Skip to content

A RCT to Evaluate the Effects of Pelvic and Abdominal Mechanical Exercises During Pregnancy on Reducing the Rate of CS and Preventing PFD

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05252455
Enrollment
200
Registered
2022-02-23
Start date
2022-03-31
Completion date
2024-03-31
Last updated
2022-02-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mode of Delivery, Pelvic Floor Dysfunction

Brief 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. 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.

Interventions

BEHAVIORALpelvic and abdominal mechanics exercise

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)

Sponsors

Qiu Jin
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 38 Years
Healthy volunteers
Yes

Inclusion criteria

1. 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); 2. Singleton pregnancy; 3. 22-24 weeks of pregnancy; 4. Pregnant women voluntarily signed an informed consent form to participate in this study.

Exclusion criteria

1. Cervical insufficiency; 2. People with low placenta (the lower edge of the placenta is less than 2 cm from the inner cervical opening); 3. Severe medical and surgical diseases before pregnancy (such as hypertension, cardiac insufficiency, arrhythmia, etc.); 4. Twin and multiple pregnancy; 5. Mid-Tang, non-invasive DNA or large row malformations suggest fetal malformations; 6. Pregnant women have genital malformations (vaginal diaphragm, uterine malformations, etc.); 7. Those who plan to participate in regular aerobic exercises during pregnancy.

Design outcomes

Primary

MeasureTime frameDescription
Mode of delivery2 yearsCesarean section rate for pregnant women who give birth at 37 weeks of gestation and later (full-term)

Secondary

MeasureTime frameDescription
Pelvic floor dysfunction2 yearsPelvic 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.

Contacts

Primary Contactjin Qiu
jeanqiuqiu@hotmail.com18121226319

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026