AnalgesiaNCT05666024
A Clinical Study on the Effect of Labor Analgesia on the Postpartum Recovery Outcome of Chinese Parturients
An observational study of Analgesia and Labor Analgesia, run by Huazhong University of Science and Technology at 1 site in China.
Trial summary
Background: The parturient will experience extreme pain during delivery. Effective labor analgesia will bring better delivery experience to the parturient, while the adverse experience during delivery may bring many adverse effects to the parturient, including postpartum depression, insomnia, and even suicide. Read more about this study
- Who is it for?
- Ages 20 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Analgesia, Labor Analgesia
- How many people
- 3,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2022to 31 Dec 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 20 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Parturients
Who may be able to join
- 20 ≤ age ≤ 45;
- ASA I ～ III;
- Willing to participate in this study and sign the informed consent form.
Who cannot join
- Take other trial drugs or participate in other clinical trials 3 months before inclusion in the study;
- Unable to cooperate with the research for any reason.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Anesthesiology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430030
Jiaoli Sun, Doctor, 13296696810, 124460788@qq.com
About this study
Official title: Clinical Study on the Effect of Labor Analgesia on the Postpartum Recovery Outcome of Chinese Parturients
Background:
The parturient will experience extreme pain during delivery. Effective labor analgesia will bring better delivery experience to the parturient, while the adverse experience during delivery may bring many adverse effects to the parturient, including postpartum depression, insomnia, and even suicide. Postpartum depression, which has a high incidence, is one of the most common diseases that affect the quality of life of pregnant women during the perinatal period. Postpartum depression even leads to maternal suicide, which is the main cause of maternal death in the first year after childbirth. At the same time, postpartum depression seriously affects the relationship between mother and baby, which significantly increases the risk of long-term psychological sequelae of their children. Its incidence in Europe and America is about 10%, while in China it even reaches 15.7-39.8%. In addition, these factors may also affect maternal breast milk and adversely affect the psychological and behavioral development of infants. Many studies report that effective analgesia can reduce the incidence of postpartum depression in the process of natural delivery, which indicates that labor analgesia is one of the effective measures to reduce postpartum depression. However, the sample size of these studies is relatively small, and they usually focus on the psychological impact on the mothers themselves, and the focus time is only 6-8 weeks after the operation. However, there is still a lack of large sample multicenter studies on the long-term outcome of postpartum mothers and newborns (including the impact of breast feeding and neonatal neurointellectual development).
Read more
Objective:
- The subjects were included and comprehensive perinatal data were collected. On this basis, the database of maternal and neonatal prognosis for labor analgesia was established;
- Different data analysis methods were used to analyze the differences of maternal and neonatal outcomes to provide evidence based medical evidence for the current situation of labor analgesia and the optimization of labor analgesia mode.
Read the detailed description
Based on the principle of Real World Study (RWS), this study is intended to conduct a prospective observational study through long-term comprehensive outcome follow-up of a large sample of multiple centers, and then, based on different studies, conduct a synchronous survey by gathering comprehensive attention on outcome indicators, and use machine learning, regression analysis, propensity matching and other analysis methods for data analysis, Finally, independent analysis based on different sub research topics combined with big data analysis will provide effective evidence-based medical evidence for the optimization of current labor analgesia.
- Conditions
- Analgesia, Labor Analgesia
- Keywords
- Labor analgesia, Chinese parturients, Postpartum recovery
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Other
Prospective observational study
| Study group | Role | What they receive |
|---|---|---|
| Parturients | Maternity about to give birth |
What is being measured
The primary outcome is the main question the study is designed to answer.
Data collection and database establishment
The subjects were included and comprehensive perinatal data were collected. On this basis, the prognostic database of parturients with labor analgesia and neonates was established
Measured: 2024
Secondary outcomes (1)
data analysis
Different data analysis methods are used to analyze the differences of maternal and neonatal outcomes, so as to provide evidence-based medical evidence for the current situation of labor analgesia and the optimization of labor analgesia mode.
Measured: 2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2022
- Study start1 Jan 2022
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for AnalgesiaStudies of the same condition, open and under way.
- More trials run by Huazhong University of Science and TechnologyThe sponsor's other registered studies.
- 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
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huazhong University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xianwei Zhang，MD, Huazhong University of Science and Technology
- Investigators
- Xianwei Zhang, Doctor, Principal investigator, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05666024
- Sponsor's protocol ID
- Labor analgesia
- Status last verified
- Dec 2022
- First submitted
- 2 Dec 2022
- Last updated
- 27 Dec 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Pollard K. MBRRACE-UK Report launch December 2016. Pract Midwife. 2017 Feb;20(2):30-2.
