Frequency of Occurrence and Risk Factors of Postoperative Nausea and Vomiting During Elective C-section Under Spinal Anesthesia With Preventive Medication

Incidence and Risk Factors of Postoperative Nausea and Vomiting (PONV) During Elective C-Section Under Spinal Anesthesia With Multimodal Antiemetic Prophylaxis

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06927830

Enrollment

400

Registered

2025-04-15

Start date

2025-03-19

Completion date

2026-04-30

Last updated

2025-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Antiemetic Therapy, Cesarean Delivery, Nausea and Vomiting, Postoperative, Spinal Anesthesia

Brief summary

The aim of this study is to learn about the incidence and risk factors of nausea and vomiting during planned caesarean section under spinal anesthesia. The main question it aims to answer is : What are the incidence and risks factors of postoperative nausea and vomiting (NV) during planned caesarean section under spinal anesthesia with administration of intrathecal morphine and multimodal antiemetic prophylaxis ? Patients who will be managed according to the standard protocol in use in the department will have to answer specific questions about NV in the post-interventional recovery room and on 2 further visits in the first 24 hours post-caesarean section.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Inclusion criteria

Any patient requiring elective caesarean section under spinal anesthesia, at a gestational age \>37 weeks of amenorrhea in the context of a single-fetal pregnancy.

Exclusion criteria

Failure to understand the French language; Contraindication to locoregional anesthesia; Nausea and/or vomiting in the 24 hours preceding the procedure; Type 1 or type 2 insulin-requiring non-gestational diabetes; Allergy or contraindication to one of the products used in the usual management protocol; Severe preeclampsia; Height \<150 cm

Design outcomes

Primary

Measure	Time frame	Description
Incidence of nausea and vomiting	From cesarean section to the 24th postoperative hour	The primary endpoint will be the incidence of PONV, including the incidence of nausea requiring rescue medication; the incidence of nausea delaying resumption of oral intake (drinks, food or analgesics); and the incidence of vomiting.

Secondary

Measure	Time frame	Description
Risk factors of PONV	From enrollment to the 24th postoperative hour	Risk factors will be evaluated among maternal, obstetrical, neonatal, procedural and anesthetic data.

Countries

Belgium

Contacts

Primary ContactThibault Michot, M.D.

tmichot@chuliege.be+32 4 3234141

Backup ContactFernande J Lois, M.D., PhD

fernande.lois@chuliege.be

Outcome results