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The Effect of Individualized Exercise Guidance on Pregnancy Outcome

The Effect of Individualized Exercise Guidance on Pregnancy Outcome: A Prospective Randomized Controlled Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05760768
Enrollment
326
Registered
2023-03-08
Start date
2021-12-01
Completion date
2022-09-30
Last updated
2023-03-08

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

Conditions

Gestational Weight Gain, Macrosomia, Fetal, Mediation, Pregnancy Outcome

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.

Detailed description

Fetal macrosomia refers to newborns with a birth weight more than 4000 grams, which poses varying degrees of risks to the health of both mother and infant and also affects the health outcomes of future generations. Research has found that exercise can effectively reduce the incidence of macrosomia and prevent gestational diabetes mellitus, pregnancy-induced hypertension, and excessive weight gain during pregnancy. However, every pregnant woman's individual situation and exercise habits are different, and personalized guidance based on their own circumstances is necessary during pregnancy exercise. The use of intelligent devices for supervision and management is also essential. To explore the impact of personalized exercise guidance during pregnancy on macrosomia, as well as the mediating effect of weight gain during pregnancy on exercise and macrosomia, we conducted a prospective randomized controlled clinical trial. The study included pregnant women who were over 20 years old, married, singleton, in the mid-term of pregnancy, and had no contraindications for exercise during pregnancy. They were randomly divided into an individualized exercise guidance group and standard clinic prenatal care group. Both groups received routine prenatal care and did not have any special dietary recommendations. The pregnant women in the individualized exercise guidance group received regular exercise guidance from a professional teacher and were supervised and managed through a WeChat group. The main outcome indicators were the incidence of macrosomia and the total weight gain during pregnancy.

Interventions

BEHAVIORALIndividualized exercise guidance

Participants accept individualized exercise guidance. They are also managed continuously through WeChat group chat during prenatal clinical interval.

Sponsors

Peking Union Medical College Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
20 Years to 45 Years
Healthy volunteers
Yes

Inclusion criteria

* 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.

Exclusion criteria

* Adverse pregnancy reaction, such as abdominal pain, vaginal bleeding and so on.

Design outcomes

Primary

MeasureTime frameDescription
macrosomiaFrom date of enrollment until the date of delivery, assessed up to 28 weeks.Neonatal birthweight is more than 4000 grams.
gestation weight gain(GWG)From date of enrollment until the date of delivery, assessed up to 28 weeks.Weight before delivery minus weight before pregnancy.

Secondary

MeasureTime frameDescription
postpartum weight retention(PPWR)From date of enrollment until the date of 42 days postpartum, assessed up to 34 weeks.Weight at a certain point after delivery minus weight before pregnancy.
diastasis recti abdominis(RDA)From date of enrollment until the date of 42 days postpartum, assessed up to 34 weeks.The separation of the left and right rectus abdominis.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 7, 2026