Cesarean Section ComplicationsNCT07049705
Factors Influencing Bradycardia During Spinal Anesthesia in Obstetric Patients Undergoing Cesarean Section
An observational study of Cesarean Section Complications, run by Superior University at 1 site in Pakistan.
Trial summary
The study titled "Factors Influencing Bradycardia During Spinal Anaesthesia in Obstetric Patients Undergoing Caesarean Section"" aims to investigate the causes and patterns of bradycardia in pregnant women receiving spinal anesthesia during cesarean deliveries. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Cesarean Section Complications
- How many people
- 289 participants
- Where
- 1 sitePakistan
- Study dates
- 17 Mar 2025to 28 Feb 2026
- Phase
- Observational
- 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
- All sexes
- No healthy volunteers
- Adult
Study population: The research seeks to enhance the understanding of both patient-specific and procedural risk factors, contributing to improved clinical management, safer anesthesia practices, and better maternal-fetal outcomes. Ethical approval and informed consent protocols are included to ensure participant safety and data confidentiality.
Who may be able to join
- Obstetric patients aged 18-40 years.
- Undergoing elective or emergency cesarean sections under spinal anesthesia.
- Classified as ASA Physical Status I or II (relatively healthy or with mild systemic disease).
- Provided informed consent (either by the patient or legal guardian).
Who cannot join
- Patients with pre-existing cardiac conditions (e.g., arrhythmias, conduction abnormalities).
- Patients taking medications that affect heart rate, such as beta-blockers or calcium channel blockers.
- Patients with contraindications to spinal anesthesia (e.g., coagulopathy, infection at the injection site).
- Those undergoing combined spinal-epidural or general anesthesia.
- Patients with incomplete medical records or unable to provide informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
The study titled "Factors Influencing Bradycardia During Spinal Anaesthesia in Obstetric Patients Undergoing Caesarean Section"" aims to investigate the causes and patterns of bradycardia in pregnant women receiving spinal anesthesia during cesarean deliveries. Bradycardia, defined as a heart rate below 60 beats per minute, is a known complication of spinal anesthesia, often resulting from sympathetic blockade and unopposed parasympathetic activity. This condition may lead to hypotension, decreased cardiac output, and compromised fetal oxygenation.
Read the detailed description
The research seeks to enhance the understanding of both patient-specific and procedural risk factors, contributing to improved clinical management, safer anesthesia practices, and better maternal-fetal outcomes. Ethical approval and informed consent protocols are included to ensure participant safety and data confidentiality.
- Conditions
- Cesarean Section Complications
What is being measured
The primary outcome is the main question the study is designed to answer.
structured questionnaire
- Section A: Demographic and Baseline Information Age, weight, height, gestational age, parity, medical history, medications.
- Section B: Anesthetic and Surgical Details Indication for cesarean (elective/emergency), baseline heart rate and BP, type/dose of anesthetic, sensory block level, fluid administration, blood loss.
- Section C: Intraoperative Hemodynamic Events Occurrence of bradycardia (HR < 60 bpm), lowest HR, time to bradycardia, associated hypotension, interventions used, maternal symptoms.
- Section D: Neonatal Outcomes
Apgar scores at 1 and 5 minutes, NICU admission and reasons.
Scoring:
There is no numerical scoring system described. Instead:
Responses are mostly categorical or numerical entries (e.g., Yes/No, HR value, BP value, Apgar score).
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2025
- Study start17 Mar 2025
- Primary completion1 Sep 2025 (estimated)
- Study completion28 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cesarean Section ComplicationsStudies of the same condition, open and under way.
- More trials run by Superior UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 289 participants (actual)
Sponsor and investigators
- Lead sponsor
- Superior University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammad Naveed Babur, Superior University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07049705
- Sponsor's protocol ID
- MSAHSW/Batch-Fall23/916
- Status last verified
- Jun 2025
- First submitted
- 25 Jun 2025
- Last updated
- 3 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 3 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Factors Influencing Bradycardia During Spinal Anesthesia in Obstetric Patients Undergoing Cesarean Section
- ClinicalTrials.gov ID
- NCT07049705
- Acronym / sponsor ID
- MSAHSW/Batch-Fall23/916
- Conditions
- Cesarean Section Complications
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 289 participants (actual)
- Lead sponsor
- Superior UniversityUniversity, hospital or other
- Study start
- 17 Mar 2025 (actual)
- Primary completion
- 1 Sep 2025 (estimated)
- Study completion
- 28 Feb 2026 (estimated)
- First posted
- 3 Jul 2025 (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.
The study titled "Factors Influencing Bradycardia During Spinal Anaesthesia in Obstetric Patients Undergoing Caesarean Section"" aims to investigate the causes and patterns of bradycardia in pregnant women receiving spinal anesthesia during cesarean deliveries. Bradycardia, defined as a heart rate below 60 beats per minute, is a known complication of spinal anesthesia, often resulting from sympathetic blockade and unopposed parasympathetic activity. This condition may lead to hypotension, decreased cardiac output, and compromised fetal oxygenation.
Detailed description
The research seeks to enhance the understanding of both patient-specific and procedural risk factors, contributing to improved clinical management, safer anesthesia practices, and better maternal-fetal outcomes. Ethical approval and informed consent protocols are included to ensure participant safety and data confidentiality.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- The research seeks to enhance the understanding of both patient-specific and procedural risk factors, contributing to improved clinical management, safer anesthesia practices, and better maternal-fetal outcomes. Ethical approval and informed consent protocols are included to ensure participant safety and data confidentiality.
Key inclusion criteria (4 listed)
- Obstetric patients aged 18-40 years.
- Undergoing elective or emergency cesarean sections under spinal anesthesia.
- Classified as ASA Physical Status I or II (relatively healthy or with mild systemic disease).
- Provided informed consent (either by the patient or legal guardian).
Key exclusion criteria (5 listed)
- Patients with pre-existing cardiac conditions (e.g., arrhythmias, conduction abnormalities).
- Patients taking medications that affect heart rate, such as beta-blockers or calcium channel blockers.
- Patients with contraindications to spinal anesthesia (e.g., coagulopathy, infection at the injection site).
- Those undergoing combined spinal-epidural or general anesthesia.
- Patients with incomplete medical records or unable to provide informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
structured questionnaire
Time frame: 12 Months
1. Section A: Demographic and Baseline Information Age, weight, height, gestational age, parity, medical history, medications. 2. Section B: Anesthetic and Surgical Details Indication for cesarean (elective/emergency), baseline heart rate and BP, type/dose of anesthetic, sensory block level, fluid administration, blood loss. 3. Section C: Intraoperative Hemodynamic Events Occurrence of bradycardia (HR < 60 bpm), lowest HR, time to bradycardia, associated hypotension, interventions used, maternal symptoms. 4. Section D: Neonatal Outcomes Apgar scores at 1 and 5 minutes, NICU admission and reasons. Scoring: There is no numerical scoring system described. Instead: Responses are mostly categorical or numerical entries (e.g., Yes/No, HR value, BP value, Apgar score).
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 3 Jul 2025.
- Individual participant dataSharing planned: No
Related trials for Cesarean Section Complications
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Not yet recruitingObservational study
Ultrasound Assessment Of Gastric Volume In Pregnant Women Undergoing Elective Cesarean Section
Gestational Diabetes Mellitus (GDM), Obstetric Anesthesia
RecruitingPhase 1
Ketamine Pharmacokinetics and Pharmacodynamics for Postpartum Depression and Pain After Cesarean Delivery
Pain, Postpartum Depression
Recruiting
Clinical Impact of Uterine Repair During Cesarean Section With Barbed Suture on the Incidence of Isthmocele
Isthmocele, Cesarean Scar Defect
Not yet recruiting
The Mepilex Cesarean Delivery Trial / MEPIDEL
Surgical Site Infection
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cesarean Section Complications, run by Superior University 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 4 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 3 Jul 2025. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
structured questionnaire (time frame: 12 Months). 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 3 Jul 2025.