Ignite Creation Date:
2025-12-24 @ 5:42 PM
Ignite Modification Date:
2025-12-30 @ 9:04 AM
Study NCT ID:
NCT05760768
Status:
COMPLETED
Last Update Posted:
2023-03-08
First Post:
2023-02-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Individualized Exercise Guidance on Pregnancy Outcome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000078064', 'term': 'Gestational Weight Gain'}, {'id': 'D017008', 'term': 'Negotiating'}, {'id': 'D005320', 'term': 'Fetal Macrosomia'}], 'ancestors': [{'id': 'D015430', 'term': 'Weight Gain'}, {'id': 'D001836', 'term': 'Body Weight Changes'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D003142', 'term': 'Communication'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D016640', 'term': 'Diabetes, Gestational'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D005315', 'term': 'Fetal Diseases'}, {'id': 'D011254', 'term': 'Pregnancy in Diabetics'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D048909', 'term': 'Diabetes Complications'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D001724', 'term': 'Birth Weight'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 326}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2022-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-06', 'studyFirstSubmitDate': '2023-02-20', 'studyFirstSubmitQcDate': '2023-03-06', 'lastUpdatePostDateStruct': {'date': '2023-03-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-01-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'macrosomia', 'timeFrame': 'From date of enrollment until the date of delivery, assessed up to 28 weeks.', 'description': 'Neonatal birthweight is more than 4000 grams.'}, {'measure': 'gestation weight gain（GWG）', 'timeFrame': 'From date of enrollment until the date of delivery, assessed up to 28 weeks.', 'description': 'Weight before delivery minus weight before pregnancy.'}], 'secondaryOutcomes': [{'measure': 'postpartum weight retention（PPWR）', 'timeFrame': 'From date of enrollment until the date of 42 days postpartum, assessed up to 34 weeks.', 'description': 'Weight at a certain point after delivery minus weight before pregnancy.'}, {'measure': 'diastasis recti abdominis（RDA）', 'timeFrame': 'From date of enrollment until the date of 42 days postpartum, assessed up to 34 weeks.', 'description': 'The separation of the left and right rectus abdominis.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pregnancy Outcome', 'Gestational Weight Gain', 'Mediation', 'Macrosomia, Fetal']}, 'referencesModule': {'references': [{'pmid': '38778289', 'type': 'DERIVED', 'citation': 'Yang X, Wang G, Liu N, Wang Y, Zhang S, Lin H, Zhu C, Liu L, Sun Y, Ma L. Mediating effect of gestational weight gain on the preventive effect of exercise during pregnancy on macrosomia: a randomized clinical trial. BMC Pregnancy Childbirth. 2024 May 22;24(1):384. doi: 10.1186/s12884-024-06527-7.'}]}, 'descriptionModule': {'briefSummary': "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.", 'detailedDescription': "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."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged between 18 and 45 years.\n* With singleton pregnancy.\n* Second trimester.\n* No contraindications to exercise during pregnancy.\n* Be able to use smart phone for chatting, read and write basic Chinese.\n* Volunteer for research.\n\nExclusion Criteria:\n\n* Adverse pregnancy reaction, such as abdominal pain, vaginal bleeding and so on.'}, 'identificationModule': {'nctId': 'NCT05760768', 'briefTitle': 'The Effect of Individualized Exercise Guidance on Pregnancy Outcome', 'organization': {'class': 'OTHER', 'fullName': 'Peking Union Medical College Hospital'}, 'officialTitle': 'The Effect of Individualized Exercise Guidance on Pregnancy Outcome: A Prospective Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '018'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Individualized exercise guidance group', 'description': 'Participants accept individualized exercise guidance. They are also managed continuously through WeChat group chat during prenatal clinical interval.', 'interventionNames': ['Behavioral: Individualized exercise guidance']}, {'type': 'NO_INTERVENTION', 'label': 'Standard clinic prenatal care (control) group', 'description': 'Participants accept regular routine prenatal care following Chinese standard.'}], 'interventions': [{'name': 'Individualized exercise guidance', 'type': 'BEHAVIORAL', 'description': 'Participants accept individualized exercise guidance. They are also managed continuously through WeChat group chat during prenatal clinical interval.', 'armGroupLabels': ['Individualized exercise guidance group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100730', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Department of ob gyn, Peking Union Medical College Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'overallOfficials': [{'name': 'Liangkun Ma', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Peking union medical college hosiptal'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking Union Medical College Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}