Mode of DeliveryNCT05252455
A RCT to Evaluate the Effects of Pelvic and Abdominal Mechanical Exercises During Pregnancy on Reducing the Rate of CS and Preventing PFD
A study testing pelvic and abdominal mechanics exercise in people with Mode of Delivery and Pelvic Floor Dysfunction, run by Qiu Jin.
Trial summary
Pelvic floor dysfunction diseases seriously affect the quality of life. Childbirth, especially vaginal birth, is significantly related to pelvic floor dysfunction diseases, which mainly cause urinary incontinence and pelvic organ prolapse. Read more about this study
- Who is it for?
- Ages 18 to 38 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Mode of Delivery, Pelvic Floor Dysfunction
- What is being tested?
- pelvic and abdominal mechanics exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Mar 2022to Mar 2024
- 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 18 to 38 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- The primipara who is 18 years old ≤ the age at delivery ≤ 38 years old (this pregnancy is the pregnant woman who gave birth for the first time);
- Singleton pregnancy;
- 22-24 weeks of pregnancy;
- Pregnant women voluntarily signed an informed consent form to participate in this study.
Who cannot join
- Cervical insufficiency;
- People with low placenta (the lower edge of the placenta is less than 2 cm from the inner cervical opening);
- Severe medical and surgical diseases before pregnancy (such as hypertension, cardiac insufficiency, arrhythmia, etc.);
- Twin and multiple pregnancy;
- Mid-Tang, non-invasive DNA or large row malformations suggest fetal malformations;
- Pregnant women have genital malformations (vaginal diaphragm, uterine malformations, etc.);
- Those who plan to participate in regular aerobic exercises during pregnancy.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Randomized Controlled Trial to Evaluate the Effects of Pelvic and Abdominal Mechanical Exercises During Pregnancy on Reducing the Rate of Cesarean Section and Preventing Pelvic Floor Dysfunction Diseases
Pelvic floor dysfunction diseases seriously affect the quality of life. Childbirth, especially vaginal birth, is significantly related to pelvic floor dysfunction diseases, which mainly cause urinary incontinence and pelvic organ prolapse. Studies have found that exercise during pregnancy can help reduce the rate of caesarean section and prevent the occurrence of organic pelvic floor disorders. Pregnant women without obvious comorbidities should be encouraged to participate in fitness programs that include core muscle exercises.
At present, there is no clinical research data about the influence of pelvic and abdominal mechanical exercise during pregnancy on the way of delivery and postpartum pelvic floor rehabilitation.
This study is a clinical randomized controlled study, use pelvic and abdominal mechanical exercises during pregnancy to train proprioception of the pelvis, increase local muscle strength, ensure physical strength while taking into account flexibility, to evaluate the impact of pelvic and abdominal mechanical exercises during pregnancy on the cesarean section rate of primiparas and on Prevention of pregnancy-related pain during pregnancy and postpartum pelvic floor dysfunction diseases.To provide strong evidence-based medical evidence for the promotion of pelvic and abdominal mechanical exercise during pregnancy in the majority of pregnant women in the future.
Read the detailed description
This study is a clinical randomized controlled study, which aims to evaluate the influence of pelvic and abdominal mechanical exercise during pregnancy on pregnancy outcome and pelvic floor health, and to provide strong evidence-based medical evidence for the promotion of pelvic and abdominal mechanical exercise during pregnancy in the majority of pregnant women in the future.
Pregnant women included in the study must be pregnant women who gave birth during the formal examination in the Obstetrics Department of Shanghai Tongren Hospital during the study period and met the enrollment criteria.
The researchers randomly divided pregnant women into two groups: exercise group and control group. The sports group or control group cards are printed and placed in an opaque envelope, which will be stored and locked in the cabinet. The recruited pregnant women select an envelope from the available envelopes to determine the group selection, and plan to enroll 10 cases each month.
Pregnant women in the exercise group will participate in the pelvic and abdominal mechanics exercise course offered by Tongren Hospital's Obstetrics Department once a week from the 24th week of pregnancy to the 38th week. The professionally certified Li Yueyue will be the coach. During this period, the pregnant women in the control group will receive the same formal prenatal examinations Maternity school curriculum (including Lamez breathing method, nutrition and weight management guidance during pregnancy, etc.), a comparative analysis of relevant evaluation indicators during pregnancy, delivery and 42-day follow-up results after delivery.
