Nausea and Vomiting, PostoperativeNCT06927830
Frequency of Occurrence and Risk Factors of Postoperative Nausea and Vomiting During Elective C-section Under Spinal Anesthesia With Preventive Medication
An observational study of Nausea and Vomiting, Postoperative and Cesarean Delivery, run by University of Liege at 2 sites in Belgium.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Nausea and Vomiting, Postoperative, Cesarean Delivery, Spinal Anesthesia
- How many people
- 400 participants
- Where
- 2 sitesBelgium
- Study dates
- 19 Mar 2025to Apr 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 years and older
- Women only
- Adult, Older adult
Study population: Patients admitted for delivery at the CHU de Liège - Notre Dame des Bruyères site and the CHR de la Citadelle site.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Fernande J Lois, M.D., PhD contact
Belgium2 sites, 2 recruiting
- Recruiting
CHU de Liège - site de Notre-Dame des Bruyères
Chenée, 4032
Thibault Michot, M.D., +32 4 3234141, tmichot@chuliege.be
Pierre-Yves Dewandre, M.D., PhD, + 32 4 3233654
- Not yet recruiting
Hôpital de la Citadelle - site Citadelle
Liège, 4000
Géraldine Lambert, M.D., +32 4 3217154, glambert@chuliege.be
Géraldine Lambert, M.D.
About this study
Official title: Incidence and Risk Factors of Postoperative Nausea and Vomiting (PONV) During Elective C-Section Under Spinal Anesthesia With Multimodal Antiemetic Prophylaxis
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.
- Conditions
- Nausea and Vomiting, Postoperative, Cesarean Delivery, Spinal Anesthesia, Antiemetic Therapy
- Medical subject headings
- Postoperative Nausea and Vomiting
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of nausea and vomiting
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.
Measured: From cesarean section to the 24th postoperative hour
Secondary outcomes (1)
Risk factors of PONV
Risk factors will be evaluated among maternal, obstetrical, neonatal, procedural and anesthetic data.
Measured: From enrollment to the 24th postoperative hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2025
- Study start19 Mar 2025
- Primary completionMar 2026 (estimated)
- Study completionApr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Nausea and Vomiting, PostoperativeStudies 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
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Liege
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06927830
- Sponsor's protocol ID
- 2024/534
- Other IDs
- B7072024000148
- Status last verified
- Apr 2025
- First submitted
- 7 Apr 2025
- Last updated
- 15 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Tan HS, Cooter M, George RB, Habib AS. A risk score for postoperative nausea and/or vomiting in women undergoing cesarean delivery with intrathecal morphine. Int J Obstet Anesth. 2020 Nov;44:126-130. doi: 10.1016/j.ijoa.2020.08.008. Epub 2020 Aug 20.
PubMed 32950029Apfel CC, Laara E, Koivuranta M, Greim CA, Roewer N. A simplified risk score for predicting postoperative nausea and vomiting: conclusions from cross-validations between two centers. Anesthesiology. 1999 Sep;91(3):693-700. doi: 10.1097/00000542-199909000-00022.
PubMed 10485781Balki M, Carvalho JC. Intraoperative nausea and vomiting during cesarean section under regional anesthesia. Int J Obstet Anesth. 2005 Jul;14(3):230-41. doi: 10.1016/j.ijoa.2004.12.004.
PubMed 15935649Sentilhes L, Schmitz T, Madar H, Bouchghoul H, Fuchs F, Garabedian C, Korb D, Nouette-Gaulain K, Pecheux O, Sananes N, Sibiude J, Senat MV, Goffinet F. [The cesarean procedure: Guidelines for clinical practice from the French College of Obstetricians and Gynecologists]. Gynecol Obstet Fertil Senol. 2023 Jan;51(1):7-34. doi: 10.1016/j.gofs.2022.10.002. Epub 2022 Oct 11. French.
PubMed 36228999Bollag L, Lim G, Sultan P, Habib AS, Landau R, Zakowski M, Tiouririne M, Bhambhani S, Carvalho B. Society for Obstetric Anesthesia and Perinatology: Consensus Statement and Recommendations for Enhanced Recovery After Cesarean. Anesth Analg. 2021 May 1;132(5):1362-1377. doi: 10.1213/ANE.0000000000005257.
PubMed 33177330Wong JY, Carvalho B, Riley ET. Intrathecal morphine 100 and 200 mug for post-cesarean delivery analgesia: a trade-off between analgesic efficacy and side effects. Int J Obstet Anesth. 2013 Jan;22(1):36-41. doi: 10.1016/j.ijoa.2012.09.006. Epub 2012 Nov 15.
PubMed 23159009Roofthooft E, Joshi GP, Rawal N, Van de Velde M; PROSPECT Working Group* of the European Society of Regional Anaesthesia and Pain Therapy and supported by the Obstetric Anaesthetists' Association. PROSPECT guideline for elective caesarean section: updated systematic review and procedure-specific postoperative pain management recommendations. Anaesthesia. 2021 May;76(5):665-680. doi: 10.1111/anae.15339. Epub 2020 Dec 28.
PubMed 33370462Caughey AB, Wood SL, Macones GA, Wrench IJ, Huang J, Norman M, Pettersson K, Fawcett WJ, Shalabi MM, Metcalfe A, Gramlich L, Nelson G, Wilson RD. Guidelines for intraoperative care in cesarean delivery: Enhanced Recovery After Surgery Society Recommendations (Part 2). Am J Obstet Gynecol. 2018 Dec;219(6):533-544. doi: 10.1016/j.ajog.2018.08.006. Epub 2018 Aug 15.
PubMed 30118692Van De Velde M, Vercauteren M, Stockman W, Roelants F, Coppens M, Bauters M, Ickx B, Dewandre PY, Soetens F, Cant P, Van Keer L, Gautier P. Recommendations and guidelines for obstetric anesthesia in Belgium. Acta Anaesthesiol Belg. 2013;64(3):97-104. No abstract available.
PubMed 24279198