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NCT01806454 Clinical Trial

Calcium Supplementation to Prevent Preeclampsia in Sichuan Province of China

Preeclampsia Clinical Trial

Official title:
Calcium Supplementation to Prevent Preeclampsia in Sichuan Province of China: a Multi-center, Prospective Random Trial

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT01806454
Other study ID # hx2ck1
Secondary ID
Status Recruiting
Phase N/A
First received March 1, 2013
Last updated August 24, 2015
Start date October 2013

Study information
Verified date April 2014
Source West China Second University Hospital
Contact peng chen
Email cpyxwd007@gmail.com
Is FDA regulated No
Health authority China: Ethics Committee
Study type Interventional

Clinical Trial 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

Recruitment information / eligibility
Status Recruiting
Enrollment 11000
Est. completion date
Est. primary completion date November 2015
Accepts healthy volunteers No
Gender Female
Age group N/A and older
Eligibility 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 )

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Drug:
• calcium

Locations
Country Name City State
n/a

Sponsors (8)
Lead Sponsor Collaborator
West China Second University Hospital Chengdu Women's and Children's Central Hospital, pengzhou shi fuyou baojianyuan, people's hospital of Guang'an, Sichuan Academy of Medical Sciences, Sichuan Provincial Maternal and Child Health Care Hospital, Suining Central Hospital, The first people's hospital of Neijiang

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary incidence of pre-eclampsia postpartum forty-two days No
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