Calcium Supplementation to Prevent Preeclampsia in Sichuan Province of China

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by West China Second University Hospital
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
ClinicalTrials.gov Identifier:
NCT01806454
First received: March 1, 2013
Last updated: April 6, 2014
Last verified: April 2014
  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: 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 West China Second University Hospital:

Primary Outcome Measures:
  • incidence of pre-eclampsia [ Time Frame: postpartum forty-two days ] [ Designated as safety issue: No ]

Estimated Enrollment: 11000
Study Start Date: October 2013
Estimated Primary Completion Date: May 2014 (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

Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Xinghui Liu, Professor, West China Second University Hospital
ClinicalTrials.gov Identifier: NCT01806454     History of Changes
Other Study ID Numbers: hx2ck1
Study First Received: March 1, 2013
Last Updated: April 6, 2014
Health Authority: China: Ethics Committee

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

ClinicalTrials.gov processed this record on September 11, 2014