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

Intrauterine Growth Restriction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04141189
• Other study ID #: BezmialemVU fetal surveillance
• Status: Recruiting
• Phase: N/A
• 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
• 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)

Related Conditions & MeSH terms

• Fetal Growth Retardation
• Fetal Surveillance
• Intrauterine Growth Restriction

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