NCT02958215

Brief Summary

Pregnant women with a positive preoperative Supine stress test were found to be a subgroup at increased risk of symptomatic hypotension after spinal anesthesia

Trial Health

87
On Track

Trial Health Score

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

Enrollment
980

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jun 2016

Shorter than P25 for phase_2

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

June 1, 2016

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 4, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 8, 2016

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
Last Updated

May 18, 2017

Status Verified

May 1, 2017

Enrollment Period

11 months

First QC Date

November 4, 2016

Last Update Submit

May 16, 2017

Conditions

Anesthesia, ObstetricalAnesthesia, Spinal

Keywords

OrthostaticCesarean sectionPregnantPhenyephrineHypotension

Outcome Measures

Primary Outcomes (1)

  • Incidence of hypotension

    blood pressure will be measured every 3 minutes within the first 30 minutes after spinal block the every 5 minutes till the end of the caesarian section. postoperatively will be checked every 15 minutes in the first hour the every 30 minutes till the recovery from spinal block

    within first 24 hours after spinal anesthesia

Secondary Outcomes (4)

  • Frequency of bradycardia

    within first 24 hours after spinal anesthesia

  • Ephedrine usage

    within first 24 hours after spinal anesthesia

  • intraoperative fluid management

    within first 24 hours after spinal anesthesia

  • Apgar scores

    within first 24 hours after spinal anesthesia

Study Arms (2)

Group A

PLACEBO COMPARATOR

This group will include patients with orthostatic hypotension and will be managed with routine spinal anesthesia Ephedrine will be used for management of intraoperative hypotension

Other: Placebo

Group B

ACTIVE COMPARATOR

This group will include patients with orthostatic hypotension and will be managed with prophylaxis single dose of phenylephrine, 50 ug IV, will be administered immediately before the spinal block then the patients will be managed with routine spinal anesthesia Ephedrine will be used for management of intraoperative hypotension

Drug: Phenylephrine

Interventions

PhenylephrineDRUG

it will be given as a prophylaxis for prevention of hypotension after spinal anesthesia in pregnant patients undergoing cesarean section

Group B
PlaceboOTHER

5 ml normal saline will be given before spinal anesthesia

Group A

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Physical status ASA I, A full term pregnancy A single fetus Elective cesarean section.

You may not qualify if:

  • Refusal of the patient to participate in the study History of hypertension Pregnancy-induced hypertension Cardiovascular or cerebrovascular disease Fetal abnormalities History of hypersensitivity to the drugs used Contraindications to spinal block.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine

Asyut, Egypt

Location

MeSH Terms

Conditions

Hypotension

Interventions

Phenylephrine

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

EthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAmines

Study Officials

  • Sayed K Abd-Elshafy, MD

    Associate professor of anesthesia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate profossor of anesthesia

Study Record Dates

First Submitted

November 4, 2016

First Posted

November 8, 2016

Study Start

June 1, 2016

Primary Completion

May 1, 2017

Study Completion

May 1, 2017

Last Updated

May 18, 2017

Record last verified: 2017-05

Locations

EG(1)