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
- 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 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
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence and Risk Factors of Postoperative Nausea and Vomiting (PONV) During Elective C-Section Under Spinal Anesthesia With Multimodal Antiemetic Prophylaxis
- ClinicalTrials.gov ID
- NCT06927830
- Acronym / sponsor ID
- 2024/534
- Conditions
- Nausea and Vomiting, Postoperative, Cesarean Delivery, Spinal Anesthesia, Antiemetic Therapy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- University of LiegeUniversity, hospital or other
- Study start
- 19 Mar 2025 (actual)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- Apr 2026 (estimated)
- First posted
- 15 Apr 2025 (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 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Age groups
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of nausea and vomiting
Time frame: 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.
1 secondary outcome
Risk factors of PONV
Time frame: From enrollment to the 24th postoperative hour
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 15 Apr 2025.
- Background: PubMed 32950029Tan 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.
- Background: PubMed 10485781Apfel 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.
- Background: PubMed 15935649Balki 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.
- Background: PubMed 36228999Sentilhes 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.
- Background: PubMed 33177330Bollag 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.
- Background: PubMed 23159009Wong 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.
- Background: PubMed 33370462Roofthooft 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.
- Background: PubMed 30118692Caughey 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.
- Background: PubMed 24279198Van 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.
- Individual participant dataSharing planned: Undecided
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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.
Fernande J Lois, M.D., PhD contact
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nausea and Vomiting, Postoperative and Cesarean Delivery, run by University of Liege at 2 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. 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: looking for participants now, as of the sponsor's last update on 15 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Contact Thibault Michot, M.D. (+32 4 3234141, tmichot@chuliege.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of nausea and vomiting (time frame: From cesarean section to the 24th postoperative hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06927830, which also lists 9 linked publications.
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 15 Apr 2025.