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Maternal Hypotension During Cesarean Section and Short Term Neonatal Outcome.
This study is not yet open for participant recruitment.
Verified by Sheba Medical Center, May 2006
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
U.S. FDA Resources
Study Type: Observational
Study Design: Screening, Longitudinal, Convenience Sample, Retrospective Study
Official Title: Maternal Hypotension During Elective Cesarean Section and Short Term Neonatal Outcome.

Further study details as provided by Sheba Medical Center:

Estimated Enrollment: 500
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.

  Eligibility

Ages Eligible for Study:   up to 1 Day
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00330512

Contacts
Contact: Ayala Maayan, Dr. 972-3-530-2451 ayala.maayan@sheba.health.gov.il

Sponsors and Collaborators
Sheba Medical Center
None
Investigators
Principal Investigator: Ayala Maayan, MD Sheba Medical Center
  More Information

Study ID Numbers: SHEBA-06--4117-AM-CTIL
Study First Received: May 25, 2006
Last Updated: May 25, 2006
ClinicalTrials.gov Identifier: NCT00330512  
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Sheba Medical Center:
regional anestesia
cesarean section
hypotention
newborn

Study placed in the following topic categories:
Hypotension
Vascular Diseases

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 15, 2009



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