An observational study in Trisomy 21 in Fetus, Trisomy 18 in Fetus and Trisomy 13 in Fetus, sponsored by Axis Shield Diagnostics Ltd. Completed at 1 site in United Kingdom. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-08-14.
Sponsored by Axis Shield Diagnostics Ltd · Observational
Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →
Among 16 studies in Down Syndrome with a site in United Kingdom — 3 open to participants now, 3 under way, none of them phase 3. Down Syndrome · United Kingdom.
Among the 16 studies in Down Syndrome with a site in United Kingdom, this one is one of 2 that started in 2017, is one of 7 observational ones, and was the 11th registered.
438 studies on the registry are indexed under Down Syndrome; 99 are open to participants now.
Browse Down Syndrome studies →3 of the 16 studies in Down Syndrome with a site in United Kingdom are open now. Recruiting first, the newest first:
Children's Health Ireland · Sites in United Kingdom, Ireland
Ages 6 mo–16 yrs
AC Immune SA · Sites in United Kingdom, United States, Spain
Ages 35–85
University of Southern California · Sites in United Kingdom, United States, France and 2 more countries
Ages 25–55
A study can be open while its sites in United Kingdom have not opened yet or have stopped. Only those recruiting at a site in United Kingdom →
Of the 75 Down Syndrome studies recruiting now, 14 (19%) set no upper age limit and 58 (77%) stop at 75 or younger; 61 take children under 18; 19 take healthy volunteers.
This study: 18 Years and older · female.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
16 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 4 · Phase 2 2 · Phase 3 1
First in 2002; this study’s year is marked. 2 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 150 is close to the median of 158 across 145 observational studies indexed under Down Syndrome.
Median enrollment 177 across the 8 interventional studies, 230 across the 7 observational. Of the 10 that completed or were terminated, 0 (0%) have results posted.
This tab as a report to print or save as PDF → With an account.
9 of 16 have an industry lead sponsor. The 10 most frequent:
Axis Shield Diagnostics Ltd is the lead sponsor of 4 studies on the registry; none are open to participants now.
Axis Shield Diagnostics Ltd has 1 study filed under Down Syndrome — fewer than ten, so there is no comparison to draw.
1 of the studies in Down Syndrome with a site in United Kingdom that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06030349Children's Health IrelandClinical Outcomes From Treatment and Evaluation of Obstructive Sleep Apnoea in Children With Down Syndrome | 2027-11-28 |
Add it to your calendar (.ics) → With an account.
Among the 16 studies in Down Syndrome with a site in United Kingdom, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
Blood samples collected will be shipped to the sponsor's laboratory to establish analytical performance characteristics of the ADVIA Centaur® Pregnancy Associated Plasma Protein A (PAPP-A) and ADVIA Centaur® Free Beta Human Chorionic Gonadotropin (Free βhCG) assays.
Blood samples are to be collected from pregnant women attending their scheduled 1st Trimester scan; the samples are to be collected immediately after the subject's routine blood sample at the clinic visit. No extra venepuncture will be required.
Blood samples collected will be shipped to the sponsor's laboratory to establish analytical performance characteristics of the ADVIA Centaur® Pregnancy Associated Plasma Protein A (PAPP-A) and ADVIA Centaur® Free Beta Human Chorionic Gonadotropin (Free βhCG) assays.
First trimester pregnancy
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
A subject is considered eligible for participation in the trial if all of the following inclusion criteria are satisfied prior to enrolment:
Exclusion Criteria:
A subject is not eligible for participation in the trial if any of the following exclusion criteria are met prior to enrolment:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Sample handling
Percentage change in PAPPA and BhCG levels from baseline sample type to sample type under test.
Time frame: 3 months
Plan to share: No
No publications or documents are linked to this record.
Ran from Nov 2017 to primary completion in Jan 2018, 2 months.
Of 55 observational studies under Down Syndrome, half reached primary completion within 34 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 80. This study's 2 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Axis Shield Diagnostics Ltd