PhenylephrinePhase 4NCT07420127
Comparison of Two Different Doses of Phenylephrine on Oxytocin Hemodynamic Effect
A Phase 4 study testing Phenylephrine bolus 75 micrograms and Phenylephrine bolus 50 micrograms in people with Phenylephrine and Cesarean Birth, run by Rawalpindi Medical College at 1 site in Pakistan.
Trial summary
Cesarean section is one of the commonly performed surgical procedures in the world. Once baby is delivered during the surgical procedure anesthesiologist administer Oxytocin drug through IV cannula which helps the Uterus to contract so that excessive blood loss doesnt occur. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Phenylephrine, Cesarean Birth
- What is being tested?
- Phenylephrine bolus 75 micrograms and Phenylephrine bolus 50 micrograms
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 sitePakistan
- Study dates
- 13 Feb 2026to 13 Jul 2026
- 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 20 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Females having a singleton pregnancy Patients planned for elective cesarean section under spinal anesthesia
Who cannot join
- Patients having a placental abnormality
- Patients taking beta-blocker and vasodilator therapy
- Patients with hypertensive disorder
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
Department of Anesthesia, Holy Family Hospital, Rawalpindi
Rawalpindi, Punjab Province, 46000
Jawad Head of Department of Anesthesia, MBBS, FCPS, +92 333 5428866, drjayzee@hotmail.com
About this study
Official title: Effects of Two Different Doses of Phenylephrine co Administration on Oxytocin- Induced Hemodynamic Effects
Cesarean section is one of the commonly performed surgical procedures in the world. Once baby is delivered during the surgical procedure anesthesiologist administer Oxytocin drug through IV cannula which helps the Uterus to contract so that excessive blood loss doesnt occur. But this is associated with fall in blood pressure frequently requiring administration of medications to treat low blood pressure. The most frequently used drug is phenylephrine which can administered along with oxytocin to prevent fall in blood pressure. This study will compare to different doses of Phenylephrine to prevent fall in blood pressure.
Read the detailed description
Cesarean section is one of the most commonly performed surgical procedures worldwide. Following delivery of the neonate, oxytocin is routinely administered intravenously to promote uterine contraction and thereby reduce the risk of postpartum hemorrhage. However, oxytocin administration is frequently associated with maternal hypotension, which may necessitate pharmacological intervention. Phenylephrine, a selective α-adrenergic agonist, is commonly used to prevent or treat oxytocin-induced hypotension due to its vasoconstrictive properties. The optimal prophylactic dose of phenylephrine administered concurrently with oxytocin remains uncertain. This study aims to compare two different doses of phenylephrine for the prevention of hypotension following oxytocin administration during cesarean section.
- Conditions
- Phenylephrine, Cesarean Birth
- Being tested
- Phenylephrine bolus 75 micrograms, Phenylephrine bolus 50 micrograms
- Keywords
- Phenylephrine, Oxytocin induced hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phenylephrine bolus 75 microgramsDrug
After delivery of Baby during C section, patient will be administered 3 IU of Oxytocin over 3 minutes along with 75 micrograms of Phenylephrine Intravenously.
Phenylephrine bolus 50 microgramsDrug
After delivery of Baby during C section, patient will be administered 3 IU of Oxytocin over 3 minutes along with 50 micrograms of Phenylephrine Intravenously.
| Study group | Role | What they receive |
|---|---|---|
| Phenylephrine 75 | Active comparator | Not described Receives: Drug: Phenylephrine bolus 75 micrograms |
| Phenylephrine 50 | Active comparator | Not described Receives: Drug: Phenylephrine bolus 50 micrograms |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Hypotensive episodes
Hypotension will be defined as fall in Mean Arterial pressure by more than 20% from baseline value.
Measured: Number of hypotensive episodes occuring upto 10 minutes after administration of Oxytocin and Phenylephrine
Secondary outcomes (1)
Rescue Phenylephrine consumed
Measured: This will be the total amount of Phenylephrine consumed to treat the hypotensive episodes occuring upto 10 minutes after administration of Oxytocin and Phenylephrine
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2026
- Study start13 Feb 2026
- Primary completion13 Jul 2026 (estimated)
- Study completion13 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PhenylephrineStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 112 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rawalpindi Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Farwa Javed, Rawalpindi Medical College
- Investigators
- Jawad Zahir, Study chair, Head of Department of Anesthesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07420127
- Sponsor's protocol ID
- 781/IREF/RMU/2025
- Status last verified
- Feb 2026
- First submitted
- 12 Feb 2026
- Last updated
- 24 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: It is not allowed by Hospital Ethical Committee
Publications
Sharma N, Agarwal S, Modi YC, Yadav A, Yadav J, Sindhi R, et al. Effect of Two Different Doses of Intravenous Phenylephrine on the Prevention of Oxytocin Induced Hypotension in Lower Segment Caesarean Section Under Subarachnoid Block: A Randomised Controlled Study. J Clin Diagn Res. 2023;17(9):16-21.
