Calcium Supplementation to Prevent Preeclampsia in Sichuan Province of China
Sponsor
West China Second University Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT01806454
Collaborator
Sichuan Academy of Medical Sciences (Other), people's hospital of Guang'an (Other), pengzhou shi fuyou baojianyuan (Other), The First People's Hospital of Neijiang (Other), Suining Central Hospital (Other), Sichuan Provincial Maternal and Child Health Care Hospital (Other), Chengdu Women's and Children's Central Hospital (Other)
11,000
1
2
Study Details
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| N/A |
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
11000 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Calcium Supplementation to Prevent Preeclampsia in Sichuan Province of China: a Multi-center, Prospective Random Trial
Study Start Date
:
Oct 1, 2013
Anticipated Primary Completion Date
:
Nov 1, 2015
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: calcium A tablets, 600mg per day,till birth |
Drug: calcium
|
| Active Comparator: calcium B tablets,1200mg per day,till birth |
Drug: calcium
|
Outcome Measures
Primary Outcome Measures
- incidence of pre-eclampsia [postpartum forty-two days]
Eligibility Criteria
Criteria
Ages Eligible for Study:
N/A
and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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 )
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Chengdu | China |
Sponsors and Collaborators
- West China Second University Hospital
- 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
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Xinghui Liu,
Professor,
West China Second University Hospital
ClinicalTrials.gov Identifier:
NCT01806454
Other Study ID Numbers:
- hx2ck1
First Posted:
Mar 7, 2013
Last Update Posted:
Aug 25, 2015
Last Verified:
Apr 1, 2014