IUGR; Cause and Relationship

Intrauterine Growth Restriction Clinical Trial

Official title:

Intra Uterine Growth Retardation;Causes and Relationship

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05142644
• Other study ID #: Early or late IUGR
• Status: Completed
• Start date: January 1, 2020
• Est. completion date: October 30, 2021

Study information

• Verified date: December 2021
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80000
• Est. completion date: October 30, 2021
• Est. primary completion date: October 30, 2021
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Fetal Growth Retardation
• Intrauterine Growth Restriction

Intervention

Procedure:
• ultrasound
An extra ultrasound performed during pregnancy

Locations

Country	Name	City	State
Sweden	Eva Wiberg-Itzel	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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