Pregnancy ComplicationsNCT06281366
Diamine Oxidase and Adverse Pregnancy Outcomes
An observational study of Pregnancy Complications, run by Hospital Universitari Vall d'Hebron Research Institute at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pregnancy Complications
- How many people
- 75 participants
- Where
- 1 siteSpain
- Study dates
- 16 Feb 2024to 31 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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)
Who may be able to join
- 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
Who cannot join
- Fetal malformation
- Fetal death
- Maternal digestive inflammatory disease or intolerance
- Refusal to give informed consent
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Manel Mendoza
Barcelona, 08035
Manel Mendoza, PhD, +34934893085, manel.mendoza@vallhebron.cat
Erika Bonacina, PhD, +34934893264, erika.bonacina@vallhebron.cat
About this study
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.
- Conditions
- Pregnancy Complications
- Keywords
- Preeclampsia, PPROM, preterm birth, Fetal death, Low birthweight
- Medical subject headings
- Pregnancy Complications, Pre-Eclampsia, Preterm Premature Rupture of the Membranes, Premature Birth, Fetal Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diamine oxidase activity first trimester
diamine oxidase enzime activity in maternal blood
Measured: 11-16+6 weeks of gestation
Diamine oxidase gene polymorphisms
variants of the AOC1 gene: rs10156191, rs1049742, rs1049793 and rs2052129
Measured: 11-16+6 weeks of gestation
Secondary outcomes (5)
Blood Diamine oxidase activity at delivery
diamine oxidase enzime activity in maternal blood
Measured: At the time of delivery
Placental Diamine oxidase activity at delivery
diamine oxidase enzime activity in placenta
Measured: At the time of delivery
Blood histamine levels at delivery
histamine levels in maternal blood
Measured: At the time of delivery
Placental histamine levels at delivery
histamine levels in placenta
Measured: At the time of delivery
Urine histamine levels at delivery
histamine levels in 24-hour maternal urine
Measured: At the time of delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2024
- Study start16 Feb 2024
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy ComplicationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Universitari Vall d'Hebron Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- DR Healthcare
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06281366
- Sponsor's protocol ID
- PR(AMI)470-2023
- Status last verified
- Mar 2024
- First submitted
- 20 Feb 2024
- Last updated
- 20 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diamine Oxidase and Adverse Pregnancy Outcomes
- ClinicalTrials.gov ID
- NCT06281366
- Acronym / sponsor ID
- PR(AMI)470-2023
- Conditions
- Pregnancy Complications
- Keywords
- Preeclampsia, PPROM, preterm birth, Fetal death, Low birthweight
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Hospital Universitari Vall d'Hebron Research InstituteUniversity, hospital or other
- Collaborators
- DR Healthcare
- Study start
- 16 Feb 2024 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 28 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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)
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- Fetal malformation
- Fetal death
- Maternal digestive inflammatory disease or intolerance
- Refusal to give informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Diamine oxidase activity first trimester
Time frame: 11-16+6 weeks of gestation
diamine oxidase enzime activity in maternal blood
Diamine oxidase gene polymorphisms
Time frame: 11-16+6 weeks of gestation
variants of the AOC1 gene: rs10156191, rs1049742, rs1049793 and rs2052129
5 secondary outcomes
Blood Diamine oxidase activity at delivery
Time frame: At the time of delivery
Placental Diamine oxidase activity at delivery
Time frame: At the time of delivery
Blood histamine levels at delivery
Time frame: At the time of delivery
Placental histamine levels at delivery
Time frame: At the time of delivery
Urine histamine levels at delivery
Time frame: At the time of delivery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy Complications, run by Hospital Universitari Vall d'Hebron Research Institute at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diamine oxidase activity first trimester (time frame: 11-16+6 weeks of gestation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2024; AzTrials last refreshed its copy on 26 Oct 2026.