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Diamine Oxidase and Adverse Pregnancy Outcomes

Diamine Oxidase and Adverse Pregnancy Outcomes

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06281366
Enrollment
75
Registered
2024-02-28
Start date
2024-02-16
Completion date
2025-12-31
Last updated
2024-03-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pregnancy Complications

Keywords

Preeclampsia, PPROM, preterm birth, Fetal death, Low birthweight

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.

Interventions

None listed

Sponsors

DR Healthcare
CollaboratorUNKNOWN
Hospital Universitari Vall d'Hebron Research Institute
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Diamine oxidase activity first trimester11-16+6 weeks of gestationdiamine oxidase enzime activity in maternal blood
Diamine oxidase gene polymorphisms11-16+6 weeks of gestationvariants of the AOC1 gene: rs10156191, rs1049742, rs1049793 and rs2052129

Secondary

MeasureTime frameDescription
Blood histamine levels at deliveryAt the time of deliveryhistamine levels in maternal blood
Blood Diamine oxidase activity at deliveryAt the time of deliverydiamine oxidase enzime activity in maternal blood
Urine histamine levels at deliveryAt the time of deliveryhistamine levels in 24-hour maternal urine
Placental histamine levels at deliveryAt the time of deliveryhistamine levels in placenta
Placental Diamine oxidase activity at deliveryAt the time of deliverydiamine oxidase enzime activity in placenta

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026