Maternal Hypotension During Cesarean Section and Short Term Neonatal Outcome.

Elective Cesarean Section Clinical Trial

Official title:

Maternal Hypotension During Elective Cesarean Section and Short Term Neonatal Outcome.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00330512
• Other study ID #: SHEBA-06-4117-AM-CTIL
• 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

Related Conditions & MeSH terms

• Elective Cesarean Section
• Hypotension
• Maternal Hypotention

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sheba Medical Center