NCT00846651

Brief Summary

The purpose of this study is to compare two methods for preventing low blood pressure associated with spinal anesthesia during Cesarean sections.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
82

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Feb 2009

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2009

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

February 18, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 19, 2009

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2010

Completed
3.4 years until next milestone

Results Posted

Study results publicly available

July 3, 2013

Completed
Last Updated

October 16, 2017

Status Verified

September 1, 2017

Enrollment Period

10 months

First QC Date

February 18, 2009

Results QC Date

February 4, 2013

Last Update Submit

September 14, 2017

Conditions

Hypotension

Keywords

spinal anesthesiacesarean section

Outcome Measures

Primary Outcomes (1)

  • Incidence of Maternal Hypotension

    participants were assessed for an average of 20 min, after performing the spinal anesthetic till the delivery of the baby

Secondary Outcomes (5)

  • Dosage of Phenylephrine Used

    participants were assessed for an average of 20 min, after performing the spinal anesthetic till the delivery of the baby

  • Incidence of Maternal Bradycardia

    participants were assessed for an average of 20 min, after performing the spinal anesthetic till the delivery of the baby

  • Fetal Cord Blood pH

    delivery of the baby

  • APGAR Scores

    Apgar scores were assessed at 1 amd 5 min after delivery of the baby

  • Incidence of Maternal Nausea and Vomiting

    participants were assessed for an average of 20 min, after performing the spinal anesthetic till the delivery of the baby

Study Arms (2)

colloid, then phenylephrine infusion

EXPERIMENTAL

colloid administration; with 0.5 L Hydroxyethylstarch solution at a rate of 17 ml/min and completed over 30 min. A phenylephrine infusion will be started immediately after performing the spinal anesthesia and continued until time of uterine incision.

Other: Colloid administrationDrug: phenylephrine infusion

crystalloid, then phenylephrine infusion

ACTIVE COMPARATOR

crystalloid administration; The patients received 1.5 L Ringer's lactate infusion at a rate of 50 ml/min and completed over 30 min prior to spinal anesthesia for cesarean section. A phenylephrine infusion will be started immediately after performing the spinal anesthesia and continued until time of uterine incision.

Other: Crystalloid administrationDrug: phenylephrine infusion

Interventions

Colloid administrationOTHER

The patients received 0.5 L colloid solution (hydroxyethylstarch 6%) or 1.5 L Ringer lactate prior to spinal anesthesia for cesarean section.

colloid, then phenylephrine infusion
Crystalloid administrationOTHER

The patients received 1.5 L Ringer lactate prior to spinal anesthesia for cesarean section.

crystalloid, then phenylephrine infusion
phenylephrine infusionDRUG

A phenylephrine infusion will be started immediately after performing the spinal anesthesia and continued until time of uterine incision.

colloid, then phenylephrine infusioncrystalloid, then phenylephrine infusion

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • American Society of Anesthesiologists (ASA) physical status I and II
  • Elective cesarean section
  • Weight 50-120 kg, Height 150-180 cm
  • Normal singleton pregnancy
  • Beyond 36 weeks gestation
  • No known fetal abnormalities
  • Ages 18-35

You may not qualify if:

  • Contraindications to spinal anesthesia
  • Multiple gestation, placenta previa, accreta
  • Pregnancy induced hypertension or preeclampsia
  • Diabetes mellitus, cardiovascular diseases
  • Coagulopathy
  • Spinal cord abnormalities, spinal surgery, or preexisting neurological dysfunction
  • Baseline HR \<65
  • Failed spinal anesthesia/inadequate sensory block for surgery
  • History of abnormal bleeding
  • History of adverse reactions to hydroxyethylstarch

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

PennState Hershey Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

MeSH Terms

Conditions

Hypotension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Limitations and Caveats

technical problems for analysing fetal pH in all newborns

Results Point of Contact

Title
Sonia Vaida
Organization
Penn State Milton S. Hershey Medical Center
svaida@hmc.psu.edu
7175318433

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D, Vice chair for research, Anesthesia Department

Study Record Dates

First Submitted

February 18, 2009

First Posted

February 19, 2009

Study Start

February 1, 2009

Primary Completion

December 1, 2009

Study Completion

February 1, 2010

Last Updated

October 16, 2017

Results First Posted

July 3, 2013

Record last verified: 2017-09

Locations

US(1)