Cesarean SectionTEASNCT02416310
Transcutaneous Electrical Acupoint Stimulation on Gastrointestinal Function After Cesarean Section
A study testing TEAS in people with Cesarean Section, run by Xijing Hospital.
Trial summary
To determine whether treating by transcutaneous electrical acupoint stimulation (TEAS) during perioperative could alleviate the postoperative gastrointestinal complications after cesarean section under combined spinal epidural anesthesia compared with control and non-acupoint group. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Cesarean Section
- What is being tested?
- TEAS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2015to 26 Mar 2016
- Phase
- Interventional
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- ASA physical status 1or2, scheduled for elective cesarean section under combined spinal epidural anesthesia
- Gestational age ≥38 weeks
- Provide written informed consent
Who cannot join
- ASA status≥Ⅲ
- Patients undergoing surgery within 12 h of admission to hospital
- Patients with fetal anomaly，medical or obstetric complications such as Diabetes mellitus、Hypertension、Obesity(BMW≥35)
- Patients suffered from drug addiction or impaired mental state
- Patients who have a history of gastrointestinal surgery or chronic gastrointestinal disease.
- Patients with contraindications to the use of electro-acupuncture, such as skin damage or infection at the acupoints
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- Patients with experience of transcutaneous electrical stimulation treatment
- Participate in the other clinical trial 3 months before the enrollment
- Not suitable to participate in this experiment
About this study
Official title: Effect of Perioperative Transcutaneous Electrical Acupoint Stimulation on Gastrointestinal Function After Cesarean Section
To determine whether treating by transcutaneous electrical acupoint stimulation (TEAS) during perioperative could alleviate the postoperative gastrointestinal complications after cesarean section under combined spinal epidural anesthesia compared with control and non-acupoint group.
Read the detailed description
Acupuncture is a traditional Chinese medical technique that involves the insertion of needles at acupoints to treat diseases.Clinical evidence supports the efficacy of acupuncture treatment in many applications. Some previous studies reported that stimulation at some acupoint exerted good effects on the digestive system.Compared with acupuncture, transcutaneous electric acupoint stimulation(TEAS) is a non-invasive technique that has similar effects to acupuncture.We hypothesize that TEAS before anesthesia and during surgery would decrease the morbidity and mortality of postoperative complications in 30 days after Cesarean section.
- Conditions
- Cesarean Section
- Being tested
- TEAS
- Keywords
- TEAS, cesarean section, gastrointestinal function
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TEASDevice
Also called Transcutaneous electrical acupoint stimulation
According to ancient Chinese medical books, acupoints SP6 and ST36 are chosen and identified.The patients in TEAS group received electrical stimulation with the 'disperse-dense' waves. Non-acupoint is located 2cm interior to the ST36 and SP6.For group TEAS and Sham, TEAS will be administered 30 minutes prior to surgery and continued until the end of the surgery.Control patients will receive the same treatment without electrical stimulation.
