Evaluation of ex-utero collection for umbilical cord blood banking: A randomized clinical trial comparing cord blood quality with the in-utero technique.
Level 2 - randomized trial
Individual randomized controlled trial
PubMed 42240935 · doi:10.1002/ijgo.71086
What was done
A prospective, unblinded, 1:1 randomized clinical trial was conducted in Barcelona (September 2023 to September 2024) comparing ex-utero collection (after placental delivery) to standard in-utero collection (before placental delivery) of umbilical cord blood (UCB). In both arms, the cord was clamped 1 minute after birth. The primary endpoint was non-inferiority in collected UCB unit weight (grams). Secondary endpoints included total nucleated cell (TNC) count, red blood cell count, hematocrit, platelet count, and bacterial contamination in units meeting minimum weight criteria (>=85 g) designated for clinical banking.
What was found
Of 129 pregnant women randomized, 101 were analyzed (48 ex-utero, 53 in-utero; 28 were excluded post-randomization). Mean UCB weight was 107.19 ± 29.51 g in the ex-utero group versus 110.81 ± 29.62 g in the in-utero group (mean difference -3.62 g, 95% CI: -13.41 to 6.16 g). The proportion of units below 85 g was comparable between groups. Positive bacterial cultures occurred in 1/22 tested ex-utero samples and 1/35 tested in-utero samples. TNC counts, red blood cell counts, hematocrit, and platelet counts did not differ significantly between arms.
Why it matters
Ex-utero cord blood collection provides comparable unit yield and cellular quality to standard in-utero harvesting. This confirms that placental delivery can precede collection, allowing for a less intrusive procedure during childbirth without compromising biobank viability.
Limits
The trial was conducted at a single center with a modest sample size. There was a notable post-randomization exclusion rate (21.7% overall; 18 in the ex-utero arm vs 10 in the in-utero arm), and secondary biological outcomes were measured only in the subset of units qualifying for clinical use rather than the entire intention-to-treat cohort.
Cited by
- supports A typical cord blood collection yields about 100 milliliters of blood, while a human placenta weighs roughly 1 kilogram.