- Conditions
- Mode of Delivery, Pelvic Floor Dysfunction
- Being tested
- pelvic and abdominal mechanics exercise
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pelvic and abdominal mechanics exerciseBehavioural
starting from 24 weeks of pregnancy, participate in the pelvic and abdominal mechanics exercises offered by the "Good Pregnancy" College of Shanghai Tongren Hospital once a week. Each class lasts one hour until the 38th week of pregnancy (attend at least 10 times)
| Study group | Role | What they receive |
|---|---|---|
| exercise group | Other | pelvic and abdominal mechanics exercise Receives: Behavioral: pelvic and abdominal mechanics exercise |
| control group | No intervention | Normal prenatal examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mode of delivery
Cesarean section rate for pregnant women who give birth at 37 weeks of gestation and later (full-term)
Measured: 2 years
Secondary outcomes (1)
Pelvic floor dysfunction
Pelvic floor impact questionnaire-short form 7 (PFIQ-7). This questionnaire score scale is 0-100, higher scores mean a worse outcome.1-32 means minor distress,33-66 means moderate distress,67-100 means severe distress.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2022
- Study startMar 2022 (estimated)
- Primary completionMar 2024 (estimated)
- Study completionMar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Mode of DeliveryStudies 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
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qiu Jin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Qiu Jin, Shanghai Tong Ren Hospital
- Investigators
- jin Qiu, Principal investigator, Shanghai Tong Ren Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05252455
- Sponsor's protocol ID
- Prof. Qiu Jin
- Status last verified
- Feb 2022
- First submitted
- 25 Dec 2021
- Last updated
- 23 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Appropriate technology for birth. Lancet. 1985 Aug 24;2(8452):436-7.
PubMed 2863457Lumbiganon P, Laopaiboon M, Gulmezoglu AM, Souza JP, Taneepanichskul S, Ruyan P, Attygalle DE, Shrestha N, Mori R, Nguyen DH, Hoang TB, Rathavy T, Chuyun K, Cheang K, Festin M, Udomprasertgul V, Germar MJ, Yanqiu G, Roy M, Carroli G, Ba-Thike K, Filatova E, Villar J; World Health Organization Global Survey on Maternal and Perinatal Health Research Group. Method of delivery and pregnancy outcomes in Asia: the WHO global survey on maternal and perinatal health 2007-08. Lancet. 2010 Feb 6;375(9713):490-9. doi: 10.1016/S0140-6736(09)61870-5. Epub 2010 Jan 11.
PubMed 20071021Qiao J, Wang Y, Li X, Jiang F, Zhang Y, Ma J, Song Y, Ma J, Fu W, Pang R, Zhu Z, Zhang J, Qian X, Wang L, Wu J, Chang HM, Leung PCK, Mao M, Ma D, Guo Y, Qiu J, Liu L, Wang H, Norman RJ, Lawn J, Black RE, Ronsmans C, Patton G, Zhu J, Song L, Hesketh T. A Lancet Commission on 70 years of women's reproductive, maternal, newborn, child, and adolescent health in China. Lancet. 2021 Jun 26;397(10293):2497-2536. doi: 10.1016/S0140-6736(20)32708-2. Epub 2021 May 24. No abstract available.
PubMed 34043953Bacchi M, Mottola MF, Perales M, Refoyo I, Barakat R. Aquatic Activities During Pregnancy Prevent Excessive Maternal Weight Gain and Preserve Birth Weight: A Randomized Clinical Trial. Am J Health Promot. 2018 Mar;32(3):729-735. doi: 10.1177/0890117117697520. Epub 2017 Mar 9.
PubMed 28279085
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial to Evaluate the Effects of Pelvic and Abdominal Mechanical Exercises During Pregnancy on Reducing the Rate of Cesarean Section and Preventing Pelvic Floor Dysfunction Diseases
- ClinicalTrials.gov ID
- NCT05252455
- Acronym / sponsor ID
- Prof. Qiu Jin
- Conditions
- Mode of Delivery, Pelvic Floor Dysfunction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Qiu JinUniversity, hospital or other
- Study start
- Mar 2022 (estimated)
- Primary completion
- Mar 2024 (estimated)
- Study completion
- Mar 2024 (estimated)
- First posted
- 23 Feb 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.
Pelvic floor dysfunction diseases seriously affect the quality of life. Childbirth, especially vaginal birth, is significantly related to pelvic floor dysfunction diseases, which mainly cause urinary incontinence and pelvic organ prolapse. Studies have found that exercise during pregnancy can help reduce the rate of caesarean section and prevent the occurrence of organic pelvic floor disorders. Pregnant women without obvious comorbidities should be encouraged to participate in fitness programs that include core muscle exercises.
At present, there is no clinical research data about the influence of pelvic and abdominal mechanical exercise during pregnancy on the way of delivery and postpartum pelvic floor rehabilitation.
This study is a clinical randomized controlled study, use pelvic and abdominal mechanical exercises during pregnancy to train proprioception of the pelvis, increase local muscle strength, ensure physical strength while taking into account flexibility, to evaluate the impact of pelvic and abdominal mechanical exercises during pregnancy on the cesarean section rate of primiparas and on Prevention of pregnancy-related pain during pregnancy and postpartum pelvic floor dysfunction diseases.To provide strong evidence-based medical evidence for the promotion of pelvic and abdominal mechanical exercise during pregnancy in the majority of pregnant women in the future.
Detailed description
This study is a clinical randomized controlled study, which aims to evaluate the influence of pelvic and abdominal mechanical exercise during pregnancy on pregnancy outcome and pelvic floor health, and to provide strong evidence-based medical evidence for the promotion of pelvic and abdominal mechanical exercise during pregnancy in the majority of pregnant women in the future.
