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

Primary Purpose

Fetal Surveillance, Intrauterine Growth Restriction

Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
weekly
bi-weekly
Sponsored by
Bezmialem Vakif University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Fetal Surveillance focused on measuring Intrauterine Growth Restriction, fetal surveillance, fetal doppler, fetal growth

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleAccepts 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)

Sites / Locations

  • Bezmialem Vakıf University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

weekly

bi-weekly (twice-weekly)

Arm Description

weekly fetal surveillance

bi-weekly fetal surveillance

Outcomes

Primary Outcome Measures

neonatal hospital stay
duration of neonatal hospital stay (days)

Secondary Outcome Measures

antenatal hospital stay
duration of antenatal hospital stay (days)

Full Information

First Posted
October 22, 2019
Last Updated
February 11, 2020
Sponsor
Bezmialem Vakif University
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1. Study Identification

Unique Protocol Identification Number
NCT04141189
Brief Title
Comparison of Follow-up Protocols in Terms of Fetal, Neonatal and Maternal Results in Intrauterine Growth Retardation
Official Title
Comparison of Follow-up Protocols in Terms of Fetal, Neonatal and Maternal Results in Intrauterine Growth Retardation: a Randomised Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Unknown status
Study Start Date
November 15, 2019 (Actual)
Primary Completion Date
October 15, 2020 (Anticipated)
Study Completion Date
November 15, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bezmialem Vakif University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fetal Surveillance, Intrauterine Growth Restriction
Keywords
Intrauterine Growth Restriction, fetal surveillance, fetal doppler, fetal growth

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
206 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
weekly
Arm Type
Experimental
Arm Description
weekly fetal surveillance
Arm Title
bi-weekly (twice-weekly)
Arm Type
Active Comparator
Arm Description
bi-weekly fetal surveillance
Intervention Type
Procedure
Intervention Name(s)
weekly
Intervention Description
fetal surveillance frequency
Intervention Type
Procedure
Intervention Name(s)
bi-weekly
Intervention Description
fetal surveillance frequency
Primary Outcome Measure Information:
Title
neonatal hospital stay
Description
duration of neonatal hospital stay (days)
Time Frame
3 months
Secondary Outcome Measure Information:
Title
antenatal hospital stay
Description
duration of antenatal hospital stay (days)
Time Frame
3 months
Other Pre-specified Outcome Measures:
Title
gestational age at delivery
Description
gestational age at delivery as days (e.g. 261days)
Time Frame
24 hours
Title
neonatal hospital stay
Description
duration of neonatal hospital stay (days)
Time Frame
3 months
Title
acidosis
Description
fetal acidosis (normal cord-blood pH ranges from 7.14 to 7.4 during labor, values below 7.14 are considered to be acidosis)
Time Frame
24 hours
Title
perinatal death
Description
The number of perinatal deaths. Perinatal death is a fetal death (stillbirth) or an early neonatal death (first 24 hours after birth)
Time Frame
3 months
Title
cesarean delivery
Description
The number of births by cesarean section
Time Frame
24 hours

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
taha takmaz, MD
Phone
+902124531700
Email
thtkmz@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
serdar kutuk, MD
Phone
+902124531700
Email
mehmetserdarkutuk@gmail.com
Facility Information:
Facility Name
Bezmialem Vakıf University Hospital
City
Istanbul
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Taha Takmaz, MD
Phone
+905548707340
Email
thtkmz@hotmail.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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