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

NCT05252455 | Unknown

• 1 other identifier: Prof. Qiu Jin
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Mode of Delivery; Pelvic Floor Dysfunction

Outcome Measures

Primary Outcomes (1)

• Mode of delivery

  Cesarean section rate for pregnant women who give birth at 37 weeks of gestation and later (full-term)

  2 years

Secondary Outcomes (1)

• Pelvic floor dysfunction

  2 years

Study Arms (2)

exercise group

OTHER

pelvic and abdominal mechanics exercise

Behavioral: pelvic and abdominal mechanics exercise

control group

NO INTERVENTION

Normal prenatal examination

Interventions

pelvic and abdominal mechanics exercise BEHAVIORAL

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)

exercise group

Eligibility Criteria

• Age: 18 Years - 38 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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;
• weeks of pregnancy;
• Pregnant women voluntarily signed an informed consent form to participate in this study.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Qiu Jin: lead

Related Publications (4)

• Appropriate technology for birth. Lancet. 1985 Aug 24;2(8452):436-7.

  PMID: 2863457 BACKGROUND

• Lumbiganon 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.

  PMID: 20071021 BACKGROUND

• Qiao 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.

  PMID: 34043953 BACKGROUND

• Bacchi 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.

  PMID: 28279085 BACKGROUND

Study Officials

• jin Qiu

  Shanghai Tongren Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

jin Qiu

CONTACT

18121226319; jeanqiuqiu@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Executive director of Obstetrics and Gynecology

Study Record Dates

• First Submitted: December 25, 2021
• First Posted: February 23, 2022
• Study Start: March 1, 2022
• Primary Completion: March 1, 2024
• Study Completion: March 1, 2024
• Last Updated: February 23, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share