Cesarean SectionNCT07784478
Effect of Oxytocin Bolus Versus Slow Infusion on Haemodynamic Stability During Caesarean Section Under Spinal Anaesthesia
A study testing Oxytocin in people with Cesarean Section and Hypotension, run by Khyber Girls Medical College at 1 site in Pakistan.
Trial summary
This study compares two standard ways of giving oxytocin (a medicine that helps the uterus contract) after the baby is born during a planned caesarean section performed under spinal anaesthesia. One group of women will receive oxytocin as a quick injection into the vein. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Cesarean Section, Hypotension, Postpartum Hemorrhage
- What is being tested?
- Oxytocin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Sep 2026to 1 Apr 2027
- 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
- No healthy volunteers
- Adult
Who may be able to join
- Adult female patients aged 18 to 40 years
- American Society of Anesthesiologists (ASA) physical status class I or II
- Singleton pregnancy at 37 to 42 weeks gestational age
- Scheduled for elective caesarean section under spinal anaesthesia
- Written informed consent obtained
Who cannot join
- Patients with anticipated hemodynamic instability including severe preeclampsia/eclampsia, placenta previa with active bleeding, placental abruption, or hemorrhagic shock
- Pre-existing cardiovascular disease including ischemic heart disease, valvular heart disease, cardiomyopathy, or arrhythmias
- Baseline systolic blood pressure < 100 mmHg or heart rate > 100 bpm before spinal block
- Known hypersensitivity to oxytocin
- Failed spinal anaesthesia requiring conversion to general anaesthesia
- Patients receiving medications that may alter the hemodynamic response to oxytocin (beta-blockers, calcium channel blockers, ACE inhibitors, or angiotensin receptor blockers)
- Pre-existing anaemia (Hb < 8 g/dL)
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
Hayatabad Medical Complex / Khyber Girls Medical College
Peshawar, Khyber Pakhtunkhwa, 25000
Fareeha Zahir, MBBS / FCPS-II Trainee, +923319932275, fareehak933@gmail.com
About this study
Official title: Effect of Oxytocin Administration Technique on Haemodynamic Stability During Caesarean Section Under Spinal Anaesthesia: A Randomised Controlled Trial
This study compares two standard ways of giving oxytocin (a medicine that helps the uterus contract) after the baby is born during a planned caesarean section performed under spinal anaesthesia. One group of women will receive oxytocin as a quick injection into the vein. The other group will receive the same dose of oxytocin as a slow infusion over 15 minutes. The researchers want to find out which method causes less drop in blood pressure and other heart-related changes, while still providing good contraction of the uterus and preventing excessive bleeding.
Read the detailed description
Postpartum haemorrhage remains a leading cause of maternal mortality worldwide. Oxytocin is the first-line uterotonic agent used after delivery of the baby during caesarean section. When given as a rapid intravenous bolus, oxytocin can cause significant hypotension, tachycardia and other haemodynamic changes, especially in women under spinal anaesthesia.
This prospective, randomised, controlled trial will compare the haemodynamic effects of oxytocin 5 IU administered as a rapid intravenous bolus versus the same dose given as a slow intravenous infusion over 15 minutes in women undergoing elective caesarean section under spinal anaesthesia.
Sixty women aged 18-40 years with singleton pregnancy at 37-42 weeks, ASA physical status I or II, will be randomly allocated to one of two groups:
Group A (Bolus): Oxytocin 5 IU given as an intravenous bolus over 15 seconds immediately after umbilical cord clamping.
Group B (Infusion): Oxytocin 5 IU diluted and infused over 15 minutes via syringe pump immediately after umbilical cord clamping.
The primary outcome is the change in systolic blood pressure from baseline at 2, 5 and 10 minutes after oxytocin administration. Secondary outcomes include changes in diastolic blood pressure and heart rate, incidence of hypotension and tachycardia, vasopressor requirements, uterine tone assessed by a 5-point scale, estimated blood loss, and side effects such as nausea, vomiting, flushing and chest discomfort.
The study will be conducted at Hayatabad Medical Complex, Peshawar. All participants will receive standard spinal anaesthesia and routine care. The results are expected to provide local evidence to support safer oxytocin administration practices during caesarean section under spinal anaesthesia.
