Trials Sponsors Conditions Drugs Pricing

Conditions

Hypotension During Surgery Cesarean Birth

Keywords

hypotensioncesarean deliveryphenylephrinenorepinephrine

Outcome Measures

Primary Outcomes (4)

Change in Uterine tone-obstetrician evaluation scores
measured by 0-10 numeric rating scale (0 = atonic, 10 = firm/optimal), assessed by obstetrician blinded to group, at fixed timepoints (2, 5, 10 minutes after delivery) - higher scores denoting more desirable
up to 2 hours
Change in Uterine tone-obstetrician evaluation scores with Uterine tone-uterotonic drug administration
measured by 0-10 numeric rating scale (0 = atonic, 10 = firm/optimal), assessed by obstetrician blinded to group, at fixed timepoints (2, 5, 10 minutes after delivery) - higher scores denoting more desirable - measured by addition of supplemental uterotonics - methylergonivine, carboprost, misoprostol, total amount of oxytocin over 20 minutes post delivery
up to 2 hours
Uterine tone-blood loss amount
Quantitative blood loss (QBL) via gravimetric sponge/lap weighing plus calibrated suction canister volume, corrected for irrigation fluid
hour 24

Secondary Outcomes (9)

Incidence of Hypotension
up to 2 hours
Incidence of Bradycardia
up to 2 hours
Number of rescue boluses of vasopressor
up to 2 hours
Nausea
up to 2 hours
Intraoperative nausea/vomiting (yes/no)
up to 2 hours
+4 more secondary outcomes

Study Arms (2)

Phenylephrine

ACTIVE COMPARATOR

Phenylephrine is a selective alpha-1 adrenergic receptor agonist and sympathomimetic medication - treatment of hypotension during cesarean delivery with the use of either phenylephrine or norepinephrine

Drug: Phenylephrine

Norepinephrine

ACTIVE COMPARATOR

Norepinephrine (also called noradrenaline) is an organic chemical in the catecholamine family that functions in the human body and brain as both a neurotransmitter and a hormone - treatment of hypotension during cesarean delivery with the use of either phenylephrine or norepinephrine

Drug: Norepinephrine

Interventions

PhenylephrineDrug

use of phenylephrine for hypotension intraoperatively during cesarean delivery

Also known as: Phenylephrine is a selective alpha-1 adrenergic receptor agonist and sympathomimetic medication

Phenylephrine

NorepinephrineDrug

use of norepinephrine for hypotension intraoperatively during cesarean delivery

Eligibility Criteria

Age18 Years+

Sexfemale(Gender-based eligibility)

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Age ≥ 18 years at the time of surgery
Require receipt of medication to treat hypotension during the cesarean delivery

Sponsors & Collaborators

Wake Forest University Health Sciences
Otherlead

Study Sites (1)

Atrium Health-Wake Forest Baptist

Winston-Salem, North Carolina, 27157, United States

B. S Segal, MDCONTACT336-716-4498 b.segal@wfusm.edu

Lynnette Harris, BSNCONTACT336-306-0778 lynnette.harris@advocatehealth.org

B. S Segal, MDPRINCIPAL INVESTIGATOR

Anna R. Wright, MDSUB INVESTIGATOR

MeSH Terms

Conditions

Hypotension

Interventions

PhenylephrineNorepinephrine

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

EthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAminesBiogenic MonoaminesBiogenic AminesCatecholamines

Study Officials

B. S Segal, MD
Advocate Health-Wake Forest School of Medicine
PRINCIPAL INVESTIGATOR

Central Study Contacts

B S Segal, MD

CONTACT

336-716-4498 b.segal@wfusm.edu

Anna Wright, MD

CONTACT

336-716-4498

Study Design

Study Type: interventional
Phase: phase 4
Allocation: RANDOMIZED
Masking: SINGLE
Who Masked: PARTICIPANT
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

October 21, 2026

First Posted

October 28, 2026

Study Start

January 2027

Estimated

Planned date reported by the registry; this milestone is not confirmed as achieved.

Primary Completion

December 2027

Estimated

OB VEGA-Phenylephrine vs Norepinephrine Outcomes

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (4)

Secondary Outcomes (9)

Study Arms (2)

Phenylephrine

Norepinephrine

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (4)

Secondary Outcomes (9)

Study Arms (2)

Phenylephrine

Norepinephrine

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations