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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00330512
Other study ID # SHEBA-06-4117-AM-CTIL
Secondary ID
Status Terminated
Phase Phase 1
First received May 25, 2006
Last updated June 28, 2009
Start date May 2006
Est. completion date July 2007

Study information

Verified date June 2009
Source Sheba Medical Center
Contact n/a
Is FDA regulated No
Health authority Israel: Israeli Health Ministry Pharmaceutical Administration
Study type Observational

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Terminated
Enrollment 500
Est. completion date July 2007
Est. primary completion date July 2007
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group N/A to 1 Day
Eligibility Inclusion Criteria:

- fullterm infants, born by elective cesarean section using regional anasthesia.

Exclusion Criteria:

- preterms, urgent CS, CS using general anasthesia, Multiple pregnancy, Congenital malformations.

Study Design

Observational Model: Cohort, Time Perspective: Retrospective


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Sheba Medical Center
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