Cesarean Section ComplicationsNCT05757401
Sleep Quality After Cesarean Delivery
An observational study of Cesarean Section Complications and Sleep Disturbance, run by Mahidol University at 1 site in Thailand.
Trial summary
Surgery causes poor sleep quality for several reasons eg. increasing stress hormonal production, pain, starvation, and environmental procedure namely noise, light, and nursing procedures. Poor sleep quality also brings numerous side effects including delirium, delayed recovery, and affect breastfeeding. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cesarean Section Complications, Sleep Disturbance, Perioperative Complication
- How many people
- 286 participants
- Where
- 1 siteThailand
- Study dates
- 14 Mar 2023to 15 May 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Adult, Older adult
Study population: Parturients age >,= 18 years old undergoing cesarean delivery
Who may be able to join
- Age >,= 18 years, undergoing cesarean delivery
- Receive spinal anesthesia with local anesthetic drug and intrathecal morphine
- Understand Thai
Who cannot join
- Patients receive epidural block or nerve block
- Patients require conversion to general anesthesia with any reasons
- Patients require endotracheal intubation with any reasons
- Patients admit to intensive care unit in postoperative period
- Patients with the end of operation at the time 24.00-6.00 AM
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Anesthesiology department, Siriraj hospital, Mahidol University
Bangkok, 10700
About this study
Official title: Sleep Quality After Cesarean Delivery Under Spinal Anesthesia With Intrathecal Morphine and Related Factors
Surgery causes poor sleep quality for several reasons eg. increasing stress hormonal production, pain, starvation, and environmental procedure namely noise, light, and nursing procedures. Poor sleep quality also brings numerous side effects including delirium, delayed recovery, and affect breastfeeding. We, therefore, aim to elucidate the incidence of poor sleep quality in parturients undergoing cesarean delivery in the early postoperative period and investigate the factors involving poor sleep conditions.
Read the detailed description
Surgery causes poor sleep quality for several reasons eg. increasing stress hormonal production, pain, starvation, and environmental procedure namely noise, light, and nursing procedures. Postoperative pain after cesarean delivery can be found as high as 70 percent in the first postoperative pain. Also, the side effect of anesthetic may cause poor sleep quality such as itching, nausea, and vomiting.
Poor sleep quality brings numerous side effects including delirium, delayed recovery, and affect breastfeeding. The data on obstetric patients sleep quality in the early postoperative period is scarce. We, therefore, aim to elucidate the incidence of poor sleep quality in parturients undergoing cesarean delivery in the early postoperative period and investigate the factors involving poor sleep conditions.
- Keywords
- cesarean delivery, sleep quality, Perioperative complication
- Medical subject headings
- Parasomnias, Sleep Initiation and Maintenance Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep quality
Sleep quality at the first postoperative day evaluated by Richard Campbell Sleep Questionaire- Thai version
Measured: 24 hours postoperative
Secondary outcomes (7)
Nausea and vomiting score
Nausea and vomiting score; 0 = no symptom, 1= mild symptom nausea and no vomiting, 2 = vomiting 1-2 times, 3 = severe vomiting or needed treatment
Measured: 24 hours postoperative
Itching
Itching score; 0 = no itching, 1= mild itching, 2 = severe itching or needed treatment
Measured: 24 hours postoperative
Postoperative pain
11-point Numerical rating score (NRS) pain scale ranging from 0-10, 0= no pain, 10 = severe pain
Measured: 24 hours postoperative
EQ-5D-5L
Quality of life evaluated by EuroQol group-5 Dimentions-5 levels questionnaire (EQ-5D-5L)- Thai version
Measured: 24 hours postoperative
LATCH score
LATCH score comprise of 5 components: Latch, Audible swallowing, Type of nipple, Comfort and Hold- each component scored from 0-2, A total of less than 8 is considered unsatisfactory
Measured: 24 hours postoperative and at the discharge day
Length of hospital stay
Length of hospital stay
Measured: Through the study completion an average 3-5 days
Neonatal weight
The weight of neonate
Measured: Postoperative day 1 and day 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2023
- Study start14 Mar 2023
- Primary completion15 May 2024
- Study completion15 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cesarean Section ComplicationsStudies 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
- 286 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Patchareya Nivatpumin, M.D., Principal investigator, Department of Anesthesiology, Faculty of Medicine Siriraj Hospital, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05757401
- Sponsor's protocol ID
- 831/2565(IRB1)
- Other IDs
- Si 898/2022
- Status last verified
- Dec 2025
- First submitted
- 26 Jan 2023
- Last updated
- 22 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The data-sharing plan is undecided.
