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NCT01232387 · ClinicalTrials.gov registry record
Identification of Early Predictors of Fetomaternal Hemorrhage
A clinical trial, sponsored by Icahn School of Medicine at Mount Sinai.
- Completed
- Registry status
- 39
- Enrollment target
NCT01232387 is a clinical trial that has completed, run by Icahn School of Medicine at Mount Sinai. The registered enrollment target is 39 participants.
The verdict
NCT01232387 has completed, sponsored by Icahn School of Medicine at Mount Sinai.
- COMPLETED
- Registry status
- 39 participants
- Enrollment target
Study Summary
Objectives: 1) To determine risk factors for fetomaternal hemorrhage. 2) To identify a cost-effective method to detect fetomaternal hemorrhage prior to significant fetal anemia. Significance/Background: Fetomaternal hemorrhage (FMH) is a condition in which occurs when the placenta transfers blood from the fetus to the mother. Normally, nutrition and gasses pass from mother to baby through the placenta and only waste products pass from baby to mother through the placenta. Whole blood cells do not normally cross the placenta in significant amounts. Mild FMH, where a small amount of whole blood passes from fetus to mother but does not hurt the mother or baby, occurs in about 75% of pregnancies. A pregnant woman does not know this occurs. It is only discovered if a special blood test that is labor-intensive to perform and difficult to interpret called the Kleihauer-Betke acid elution test is done. As mild FMH hurts no one, this test is not part of routine care. In most cases, testing is done only if a baby is born sick with unexplained anemia. Severe FMH, which can cause the baby to become sick from anemia (low red blood cell count) is caused by large blood loss into the mother, occurs in only 1-3 per 1000 births. Severe anemia caused by FMH can result in death of the baby before or after birth, or significant illness in the newborn period. Short term problems for the baby include difficulty breathing, difficulty maintaining blood pressure, and difficulty providing oxygen to all parts of the body. This can cause multiple problems with the function of internal organs including the liver, kidneys, intestines, and brain. Babies who become sick from severe FMH can develop long-term problems including cerebral palsy (a lifelong problem with body movements) and/or mental retardation. It is not known why some pregnancies are affected by FMH and others are not. It is thought that FMH may occur more frequently now than in the past, but no one knows why. If identified early, FM
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 39 participants |
| Start Date | 2011-05 |
| Est. Completion | 2013-09 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01232387
The ClinicalTrials.gov registry entry for NCT01232387 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 39 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Icahn School of Medicine at Mount Sinai, which has 708 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 0 interventions.
NCT01232387 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01232387 about?
NCT01232387 is a clinical study titled "Identification of Early Predictors of Fetomaternal Hemorrhage". Objectives: 1) To determine risk factors for fetomaternal hemorrhage. 2) To identify a cost-effective method to detect fetomaternal hemorrhage prior to significant fetal anemia. Significance/Background: Fetomaternal hemorrhage (FMH) is a condition in which occurs when the placenta transfers blood f...
What is the current status of trial NCT01232387?
This trial is currently completed. The enrollment target is 39 participants. The study started on 2011-05. Estimated completion is 2013-09.
Who is sponsoring clinical trial NCT01232387?
This trial is sponsored by Icahn School of Medicine at Mount Sinai, which has 708 total clinical trials registered on ClinicalTrials.gov.
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