IUGR; Cause and Relationship

Intra Uterine Growth Retardation;Causes 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.

Study Overview

• Status: Completed
• Conditions: Intrauterine Growth Restriction
• Intervention / Treatment: Procedure: ultrasound

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 Type: Observational
• Enrollment (Actual): 80000

Contacts and Locations

Study Locations

• Sweden
  • Stockholm, Sweden, 18239
    • Eva Wiberg-Itzel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

All pregnant women in Stockholm during 2014-2017

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Early / growth restriction; Intrauterine growth restriction with onset before 32 weeks of gestation	Procedure: ultrasound; An extra ultrasound performed during pregnancy
Late growth restriction; Intrauterine growth restriction with onset after 32 weeks of gestation	Procedure: ultrasound; An extra ultrasound performed during pregnancy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
The frequency of newborns with an affected perinatal outcome (low Apgar score and or affected acid-base status at labor)(2)	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)?	January 1th 2014- december 31th 2017

Collaborators and Investigators

• Sponsor: Karolinska Institutet
• Investigators: Principal Investigator: Eva Wiberg-Itzel, PhD, Karolinska Institute Sodersjukhuset Sweden

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2020
• Primary Completion (Actual): October 30, 2021
• Study Completion (Actual): October 30, 2021

Study Registration Dates

• First Submitted: November 21, 2021
• First Submitted That Met QC Criteria: November 21, 2021
• First Posted (Actual): December 2, 2021

Study Record Updates

• Last Update Posted (Actual): January 4, 2022
• Last Update Submitted That Met QC Criteria: December 28, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: IUGR; SGA
• Additional Relevant MeSH Terms: Pathologic Processes; Fetal Diseases; Pregnancy Complications; Growth Disorders; Fetal Growth Retardation
• Other Study ID Numbers: Early or late IUGR

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No