The Effect of Individualized Exercise Guidance on Pregnancy Outcome

Sponsor
Peking Union Medical College Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT05760768
Collaborator
(none)
326
1
2
10
32.7

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Individualized exercise guidance
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
326 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Health Services Research
Official Title:
The Effect of Individualized Exercise Guidance on Pregnancy Outcome: A Prospective Randomized Controlled Trial
Actual Study Start Date :
Dec 1, 2021
Actual Primary Completion Date :
Jan 31, 2022
Actual Study Completion Date :
Sep 30, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Individualized exercise guidance group

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

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

No Intervention: Standard clinic prenatal care (control) group

Participants accept regular routine prenatal care following Chinese standard.

Outcome Measures

Primary Outcome Measures

  1. macrosomia [From date of enrollment until the date of delivery, assessed up to 28 weeks.]

    Neonatal birthweight is more than 4000 grams.

  2. 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 Outcome Measures

  1. 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.

  2. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 45 Years
Sexes Eligible for Study:
Female
Accepts 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Department of ob gyn, Peking Union Medical College Hospital Beijing Beijing China 100730

Sponsors and Collaborators

  • Peking Union Medical College Hospital

Investigators

  • Study Director: Liangkun Ma, Peking union medical college hosiptal

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Peking Union Medical College Hospital
ClinicalTrials.gov Identifier:
NCT05760768
Other Study ID Numbers:
  • 018
First Posted:
Mar 8, 2023
Last Update Posted:
Mar 8, 2023
Last Verified:
Nov 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 8, 2023