Comparing 2 Techniques of iv Oxytocin Causing Hemodynamic ChangesNCT07687355
Compare Hemodynamic Effect of Oxytocin Bolus and Infusion During Cesarean Section Under Spinal Anesthesia
A study testing Oxytocin bolus in people with Comparing 2 Techniques of iv Oxytocin Causing Hemodynamic Changes, run by Hayatabad Medical Complex.
Trial summary
Oxytocin is routinely used during a cesarean section to promote uterine contraction and prevent postpartum hemorrhage. It is typically administered immediately after delivery of the baby, either as a slow intravenous bolus followed by a continuous infusion or as an infusion alone, depending on clinical protocols. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Comparing 2 Techniques of iv Oxytocin Causing Hemodynamic Changes
- What is being tested?
- Oxytocin bolus
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 262 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2026to 1 Oct 2026
- Phase
- Interventional
- 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 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women within age range 18-40 Years Women undergoing caesarian with oxytocin under spinal anesthesia as defined in the operational definition.
- Exclusion Criteria Women with placenta praevia Women with ruptured membranes Women with hypertensive disorders or diabetes mellitus Women on immunosuppressant
Who cannot join
None listed.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Dr Navishta Sahar Arif Trainee medical officer, MBBS contact
About this study
Official title: STUDY OF EFFECT OF HEMODYNAMIC CHANGES CAUSED BY OXYTOCIN DURING CESAREAN SECTION UNDER SPINAL ANESTHESIA: COMPARISON BETWEEN INTRAVENOUS BOLUS AND INFUSION TECHNIQUE
Oxytocin is routinely used during a cesarean section to promote uterine contraction and prevent postpartum hemorrhage. It is typically administered immediately after delivery of the baby, either as a slow intravenous bolus followed by a continuous infusion or as an infusion alone, depending on clinical protocols. By stimulating the uterine muscles to contract, oxytocin helps reduce blood loss and facilitates uterine involution. Care is taken to avoid rapid high-dose administration, as this may lead to side effects such as hypotension and tachycardia
Read the detailed description
The administration of Oxytocin during cesarean section under Spinal anesthesia is associated with significant hemodynamic changes, and these effects differ depending on whether the drug is given as an intravenous bolus or as a controlled infusion. Oxytocin causes vasodilation and decreases systemic vascular resistance, which can lead to hypotension, reflex tachycardia, and occasionally nausea or flushing-effects that are often exaggerated under spinal anesthesia due to pre-existing sympathetic blockade. When given as a rapid IV bolus (e.g., 5-10 IU), there is a sudden drop in blood pressure and a marked increase in heart rate, sometimes accompanied by transient myocardial ischemia in susceptible patients. In contrast, administering oxytocin as a slow infusion (e.g., 10-40 IU diluted in IV fluids over time) results in more gradual hemodynamic changes, with better stability of blood pressure and heart rate. Comparative studies have consistently shown that infusion regimens are associated with fewer adverse cardiovascular effects while still providing adequate uterine contraction. Therefore, current clinical practice favors low-dose slow bolus followed by infusion, or infusion alone, to minimize hemodynamic instability while effectively preventing postpartum hemorrhage.
- Being tested
- Oxytocin bolus
- Keywords
- Oxytocin bolus, Oxytocin nfusion technique, Blood pressure changes by oxytocin, Oxytocin in cesarean section
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxytocin bolusDrug
5IU OXYTOCIN diluted in 5ml normal saline, given as bolus over 5 second
| Study group | Role | What they receive |
|---|---|---|
| Oxytocin bolus group | Experimental | Patient recieving oxytocin bolus I/v during Cesarean section under spinal anesthesia Receives: Drug: Oxytocin bolus |
| Oxytocin infusion group | Active comparator | Oxytocin iv transfusion during Cesarean section Receives: Drug: Oxytocin bolus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart rate and blood pressure changes in beats per minute and mmHg respectively by comparing intravenous bolus and infusion oxytocin during Cesarean section under spinal anesthesia
Comparison of iv bolus and infusion technique of oxytocin causing changes hemodynamic are noticed while it is given to patient undergoing Cesarean section under spinal anesthesia
Measured: Over period of giving the drug and after 2 to 5 mins of giving drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2026
- Study start1 Jul 2026 (estimated)
- Primary completion1 Oct 2026 (estimated)
- Study completion1 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Comparing 2 Techniques of iv Oxytocin Causing Hemodynamic ChangesStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 262 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hayatabad Medical Complex
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Amina Sultan, Hayatabad Medical Complex
- Investigators
- Dr Navishta Sahar Arif, Trainee medical officer, MBBS, Principal investigator, PGMI/ Hayatabad medical complex, peshawar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07687355
- Sponsor's protocol ID
- ENJAY-PROP-01
- Status last verified
- Jul 2026
- First submitted
- 7 May 2026
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to patient confidentiality and institutional policies
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- STUDY OF EFFECT OF HEMODYNAMIC CHANGES CAUSED BY OXYTOCIN DURING CESAREAN SECTION UNDER SPINAL ANESTHESIA: COMPARISON BETWEEN INTRAVENOUS BOLUS AND INFUSION TECHNIQUE
- ClinicalTrials.gov ID
- NCT07687355
- Acronym / sponsor ID
- ENJAY-PROP-01
- Keywords
- Oxytocin bolus, Oxytocin nfusion technique, Blood pressure changes by oxytocin, Oxytocin in cesarean section
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 262 participants (estimated)
- Lead sponsor
- Hayatabad Medical ComplexOther government
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 1 Oct 2026 (estimated)
- First posted
- 7 Jul 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.