| Study group | Role | What they receive |
|---|---|---|
| TEAS group | Experimental | TEAS are performed by a specific investigator on the specially acupoint. Receives: Device: TEAS |
| Sham group | Sham comparator | TEAS are performed by a specific investigator on the non-acupoint. Receives: Device: TEAS |
| Control group | Placebo comparator | Only place cutted electrodes but do not give any electrical stimulation. Receives: Device: TEAS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to the presence of bowel sound, time to the first passage of flatus, time to the first passage of stool , time to the start of regular diet
This is a composite outcome to estimate the gastrointestinal motility function
Measured: Participants will be followed for the duration of hospital stay, an expected average of 5 days
Secondary outcomes (4)
Electrogastrogram
Measured: The first and second days after surgery
Rate of nausea, vomiting, cramping abdominal pain, abdominal distension
This is a composite outcome to estimate the complication of digestive system
Measured: Participants will be followed for the duration of hospital stay, an expected average of 5 days
length of postoperative hospital stay
Measured: Participants will be followed for the duration of hospital stay, an expected average of 5 days
Quality of life during 30 days after surgery
This is a scale to evaluate the quality of life after surgery
Measured: One month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2015 (estimated)
- Study start1 Sep 2015
- Primary completion1 Mar 2016
- Study completion26 Mar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Cesarean 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Northwest Women's and Children's Hospital, Xi'an, Shaanxi
- Responsible party
- Principal investigator, wangqiang, Xijing Hospital
- Investigators
- Qiang Wang, Study chair, Xijing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02416310
- Sponsor's protocol ID
- Xijing H
- Other IDs
- mazuike
- Acronym
- TEAS
- Status last verified
- Aug 2017
- First submitted
- 2 Apr 2015
- Last updated
- 9 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Larson JD, Gutowski KA, Marcus BC, Rao VK, Avery PG, Stacey DH, Yang RZ. The effect of electroacustimulation on postoperative nausea, vomiting, and pain in outpatient plastic surgery patients: a prospective, randomized, blinded, clinical trial. Plast Reconstr Surg. 2010 Mar;125(3):989-94. doi: 10.1097/PRS.0b013e3181ccdc23.
PubMed 20195124Kotani N, Hashimoto H, Sato Y, Sessler DI, Yoshioka H, Kitayama M, Yasuda T, Matsuki A. Preoperative intradermal acupuncture reduces postoperative pain, nausea and vomiting, analgesic requirement, and sympathoadrenal responses. Anesthesiology. 2001 Aug;95(2):349-56. doi: 10.1097/00000542-200108000-00015.
PubMed 11506105Cheong KB, Zhang JP, Huang Y. The effectiveness of acupuncture in postoperative gastroparesis syndrome--a systematic review and meta-analysis. Complement Ther Med. 2014 Aug;22(4):767-86. doi: 10.1016/j.ctim.2014.05.002. Epub 2014 May 12.
PubMed 25146082Oshima M, Aoyama K, Warabi K, Akazawa T, Inada E. Electrogastrography during and after cesarean delivery. J Anesth. 2009;23(1):75-9. doi: 10.1007/s00540-008-0692-5. Epub 2009 Feb 22.
PubMed 19234827Dresang LT, Leeman L. Cesarean delivery. Prim Care. 2012 Mar;39(1):145-65. doi: 10.1016/j.pop.2011.11.007.
PubMed 22309587
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Perioperative Transcutaneous Electrical Acupoint Stimulation on Gastrointestinal Function After Cesarean Section
- ClinicalTrials.gov ID
- NCT02416310
- Acronym / sponsor ID
- TEAS / Xijing H
- Conditions
- Cesarean Section
- Keywords
- TEAS, cesarean section, gastrointestinal function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Collaborators
- Northwest Women's and Children's Hospital, Xi'an, Shaanxi
- Study start
- 1 Sep 2015 (actual)
- Primary completion
- 1 Mar 2016 (actual)
- Study completion
- 26 Mar 2016 (actual)
- First posted
- 15 Apr 2015 (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 determine whether treating by transcutaneous electrical acupoint stimulation (TEAS) during perioperative could alleviate the postoperative gastrointestinal complications after cesarean section under combined spinal epidural anesthesia compared with control and non-acupoint group.
Detailed description
Acupuncture is a traditional Chinese medical technique that involves the insertion of needles at acupoints to treat diseases.Clinical evidence supports the efficacy of acupuncture treatment in many applications. Some previous studies reported that stimulation at some acupoint exerted good effects on the digestive system.Compared with acupuncture, transcutaneous electric acupoint stimulation(TEAS) is a non-invasive technique that has similar effects to acupuncture.We hypothesize that TEAS before anesthesia and during surgery would decrease the morbidity and mortality of postoperative complications in 30 days after Cesarean section.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| TEAS group | Experimental | Device: TEASTEAS are performed by a specific investigator on the specially acupoint. |
| Sham group | Sham comparator | Device: TEASTEAS are performed by a specific investigator on the non-acupoint. |
| Control group | Placebo comparator | Device: TEASOnly place cutted electrodes but do not give any electrical stimulation. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- ASA physical status 1or2, scheduled for elective cesarean section under combined spinal epidural anesthesia
- Gestational age ≥38 weeks
- Provide written informed consent
Key exclusion criteria (9 listed)
- ASA status≥Ⅲ
- Patients undergoing surgery within 12 h of admission to hospital
- Patients with fetal anomaly，medical or obstetric complications such as Diabetes mellitus、Hypertension、Obesity(BMW≥35)
- Patients suffered from drug addiction or impaired mental state
- Patients who have a history of gastrointestinal surgery or chronic gastrointestinal disease.
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 |
|---|---|---|
| TEASAlso: Transcutaneous electrical acupoint stimulationAccording to ancient Chinese medical books, acupoints SP6 and ST36 are chosen and identified.The patients in TEAS group received electrical stimulation with the 'disperse-dense' waves. Non-acupoint is located 2cm interior to the ST36 and SP6.For group TEAS and Sham, TEAS will be administered 30 minutes prior to surgery and continued until the end of the surgery.Control patients will receive the same treatment without electrical stimulation. | Device | Control group, Sham group, TEAS group |
Primary outcome
Time to the presence of bowel sound, time to the first passage of flatus, time to the first passage of stool , time to the start of regular diet
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 5 days
This is a composite outcome to estimate the gastrointestinal motility function
4 secondary outcomes
Electrogastrogram
Time frame: The first and second days after surgery
Rate of nausea, vomiting, cramping abdominal pain, abdominal distension
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 5 days
length of postoperative hospital stay
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 5 days
Quality of life during 30 days after surgery
Time frame: One month
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 9 Aug 2017.
- Background: PubMed 20195124Larson JD, Gutowski KA, Marcus BC, Rao VK, Avery PG, Stacey DH, Yang RZ. The effect of electroacustimulation on postoperative nausea, vomiting, and pain in outpatient plastic surgery patients: a prospective, randomized, blinded, clinical trial. Plast Reconstr Surg. 2010 Mar;125(3):989-94. doi: 10.1097/PRS.0b013e3181ccdc23.
- Background: PubMed 11506105Kotani N, Hashimoto H, Sato Y, Sessler DI, Yoshioka H, Kitayama M, Yasuda T, Matsuki A. Preoperative intradermal acupuncture reduces postoperative pain, nausea and vomiting, analgesic requirement, and sympathoadrenal responses. Anesthesiology. 2001 Aug;95(2):349-56. doi: 10.1097/00000542-200108000-00015.
- Background: PubMed 25146082Cheong KB, Zhang JP, Huang Y. The effectiveness of acupuncture in postoperative gastroparesis syndrome--a systematic review and meta-analysis. Complement Ther Med. 2014 Aug;22(4):767-86. doi: 10.1016/j.ctim.2014.05.002. Epub 2014 May 12.
- Background: PubMed 19234827Oshima M, Aoyama K, Warabi K, Akazawa T, Inada E. Electrogastrography during and after cesarean delivery. J Anesth. 2009;23(1):75-9. doi: 10.1007/s00540-008-0692-5. Epub 2009 Feb 22.
- Background: PubMed 22309587Dresang LT, Leeman L. Cesarean delivery. Prim Care. 2012 Mar;39(1):145-65. doi: 10.1016/j.pop.2011.11.007.
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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.
Qiang Wang study chair
Xijing Hospital
Questions about this trial
What is this clinical trial studying?
A study testing TEAS in people with Cesarean Section, run by Xijing Hospital.
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 9 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 9 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Time to the presence of bowel sound, time to the first passage of flatus, time to the first passage of stool , time to the start of regular diet (time frame: Participants will be followed for the duration of hospital stay, an expected average of 5 days). 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 NCT02416310, which also lists 5 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 9 Aug 2017.