IUGR; Cause and Relationship

NCT ID: NCT05142644

Last Updated: 2022-01-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

80000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-01-01

Study Completion Date

2021-10-30

Brief Summary

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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

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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

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Intrauterine Growth Restriction

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Early / growth restriction

Intrauterine growth restriction with onset before 32 weeks of gestation

ultrasound

Intervention Type PROCEDURE

An extra ultrasound performed during pregnancy

Late growth restriction

Intrauterine growth restriction with onset after 32 weeks of gestation

ultrasound

Intervention Type PROCEDURE

An extra ultrasound performed during pregnancy

Interventions

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ultrasound

An extra ultrasound performed during pregnancy

Intervention Type PROCEDURE

Eligibility Criteria

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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
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Karolinska Institutet

OTHER

Sponsor Role lead

Responsible Party

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Eva Wiberg-Itzel

Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Eva Wiberg-Itzel, PhD

Role: PRINCIPAL_INVESTIGATOR

Karolinska Institute Sodersjukhuset Sweden

Locations

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Eva Wiberg-Itzel

Stockholm, , Sweden

Site Status

Countries

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Sweden

Other Identifiers

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Early or late IUGR

Identifier Type: -

Identifier Source: org_study_id

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