Oxytocin is routinely used during a cesarean section to promote uterine contraction and prevent postpartum hemorrhage. It is typically administered immediately after delivery of the baby, either as a slow intravenous bolus followed by a continuous infusion or as an infusion alone, depending on clinical protocols. By stimulating the uterine muscles to contract, oxytocin helps reduce blood loss and facilitates uterine involution. Care is taken to avoid rapid high-dose administration, as this may lead to side effects such as hypotension and tachycardia
Detailed description
The administration of Oxytocin during cesarean section under Spinal anesthesia is associated with significant hemodynamic changes, and these effects differ depending on whether the drug is given as an intravenous bolus or as a controlled infusion. Oxytocin causes vasodilation and decreases systemic vascular resistance, which can lead to hypotension, reflex tachycardia, and occasionally nausea or flushing-effects that are often exaggerated under spinal anesthesia due to pre-existing sympathetic blockade. When given as a rapid IV bolus (e.g., 5-10 IU), there is a sudden drop in blood pressure and a marked increase in heart rate, sometimes accompanied by transient myocardial ischemia in susceptible patients. In contrast, administering oxytocin as a slow infusion (e.g., 10-40 IU diluted in IV fluids over time) results in more gradual hemodynamic changes, with better stability of blood pressure and heart rate. Comparative studies have consistently shown that infusion regimens are associated with fewer adverse cardiovascular effects while still providing adequate uterine contraction. Therefore, current clinical practice favors low-dose slow bolus followed by infusion, or infusion alone, to minimize hemodynamic instability while effectively preventing postpartum hemorrhage.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oxytocin bolus group | Experimental | Drug: Oxytocin bolusPatient recieving oxytocin bolus I/v during Cesarean section under spinal anesthesia |
| Oxytocin infusion group | Active comparator | Drug: Oxytocin bolusOxytocin iv transfusion during Cesarean section |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Women within age range 18-40 Years Women undergoing caesarian with oxytocin under spinal anesthesia as defined in the operational definition.
- Exclusion Criteria Women with placenta praevia Women with ruptured membranes Women with hypertensive disorders or diabetes mellitus Women on immunosuppressant
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Oxytocin bolus5IU OXYTOCIN diluted in 5ml normal saline, given as bolus over 5 second | Drug | Oxytocin bolus group, Oxytocin infusion group |
Primary outcome
Heart rate and blood pressure changes in beats per minute and mmHg respectively by comparing intravenous bolus and infusion oxytocin during Cesarean section under spinal anesthesia
Time frame: Over period of giving the drug and after 2 to 5 mins of giving drug
Comparison of iv bolus and infusion technique of oxytocin causing changes hemodynamic are noticed while it is given to patient undergoing Cesarean section under spinal anesthesia
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 7 Jul 2026.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to patient confidentiality and institutional policies
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.
Dr Navishta Sahar Arif Trainee medical officer, MBBS contact
Dr Navishta Sahar Arif, Trainee medical officer, MBBS principal investigator
PGMI/ Hayatabad medical complex, peshawar
Questions about this trial
What is this clinical trial studying?
A study testing Oxytocin bolus in people with Comparing 2 Techniques of iv Oxytocin Causing Hemodynamic Changes, run by Hayatabad Medical Complex.
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 0 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 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
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.
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 Dr Navishta Sahar Arif Trainee medical officer, MBBS (+923333493330 ext. +92, lailo_dr@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heart rate and blood pressure changes in beats per minute and mmHg respectively by comparing intravenous bolus and infusion oxytocin during Cesarean section under spinal anesthesia (time frame: Over period of giving the drug and after 2 to 5 mins of giving drug). 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 7 Jul 2026.