Skip to content

CORDHA study: Optimization of the viability of stem cells derived from umbilical CORd blood after maternal supplementation with docosahexaenoic acid (DHA) during the second or third trimester of pregnancy

A randomised controlled trial for the optimization of the viability of stem cells derived from umbilical CORd blood after maternal supplementation with DHA during the second or third trimester of pregnancy

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN58396079
Enrollment
150
Registered
2013-10-08
Start date
2010-09-01
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Increase the quantity and viability of the stem cells, in the umbilical cord blood samples in pregnant women supplemented with DHA. Pregnancy and Childbirth

Interventions

150 pregnant women will be recruited from the Gynaecological and Obstetrics Service of the ?San Giovanni Calibita FatebeneFratelli-Roma hospital, and from the SmartBank?s clients. ?Each participant re
oxidant impurities, dioxins and furans, dioxin-type polychlorinated biphenyls, polycyclic aromatic hydrocarbons). The packaging of the capsules in the two groups is identical. Additionally, all partic

Sponsors

SmartBank (Italy)
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1. Age >18 years 2. Absence of: diabetes, hypertension or any other type of pathology requiring pharmacological therapy, genetic diseases, chromosome abnormalities and/or congenital malformations in the foetus and the absence of infectious disease (hepatitis B, hepatitis C, HIV and cytomegalovirus).

Exclusion criteria

Exclusion criteria: 1. Age <18 years 2. Presence of: diabetes, hypertension or any other type of pathology requiring pharmacological therapy, genetic diseases, chromosome abnormalities and/or congenital malformations in the foetus and the presence of infectious disease (hepatitis B, hepatitis C, HIV and cytomegalovirus). 3. Cord blood samples with a volume of less than 80 ml and/or less than 70% cell vitality are excluded from the study.

Design outcomes

Primary

MeasureTime frame
Measure of the viability (%) and the number of CD34+ cells collected from the umbilical cord blood at birth from the patients treated with placebo or DHA from the 20th or from the 28th week.

Secondary

MeasureTime frame
Understand which stage of the supplementation with DHA (the second or the third trimester of pregnancy) is more effective in terms of quantity and viability of the stem cells, in the umbilical cord blood samples.

Countries

Italy

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 20, 2026