Diamine Oxidase and Adverse Pregnancy Outcomes

Vall d'Hebron University Hospital (HUVH)

Status: Enrolling

Conditions: Pregnancy Complications

Study type: Observational

Funder types: Other

Identifiers

NCT06281366

PR(AMI)470-2023

Details and patient eligibility

About

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.

Enrollment: 75 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

75 participants in 2 patient groups

Control

Description:

Pregnant women with a positive first-trimester screening for preeclampsia (high risk) and no pregnancy complications (preeclampsia, fetal death, preterm birth, PPROM, low birthweight).

Cases

Description:

Pregnant women with a positive first-trimester screening for preeclampsia (high risk) and any of the following pregnancy complications: preeclampsia, fetal death, preterm birth, PPROM, low birthweight.