- Being tested
- Oxytocin
- Keywords
- Oxytocin, Bolus, Infusion, Haemodynamic stability, Elective caesarean section, Spinal anaesthesia, Uterine tone, Vasopressor
- Medical subject headings
- Hypotension, Postpartum Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxytocinDrug
Also called Syntocinon
Oxytocin 5 IU administered either as a rapid intravenous bolus over 15 seconds or as a slow intravenous infusion over 15 minutes immediately after umbilical cord clamping during elective caesarean section under spinal anaesthesia.
| Study group | Role | What they receive |
|---|---|---|
| Bolus Group | Active comparator | Participants will receive oxytocin 5 IU in 1 mL normal saline as an intravenous bolus over 15 seconds immediately after umbilical cord clamping, followed by 9 mL normal saline infusion over 15 minutes (to maintain blinding). Receives: Drug: Oxytocin |
| Infusion Group | Experimental | Participants will receive oxytocin 5 IU diluted in 50 mL normal saline administered via syringe pump over 15 minutes immediately after umbilical cord clamping. A simultaneous 1 mL normal saline bolus will be given over 15 seconds to maintain blinding of the initial injection. Receives: Drug: Oxytocin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Systolic Blood Pressure (SBP) from Baseline
Change in systolic blood pressure from baseline (mean of three pre-anaesthesia readings) measured at 2, 5, and 10 minutes after oxytocin administration.
Measured: Baseline; 2 minutes, 5 minutes, and 10 minutes after oxytocin administration
Secondary outcomes (3)
Change in Diastolic Blood Pressure and Heart Rate from Baseline
Change in diastolic blood pressure and heart rate from baseline at defined time points after oxytocin administration.
Measured: 1, 2, 3, 5, 10, 15, and 20 minutes after oxytocin administration
Incidence of Clinically Significant Hypotension
Proportion of participants who develop systolic blood pressure < 90 mmHg or a fall of > 20% from baseline after oxytocin administration.
Measured: Within 20 minutes after oxytocin administration
Uterine Contraction Scale Score
Uterine tone assessed by the operating obstetrician using a 5-point scale (Grade 1 = atonic to Grade 5 = very well contracted) at 5 minutes after placental delivery. Grade 1 or 2 is classified as uterine atony.
Measured: 5 minutes after placental delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2026
- Study start1 Sep 2026 (estimated)
- Primary completion1 Apr 2027 (estimated)
- Study completion1 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cesarean SectionStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two-group parallel randomised controlled trial comparing oxytocin bolus versus slow infusion.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Khyber Girls Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07784478
- Sponsor's protocol ID
- CHR-IREB-2026-0050
- Status last verified
- Aug 2026
- First submitted
- 20 Aug 2026
- Last updated
- 25 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Oxytocin Administration Technique on Haemodynamic Stability During Caesarean Section Under Spinal Anaesthesia: A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT07784478
- Acronym / sponsor ID
- CHR-IREB-2026-0050
- Keywords
- Oxytocin, Bolus, Infusion, Haemodynamic stability, Elective caesarean section, Spinal anaesthesia, Uterine tone, Vasopressor
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Khyber Girls Medical CollegeUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 1 Apr 2027 (estimated)
- First posted
- 25 Aug 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.
This study compares two standard ways of giving oxytocin (a medicine that helps the uterus contract) after the baby is born during a planned caesarean section performed under spinal anaesthesia. One group of women will receive oxytocin as a quick injection into the vein. The other group will receive the same dose of oxytocin as a slow infusion over 15 minutes. The researchers want to find out which method causes less drop in blood pressure and other heart-related changes, while still providing good contraction of the uterus and preventing excessive bleeding.
Detailed description
Postpartum haemorrhage remains a leading cause of maternal mortality worldwide. Oxytocin is the first-line uterotonic agent used after delivery of the baby during caesarean section. When given as a rapid intravenous bolus, oxytocin can cause significant hypotension, tachycardia and other haemodynamic changes, especially in women under spinal anaesthesia.
This prospective, randomised, controlled trial will compare the haemodynamic effects of oxytocin 5 IU administered as a rapid intravenous bolus versus the same dose given as a slow intravenous infusion over 15 minutes in women undergoing elective caesarean section under spinal anaesthesia.
Sixty women aged 18-40 years with singleton pregnancy at 37-42 weeks, ASA physical status I or II, will be randomly allocated to one of two groups:
Group A (Bolus): Oxytocin 5 IU given as an intravenous bolus over 15 seconds immediately after umbilical cord clamping.
