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Maternal Hypotension During Cesarean Section and Short Term Neonatal Outcome.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00330512
Recruitment Status : Terminated
First Posted : May 26, 2006
Last Update Posted : June 30, 2009
Sponsor:
Information provided by:
Sheba Medical Center

Study Description
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Brief 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.


Condition or disease
Elective Cesarean Section Maternal Hypotention

Detailed 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.

Study Design
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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Maternal Hypotension During Elective Cesarean Section and Short Term Neonatal Outcome.
Study Start Date : May 2006
Actual Primary Completion Date : July 2007
Actual Study Completion Date : July 2007

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Groups and Cohorts
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Outcome Measures
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Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   up to 1 Day   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
primary care clinic
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00330512


Sponsors and Collaborators
Sheba Medical Center
Investigators
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Principal Investigator: Ayala Maayan, MD Sheba Medical Center
More Information
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Responsible Party: Dr. Ayala Maayan, Sehba Medical Center
ClinicalTrials.gov Identifier: NCT00330512    
Other Study ID Numbers: SHEBA-06-4117-AM-CTIL
First Posted: May 26, 2006    Key Record Dates
Last Update Posted: June 30, 2009
Last Verified: June 2009
Keywords provided by Sheba Medical Center:
regional anestesia
cesarean section
hypotention
newborn
Additional relevant MeSH terms:
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Hypotension
Vascular Diseases
Cardiovascular Diseases