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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06281366
Other study ID # PR(AMI)470-2023
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date February 16, 2024
Est. completion date December 31, 2025

Study information

Verified date March 2024
Source Hospital Universitari Vall d'Hebron Research Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

In normal pregnancies, blood histamine concentration remains within normal values; however, the serum histaminolytic activity is increased. Histamine is mainly produced by mast cells, platelets, basophils, neurons and enterochromatin cells, where it is stored and released when required. Reduced DAO activities have been found in high-risk pregnancies. Lower DAO activity has been associated to miscarriage, fetal demise, preeclampsia, low birthweight and preterm birth. The placenta is very rich in DAO activity and is the principal source of increased histaminolytic activity in normal pregnancies. First-trimester screening for preeclampsia (PE) is a routine screening which is performed in the first trimester. Women with a positive result are at a greater risk of PE but also other pregnancy complications such as stillbirth, preterm birth and low birthweight. These cases are prescribed aspirin until term. This intervention has demonstrated to significantly reduce the risk of PE and other complications. Unfortunately, aspirin does not avoid all cases with adverse outcomes, indicating that additional mechanisms may be involved in the development of such pregnancy complications, such as DAO decreased activity.


Recruitment information / eligibility

Status Recruiting
Enrollment 75
Est. completion date December 31, 2025
Est. primary completion date December 31, 2025
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria: - Single pregnancy - Maternal age =18 - High risk (=1/50) in the first-trimester screening for preeclampsia - Gestational age between 11+0 and 16+6 weeks of gestation Exclusion Criteria: - Fetal malformation - Fetal death - Maternal digestive inflammatory disease or intolerance - Refusal to give informed consent

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Spain Manel Mendoza Barcelona

Sponsors (2)

Lead Sponsor Collaborator
Hospital Universitari Vall d'Hebron Research Institute DR Healthcare

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Diamine oxidase activity first trimester diamine oxidase enzime activity in maternal blood 11-16+6 weeks of gestation
Primary Diamine oxidase gene polymorphisms variants of the AOC1 gene: rs10156191, rs1049742, rs1049793 and rs2052129 11-16+6 weeks of gestation
Secondary Blood Diamine oxidase activity at delivery diamine oxidase enzime activity in maternal blood At the time of delivery
Secondary Placental Diamine oxidase activity at delivery diamine oxidase enzime activity in placenta At the time of delivery
Secondary Blood histamine levels at delivery histamine levels in maternal blood At the time of delivery
Secondary Placental histamine levels at delivery histamine levels in placenta At the time of delivery
Secondary Urine histamine levels at delivery histamine levels in 24-hour maternal urine At the time of delivery
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