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Maternal Exercise and Antenatal Anxiety

NCT ID: NCT04624802

Last Updated: 2020-11-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

220 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-10

Study Completion Date

2023-08-01

Brief Summary

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This is a randomized controlled trial study. We evaluate effectiveness of maternal exercise on anxiety during normal pregnancy compared to those who receive antenatal care regularly. We plan to recruit 220 healthy pregnant women over the age of 18 in Shenzhen and to use a standard maternal exercise from Korea as intervention.

Detailed Description

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Conditions

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Anxiety

Keywords

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anxiety pregnancy exercise

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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maternal exercise training group

Pregnant women in experimental group are invited to participate in 16 exercise weekly classes for 40 min including 15 min aerobic exercise，10 min relaxation exercise, and 15 min aerobic exercise, from week 16 to week 32 of gestation, and receive antenatal care and examination regularly.

Group Type EXPERIMENTAL

maternal exercise

Intervention Type BEHAVIORAL

The maternal exercise is broadly practiced by pregnant women in China. It is designed by a team led by Shen Shanmei, a professor of Maternity Exercises at Department of Obstetrics and Gynecology of First Hospital in Korea.

antenatal care group

Pregnant women in antenatal care group receive antenatal care and examination regularly.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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maternal exercise

The maternal exercise is broadly practiced by pregnant women in China. It is designed by a team led by Shen Shanmei, a professor of Maternity Exercises at Department of Obstetrics and Gynecology of First Hospital in Korea.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Pregnant women who are over 18 years old and confirmed to be pregnant in Shenzhen Dapeng New District.

Exclusion Criteria

* 1.pregnant women who have accepted maternal exercise training (at least twice a week in last month);2.pregnant women who have orthopedics, cardiovascular or mental diseases; 3.pregnant women who have or had any condition as follows:miscarriage more than two times,premature delivery,placenta previa,fetal dysplasia, low weight before pregnancy (BMI \<17.5),polycyesis,preeclampsia,premature rupture of membranes,Uterine growth retardation,cervical/ligation,repeated vaginal bleeding,anemia or diabetes; 4.the gestational age is less than 12 weeks or more than 16 weeks;5.received psychotherapy or psychotropic medication within 6 months before the study;6.can not participate in regular inspections.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Shenzhen Second People's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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20200601031-FS01

Identifier Type: -

Identifier Source: org_study_id