Hypotension During SurgeryPhase 4NCT07900919
OB VEGA-Phenylephrine vs Norepinephrine Outcomes
A Phase 4 study testing Phenylephrine and Norepinephrine in people with Hypotension During Surgery and Cesarean Birth, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
OB VEGA-Phenylephrine vs Norepinephrine Outcomes evaluation Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Hypotension During Surgery, Cesarean Birth
- What is being tested?
- Phenylephrine and Norepinephrine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,500 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2027to Dec 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years at the time of surgery
- Require receipt of medication to treat hypotension during the cesarean delivery
Who cannot join
- <18 years of age
- Not require treatment for hypotension
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Atrium Health-Wake Forest Baptist
Winston-Salem, North Carolina, 27157
B. S Segal, MD, 336-716-4498, b.segal@wfusm.edu
Lynnette Harris, BSN, 336-306-0778, lynnette.harris@advocatehealth.org
About this study
OB VEGA-Phenylephrine vs Norepinephrine Outcomes evaluation
Read the detailed description
This study aims to evaluate the comparison of phenylephrine to norepinephrine for the treatment of anesthesia induced hypotension during cesarean delivery
- Conditions
- Hypotension During Surgery, Cesarean Birth
- Being tested
- Phenylephrine, Norepinephrine
- Keywords
- hypotension, cesarean delivery, phenylephrine, norepinephrine
- Medical subject headings
- Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhenylephrineDrug
Also called Phenylephrine is a selective alpha-1 adrenergic receptor agonist and sympathomimetic medication
use of phenylephrine for hypotension intraoperatively during cesarean delivery
NorepinephrineDrug
Also called noradrenaline
use of norepinephrine for hypotension intraoperatively during cesarean delivery
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: Norepinephrine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: hour 24
Uterine tone-blood loss amount - Postoperative hemoglobin drop
Quantitative blood loss (QBL) Postoperative hemoglobin drop (pre-op minus postoperative day 1 hemoglobin)
Measured: hour 24
Secondary outcomes (9)
Incidence of Hypotension
systolic blood pressure <80% baseline
Measured: up to 2 hours
Incidence of Bradycardia
heart rate <60bpm
Measured: up to 2 hours
Number of rescue boluses of vasopressor
number of rescue bolus doses of vasopressors used
Measured: up to 2 hours
Nausea
presence or absence of nausea occurring
Measured: up to 2 hours
Intraoperative nausea/vomiting (yes/no)
presence or absence of vomiting occurring
Measured: up to 2 hours
umbilical blood gas
if done, measurement of pH, base excess, and lactate
Measured: up to 2 hours
Fetal Apgar scores
measurement of Apgar scores at minutes 1 and 5 after birth
- 7 to 10: Normal and healthy; the baby is doing well.
- 4 to 6: Fairly low; the baby might need some help breathing or warming up.
- 3 or lower: Critically low; the baby needs immediate medical care or life-saving help
Measured: Minute 1 and 5
Incidence of Postpartum hemorrhage
incidence of postpartum hemorrhage and if transfusion or other blood product derivative required
Measured: Hour 24
Incidence of Maternal Shivering
incidence of shivering occurring -yes or no
Measured: up to 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2026
- Study startJan 2027 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypotension During SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- B. S Segal, MD, Principal investigator, Advocate Health-Wake Forest School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07900919
- Sponsor's protocol ID
- IRB00156803
- Status last verified
- Oct 2026
- First submitted
- 21 Oct 2026
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OB VEGA-Phenylephrine vs Norepinephrine Outcomes
- ClinicalTrials.gov ID
- NCT07900919
- Acronym / sponsor ID
- IRB00156803
- Conditions
- Hypotension During Surgery, Cesarean Birth
- Keywords
- hypotension, cesarean delivery, phenylephrine, norepinephrine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- Jan 2027 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 28 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
OB VEGA-Phenylephrine vs Norepinephrine Outcomes evaluation
Detailed description
This study aims to evaluate the comparison of phenylephrine to norepinephrine for the treatment of anesthesia induced hypotension during cesarean delivery
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phenylephrine | Active comparator | Drug: PhenylephrinePhenylephrine 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 |
| Norepinephrine | Active comparator | Drug: NorepinephrineNorepinephrine (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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age ≥ 18 years at the time of surgery
- Require receipt of medication to treat hypotension during the cesarean delivery
Key exclusion criteria (2 listed)
- <18 years of age
- Not require treatment for hypotension
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PhenylephrineAlso: Phenylephrine is a selective alpha-1 adrenergic receptor agonist and sympathomimetic medicationuse of phenylephrine for hypotension intraoperatively during cesarean delivery | Drug | Phenylephrine |
| NorepinephrineAlso: noradrenalineuse of norepinephrine for hypotension intraoperatively during cesarean delivery | Drug | Norepinephrine |
Primary outcome
Change in Uterine tone-obstetrician evaluation scores
Time frame: up to 2 hours
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
Change in Uterine tone-obstetrician evaluation scores with Uterine tone-uterotonic drug administration
Time frame: up to 2 hours
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
Uterine tone-blood loss amount
Time frame: hour 24
Quantitative blood loss (QBL) via gravimetric sponge/lap weighing plus calibrated suction canister volume, corrected for irrigation fluid
Uterine tone-blood loss amount - Postoperative hemoglobin drop
Time frame: hour 24
Quantitative blood loss (QBL) Postoperative hemoglobin drop (pre-op minus postoperative day 1 hemoglobin)
9 secondary outcomes
Incidence of Hypotension
Time frame: up to 2 hours
Incidence of Bradycardia
Time frame: up to 2 hours
Number of rescue boluses of vasopressor
Time frame: up to 2 hours
Nausea
Time frame: up to 2 hours
Intraoperative nausea/vomiting (yes/no)
Time frame: up to 2 hours
umbilical blood gas
Time frame: up to 2 hours
Fetal Apgar scores
Time frame: Minute 1 and 5
Incidence of Postpartum hemorrhage
Time frame: Hour 24
Incidence of Maternal Shivering
Time frame: up to 2 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
B. S Segal, MD principal investigator
Advocate Health-Wake Forest School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Phenylephrine and Norepinephrine in people with Hypotension During Surgery and Cesarean Birth, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact B S Segal, MD (336-716-4498, b.segal@wfusm.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Uterine tone-obstetrician evaluation scores (time frame: up to 2 hours). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2026.