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The goal of this study is to determine whether the use of sequential compression devices (lower limb compression) can reduce the rate of maternal hypotension after epidural, and therefore reduce the incidence of fetal heart tracing complications during labor.
Maternal hypotension during epidural anesthesia in laboring patients can cause a number of problems for both mother and fetus. Despite standard anesthesia protocols designed to minimize the occurrence of hypotension during epidural placement, approximately 30% of laboring patients will still experience clinically significant hypotension. Maternal hypotension can affect placental blood flow causing fetal bradycardia and academia, as well as maternal symptoms such as dizziness, nausea, and vomiting. Therefore, there is a need for improved management of women in labor at time of epidural placement to avoid negative consequences for mother and fetus. We plan to investigate whether the use of lower limb compression devices at the time of epidural would decrease maternal hypotension.
Pregnant women who request epidural anesthesia during labor will be recruited and enrolled in this single site, randomized controlled trial. Patients will be randomized into either control or sequential compression device (SCD) groups. Following epidural, blood pressures will be measured at 1, 5, 15, 30, 45, and 60 minutes and rates of hypotension with subsequent fetal heart tracing abnormalities will be recorded.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | No intervention, the patient will be provided routine care at time of epidural placement without use of sequential compression devices. | |
| Lower Extremity Compression | Experimental | Patients will have sequential compression devices prior to epidural placement, and maintained for at least one hour following procedure. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sequential compression devices | Device | Two lower limb intermittent compression devices to be placed on the mid-calf of each leg. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maternal hypotension | Determined by maternal blood pressure measurements. | Blood pressures measured at 1 minute following epidural placement. |
| Maternal hypotension | Determined by maternal blood pressure measurements. | Blood pressures measured at 5 minutes following epidural placement. |
| Maternal hypotension | Determined by maternal blood pressure measurements. | Blood pressures measured at 15 minutes following epidural placement. |
| Maternal hypotension | Determined by maternal blood pressure measurements. | Blood pressures measured at 30 minutes following epidural placement. |
| Maternal hypotension | Determined by maternal blood pressure measurements. | Blood pressures measured at 45 minutes following epidural placement. |
| Maternal hypotension | Determined by maternal blood pressure measurements. | Blood pressures measured at 60 minutes following epidural placement. |
| Measure | Description | Time Frame |
|---|---|---|
| Fetal heart rate tracing category | Determination of category I, II or III fetal heart rate tracing. | Two hours following epidural placement. |
| Delivery method | Vaginal or cesarean delivery ( report) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jeffrey Johnson, MD | Detroit Medical Center/Wayne State University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Detroit Medical Center | Detroit | Michigan | 48201 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 3674479 | Background | Brizgys RV, Dailey PA, Shnider SM, Kotelko DM, Levinson G. The incidence and neonatal effects of maternal hypotension during epidural anesthesia for cesarean section. Anesthesiology. 1987 Nov;67(5):782-6. doi: 10.1097/00000542-198711000-00025. No abstract available. | |
| 12100826 | Background | Goetzl LM; ACOG Committee on Practice Bulletins-Obstetrics. ACOG Practice Bulletin. Clinical Management Guidelines for Obstetrician-Gynecologists Number 36, July 2002. Obstetric analgesia and anesthesia. Obstet Gynecol. 2002 Jul;100(1):177-91. doi: 10.1016/s0029-7844(02)02156-7. |
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| ID | Term |
|---|---|
| D048949 | Labor Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Randomization of patients to either control or study groups.
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| length of labor. |
| 7091625 | Background | Corke BC, Datta S, Ostheimer GW, Weiss JB, Alper MH. Spinal anaesthesia for Caesarean section. The influence of hypotension on neonatal outcome. Anaesthesia. 1982 Jun;37(6):658-62. doi: 10.1111/j.1365-2044.1982.tb01278.x. |
| 17413923 | Background | American Society of Anesthesiologists Task Force on Obstetric Anesthesia. Practice guidelines for obstetric anesthesia: an updated report by the American Society of Anesthesiologists Task Force on Obstetric Anesthesia. Anesthesiology. 2007 Apr;106(4):843-63. doi: 10.1097/01.anes.0000264744.63275.10. No abstract available. |