NCT04141189

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
206

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2019

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 22, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 28, 2019

Completed
18 days until next milestone

Study Start

First participant enrolled

November 15, 2019

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2020

Completed
Last Updated

February 12, 2020

Status Verified

February 1, 2020

Enrollment Period

11 months

First QC Date

October 22, 2019

Last Update Submit

February 11, 2020

Conditions

Fetal SurveillanceIntrauterine Growth Restriction

Keywords

Intrauterine Growth Restrictionfetal surveillancefetal dopplerfetal growth

Outcome Measures

Primary Outcomes (1)

  • neonatal hospital stay

    duration of neonatal hospital stay (days)

    3 months

Secondary Outcomes (1)

  • antenatal hospital stay

    3 months

Other Outcomes (5)

  • gestational age at delivery

    24 hours

  • neonatal hospital stay

    3 months

  • acidosis

    24 hours

  • +2 more other outcomes

Study Arms (2)

weekly

EXPERIMENTAL

weekly fetal surveillance

Procedure: weekly

bi-weekly (twice-weekly)

ACTIVE COMPARATOR

bi-weekly fetal surveillance

Procedure: bi-weekly

Interventions

weeklyPROCEDURE

fetal surveillance frequency

weekly
bi-weeklyPROCEDURE

fetal surveillance frequency

bi-weekly (twice-weekly)

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • weeks pregnant women with estimated fetal weight below 10 percentile
  • singlton pregnancy

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bezmialem Vakıf University Hospital

Istanbul, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Fetal Growth Retardation

Condition Hierarchy (Ancestors)

Fetal DiseasesPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesGrowth DisordersPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

taha takmaz, MD

CONTACT

+902124531700thtkmz@hotmail.com

serdar kutuk, MD

CONTACT

+902124531700mehmetserdarkutuk@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 22, 2019

First Posted

October 28, 2019

Study Start

November 15, 2019

Primary Completion

October 15, 2020

Study Completion

November 15, 2020

Last Updated

February 12, 2020

Record last verified: 2020-02

Locations

TU(1)