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RecruitingNCT06927830Updated Apr 15, 2025

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

An observational study in Nausea and Vomiting, Postoperative, Cesarean Delivery and Spinal Anesthesia, sponsored by University of Liege. Recruiting at 2 sites in Belgium. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-04-15.

Sponsored by University of Liege · Observational

From the registry’s dates

  • Primary completion was expected by Mar 2026, 7 months ago, but the record still lists the study as recruiting.
  • Started Mar 2025; still recruiting 1 year 7 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
400
Ages
18 Years and older
Sex
Female
01

Study 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.

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Conditions studied

  • Nausea and Vomiting, Postoperative
  • Cesarean Delivery
  • Spinal Anesthesia
  • Antiemetic Therapy
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In context

Postoperative Nausea and Vomiting

629 studies on the registry are indexed under Postoperative Nausea and Vomiting; 113 are open to participants now.

This study's planned enrollment of 400 is above the median of 197 across 88 observational studies indexed under Postoperative Nausea and Vomiting.

Browse Postoperative Nausea and Vomiting studies →

Lead sponsor

University of Liege is the lead sponsor of 250 studies on the registry; 49 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Sampling method
Non-probability sample

Study population

Patients admitted for delivery at the CHU de Liège - Notre Dame des Bruyères site and the CHR de la Citadelle site.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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

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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
400 participants (estimated)
Patient registry
No
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What researchers measure

Primary outcomes

  1. 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.

    Time frame: 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.

    Time frame: From enrollment to the 24th postoperative hour

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Study locations

1 of 2 sites recruiting
  • CHU de Liège - site de Notre-Dame des Bruyères
    Chenée, 4032, Belgium
    • Thibault Michot, M.D. · Contact · tmichot@chuliege.be · +32 4 3234141
    • Pierre-Yves Dewandre, M.D., PhD · Contact · + 32 4 3233654
    • Thibault Michot, M.D. · Principal investigator
    • Pierre-Yves Dewandre, M.D., PhD · Sub investigator
    • Fernande J Lois, M.D., PhD · Sub investigator
    Recruiting
  • Hôpital de la Citadelle - site Citadelle
    Liège, 4000, Belgium
    • Géraldine Lambert, M.D. · Contact · glambert@chuliege.be · +32 4 3217154
    • Géraldine Lambert, M.D. · Principal investigator
    Not yet recruiting
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References and documents

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 32950029 ↗
  • Apfel 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 10485781 ↗
  • Balki 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 15935649 ↗
  • Sentilhes 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 36228999 ↗
  • Bollag 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 33177330 ↗
  • Wong 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 23159009 ↗
  • Roofthooft 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 33370462 ↗
  • Caughey 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 30118692 ↗
  • Van 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 ↗

Individual participant data

Plan to share: Undecided

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 15, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06927830
Responsible party
Sponsor
First posted
Apr 15, 2025
Start date
Mar 19, 2025
Primary completion
Mar 2026 (estimated)
Completion
Apr 2026 (estimated)
Last update
Apr 15, 2025

Study contacts

Thibault Michot, M.D.
Contact
tmichot@chuliege.be
+32 4 3234141
Fernande J Lois, M.D., PhD
Contact
fernande.lois@chuliege.be

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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