PubMed 30462430Pearson RM, Evans J, Kounali D, Lewis G, Heron J, Ramchandani PG, O'Connor TG, Stein A. Maternal depression during pregnancy and the postnatal period: risks and possible mechanisms for offspring depression at age 18 years. JAMA Psychiatry. 2013 Dec;70(12):1312-9. doi: 10.1001/jamapsychiatry.2013.2163.
PubMed 24108418Munk-Olsen T, Laursen TM, Pedersen CB, Mors O, Mortensen PB. New parents and mental disorders: a population-based register study. JAMA. 2006 Dec 6;296(21):2582-9. doi: 10.1001/jama.296.21.2582.
PubMed 17148723Howard LM, Molyneaux E, Dennis CL, Rochat T, Stein A, Milgrom J. Non-psychotic mental disorders in the perinatal period. Lancet. 2014 Nov 15;384(9956):1775-88. doi: 10.1016/S0140-6736(14)61276-9. Epub 2014 Nov 14.
PubMed 25455248Siu BW, Leung SS, Ip P, Hung SF, O'Hara MW. Antenatal risk factors for postnatal depression: a prospective study of Chinese women at maternal and child health centres. BMC Psychiatry. 2012 Mar 22;12:22. doi: 10.1186/1471-244X-12-22.
PubMed 22436053Wang SY, Jiang XY, Jan WC, Chen CH. A comparative study of postnatal depression and its predictors in Taiwan and mainland China. Am J Obstet Gynecol. 2003 Nov;189(5):1407-12. doi: 10.1067/s0002-9378(03)00673-2.
PubMed 14634578Goldbort J. Transcultural analysis of postpartum depression. MCN Am J Matern Child Nurs. 2006 Mar-Apr;31(2):121-6. doi: 10.1097/00005721-200603000-00012.
PubMed 16523038Lim G, Facco FL, Nathan N, Waters JH, Wong CA, Eltzschig HK. A Review of the Impact of Obstetric Anesthesia on Maternal and Neonatal Outcomes. Anesthesiology. 2018 Jul;129(1):192-215. doi: 10.1097/ALN.0000000000002182.
PubMed 29561267Ding T, Wang DX, Qu Y, Chen Q, Zhu SN. Epidural labor analgesia is associated with a decreased risk of postpartum depression: a prospective cohort study. Anesth Analg. 2014 Aug;119(2):383-392. doi: 10.1213/ANE.0000000000000107.
PubMed 24797120Lim G, Farrell LM, Facco FL, Gold MS, Wasan AD. Labor Analgesia as a Predictor for Reduced Postpartum Depression Scores: A Retrospective Observational Study. Anesth Analg. 2018 May;126(5):1598-1605. doi: 10.1213/ANE.0000000000002720.
PubMed 29239949Stewart DE, Vigod S. Postpartum Depression. N Engl J Med. 2016 Dec 1;375(22):2177-2186. doi: 10.1056/NEJMcp1607649. No abstract available.
PubMed 27959754
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study on the Effect of Labor Analgesia on the Postpartum Recovery Outcome of Chinese Parturients
- ClinicalTrials.gov ID
- NCT05666024
- Acronym / sponsor ID
- Labor analgesia
- Conditions
- Analgesia, Labor Analgesia
- Keywords
- Labor analgesia, Chinese parturients, Postpartum recovery
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Huazhong University of Science and TechnologyUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 27 Dec 2022 (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.
Background:
The parturient will experience extreme pain during delivery. Effective labor analgesia will bring better delivery experience to the parturient, while the adverse experience during delivery may bring many adverse effects to the parturient, including postpartum depression, insomnia, and even suicide. Postpartum depression, which has a high incidence, is one of the most common diseases that affect the quality of life of pregnant women during the perinatal period. Postpartum depression even leads to maternal suicide, which is the main cause of maternal death in the first year after childbirth. At the same time, postpartum depression seriously affects the relationship between mother and baby, which significantly increases the risk of long-term psychological sequelae of their children. Its incidence in Europe and America is about 10%, while in China it even reaches 15.7-39.8%. In addition, these factors may also affect maternal breast milk and adversely affect the psychological and behavioral development of infants. Many studies report that effective analgesia can reduce the incidence of postpartum depression in the process of natural delivery, which indicates that labor analgesia is one of the effective measures to reduce postpartum depression. However, the sample size of these studies is relatively small, and they usually focus on the psychological impact on the mothers themselves, and the focus time is only 6-8 weeks after the operation. However, there is still a lack of large sample multicenter studies on the long-term outcome of postpartum mothers and newborns (including the impact of breast feeding and neonatal neurointellectual development).
Objective:
- The subjects were included and comprehensive perinatal data were collected. On this basis, the database of maternal and neonatal prognosis for labor analgesia was established;
- Different data analysis methods were used to analyze the differences of maternal and neonatal outcomes to provide evidence based medical evidence for the current situation of labor analgesia and the optimization of labor analgesia mode.
