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| Sponsors and Collaborators: |
Sheba Medical Center None |
| Information provided by: | Sheba Medical Center |
| ClinicalTrials.gov Identifier: | NCT00330512 |
Purpose
About 20-25% of deliveries are by cesarean section. Most are elective with use of regional anesthesia (spinal/epidural). Drop of blood pressure after regional anesthesia is common. It have the risk of reduction of blood flow to the placenta and the fetus.
No studies had followed the newborns their first days of live,of mothers who developed hypotension in durins CS.
| Condition | Phase |
|
Elective Cesarean Section Maternal Hypotention |
Phase I |
| MedlinePlus related topics: | Cesarean Section Low Blood Pressure |
| Study Type: | Observational |
| Study Design: | Screening, Longitudinal, Convenience Sample, Retrospective Study |
| Official Title: | Maternal Hypotension During Elective Cesarean Section and Short Term Neonatal Outcome. |
| Estimated Enrollment: | 500 |
A reterospective study of all full term babies, born in elective cesarean section with use of regional anesthesia. Two groups will be define rgarding maternal hypotention following regional anesthesia - maternal hypotention (study group) or normal maternal BP. The definition of Maternal hypotension: decrease in 10% or more in mean BP in compared to first BP taken at admition.
Data will colect from mothers and neonates records as well as operation data. Maternal data: gravida, parity, diseases, medications, demographics, and all data regarding the operation (blood pressures, Heart rates, saturation, treatment given etc.).
Infant data: gestational age, birth weight, sex, Apgar, cord pH, clinical manifestations, medications, time of hospitalization.
Eligibility
| Ages Eligible for Study: | up to 1 Day |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Ayala Maayan, Dr. | 972-3-530-2451 | ayala.maayan@sheba.health.gov.il |
| Sheba Medical Center |
| None |
| Principal Investigator: | Ayala Maayan, MD | Sheba Medical Center |
More Information
| Study ID Numbers: | SHEBA-06--4117-AM-CTIL |
| First Received: | May 25, 2006 |
| Last Updated: | May 25, 2006 |
| ClinicalTrials.gov Identifier: | NCT00330512 |
| Health Authority: | Israel: Israeli Health Ministry Pharmaceutical Administration |
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