Back to resultsCalcium Supplementation to Prevent Preeclampsia in Sichuan Province of China
Primary Purpose
Preeclampsia
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
calcium
Sponsored by
About this trial
This is an interventional prevention trial for Preeclampsia
Eligibility Criteria
Inclusion Criteria:
- Nulliparity;age ≥35 years;Previous pre-eclampsia;Family history of pre-eclampsia;Multiple pregnancy;Time between pregnancies ≥10years;Body mass index ≥25;diastolic pressure ≥ 80 mm Hg before 20 weeks' gestation;Proteinuria ≥+ on more than one occasion or ≥ 300 mg/24 h before 20 weeks' gestation;Underlying medical conditions(Pre-existing hypertension;Pre-existing renal disease;Pre-existing diabetes;Presence of antiphospholipid antibodies;Chronic autoimmune disease);male sex partner's predecessor wife has Previous pre-eclampsia
Exclusion Criteria:
- first prenatal visit after 16 weeks' gestation;severe anemia;other Underlying medical conditions which need treatment first (such as uncontrolled hyperthyreosis )
Sites / Locations
- Recruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
calcium A
calcium B
Arm Description
tablets, 600mg per day,till birth
tablets,1200mg per day,till birth
Outcomes
Primary Outcome Measures
incidence of pre-eclampsia
Secondary Outcome Measures
Full Information
NCT ID
NCT01806454
First Posted
March 1, 2013
Last Updated
August 24, 2015
Sponsor
West China Second University Hospital
Collaborators
Sichuan Academy of Medical Sciences, people's hospital of Guang'an, pengzhou shi fuyou baojianyuan, The First People's Hospital of Neijiang, Suining Central Hospital, Sichuan Provincial Maternal and Child Health Care Hospital, Chengdu Women's and Children's Central Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01806454
Brief Title
Calcium Supplementation to Prevent Preeclampsia in Sichuan Province of China
Official Title
Calcium Supplementation to Prevent Preeclampsia in Sichuan Province of China: a Multi-center, Prospective Random Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2014
Overall Recruitment Status
Unknown status
Study Start Date
October 2013 (undefined)
Primary Completion Date
November 2015 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
West China Second University Hospital
Collaborators
Sichuan Academy of Medical Sciences, people's hospital of Guang'an, pengzhou shi fuyou baojianyuan, The First People's Hospital of Neijiang, Suining Central Hospital, Sichuan Provincial Maternal and Child Health Care Hospital, Chengdu Women's and Children's Central Hospital
4. Oversight
5. Study Description
Brief Summary
the purpose of this study is to determine whether calcium supplementation is effective to prevent preeclampsia in Sichuang Province of china and which dose is more suitable
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preeclampsia
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
11000 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
calcium A
Arm Type
Active Comparator
Arm Description
tablets, 600mg per day,till birth
Arm Title
calcium B
Arm Type
Active Comparator
Arm Description
tablets,1200mg per day,till birth
Intervention Type
Drug
Intervention Name(s)
calcium
Primary Outcome Measure Information:
Title
incidence of pre-eclampsia
Time Frame
postpartum forty-two days
10. Eligibility
Sex
Female
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Nulliparity;age ≥35 years;Previous pre-eclampsia;Family history of pre-eclampsia;Multiple pregnancy;Time between pregnancies ≥10years;Body mass index ≥25;diastolic pressure ≥ 80 mm Hg before 20 weeks' gestation;Proteinuria ≥+ on more than one occasion or ≥ 300 mg/24 h before 20 weeks' gestation;Underlying medical conditions(Pre-existing hypertension;Pre-existing renal disease;Pre-existing diabetes;Presence of antiphospholipid antibodies;Chronic autoimmune disease);male sex partner's predecessor wife has Previous pre-eclampsia
Exclusion Criteria:
first prenatal visit after 16 weeks' gestation;severe anemia;other Underlying medical conditions which need treatment first (such as uncontrolled hyperthyreosis )
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
peng chen
Email
cpyxwd007@gmail.com
Facility Information:
City
Chengdu
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
peng chen
12. IPD Sharing Statement
Learn more about this trial
Calcium Supplementation to Prevent Preeclampsia in Sichuan Province of China
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