Diamine Oxidase and Adverse Pregnancy Outcomes

Pregnancy Complications Clinical Trial

Official title:

Diamine Oxidase and Adverse Pregnancy Outcomes

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06281366
• Other study ID #: PR(AMI)470-2023
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

• Pregnancy Complications

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