Compare Hemodynamic Effect of Oxytocin Bolus and Infusion During Cesarean Section Under Spinal Anesthesia

July 4, 2026 updated by: Amina Sultan, Hayatabad Medical Complex

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
262

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Dr Navishta Sahar Arif Trainee medical officer, MBBS
  • Phone Number: +92 +923333493330
  • Email: lailo_dr@yahoo.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Oxytocin bolus group
Patient recieving oxytocin bolus I/v during Cesarean section under spinal anesthesia
Drug: Oxytocin bolus
5IU OXYTOCIN diluted in 5ml normal saline, given as bolus over 5 second
Active Comparator: Oxytocin infusion group
Oxytocin iv transfusion during Cesarean section
Drug: Oxytocin bolus
5IU OXYTOCIN diluted in 5ml normal saline, given as bolus over 5 second

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Over period of giving the drug and after 2 to 5 mins of giving drug

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hayatabad Medical Complex

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Dr Navishta Sahar Arif, Trainee medical officer, MBBS, PGMI/ Hayatabad medical complex, peshawar

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 7, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 4, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 7, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 7, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 4, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ENJAY-PROP-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be shared due to patient confidentiality and institutional policies

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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