Viewing Study NCT05252455



Ignite Creation Date: 2024-05-06 @ 5:17 PM
Last Modification Date: 2024-10-26 @ 2:25 PM
Study NCT ID: NCT05252455
Status: UNKNOWN
Last Update Posted: 2022-02-23
First Post: 2021-12-25

Brief Title: A RCT to Evaluate the Effects of Pelvic and Abdominal Mechanical Exercises During Pregnancy on Reducing the Rate of CS and Preventing PFD
Sponsor: Qiu Jin
Organization: Shanghai Tong Ren Hospital

Study Overview

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
Status: UNKNOWN
Status Verified Date: 2022-02
Last Known Status: NOT_YET_RECRUITING
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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 diseasesTo 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 Hospitals 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 Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None