Caesarean SectionNCT03009955
Comparison of Postoperative Pain Between Patients Received Primary and Repeated Caesarean Section
An observational study of Caesarean Section, run by Xinqiao Hospital of Chongqing at 1 site in China.
Trial summary
To everyone knows, more and more patients received repeated caesarean section in China. However, at present it is not known what is it like about their postoperative pain intensity, and is it different from those patients who received primary caesarean section. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Caesarean Section
- How many people
- 168 participants
- Where
- 1 siteChina
- Study dates
- Dec 2016to Jun 2017
- 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 20 to 40 years
- Women only
- No healthy volunteers
- Adult
Study population: Patients who receiving primary and repeated caesarean section.
Who may be able to join
- single birth
- full-term pregnancy
- in accordance with cesarean section indications
- transverse incision of lower uterine segment
Who cannot join
- history of dementia, psychiatric illness or any diseases of central nervous system
- accompanying liver or kidney function deficiency
- alcoholism and drug dependence
- patients previously included in this study or currently included in the other clinical study
- patients who have second surgery during the study period
- difficult to follow up or patients with poor compliance
- history of chronic pain
Trial locations and contacts
1 site in 1 country.
China1 site
Xinqiao Hospital, Third Military Medical University
Chongqing, Chongqing Municipality, 400037
About this study
To everyone knows, more and more patients received repeated caesarean section in China. However, at present it is not known what is it like about their postoperative pain intensity, and is it different from those patients who received primary caesarean section. Thus through postoperative follow-up, the current study aimed to investigate and compare the postoperative pain between patients received primary and repeated caesarean section.
Read the detailed description
According to whether or not to receive repeated caesarean patients were grouped into group P or group R. For all maternal,standardized epidural anesthesia and caesarean section were performed. Then the pain VAS scores and Ramsay scores at 4h, 8h, 12h, 24h and 48h after the surgery were recorded. And sleep quality at 1 day and 2 day after the surgery were recorded. In addition, pain situation at 1 week and 4 weeks after the surgery was followed up.
- Conditions
- Caesarean Section
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group P | patients who received primary caesarean section | |
| Group R | patients who received repeated caesarean section |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain VAS at 4, 8, 12, 24 and 48 hours after the surgery
Measured: At 4, 8, 12, 24 and 48 hours after the surgery
Secondary outcomes (2)
Pain intensity at 3 to 7 days after the surgery
Measured: At 3 to 7 days after the surgery
Pain intensity at 4 weeks after the surgery
Measured: At 4 weeks after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2017 (estimated)
- Study startDec 2016
- Primary completionMay 2017
- Study completionJun 2017
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 Caesarean SectionStudies 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
- 168 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xinqiao Hospital of Chongqing
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hong Li, Xinqiao Hospital of Chongqing
- Investigators
- Hong Li, M.D., Principal investigator, Department of Anesthesiology, Xinqiao Hospital, Third Military Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03009955
- Sponsor's protocol ID
- Postoperative pain
- Status last verified
- Jul 2017
- First submitted
- 30 Dec 2016
- Last updated
- 6 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Duan G, Yang G, Peng J, Duan Z, Li J, Tang X, Li H. Comparison of postoperative pain between patients who underwent primary and repeated cesarean section: a prospective cohort study. BMC Anesthesiol. 2019 Oct 22;19(1):189. doi: 10.1186/s12871-019-0865-9.
PubMed 31640565
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Postoperative Pain Between Patients Received Primary and Repeated Caesarean Section
- ClinicalTrials.gov ID
- NCT03009955
- Acronym / sponsor ID
- Postoperative pain
- Conditions
- Caesarean Section
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 168 participants (actual)
- Lead sponsor
- Xinqiao Hospital of ChongqingUniversity, hospital or other
- Study start
- Dec 2016
- Primary completion
- May 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 4 Jan 2017 (estimated)
- 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.
To everyone knows, more and more patients received repeated caesarean section in China. However, at present it is not known what is it like about their postoperative pain intensity, and is it different from those patients who received primary caesarean section. Thus through postoperative follow-up, the current study aimed to investigate and compare the postoperative pain between patients received primary and repeated caesarean section.
Detailed description
According to whether or not to receive repeated caesarean patients were grouped into group P or group R. For all maternal,standardized epidural anesthesia and caesarean section were performed. Then the pain VAS scores and Ramsay scores at 4h, 8h, 12h, 24h and 48h after the surgery were recorded. And sleep quality at 1 day and 2 day after the surgery were recorded. In addition, pain situation at 1 week and 4 weeks after the surgery was followed up.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group P | – | –patients who received primary caesarean section |
| Group R | – | –patients who received repeated caesarean section |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients who receiving primary and repeated caesarean section.
Key inclusion criteria (4 listed)
- single birth
- full-term pregnancy
- in accordance with cesarean section indications
- transverse incision of lower uterine segment
Key exclusion criteria (7 listed)
- history of dementia, psychiatric illness or any diseases of central nervous system
- accompanying liver or kidney function deficiency
- alcoholism and drug dependence
- patients previously included in this study or currently included in the other clinical study
- patients who have second surgery during the study period
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
Pain VAS at 4, 8, 12, 24 and 48 hours after the surgery
Time frame: At 4, 8, 12, 24 and 48 hours after the surgery
2 secondary outcomes
Pain intensity at 3 to 7 days after the surgery
Time frame: At 3 to 7 days after the surgery
Pain intensity at 4 weeks after the surgery
Time frame: At 4 weeks after the surgery
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 6 Jul 2017.
- Derived from this study: PubMed 31640565Duan G, Yang G, Peng J, Duan Z, Li J, Tang X, Li H. Comparison of postoperative pain between patients who underwent primary and repeated cesarean section: a prospective cohort study. BMC Anesthesiol. 2019 Oct 22;19(1):189. doi: 10.1186/s12871-019-0865-9.
- 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. This study is not recruiting at the moment.
Hong Li, M.D. principal investigator
Department of Anesthesiology, Xinqiao Hospital, Third Military Medical 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 Caesarean Section, run by Xinqiao Hospital of Chongqing at 1 site in China.
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 4 inclusion and 7 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 6 Jul 2017. 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 China. 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?
Pain VAS at 4, 8, 12, 24 and 48 hours after the surgery (time frame: At 4, 8, 12, 24 and 48 hours after the surgery). 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 NCT03009955, 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 6 Jul 2017; AzTrials last refreshed its copy on 6 Nov 2026.