IUGR; Cause and Relationship

Completed

• Conditions: Intrauterine Growth Restriction
• Interventions: Procedure: ultrasound

• Registration Number: NCT05142644
• Lead Sponsor: Karolinska Institutet

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.

Study Timeline

• Study Start: 2020-01-01
• Primary Completion: 2021-10-30
• Study Completion: 2021-10-30
• Study First Submitted: 2021-11-21
• Study First Submitted QC: 2021-11-21
• Status Verified: 2021-12
• Study First Posted: 2021-12-02
• Last Update Submitted: 2021-12-28
• Last Update Posted: 2022-01-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 80000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Late growth restriction	ultrasound	Intrauterine growth restriction with onset after 32 weeks of gestation
Early / growth restriction	ultrasound	Intrauterine growth restriction with onset before 32 weeks of gestation

Primary Outcome Measures

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

Name	Time	Method
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	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)?

Trial Locations

Locations (1)

Eva Wiberg-Itzel; 🇸🇪 Stockholm, Sweden