Detailed description
Based on the principle of Real World Study (RWS), this study is intended to conduct a prospective observational study through long-term comprehensive outcome follow-up of a large sample of multiple centers, and then, based on different studies, conduct a synchronous survey by gathering comprehensive attention on outcome indicators, and use machine learning, regression analysis, propensity matching and other analysis methods for data analysis, Finally, independent analysis based on different sub research topics combined with big data analysis will provide effective evidence-based medical evidence for the optimization of current labor analgesia.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Parturients | – | –Maternity about to give birth |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Parturients
Key inclusion criteria (3 listed)
- 20 ≤ age ≤ 45;
- ASA I ～ III;
- Willing to participate in this study and sign the informed consent form.
Key exclusion criteria (2 listed)
- Take other trial drugs or participate in other clinical trials 3 months before inclusion in the study;
- Unable to cooperate with the research for any reason.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prospective observational study | Other | Parturients |
Primary outcome
Data collection and database establishment
Time frame: 2024
The subjects were included and comprehensive perinatal data were collected. On this basis, the prognostic database of parturients with labor analgesia and neonates was established
1 secondary outcome
data analysis
Time frame: 2024
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2022.
- Background: PubMed 30462430Pollard K. MBRRACE-UK Report launch December 2016. Pract Midwife. 2017 Feb;20(2):30-2.
- Background: PubMed 24108418Pearson RM, Evans J, Kounali D, Lewis G, Heron J, Ramchandani PG, O'Connor TG, Stein A. Maternal depression during pregnancy and the postnatal period: risks and possible mechanisms for offspring depression at age 18 years. JAMA Psychiatry. 2013 Dec;70(12):1312-9. doi: 10.1001/jamapsychiatry.2013.2163.
- Background: PubMed 17148723Munk-Olsen T, Laursen TM, Pedersen CB, Mors O, Mortensen PB. New parents and mental disorders: a population-based register study. JAMA. 2006 Dec 6;296(21):2582-9. doi: 10.1001/jama.296.21.2582.
- Background: PubMed 25455248Howard LM, Molyneaux E, Dennis CL, Rochat T, Stein A, Milgrom J. Non-psychotic mental disorders in the perinatal period. Lancet. 2014 Nov 15;384(9956):1775-88. doi: 10.1016/S0140-6736(14)61276-9. Epub 2014 Nov 14.
- Background: PubMed 22436053Siu BW, Leung SS, Ip P, Hung SF, O'Hara MW. Antenatal risk factors for postnatal depression: a prospective study of Chinese women at maternal and child health centres. BMC Psychiatry. 2012 Mar 22;12:22. doi: 10.1186/1471-244X-12-22.
- Background: PubMed 14634578Wang SY, Jiang XY, Jan WC, Chen CH. A comparative study of postnatal depression and its predictors in Taiwan and mainland China. Am J Obstet Gynecol. 2003 Nov;189(5):1407-12. doi: 10.1067/s0002-9378(03)00673-2.
- Background: PubMed 16523038Goldbort J. Transcultural analysis of postpartum depression. MCN Am J Matern Child Nurs. 2006 Mar-Apr;31(2):121-6. doi: 10.1097/00005721-200603000-00012.
- Background: PubMed 29561267Lim G, Facco FL, Nathan N, Waters JH, Wong CA, Eltzschig HK. A Review of the Impact of Obstetric Anesthesia on Maternal and Neonatal Outcomes. Anesthesiology. 2018 Jul;129(1):192-215. doi: 10.1097/ALN.0000000000002182.
- Background: PubMed 24797120Ding T, Wang DX, Qu Y, Chen Q, Zhu SN. Epidural labor analgesia is associated with a decreased risk of postpartum depression: a prospective cohort study. Anesth Analg. 2014 Aug;119(2):383-392. doi: 10.1213/ANE.0000000000000107.
- Background: PubMed 29239949Lim G, Farrell LM, Facco FL, Gold MS, Wasan AD. Labor Analgesia as a Predictor for Reduced Postpartum Depression Scores: A Retrospective Observational Study. Anesth Analg. 2018 May;126(5):1598-1605. doi: 10.1213/ANE.0000000000002720.
- Results publication: PubMed 27959754Stewart DE, Vigod S. Postpartum Depression. N Engl J Med. 2016 Dec 1;375(22):2177-2186. doi: 10.1056/NEJMcp1607649. 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. This study is not recruiting at the moment.
Xianwei Zhang, Doctor principal investigator
Huazhong University of Science and Technology
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 Analgesia and Labor Analgesia, run by Huazhong University of Science and Technology 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 3 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 27 Dec 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xianwei Zhang, Doctor (13296696810, ourpain@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Data collection and database establishment (time frame: 2024). 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 NCT05666024, which also lists 11 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 27 Dec 2022.