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Clinical Trials/NCT05142644
NCT05142644
Completed
Not Applicable

Intra Uterine Growth Retardation;Causes and Relationship

Karolinska Institutet1 site in 1 country80,000 target enrollmentJanuary 1, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Intrauterine Growth Restriction
Sponsor
Karolinska Institutet
Enrollment
80000
Locations
1
Primary Endpoint
The frequency of newborns with an affected perinatal outcome (low Apgar score and or affected acid-base status at labor)
Status
Completed
Last Updated
4 years ago

Overview

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.

Detailed Description

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

Registry
clinicaltrials.gov
Start Date
January 1, 2020
End Date
October 30, 2021
Last Updated
4 years ago
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Eva Wiberg-Itzel

Associate professor

Karolinska Institutet

Eligibility Criteria

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

Outcomes

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)(January 1th 2014- december 31th 2017)

Study Sites (1)

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