Group B (Infusion): Oxytocin 5 IU diluted and infused over 15 minutes via syringe pump immediately after umbilical cord clamping.
The primary outcome is the change in systolic blood pressure from baseline at 2, 5 and 10 minutes after oxytocin administration. Secondary outcomes include changes in diastolic blood pressure and heart rate, incidence of hypotension and tachycardia, vasopressor requirements, uterine tone assessed by a 5-point scale, estimated blood loss, and side effects such as nausea, vomiting, flushing and chest discomfort.
The study will be conducted at Hayatabad Medical Complex, Peshawar. All participants will receive standard spinal anaesthesia and routine care. The results are expected to provide local evidence to support safer oxytocin administration practices during caesarean section under spinal anaesthesia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Two-group parallel randomised controlled trial comparing oxytocin bolus versus slow infusion.
| Arm | Type | Receives |
|---|---|---|
| Bolus Group | Active comparator | Drug: OxytocinParticipants will receive oxytocin 5 IU in 1 mL normal saline as an intravenous bolus over 15 seconds immediately after umbilical cord clamping, followed by 9 mL normal saline infusion over 15 minutes (to maintain blinding). |
| Infusion Group | Experimental | Drug: OxytocinParticipants will receive oxytocin 5 IU diluted in 50 mL normal saline administered via syringe pump over 15 minutes immediately after umbilical cord clamping. A simultaneous 1 mL normal saline bolus will be given over 15 seconds to maintain blinding of the initial injection. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Adult female patients aged 18 to 40 years
- American Society of Anesthesiologists (ASA) physical status class I or II
- Singleton pregnancy at 37 to 42 weeks gestational age
- Scheduled for elective caesarean section under spinal anaesthesia
- Written informed consent obtained
Key exclusion criteria (7 listed)
- Patients with anticipated hemodynamic instability including severe preeclampsia/eclampsia, placenta previa with active bleeding, placental abruption, or hemorrhagic shock
- Pre-existing cardiovascular disease including ischemic heart disease, valvular heart disease, cardiomyopathy, or arrhythmias
- Baseline systolic blood pressure < 100 mmHg or heart rate > 100 bpm before spinal block
- Known hypersensitivity to oxytocin
- Failed spinal anaesthesia requiring conversion to general anaesthesia
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 |
|---|---|---|
| OxytocinAlso: SyntocinonOxytocin 5 IU administered either as a rapid intravenous bolus over 15 seconds or as a slow intravenous infusion over 15 minutes immediately after umbilical cord clamping during elective caesarean section under spinal anaesthesia. | Drug | Bolus Group, Infusion Group |
Primary outcome
Change in Systolic Blood Pressure (SBP) from Baseline
Time frame: Baseline; 2 minutes, 5 minutes, and 10 minutes after oxytocin administration
Change in systolic blood pressure from baseline (mean of three pre-anaesthesia readings) measured at 2, 5, and 10 minutes after oxytocin administration.
3 secondary outcomes
Change in Diastolic Blood Pressure and Heart Rate from Baseline
Time frame: 1, 2, 3, 5, 10, 15, and 20 minutes after oxytocin administration
Incidence of Clinically Significant Hypotension
Time frame: Within 20 minutes after oxytocin administration
Uterine Contraction Scale Score
Time frame: 5 minutes after placental delivery
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 25 Aug 2026.
- Individual participant dataSharing planned: No
Related trials for Cesarean Section
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Ultrasound Assessment Of Gastric Volume In Pregnant Women Undergoing Elective Cesarean Section
Gestational Diabetes Mellitus (GDM), Obstetric Anesthesia
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Effect of Dexmedetomidine on Postoperative Pain in Spinal Anesthesia for Cesarean Section at Assuit University Hospital
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Active, not recruiting
Implementation of a Disparities in Labor Outcomes Dashboard
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oxytocin in people with Cesarean Section and Hypotension, run by Khyber Girls 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 5 inclusion and 7 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 25 Aug 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.
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 Fareeha Zahir, MBBS / FCPS-II Trainee (+923319932275, fareehak933@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Systolic Blood Pressure (SBP) from Baseline (time frame: Baseline; 2 minutes, 5 minutes, and 10 minutes after oxytocin administration). 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 25 Aug 2026.