Calcium Supplementation to Prevent Preeclampsia in Sichua... | NCT01806454

Studies
Calcium Supplementation to Prevent Preeclampsia in Sichuan Province of China

NCT01806454

Sponsor

West China Second University Hospital

Status

Unknown status

Last Update Posted

Aug 25, 2015Estimated

Enrollment

11,000Estimated

Phase

Not Applicable

Conditions

Preeclampsia

Interventions

calcium

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2014

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2013

Primary Completion Date

Nov 2015Estimated

Completion Date

Not provided

First Submitted Date

Mar 1, 2013

First Submission Date that Met QC Criteria

Mar 6, 2013

First Posted Date

Mar 7, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 24, 2015

Last Update Posted Date

Aug 25, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Xinghui Liu, Professor, West China Second University HospitalPrincipal Investigator

Lead Sponsor

West China Second University HospitalOTHER

Collaborators

Name	Class
Sichuan Academy of Medical Sciences	OTHER
Guang'an people's hospital of Sichuan province	OTHER
pengzhou shi fuyou baojianyuan	UNKNOWN
The First People's Hospital of Neijiang

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

11,000Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
calcium A	Active Comparator	tablets, 600mg per day,till birth	Drug: calcium
calcium B	Active Comparator	tablets,1200mg per day,till birth	Drug: calcium

Interventions

Name	Type	Description	Arm Group Labels	Other Names
calcium	Drug		calcium A calcium B

Measure	Description	Time Frame
incidence of pre-eclampsia		postpartum forty-two days

Eligibility Module

Eligibility 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 )

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Role	Phone	Extension	Email
peng chen	Contact			cpyxwd007@gmail.com

Condition Browse Module

MeSH Terms

ID	Term
D011225	Pre-Eclampsia

Ancestor Terms

ID	Term
D046110	Hypertension, Pregnancy-Induced
D011248	Pregnancy Complications
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D002118	Calcium

Ancestor Terms

ID	Term
D008673	Metals, Alkaline Earth
D004602	Elements
D007287	Inorganic Chemicals
D008670	Metals

Browse Leaves

Not provided

Browse Branches

Not provided