UnknownNot Applicable

Diastolic Deceleration Area in Early-onset FGR

Bulgaria300 participantsStarted 2022-04-19

Plain-language summary

DDA is a new Doppler parameter aiming to assess fetal well-being in-utero. Early-onset SGR is a specific subgroup of fetuses where the clinical application of this Doppler modality could play an important role in the detection of hypoxia, anemia, and brain-sparing.

Who can participate

Age range

18 Years – 48 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * absence of fetal abnormalities and/or genetic conditions; * single pregnancy; * fetal growth restriction (FGR) \< 10%, according to the INTERGROWTH 21st nomograms, appearing before 32nd week of gestation Exclusion Criteria: * documented fetal abnormalities and/or genetic conditions in the course of the pregnancy; * multiple pregnancy; * absence of fetal growth restriction (FGR) \< 10%, according to the INTERGROWTH 21st nomograms before 32nd week of gestation

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Hypoxia in the newborn

Timeframe: immediately after delivery

Anemia in the newborn

Timeframe: immediately after delivery

Occurence of hypoxic-ischemic encephalopathy

Timeframe: first 72 hours after delivery

Trial details

NCT IDNCT05820464

SponsorOrthogyn Medical Center, Bulgaria

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2024-02-01

Contact for this trial

Petar N Ignatov, PhD

+359888963189 ignatov@orthogyn.com

View on ClinicalTrials.gov More Hypoxia trials