The Effect of Individualized Exercise Guidance on Pregnancy Outcome

Gestational Weight Gain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05760768
• Other study ID #: 018
• Status: Completed
• Phase: N/A
• Start date: December 1, 2021
• Est. completion date: September 30, 2022

Study information

• Verified date: November 2021
• Source: Peking Union Medical College Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 326
• Est. completion date: September 30, 2022
• Est. primary completion date: January 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
China	Department of ob gyn, Peking Union Medical College Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	macrosomia	Neonatal birthweight is more than 4000 grams.	From date of enrollment until the date of delivery, assessed up to 28 weeks.
Primary	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	postpartum weight retention(PPWR)	Weight at a certain point after delivery minus weight before pregnancy.	From date of enrollment until the date of 42 days postpartum, assessed up to 34 weeks.
Secondary	diastasis recti abdominis(RDA)	The separation of the left and right rectus abdominis.	From date of enrollment until the date of 42 days postpartum, assessed up to 34 weeks.