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NCT00462839 · ClinicalTrials.gov registry record · NA

Accuracy of Blood Loss Estimation After Vaginal Delivery

A NA study, sponsored by Northwestern University.

Completed
Registry status
NA
Development phase
106
Enrollment target

NCT00462839: Completed NA study, sponsored by Northwestern University.

NCT00462839 is a NA study that has completed, run by Northwestern University. The registered enrollment target is 106 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00462839, a NA study, has completed, sponsored by Northwestern University.

COMPLETED
Registry status
NA
Development phase
106 participants
Enrollment target

Study Summary

Post-partum hemorrhage (PPH) is defined as blood loss greater than 500 mL after vaginal delivery. Delayed diagnosis of PPH is a major cause of maternal morbidity and mortality. Obstetricians estimate blood loss at delivery by visual estimation of blood collected in the obstetric drapes. Blood is often mixed with urine and surgical sponges. The urine, blood, and sponges collect in a cone shaped plastic bag that is suspended from the perineum during delivery. Visual estimation of blood loss is insensitive in diagnosing PPH. In one study visual assessment of blood loss underestimated postpartum blood loss by 33% to 50% compared to an objective measurement of blood loss using photospectrometry. Other studies have shown that the magnitude of underestimation increases as the amount of blood loss is increased. A limitation of previous studies is that there is no "gold standard" for blood loss determination in the third stage of labor. Care providers (obstetricians, anesthesiologists, and labor \& delivery nurses) need to be able to accurately estimate blood loss in order to better care for mothers and prevent morbidity and mortality. It is unknown whether provider type or experience (obstetric and anesthesiology resident, fellow, attending physicians, and nurses) influences the accuracy of blood loss estimation, or whether blood loss estimation can be improved by providing graduated markings on the vaginal delivery drape.

Primary Outcome

Two types of drapes were used: drapes with and without volume calibrations. Calibrated drapes had volume markings beginning at 500ml with 500ml increments to a total of 2500ml. The participants were asked to estimate the volume contained in the bag and the difference in milliliters between the estimate and actual volume was calculated.

Interventions

  • PROCEDURE blood loss estimation

Trial Details

FieldValue
Enrollment Target 106 participants
Start Date 2006-07
Est. Completion 2008-04
Phase NA
Northwestern University

1,209 total trials

What the finished NCT00462839 record still lists

NCT00462839 is an interventional study that assigns participants to a tested intervention. The registered 106 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (92% lower).

The record links to 0 conditions, and to 1 intervention - of which blood loss estimation is the first listed.

NCT00462839 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00462839 about?

NCT00462839 is a clinical study titled "Accuracy of Blood Loss Estimation After Vaginal Delivery". Post-partum hemorrhage (PPH) is defined as blood loss greater than 500 mL after vaginal delivery. Delayed diagnosis of PPH is a major cause of maternal morbidity and mortality. Obstetricians estimate blood loss at delivery by visual estimation of blood collected in the obstetric drapes. Blood is oft...

What is the current status of trial NCT00462839?

This trial is currently completed. It is a NA study. The enrollment target is 106 participants. The study started on 2006-07. Estimated completion is 2008-04.

What interventions are being tested in trial NCT00462839?

The interventions under investigation include: blood loss estimation (PROCEDURE).

Who is sponsoring clinical trial NCT00462839?

This trial is sponsored by Northwestern University, which has 1,209 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00462839's enrollment target sits among peer trials

106 830th of 2000 higher than 1,167 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00462839, the US trial registry maintained by the National Library of Medicine. NCT00462839 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.