ParturientsNCT07438171

Maternal Satisfaction After Spinal Anesthesia for Cesarean Delivery

An observational study of Parturients and Elective Cesarean Delivery, run by University of Novi Sad.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

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

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.

2 Mar 20261 Sep 2026

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)

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