Maternal Hypotension During Cesarean Section and Short Term Neonatal Outcome.

NCT ID: NCT00330512

Last Updated: 2009-06-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-05-31

Study Completion Date

2007-07-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Elective Cesarean Section Maternal Hypotention

Keywords

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regional anestesia cesarean section hypotention newborn

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

1 Day

Maximum Eligible Age

1 Day

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Sheba Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Sehba Medical Center

Principal Investigators

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Ayala Maayan, MD

Role: PRINCIPAL_INVESTIGATOR

Sheba Medical Center

Other Identifiers

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SHEBA-06-4117-AM-CTIL

Identifier Type: -

Identifier Source: org_study_id