The Effect of Individualized Exercise Guidance on Pregnancy Outcome
1 other identifier
interventional
326
1 country
1
Brief Summary
A single center, randomized controlled trial was conducted to investigate whether individualized exercise guidance was more effective in improving pregnancy outcomes in normal pregnant women. What's more, the trial was also conducted to find out whether there is a mediating effect between prenatal exercise and pregnancy outcomes.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2021
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2022
CompletedFirst Submitted
Initial submission to the registry
February 20, 2023
CompletedFirst Posted
Study publicly available on registry
March 8, 2023
CompletedMarch 8, 2023
November 1, 2021
2 months
February 20, 2023
March 6, 2023
Conditions
Outcome Measures
Primary Outcomes (2)
macrosomia
Neonatal birthweight is more than 4000 grams.
From date of enrollment until the date of delivery, assessed up to 28 weeks.
gestation weight gain（GWG）
Weight before delivery minus weight before pregnancy.
From date of enrollment until the date of delivery, assessed up to 28 weeks.
Secondary Outcomes (2)
postpartum weight retention（PPWR）
From date of enrollment until the date of 42 days postpartum, assessed up to 34 weeks.
diastasis recti abdominis（RDA）
From date of enrollment until the date of 42 days postpartum, assessed up to 34 weeks.
Study Arms (2)
Individualized exercise guidance group
EXPERIMENTALParticipants accept individualized exercise guidance. They are also managed continuously through WeChat group chat during prenatal clinical interval.
Standard clinic prenatal care (control) group
NO INTERVENTIONParticipants accept regular routine prenatal care following Chinese standard.
Interventions
Participants accept individualized exercise guidance. They are also managed continuously through WeChat group chat during prenatal clinical interval.
Eligibility Criteria
You may qualify if:
- Aged between 18 and 45 years.
- With singleton pregnancy.
- Second trimester.
- No contraindications to exercise during pregnancy.
- Be able to use smart phone for chatting, read and write basic Chinese.
- Volunteer for research.
You may not qualify if:
- Adverse pregnancy reaction, such as abdominal pain, vaginal bleeding and so on.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of ob gyn, Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730, China
Related Publications (1)
Yang X, Wang G, Liu N, Wang Y, Zhang S, Lin H, Zhu C, Liu L, Sun Y, Ma L. Mediating effect of gestational weight gain on the preventive effect of exercise during pregnancy on macrosomia: a randomized clinical trial. BMC Pregnancy Childbirth. 2024 May 22;24(1):384. doi: 10.1186/s12884-024-06527-7.
PMID: 38778289DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Liangkun Ma
Peking union medical college hosiptal
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 20, 2023
First Posted
March 8, 2023
Study Start
December 1, 2021
Primary Completion
January 31, 2022
Study Completion
September 30, 2022
Last Updated
March 8, 2023
Record last verified: 2021-11
Data Sharing
- IPD Sharing
- Will not share