Clinical trial NCT05142644: IUGR; Cause and Relationship
Official title: Intra Uterine Growth Retardation;Causes and Relationship
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intrauterine Growth Restriction
Keywords: IUGR
SGA
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2021-12-02
Enrollment: 80000
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All pregnant women in Stockholm during 2014-2017

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.

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.

Eligibility 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

Primary outcomes:
measure: The frequency of newborns with an affected perinatal outcome (low Apgar score and or affected acid-base status at labor)
timeFrame: 2014-2017
Secondary outcomes:
measure: The frequency of newborns with an affected perinatal outcome (low Apgar score and or affected acid-base status at labor)(2)
timeFrame: January 1th 2014- december 31th 2017
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Eva Wiberg-Itzel
Study officials:
affiliation: Karolinska Institute Sodersjukhuset Sweden
name: Eva Wiberg-Itzel, PhD
role: PRINCIPAL_INVESTIGATOR
References: