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Calcium Supplementation to Prevent Preeclampsia in Sichuan Province of China

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01806454
Recruitment Status : Unknown
Verified April 2014 by Xinghui Liu, West China Second University Hospital.
Recruitment status was:  Recruiting
First Posted : March 7, 2013
Last Update Posted : August 25, 2015
Sponsor:
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
Information provided by (Responsible Party):
Xinghui Liu, West China Second University Hospital

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
Preeclampsia Drug: calcium

Study Type : Interventional  (Clinical Trial)
Estimated 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 : October 2013
Estimated Primary Completion Date : November 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Calcium
U.S. FDA Resources

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



Primary Outcome Measures :
  1. incidence of pre-eclampsia [ Time Frame: postpartum forty-two days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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 )

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01806454


Contacts
Contact: peng chen cpyxwd007@gmail.com

Locations
China
Recruiting
Chengdu, China
Sub-Investigator: peng chen         
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

Responsible Party: Xinghui Liu, Professor, West China Second University Hospital
ClinicalTrials.gov Identifier: NCT01806454     History of Changes
Other Study ID Numbers: hx2ck1
First Posted: March 7, 2013    Key Record Dates
Last Update Posted: August 25, 2015
Last Verified: April 2014

Additional relevant MeSH terms:
Pre-Eclampsia
Hypertension, Pregnancy-Induced
Pregnancy Complications
Calcium, Dietary
Bone Density Conservation Agents
Physiological Effects of Drugs