ParturientsNCT07438171
Maternal Satisfaction After Spinal Anesthesia for Cesarean Delivery
An observational study of Parturients and Elective Cesarean Delivery, run by University of Novi Sad.
Trial summary
The goal of this observational study is to evaluate the impact of four different spinal anesthesia regimens on maternal satisfaction following cesarean delivery. The main questions this study aims to answer are: Primary outcome: Patient satisfaction with the provided analgesia during the first 24 hours… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Parturients, Elective Cesarean Delivery
- What is being tested?
- Bupivacaine %0.5 (hyperbaric), Bupivacaine %0.5 (hyperbaric) and morphine and Bupivacaine %0.5 (hyperbaric), morphine and fentanyl 15
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 2 Mar 2026to 1 Sep 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 45 years
- Women only
- No healthy volunteers
- Adult
Study population: Pregnant women, 18- 45 y old, with singleton pregnancy, scheduled for elective cesarean delivery
Inclusion Criteria: Parturients for elective cesarean delivery, ASA, status II and III, age between 18 and 45 years, singleton pregnancy, able to provide inform consent. -
Exclusion Criteria: Refuse to participate in the study, spinal anesthesia refused, known drug allergies to drugs included in the study, multiple pregnancy, preterm gestation, skin lesion at the beck, severe maternal comorbidities, chronic opioid use and chronic pain. -
About this study
Official title: Maternal Satisfaction Following Different Spinal Anesthesia Regimens for Elective Cesarean Delivery: a Prospective Observational Study
The goal of this observational study is to evaluate the impact of four different spinal anesthesia regimens on maternal satisfaction following cesarean delivery.
The main questions this study aims to answer are:
- Primary outcome: Patient satisfaction with the provided analgesia during the first 24 hours postoperatively.
- Secondary outcome: The need for rescue analgesics. Participants will complete a specially designed questionnaire 24 hours after cesarean delivery.
- Conditions
- Parturients, Elective Cesarean Delivery
- Being tested
- Bupivacaine %0.5 (hyperbaric), Bupivacaine %0.5 (hyperbaric) and morphine, Bupivacaine %0.5 (hyperbaric), morphine and fentanyl 15, Bupivacaine, morphine and fentanyl 20
- Keywords
- Maternal satisfaction, Spinal anesthesia, cesarean delivery, postcesarean analgesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bupivacaine %0.5 (hyperbaric)Drug
Only Bupivacaine %0.5 (hyperbaric) for spinal anesthesia
Bupivacaine %0.5 (hyperbaric) and morphineDrug
Combination of bupivacaine and morphine for spinal anesthesia
Bupivacaine %0.5 (hyperbaric), morphine and fentanyl 15Drug
Bupivacaine %0.5 (hyperbaric) , morphine and fentanyl 15 mcg for spinal anesthesia
Bupivacaine, morphine and fentanyl 20Drug
Bupivacaine, morphine and fentanyl 20 mcg for spinal anesthesia
What is being measured
The primary outcome is the main question the study is designed to answer.
Maternal satisfaction with provided analgesia during first 24 h following cesarean delivery
Measured: 24 hours
Secondary outcomes (1)
The need for rescue analgesics
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start2 Mar 2026 (estimated)
- Primary completion31 Aug 2026 (estimated)
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ParturientsStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Novi Sad
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pujic Borislava, University of Novi Sad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07438171
- Sponsor's protocol ID
- 6-00-34/5
- Status last verified
- Feb 2026
- First submitted
- 22 Feb 2026
- Last updated
- 27 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maternal Satisfaction Following Different Spinal Anesthesia Regimens for Elective Cesarean Delivery: a Prospective Observational Study
- ClinicalTrials.gov ID
- NCT07438171
- Acronym / sponsor ID
- 6-00-34/5
- Conditions
- Parturients, Elective Cesarean Delivery
- Keywords
- Maternal satisfaction, Spinal anesthesia, cesarean delivery, postcesarean analgesia
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of Novi SadUniversity, hospital or other
- Study start
- 2 Mar 2026 (estimated)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 27 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.
The goal of this observational study is to evaluate the impact of four different spinal anesthesia regimens on maternal satisfaction following cesarean delivery.
The main questions this study aims to answer are:
- Primary outcome: Patient satisfaction with the provided analgesia during the first 24 hours postoperatively.
- Secondary outcome: The need for rescue analgesics. Participants will complete a specially designed questionnaire 24 hours after cesarean delivery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Pregnant women, 18- 45 y old, with singleton pregnancy, scheduled for elective cesarean delivery
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 |
|---|---|---|
| Bupivacaine %0.5 (hyperbaric)Only Bupivacaine %0.5 (hyperbaric) for spinal anesthesia | Drug | – |
| Bupivacaine %0.5 (hyperbaric) and morphineCombination of bupivacaine and morphine for spinal anesthesia | Drug | – |
| Bupivacaine %0.5 (hyperbaric), morphine and fentanyl 15Bupivacaine %0.5 (hyperbaric) , morphine and fentanyl 15 mcg for spinal anesthesia | Drug | – |
| Bupivacaine, morphine and fentanyl 20Bupivacaine, morphine and fentanyl 20 mcg for spinal anesthesia | Drug | – |
Primary outcome
Maternal satisfaction with provided analgesia during first 24 h following cesarean delivery
Time frame: 24 hours
1 secondary outcome
The need for rescue analgesics
Time frame: 24 hours
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 27 Feb 2026.
- Individual participant dataSharing planned: Undecided
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Cesarean Section (MeSH: D002585), Postoperative Pain After Cesarean Section
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Wearable Ultrasound Patch in Parturients
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Routine Antiemetic Prophylaxis for Nonfasted Parturients Undergoing Cesarean Sections Under Spinal Anesthesia
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Parturients and Elective Cesarean Delivery, run by University of Novi Sad.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 27 Feb 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?
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?
Maternal satisfaction with provided analgesia during first 24 h following cesarean delivery (time frame: 24 hours). 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 27 Feb 2026.