Publications
Jintadawong T, Nivatpumin P, Swaengrujitham M, Punchuklang W, Lertbunnaphong T. Sleep quality after caesarean delivery: associated factors and effects on quality of life and early breastfeeding. Ann Med. 2025 Dec;57(1):2582917. doi: 10.1080/07853890.2025.2582917. Epub 2025 Nov 12.
PubMed 41229134
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep Quality After Cesarean Delivery Under Spinal Anesthesia With Intrathecal Morphine and Related Factors
- ClinicalTrials.gov ID
- NCT05757401
- Acronym / sponsor ID
- 831/2565(IRB1)
- Keywords
- cesarean delivery, sleep quality, Perioperative complication
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 286 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- 14 Mar 2023 (actual)
- Primary completion
- 15 May 2024 (actual)
- Study completion
- 15 May 2024 (actual)
- First posted
- 7 Mar 2023 (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.
Surgery causes poor sleep quality for several reasons eg. increasing stress hormonal production, pain, starvation, and environmental procedure namely noise, light, and nursing procedures. Poor sleep quality also brings numerous side effects including delirium, delayed recovery, and affect breastfeeding. We, therefore, aim to elucidate the incidence of poor sleep quality in parturients undergoing cesarean delivery in the early postoperative period and investigate the factors involving poor sleep conditions.
Detailed description
Surgery causes poor sleep quality for several reasons eg. increasing stress hormonal production, pain, starvation, and environmental procedure namely noise, light, and nursing procedures. Postoperative pain after cesarean delivery can be found as high as 70 percent in the first postoperative pain. Also, the side effect of anesthetic may cause poor sleep quality such as itching, nausea, and vomiting.
Poor sleep quality brings numerous side effects including delirium, delayed recovery, and affect breastfeeding. The data on obstetric patients sleep quality in the early postoperative period is scarce. We, therefore, aim to elucidate the incidence of poor sleep quality in parturients undergoing cesarean delivery in the early postoperative period and investigate the factors involving poor sleep conditions.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Parturients age >,= 18 years old undergoing cesarean delivery
Key inclusion criteria (3 listed)
- Age >,= 18 years, undergoing cesarean delivery
- Receive spinal anesthesia with local anesthetic drug and intrathecal morphine
- Understand Thai
Key exclusion criteria (5 listed)
- Patients receive epidural block or nerve block
- Patients require conversion to general anesthesia with any reasons
- Patients require endotracheal intubation with any reasons
- Patients admit to intensive care unit in postoperative period
- Patients with the end of operation at the time 24.00-6.00 AM
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
Sleep quality
Time frame: 24 hours postoperative
Sleep quality at the first postoperative day evaluated by Richard Campbell Sleep Questionaire- Thai version
7 secondary outcomes
Nausea and vomiting score
Time frame: 24 hours postoperative
Itching
Time frame: 24 hours postoperative
Postoperative pain
Time frame: 24 hours postoperative
EQ-5D-5L
Time frame: 24 hours postoperative
LATCH score
Time frame: 24 hours postoperative and at the discharge day
Length of hospital stay
Time frame: Through the study completion an average 3-5 days
Neonatal weight
Time frame: Postoperative day 1 and day 3
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2025.
- Results publication: PubMed 41229134Jintadawong T, Nivatpumin P, Swaengrujitham M, Punchuklang W, Lertbunnaphong T. Sleep quality after caesarean delivery: associated factors and effects on quality of life and early breastfeeding. Ann Med. 2025 Dec;57(1):2582917. doi: 10.1080/07853890.2025.2582917. Epub 2025 Nov 12.
- Individual participant dataSharing planned: Undecided. The data-sharing plan is 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. This study is not recruiting at the moment.
Patchareya Nivatpumin, M.D. principal investigator
Department of Anesthesiology, Faculty of Medicine Siriraj Hospital, Mahidol University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cesarean Section Complications and Sleep Disturbance, run by Mahidol University at 1 site in Thailand.
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 3 inclusion and 5 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: finished, as of the sponsor's last update on 22 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep quality (time frame: 24 hours postoperative). 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 NCT05757401, which also lists 1 linked publication.
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 22 Dec 2025.