NCT06281366

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
75

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2024

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 16, 2024

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

February 20, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 28, 2024

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

March 20, 2024

Status Verified

March 1, 2024

Enrollment Period

1.9 years

First QC Date

February 20, 2024

Last Update Submit

March 18, 2024

Conditions

Pregnancy Complications

Keywords

PreeclampsiaPPROMpreterm birthFetal deathLow birthweight

Outcome Measures

Primary Outcomes (2)

  • Diamine oxidase activity first trimester

    diamine oxidase enzime activity in maternal blood

    11-16+6 weeks of gestation

  • Diamine oxidase gene polymorphisms

    variants of the AOC1 gene: rs10156191, rs1049742, rs1049793 and rs2052129

    11-16+6 weeks of gestation

Secondary Outcomes (5)

  • Blood Diamine oxidase activity at delivery

    At the time of delivery

  • Placental Diamine oxidase activity at delivery

    At the time of delivery

  • Blood histamine levels at delivery

    At the time of delivery

  • Placental histamine levels at delivery

    At the time of delivery

  • Urine histamine levels at delivery

    At the time of delivery

Study Arms (2)

Control

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

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.

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Single pregnancies between 11+0 and 16+6 weeks of gestation and high risk for preeclampsia in the first trimester screening (risk ≥1/50)

You may qualify if:

  • 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

You may not qualify if:

  • Fetal malformation
  • Fetal death
  • Maternal digestive inflammatory disease or intolerance
  • Refusal to give informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Manel Mendoza

Barcelona, 08035, Spain

RECRUITING

MeSH Terms

Conditions

Pregnancy ComplicationsPre-EclampsiaPreterm Premature Rupture of the MembranesPremature BirthFetal Death

Condition Hierarchy (Ancestors)

Female Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesHypertension, Pregnancy-InducedObstetric Labor, PrematureObstetric Labor ComplicationsDeathPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 20, 2024

First Posted

February 28, 2024

Study Start

February 16, 2024

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

March 20, 2024

Record last verified: 2024-03

Locations

ES(1)