Clinical trial NCT05760768: The Effect of Individualized Exercise Guidance on Pregnancy Outcome
Official title: The Effect of Individualized Exercise Guidance on Pregnancy Outcome: A Prospective Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy Outcome
Gestational Weight Gain
Mediation
Macrosomia, Fetal
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2023-03-08
Enrollment: 326
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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.

Primary outcomes:
measure: macrosomia
timeFrame: From date of enrollment until the date of delivery, assessed up to 28 weeks.
measure: gestation weight gain（GWG）
timeFrame: From date of enrollment until the date of delivery, assessed up to 28 weeks.
Secondary outcomes:
measure: postpartum weight retention（PPWR）
timeFrame: From date of enrollment until the date of 42 days postpartum, assessed up to 34 weeks.
measure: diastasis recti abdominis（RDA）
timeFrame: From date of enrollment until the date of 42 days postpartum, assessed up to 34 weeks.
Other outcomes:
Locations:
city: Beijing
country: China
facility: Department of ob gyn, Peking Union Medical College Hospital
state: Beijing
Study officials:
affiliation: Peking union medical college hosiptal
name: Liangkun Ma
role: STUDY_DIRECTOR
References: