NCT00330512

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2006

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2006

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

May 25, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 26, 2006

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2007

Completed
Last Updated

June 30, 2009

Status Verified

June 1, 2009

Enrollment Period

1.2 years

First QC Date

May 25, 2006

Last Update Submit

June 28, 2009

Conditions

Elective Cesarean SectionMaternal Hypotention

Keywords

regional anestesiacesarean sectionhypotentionnewborn

Eligibility Criteria

Age1 Day - 1 Day
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

primary care clinic

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Ayala Maayan, MD

    Sheba Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

May 25, 2006

First Posted

May 26, 2006

Study Start

May 1, 2006

Primary Completion

July 1, 2007

Study Completion

July 1, 2007

Last Updated

June 30, 2009

Record last verified: 2009-06