction; Fetal Surveillance
• Intervention / Treatment: Procedure: weekly; Procedure: bi-weekly

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 Type: Interventional
• Enrollment (Anticipated): 206
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey
    • Recruiting
    • Bezmialem Vakıf University Hospital
    • Contact: Taha Takmaz, MD; Phone Number: +905548707340; Email: thtkmz@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: weekly; weekly fetal surveillance	Procedure: weekly; fetal surveillance frequency
Active Comparator: bi-weekly (twice-weekly); bi-weekly fetal surveillance	Procedure: bi-weekly; fetal surveillance frequency

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
neonatal hospital stay	duration of neonatal hospital stay (days)	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
antenatal hospital stay	duration of antenatal hospital stay (days)	3 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
neonatal hospital stay	duration of neonatal hospital stay (days)	3 months
gestational age at delivery	gestational age at delivery as days (e.g. 261days)	24 hours
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
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
cesarean delivery	The number of births by cesarean section	24 hours

Collaborators and Investigators

• Sponsor: Bezmialem Vakif University

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2019
• Primary Completion (Anticipated): October 15, 2020
• Study Completion (Anticipated): November 15, 2020

Study Registration Dates

• First Submitted: October 22, 2019
• First Submitted That Met QC Criteria: October 24, 2019
• First Posted (Actual): October 28, 2019

Study Record Updates

• Last Update Posted (Actual): February 12, 2020
• Last Update Submitted That Met QC Criteria: February 11, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: Intrauterine Growth Restriction; fetal growth; fetal surveillance; fetal doppler
• Additional Relevant MeSH Terms: Pathologic Processes; Fetal Diseases; Pregnancy Complications; Growth Disorders; Fetal Growth Retardation
• Other Study ID Numbers: BezmialemVU fetal surveillance

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No