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Two Different Doses of Phenylephrine co Administration on Oxytocin- Induced Hemodynamic Effects
- ClinicalTrials.gov ID
- NCT07420127
- Acronym / sponsor ID
- 781/IREF/RMU/2025
- Conditions
- Phenylephrine, Cesarean Birth
- Keywords
- Phenylephrine, Oxytocin induced hypotension
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 112 participants (estimated)
- Lead sponsor
- Rawalpindi Medical CollegeUniversity, hospital or other
- Study start
- 13 Feb 2026 (actual)
- Primary completion
- 13 Jul 2026 (estimated)
- Study completion
- 13 Jul 2026 (estimated)
- First posted
- 19 Feb 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.
Cesarean section is one of the commonly performed surgical procedures in the world. Once baby is delivered during the surgical procedure anesthesiologist administer Oxytocin drug through IV cannula which helps the Uterus to contract so that excessive blood loss doesnt occur. But this is associated with fall in blood pressure frequently requiring administration of medications to treat low blood pressure. The most frequently used drug is phenylephrine which can administered along with oxytocin to prevent fall in blood pressure. This study will compare to different doses of Phenylephrine to prevent fall in blood pressure.
Detailed description
Cesarean section is one of the most commonly performed surgical procedures worldwide. Following delivery of the neonate, oxytocin is routinely administered intravenously to promote uterine contraction and thereby reduce the risk of postpartum hemorrhage. However, oxytocin administration is frequently associated with maternal hypotension, which may necessitate pharmacological intervention. Phenylephrine, a selective α-adrenergic agonist, is commonly used to prevent or treat oxytocin-induced hypotension due to its vasoconstrictive properties. The optimal prophylactic dose of phenylephrine administered concurrently with oxytocin remains uncertain. This study aims to compare two different doses of phenylephrine for the prevention of hypotension following oxytocin administration during cesarean section.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phenylephrine 75 | Active comparator | Drug: Phenylephrine bolus 75 micrograms |
| Phenylephrine 50 | Active comparator | Drug: Phenylephrine bolus 50 micrograms |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Females having a singleton pregnancy Patients planned for elective cesarean section under spinal anesthesia
Key exclusion criteria (3 listed)
- Patients having a placental abnormality
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 |
|---|---|---|
| Phenylephrine bolus 75 microgramsAfter delivery of Baby during C section, patient will be administered 3 IU of Oxytocin over 3 minutes along with 75 micrograms of Phenylephrine Intravenously. | Drug | Phenylephrine 75 |
| Phenylephrine bolus 50 microgramsAfter delivery of Baby during C section, patient will be administered 3 IU of Oxytocin over 3 minutes along with 50 micrograms of Phenylephrine Intravenously. | Drug | Phenylephrine 50 |
Primary outcome
Number of Hypotensive episodes
Time frame: Number of hypotensive episodes occuring upto 10 minutes after administration of Oxytocin and Phenylephrine
Hypotension will be defined as fall in Mean Arterial pressure by more than 20% from baseline value.
1 secondary outcome
Rescue Phenylephrine consumed
Time frame: This will be the total amount of Phenylephrine consumed to treat the hypotensive episodes occuring upto 10 minutes after administration of Oxytocin and Phenylephrine
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 24 Feb 2026.
- BackgroundSharma N, Agarwal S, Modi YC, Yadav A, Yadav J, Sindhi R, et al. Effect of Two Different Doses of Intravenous Phenylephrine on the Prevention of Oxytocin Induced Hypotension in Lower Segment Caesarean Section Under Subarachnoid Block: A Randomised Controlled Study. J Clin Diagn Res. 2023;17(9):16-21.
- Individual participant dataSharing planned: No. It is not allowed by Hospital Ethical Committee
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ED50/ED90 of Phenylephrine Infusion for Preventing Spinal Anesthesia-Induced Hypotension: Supine vs Left-Tilt 15°
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Superiority of Phenylephrine Versus Norepinephrine in Complex Spine Surgery (SPiNeS)
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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.
Jawad Zahir study chair
Head of Department of Anesthesia
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 bolus 75 micrograms and Phenylephrine bolus 50 micrograms in people with Phenylephrine and Cesarean Birth, run by Rawalpindi Medical College at 1 site in Pakistan.
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 1 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 24 Feb 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 Pakistan. 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 Farwa Javed Principal Investigator, MBBS (+92 304 8954091, farwajaved44@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Hypotensive episodes (time frame: Number of hypotensive episodes occuring upto 10 minutes after administration of Oxytocin and Phenylephrine). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07420127, which also lists 1 linked publication.
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 24 Feb 2026.