Clinical Trials Directory

Trials / Completed

CompletedNCT05142644

IUGR; Cause and Relationship

Intra Uterine Growth Retardation;Causes and Relationship

Status
Completed
Phase
Study type
Observational
Enrollment
80,000 (actual)
Sponsor
Karolinska Institutet · Academic / Other
Sex
Female
Age
Healthy volunteers

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.

Conditions

Interventions

TypeNameDescription
PROCEDUREultrasoundAn extra ultrasound performed during pregnancy

Timeline

Start date
2020-01-01
Primary completion
2021-10-30
Completion
2021-10-30
First posted
2021-12-02
Last updated
2022-01-04

Locations

1 site across 1 country: Sweden

Source: ClinicalTrials.gov record NCT05142644. Inclusion in this directory is not an endorsement.