- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04777903
The Relationship Between Pre-pregnancy BMI and Weight Gain and Outcomes in Women With Twin Pregnancy
March 1, 2021 updated by: Second Affiliated Hospital of Wenzhou Medical University
The Relationship Between Pre-pregnancy Body Mass Index (BMI) and Pregnancy Weight Gain and Pregnancy Outcomes in Women With Twin Pregnancy
Prepregnancy body mass index (BMI) and gestational weight gain (GWG) have Significant effects on the risk of pregnancy outcomes such as gestational hypertension disease and gestational diabetes mellitus in singleton pregnancies.
This paper is to investigate the relationship between pre-pregnancy body mass index (BMI) and weight gain during pregnancy and pregnancy outcomes in women with twin pregnancy.
Study Overview
Status
Unknown
Intervention / Treatment
Study Type
Observational
Enrollment (Anticipated)
250
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Ying Hua
- Phone Number: +8613676403165 +8613676403165
- Email: wzfeyhy1015@126.com
Study Locations
-
-
Zhejiang
-
Wenzhou, Zhejiang, China, 325027
- Recruiting
- department of obstetrics of Second Affiliated Hospital of Wenzhou Medical University
-
Contact:
- ying hua, Doctor
- Phone Number: 13676403165
- Email: wzfeyhy1015@126.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 40 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Sampling Method
Probability Sample
Study Population
The participants include women with twin pregnancy meeting the inclusion criteria
Description
Inclusion Criteria:
- Age 18 ~ 41 years old;
- The gestational age of the first diagnosed twin pregnancy is ≤10weeks;
- Double chorionic double amniotic sac pregnancy;
Exclusion Criteria:
- with heart disease, liver disease, kidney disease, complications (chronic hypertension, hyperthyroidism, diabetes and others ), genetic diseases, psychological and mental diseases;
- with history of habitual abortion and cervical insufficiency;
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
underweight woman with twin pregnancy
underweight (BMI < 18.5 kg/m2)
|
a standardized and structured questionnaire that included information on age, residence, education, pregnancy history, disease history, height, and conception method, after obtaining the consent of all participants.
|
normal weight woman with twin pregnancy
normal (BMI: 18.5-23.9 kg/m2)
|
a standardized and structured questionnaire that included information on age, residence, education, pregnancy history, disease history, height, and conception method, after obtaining the consent of all participants.
|
overweight and obese woman with twin pregnancy
overweight and obese (BMI ≥24 kg/m2)
|
a standardized and structured questionnaire that included information on age, residence, education, pregnancy history, disease history, height, and conception method, after obtaining the consent of all participants.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
the incidence of gestational diabetes mellitus, gestational hypertension and small for gestational age
Time Frame: 35 weeks to 40 weeks gestation
|
pregnant outcome
|
35 weeks to 40 weeks gestation
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2016
Primary Completion (Actual)
December 31, 2020
Study Completion (Anticipated)
June 30, 2021
Study Registration Dates
First Submitted
February 28, 2021
First Submitted That Met QC Criteria
March 1, 2021
First Posted (Actual)
March 2, 2021
Study Record Updates
Last Update Posted (Actual)
March 2, 2021
Last Update Submitted That Met QC Criteria
March 1, 2021
Last Verified
February 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SAHoWMU-CR2021-07-201
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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