IUGR; Cause and Relationship

NCT05142644 | Completed

• 1 other identifier: Early or late IUGR
• Study Type: observational
• Target: 80,000
• Locations: 1 country
• Sites: 1

Brief Summary

Intrauterine growth restriction (IUGR) is a pregnancy complication in about 3-5% of all pregnancies in Sweden. IUGR fetuses are at high risk of morbidity and death. The method used in Sweden to detect IUGR is repeated measurements of pregnant women's symphysis-fundus measure (SF measure). Weight estimation with ultrasound is performed only on indication; stagnant or deplaning SF dimensions or in the event of complications. Only high-risk pregnancies have repeated growth checks during pregnancy from the beginning. There are potential benefits to detecting IUGR fetuses during pregnancy. Still, the effect is questioned. A meta-analysis of randomized studies could not benefit from a routine ultrasound in the third trimester. The scientific purpose of this work is to evaluate the benefits of early detection and care of SGA (small for gestational age)/IUGR (growth-inhibited) fetuses and, if possible, to increase knowledge about this patient group. The hope is that this will lead to a better opportunity to personalize both preventive care and treatment of these women and children.

Conditions

Intrauterine Growth Restriction

Keywords

IUGR; SGA

Outcome Measures

Primary Outcomes (1)

• The frequency of newborns with an affected perinatal outcome (low Apgar score and or affected acid-base status at labor)

  Will the perinatal outcome at delivery( be measured as a low Apgar score at 5 minutes or an affected acid-base status in cord blood) be improved if IUGR(intrauterine growth restriction) is identified before labor

  2014-2017

Secondary Outcomes (1)

• The frequency of newborns with an affected perinatal outcome (low Apgar score and or affected acid-base status at labor)(2)

  January 1th 2014- december 31th 2017

Study Arms (2)

Early / growth restriction

Intrauterine growth restriction with onset before 32 weeks of gestation

Procedure: ultrasound

Late growth restriction

Intrauterine growth restriction with onset after 32 weeks of gestation

Procedure: ultrasound

Interventions

ultrasound PROCEDURE

An extra ultrasound performed during pregnancy

Early / growth restriction; Late growth restriction

Eligibility Criteria

• Gender Eligibility Details: Pregnant women
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All pregnant women in Stockholm during 2014-2017

You may qualify if:

• All pregnancies in Stockholm with a fetus, born between 2014 and 2017 and without chromosomal abnormalities or other serious structural abnormalities, will be included in the project.

You may not qualify if:

• Pregnancies with known chromosomal abnormalities or other serious structural abnormalities

Sponsors & Collaborators

• Karolinska Institutet: lead

Study Sites (1)

Eva Wiberg-Itzel

Stockholm, 18239, Sweden

Location

MeSH Terms

Conditions

Fetal Growth Retardation

Interventions

High-Energy Shock Waves

Condition Hierarchy (Ancestors)

Fetal Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Growth Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ultrasonic Waves; Sound; Radiation, Nonionizing; Radiation; Physical Phenomena

Study Officials

• Eva Wiberg-Itzel, PhD

  Karolinska Institute Sodersjukhuset Sweden

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: November 21, 2021
• First Posted: December 2, 2021
• Study Start: January 1, 2020
• Primary Completion: October 30, 2021
• Study Completion: October 30, 2021
• Last Updated: January 4, 2022

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)