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Not yet recruitingNCT07900919Updated Oct 28, 2026

OB VEGA-Phenylephrine vs Norepinephrine Outcomes

A Phase 4 interventional study of Phenylephrine and Norepinephrine in Hypotension During Surgery and Cesarean Birth, sponsored by Wake Forest University Health Sciences. Not yet recruiting at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-28.

Sponsored by Wake Forest University Health Sciences · Phase 4, Interventional, and Treatment

Updated Oct 28, 2026Newly registeredGo to Updates ↓
Phase
Phase 4
Study type
Interventional
Enrollment
1,500
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Study summary

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

02

Conditions studied

  • Hypotension During Surgery
  • Cesarean Birth

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Keywords

  • hypotension
  • cesarean delivery
  • phenylephrine
  • norepinephrine
03

In context

Hypotension

885 studies on the registry are indexed under Hypotension; 195 are open to participants now.

This study's planned enrollment of 1,500 is above the median of 87 across 590 interventional studies indexed under Hypotension.

Browse Hypotension studies →

Lead sponsor

Wake Forest University Health Sciences is the lead sponsor of 1,351 studies on the registry; 201 are open to participants now.

Of its 332 completed or terminated interventional studies of FDA-regulated products, 251 (76%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria

  • \<18 years of age
  • Not require treatment for hypotension
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
1,500 participants (estimated)

Study arms

  • Active comparator
    Phenylephrine

    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

  • Active comparator
    Norepinephrine

    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

  • use of phenylephrine for hypotension intraoperatively during cesarean delivery

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

  • use of norepinephrine for hypotension intraoperatively during cesarean delivery

    Also known as: noradrenaline

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: up to 2 hours

  2. 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

    Time frame: up to 2 hours

  3. Uterine tone-blood loss amount

    Quantitative blood loss (QBL) via gravimetric sponge/lap weighing plus calibrated suction canister volume, corrected for irrigation fluid

    Time frame: hour 24

  4. Uterine tone-blood loss amount - Postoperative hemoglobin drop

    Quantitative blood loss (QBL) Postoperative hemoglobin drop (pre-op minus postoperative day 1 hemoglobin)

    Time frame: hour 24

Secondary outcomes

  1. Incidence of Hypotension

    systolic blood pressure \<80% baseline

    Time frame: up to 2 hours

  2. Incidence of Bradycardia

    heart rate \<60bpm

    Time frame: up to 2 hours

  3. Number of rescue boluses of vasopressor

    number of rescue bolus doses of vasopressors used

    Time frame: up to 2 hours

  4. Nausea

    presence or absence of nausea occurring

    Time frame: up to 2 hours

  5. Intraoperative nausea/vomiting (yes/no)

    presence or absence of vomiting occurring

    Time frame: up to 2 hours

  6. umbilical blood gas

    if done, measurement of pH, base excess, and lactate

    Time frame: up to 2 hours

  7. 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

    Time frame: Minute 1 and 5

  8. Incidence of Postpartum hemorrhage

    incidence of postpartum hemorrhage and if transfusion or other blood product derivative required

    Time frame: Hour 24

  9. Incidence of Maternal Shivering

    incidence of shivering occurring -yes or no

    Time frame: up to 2 hours

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Oct 28, 2026
Show all 1 update
  1. Oct 28, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07900919
Responsible party
Sponsor
First posted
Oct 28, 2026
Start date
Jan 2027 (estimated)
Primary completion
Dec 2027 (estimated)
Completion
Dec 2027 (estimated)
Last update
Oct 28, 2026

Study contacts

B S Segal, MD
Contact
b.segal@wfusm.edu
336-716-4498
Anna Wright, MD
Contact
Anna.R.Wright@advocatehealth.org
336-716-4498
B. S Segal, MD
principal investigator · Advocate Health-Wake Forest School of Medicine

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drugs tested here: Phenylephrine · Norepinephrine

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