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IUGR; Cause and Relationship

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05142644
Recruitment Status : Completed
First Posted : December 2, 2021
Last Update Posted : January 4, 2022
Sponsor:
Information provided by (Responsible Party):
Eva Wiberg-Itzel, 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.


Condition or disease Intervention/treatment
Intrauterine Growth Restriction 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.

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Study Type : Observational
Actual Enrollment : 80000 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Intra Uterine Growth Retardation;Causes and Relationship
Actual Study Start Date : January 1, 2020
Actual Primary Completion Date : October 30, 2021
Actual Study Completion Date : October 30, 2021

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




Primary Outcome Measures :
  1. The frequency of newborns with an affected perinatal outcome (low Apgar score and or affected acid-base status at labor) [ Time Frame: 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 :
  1. The frequency of newborns with an affected perinatal outcome (low Apgar score and or affected acid-base status at labor)(2) [ Time Frame: 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)?



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Pregnant women
Sampling Method:   Probability Sample
Study Population
All pregnant women in Stockholm during 2014-2017
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05142644


Locations
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Sweden
Eva Wiberg-Itzel
Stockholm, Sweden, 18239
Sponsors and Collaborators
Karolinska Institutet
Investigators
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Principal Investigator: Eva Wiberg-Itzel, PhD Karolinska Institute Sodersjukhuset Sweden
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Responsible Party: Eva Wiberg-Itzel, Associate professor, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT05142644    
Other Study ID Numbers: Early or late IUGR
First Posted: December 2, 2021    Key Record Dates
Last Update Posted: January 4, 2022
Last Verified: December 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Eva Wiberg-Itzel, Karolinska Institutet:
IUGR
SGA
Additional relevant MeSH terms:
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Fetal Growth Retardation
Fetal Diseases
Pregnancy Complications
Growth Disorders
Pathologic Processes