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The Effect of Individualized Exercise Guidance on Pregnancy Outcome

Primary Purpose

Pregnancy Outcome, Gestational Weight Gain, Mediation

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Individualized exercise guidance
Sponsored by
Peking Union Medical College Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Pregnancy Outcome

Eligibility Criteria

20 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Department of ob gyn, Peking Union Medical College Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Individualized exercise guidance group

Standard clinic prenatal care (control) group

Arm Description

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

Participants accept regular routine prenatal care following Chinese standard.

Outcomes

Primary Outcome Measures

macrosomia
Neonatal birthweight is more than 4000 grams.
gestation weight gain(GWG)
Weight before delivery minus weight before pregnancy.

Secondary Outcome Measures

postpartum weight retention(PPWR)
Weight at a certain point after delivery minus weight before pregnancy.
diastasis recti abdominis(RDA)
The separation of the left and right rectus abdominis.

Full Information

First Posted
February 20, 2023
Last Updated
March 6, 2023
Sponsor
Peking Union Medical College Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05760768
Brief Title
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

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
December 1, 2021 (Actual)
Primary Completion Date
January 31, 2022 (Actual)
Study Completion Date
September 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Peking Union Medical College Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pregnancy Outcome, Gestational Weight Gain, Mediation, Macrosomia, Fetal

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
326 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Individualized exercise guidance group
Arm Type
Experimental
Arm Description
Participants accept individualized exercise guidance. They are also managed continuously through WeChat group chat during prenatal clinical interval.
Arm Title
Standard clinic prenatal care (control) group
Arm Type
No Intervention
Arm Description
Participants accept regular routine prenatal care following Chinese standard.
Intervention Type
Behavioral
Intervention Name(s)
Individualized exercise guidance
Intervention Description
Participants accept individualized exercise guidance. They are also managed continuously through WeChat group chat during prenatal clinical interval.
Primary Outcome Measure Information:
Title
macrosomia
Description
Neonatal birthweight is more than 4000 grams.
Time Frame
From date of enrollment until the date of delivery, assessed up to 28 weeks.
Title
gestation weight gain(GWG)
Description
Weight before delivery minus weight before pregnancy.
Time Frame
From date of enrollment until the date of delivery, assessed up to 28 weeks.
Secondary Outcome Measure Information:
Title
postpartum weight retention(PPWR)
Description
Weight at a certain point after delivery minus weight before pregnancy.
Time Frame
From date of enrollment until the date of 42 days postpartum, assessed up to 34 weeks.
Title
diastasis recti abdominis(RDA)
Description
The separation of the left and right rectus abdominis.
Time Frame
From date of enrollment until the date of 42 days postpartum, assessed up to 34 weeks.

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Liangkun Ma
Organizational Affiliation
Peking union medical college hosiptal
Official's Role
Study Director
Facility Information:
Facility Name
Department of ob gyn, Peking Union Medical College Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100730
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

The Effect of Individualized Exercise Guidance on Pregnancy Outcome

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