Pregnant women included in the study must be pregnant women who gave birth during the formal examination in the Obstetrics Department of Shanghai Tongren Hospital during the study period and met the enrollment criteria.
The researchers randomly divided pregnant women into two groups: exercise group and control group. The sports group or control group cards are printed and placed in an opaque envelope, which will be stored and locked in the cabinet. The recruited pregnant women select an envelope from the available envelopes to determine the group selection, and plan to enroll 10 cases each month.
Pregnant women in the exercise group will participate in the pelvic and abdominal mechanics exercise course offered by Tongren Hospital's Obstetrics Department once a week from the 24th week of pregnancy to the 38th week. The professionally certified Li Yueyue will be the coach. During this period, the pregnant women in the control group will receive the same formal prenatal examinations Maternity school curriculum (including Lamez breathing method, nutrition and weight management guidance during pregnancy, etc.), a comparative analysis of relevant evaluation indicators during pregnancy, delivery and 42-day follow-up results after delivery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| exercise group | Other | Behavioral: pelvic and abdominal mechanics exercisepelvic and abdominal mechanics exercise |
| control group | No intervention | –Normal prenatal examination |
Who may qualify
- Ages
- 18 to 38 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- The primipara who is 18 years old ≤ the age at delivery ≤ 38 years old (this pregnancy is the pregnant woman who gave birth for the first time);
- Singleton pregnancy;
- 22-24 weeks of pregnancy;
- Pregnant women voluntarily signed an informed consent form to participate in this study.
Key exclusion criteria (7 listed)
- Cervical insufficiency;
- People with low placenta (the lower edge of the placenta is less than 2 cm from the inner cervical opening);
- Severe medical and surgical diseases before pregnancy (such as hypertension, cardiac insufficiency, arrhythmia, etc.);
- Twin and multiple pregnancy;
- Mid-Tang, non-invasive DNA or large row malformations suggest fetal malformations;
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 |
|---|---|---|
| pelvic and abdominal mechanics exercisestarting from 24 weeks of pregnancy, participate in the pelvic and abdominal mechanics exercises offered by the "Good Pregnancy" College of Shanghai Tongren Hospital once a week. Each class lasts one hour until the 38th week of pregnancy (attend at least 10 times) | Behavioural | exercise group |
Primary outcome
Mode of delivery
Time frame: 2 years
Cesarean section rate for pregnant women who give birth at 37 weeks of gestation and later (full-term)
1 secondary outcome
Pelvic floor dysfunction
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2022.
- Background: PubMed 2863457Appropriate technology for birth. Lancet. 1985 Aug 24;2(8452):436-7.
- Background: PubMed 20071021Lumbiganon P, Laopaiboon M, Gulmezoglu AM, Souza JP, Taneepanichskul S, Ruyan P, Attygalle DE, Shrestha N, Mori R, Nguyen DH, Hoang TB, Rathavy T, Chuyun K, Cheang K, Festin M, Udomprasertgul V, Germar MJ, Yanqiu G, Roy M, Carroli G, Ba-Thike K, Filatova E, Villar J; World Health Organization Global Survey on Maternal and Perinatal Health Research Group. Method of delivery and pregnancy outcomes in Asia: the WHO global survey on maternal and perinatal health 2007-08. Lancet. 2010 Feb 6;375(9713):490-9. doi: 10.1016/S0140-6736(09)61870-5. Epub 2010 Jan 11.
- Background: PubMed 34043953Qiao J, Wang Y, Li X, Jiang F, Zhang Y, Ma J, Song Y, Ma J, Fu W, Pang R, Zhu Z, Zhang J, Qian X, Wang L, Wu J, Chang HM, Leung PCK, Mao M, Ma D, Guo Y, Qiu J, Liu L, Wang H, Norman RJ, Lawn J, Black RE, Ronsmans C, Patton G, Zhu J, Song L, Hesketh T. A Lancet Commission on 70 years of women's reproductive, maternal, newborn, child, and adolescent health in China. Lancet. 2021 Jun 26;397(10293):2497-2536. doi: 10.1016/S0140-6736(20)32708-2. Epub 2021 May 24. No abstract available.
- Background: PubMed 28279085Bacchi M, Mottola MF, Perales M, Refoyo I, Barakat R. Aquatic Activities During Pregnancy Prevent Excessive Maternal Weight Gain and Preserve Birth Weight: A Randomized Clinical Trial. Am J Health Promot. 2018 Mar;32(3):729-735. doi: 10.1177/0890117117697520. Epub 2017 Mar 9.
- Individual participant dataSharing planned: No
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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.
jin Qiu principal investigator
Shanghai Tong Ren Hospital
Questions about this trial
What is this clinical trial studying?
A study testing pelvic and abdominal mechanics exercise in people with Mode of Delivery and Pelvic Floor Dysfunction, run by Qiu Jin.
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: status not confirmed, as of the sponsor's last update on 23 Feb 2022. 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. 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 jin Qiu (18121226319, jeanqiuqiu@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mode of delivery (time frame: 2 years). 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 NCT05252455, which also lists 4 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 23 Feb 2022.