IUGR; Cause and Relationship
Study Details
Study Description
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 | Phase |
|---|---|---|
|
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
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HIE (hypoxic-ischemic encephalopathy)2-3 (neonatal convulsions in the fetus after childbirth),
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Intracranial hemorrhage,
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Apgar score < 4 at 5 minutes,
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Arterial umbilical cord pH (potential of hydrogen) < 7.10,
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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 Design
Arms and Interventions
| Arm | 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
|
Outcome Measures
Primary Outcome Measures
- 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
- 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)?
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Eva Wiberg-Itzel | Stockholm | Sweden | 18239 |
Sponsors and Collaborators
- Karolinska Institutet
Investigators
- Principal Investigator: Eva Wiberg-Itzel, PhD, Karolinska Institute Sodersjukhuset Sweden
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Early or late IUGR