Ignite Creation Date:
2024-05-05 @ 11:38 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00098709
Status:
TERMINATED
Last Update Posted:
2022-03-18
First Post:
2004-12-07
Brief Title:
Fetal Pulse Oximetry Trial FOX
Sponsor:
The George Washington University Biostatistics Center
Organization:
The George Washington University Biostatistics Center
Study Overview
Official Title:
A Randomized Clinical Trial of Fetal Pulse Oximetry
Status:
TERMINATED
Status Verified Date:
2022-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine if the information provided to the physician by a fetal pulse oximeter during labor will reduce the chances of a cesarean delivery
Detailed Description:
Information on fetal well-being during labor is of great importance to the managing physician The current use of the fetal heart rate monitor provides some information on fetal condition and is the primary tool used to determine if immediate operative delivery is required The fetal pulse oximeter can provide additional information regarding fetal oxygen saturation
Intervention A fetal oxygen saturation sensor is placed in the uterus between the fetal cheek or forehead and the uterine wall In half of the patients the managing physician will have access to fetal oxygen saturation and fetal heart rate monitoring In the other half of the patients labor will be monitored by fetal heart rate alone
Study hypothesis The additional information provided by the use of the fetal pulse oximeter will reduce the chances of a cesarean delivery The primary outcome is cesarean section for any indication and secondary outcomes are cesarean delivery for non-reassuring fetal heart rate or dystocia and neonatal morbidity
Intervention A fetal oxygen saturation sensor is placed in the uterus between the fetal cheek or forehead and the uterine wall In half of the patients the managing physician will have access to fetal oxygen saturation and fetal heart rate monitoring In the other half of the patients labor will be monitored by fetal heart rate alone
Study hypothesis The additional information provided by the use of the fetal pulse oximeter will reduce the chances of a cesarean delivery The primary outcome is cesarean section for any indication and secondary outcomes are cesarean delivery for non-reassuring fetal heart rate or dystocia and neonatal morbidity
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U10HD036801 | NIH | None | httpsreporternihgovquickSearchU10HD036801 |
| U10HD021410 | NIH | None | None |
| U10HD027869 | NIH | None | None |
| U10HD027917 | NIH | None | None |
| U10HD027860 | NIH | None | None |
| U10HD034116 | NIH | None | None |
| U10HD034208 | NIH | None | None |
| U10HD034136 | NIH | None | None |
| U10HD040500 | NIH | None | None |
| U10HD040485 | NIH | None | None |
| U10HD040544 | NIH | None | None |
| U10HD040545 | NIH | None | None |
| U10HD040560 | NIH | None | None |
| U10HD040512 | NIH | None | None |