Diamine Oxidase and Adverse Pregnancy Outcomes

Recruiting

• Conditions: Pregnancy Complications

• Registration Number: NCT06281366
• Lead Sponsor: Hospital Universitari Vall d'Hebron Research Institute

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-02-16
• Study First Submitted: 2024-02-20
• Study First Submitted QC: 2024-02-20
• Study First Posted: 2024-02-28
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-18
• Last Update Posted: 2024-03-20
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 75

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Diamine oxidase activity first trimester	11-16+6 weeks of gestation	diamine oxidase enzime activity in maternal blood
Diamine oxidase gene polymorphisms	11-16+6 weeks of gestation	variants of the AOC1 gene: rs10156191, rs1049742, rs1049793 and rs2052129

Secondary Outcome Measures

Name	Time	Method
Placental histamine levels at delivery	At the time of delivery	histamine levels in placenta
Blood histamine levels at delivery	At the time of delivery	histamine levels in maternal blood
Placental Diamine oxidase activity at delivery	At the time of delivery	diamine oxidase enzime activity in placenta
Urine histamine levels at delivery	At the time of delivery	histamine levels in 24-hour maternal urine
Blood Diamine oxidase activity at delivery	At the time of delivery	diamine oxidase enzime activity in maternal blood

Trial Locations

Locations (1)

Manel Mendoza; 🇪🇸 Barcelona, Spain