IUGR; Cause and Relationship

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.

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Key information

Conditions

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

Sex eligibility

Female

Study type

Observational

Primary location

Eva Wiberg-Itzel

Stockholm, 18239, Sweden

About this study

Design: Register-based cohort study. Population: All pregnancies in Stockholm from 2014 to 2017 A Composite outcome for the study is constructed and consists of at least one of the following outcomes

HIE (hypoxic-ischemic encephalopathy)2-3 (neonatal convulsions in the fetus after childbirth),
Intracranial hemorrhage,
Apgar score < 4 at 5 minutes,
Arterial umbilical cord pH (potential of hydrogen) < 7.10,
Intrauterine fetal death, 6)intrapartal death.

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

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

Pregnancies with known chromosomal abnormalities or other serious structural abnormalities

Treatment and study plan

Ultrasound

Procedure

An extra ultrasound performed during pregnancy

Primary outcomes

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

Time frame: 2014-2017

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

Secondary outcomes

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

Time frame: January 1th 2014- december 31th 2017

Will the outcome changes persist if the group with IUGR will be divided into early- or late-diagnosed IUGR (before and after week 32 of pregnancy)?

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Registry information

Official study title

Intra Uterine Growth Retardation;Causes and Relationship

Important dates

Study start: 2020
Primary completion: 2021
Study completion: 2021
First posted: Dec 2, 2021
Registry last updated: Jan 4, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed