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| ID | Type | Description | Link |
|---|---|---|---|
| 2016- A00846-45 | Other Identifier | ANSM |
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Fetal heart rate abnormalities are common. Miller et al. have demonstrated that new onset fetal heart rate abnormalities after initial labor epidural dosing occur more frequently in women with a low admission pulse pressure than those with a normal admission pulse. The aim of the present study is to look for a statistical link between the occurrence of a fetal heart abnormality requiring an intervention and maternal hemodynamic factors (blood pressure, pulse pressure, and cardiac output) measured before epidural analgesia in two positions: dorsal decubitus position and in the left lateral decubitus.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pregnant women | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nicom (TM) | Device | Heart rate, arterial pressure and cardiac output measurements (monitor NICOM) performed in the dorsal decubitus position and in the left lateral decubitus |
|
| Measure | Description | Time Frame |
|---|---|---|
| Fetal heart rate | Fetal heart rate abnormalities occurring during the first hour of epidural analgesia and requiring an intervention. Relationship between maternal hemodynamic factors (heart rate, blood pressure, pulse pressure, and cardiac output) measured before epidural analgesia in two positions (dorsal decubitus position and in the left lateral decubitus) and fetal heart rate abnormalities occurring during the first hour of epidural analgesia and requiring an intervention. | 4 days |
| Measure | Description | Time Frame |
|---|---|---|
| Fetal heart rate | Fetal heart rate abnormalities occurring during the labor (>1 hour) and requiring an intervention. Comparison of the prognostic performance of pulse pressure and cardiac output to detect fetal heart rate abnormalities | 4 days |
| Mode of delivery |
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Inclusion Criteria:
Non-inclusion Criteria:
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Morgan Le Guen, MD | Hôpital Foch | Principal Investigator |
| Marc Fischler, MD PhD | Hôpital Foch | Study Chair |
| Frédéric Mercier, MD PhD | AP-HP Hôpital A. Béclère | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AP-HP Hopital Antoine Beclere | Clamart | 92140 | France | |||
| Institut Hospitalier Franco-Britannique |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23769849 | Background | Miller NR, Cypher RL, Nielsen PE, Foglia LM. Maternal pulse pressure at admission is a risk factor for fetal heart rate changes after initial dosing of a labor epidural: a retrospective cohort study. Am J Obstet Gynecol. 2013 Oct;209(4):382.e1-8. doi: 10.1016/j.ajog.2013.05.049. Epub 2013 Jun 13. |
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Relationship between maternal hemodynamic factors (heart rate, blood pressure, pulse pressure, and cardiac output) measured before epidural analgesia in two positions (dorsal decubitus position and in the left lateral decubitus) and mode of delivery. |
| 4 days |
| Newborn heart rate, blood pressure, pulse pressure, and cardiac output | Relationship between maternal hemodynamic factors (heart rate, blood pressure, pulse pressure, and cardiac output) measured before epidural analgesia in two positions (dorsal decubitus position and in the left lateral decubitus) and newborn health status. | 4 days |
| Number of patients with hemodynamic abnormalities | Heart rate, blood pressure, pulse pressure, and cardiac output measured before and after epidural analgesia. | 4 days |
| Levallois-Perret |
| 92300 |
| France |
| Institut Mutualiste Montsouris | Paris | 75014 | France |
| Hopital Foch | Suresnes | 92150 | France |