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Calcium Supplementation to Prevent Preeclampsia in Sichuan Province of China

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2014 by Xinghui Liu, West China Second University Hospital.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01806454
First Posted: March 7, 2013
Last Update Posted: August 25, 2015
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.
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
  Purpose
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 Intervention
Preeclampsia Drug: calcium

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Xinghui Liu, West China Second University Hospital:

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

Estimated Enrollment: 11000
Study Start Date: October 2013
Estimated Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: calcium A
tablets, 600mg per day,till birth
Drug: calcium
Active Comparator: calcium B
tablets,1200mg per day,till birth
Drug: calcium

  Eligibility

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 )
  Contacts and Locations
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
  More Information

Responsible Party: Xinghui Liu, Professor, West China Second University Hospital
ClinicalTrials.gov Identifier: NCT01806454     History of Changes
Other Study ID Numbers: hx2ck1
First Submitted: March 1, 2013
First Posted: March 7, 2013
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