NCT01806454

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

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11,000

participants targeted

Target at P75+ for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 1, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 7, 2013

Completed
7 months until next milestone

Study Start

First participant enrolled

October 1, 2013

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
Last Updated

August 25, 2015

Status Verified

April 1, 2014

Enrollment Period

2.1 years

First QC Date

March 1, 2013

Last Update Submit

August 24, 2015

Conditions

Preeclampsia

Outcome Measures

Primary Outcomes (1)

  • incidence of pre-eclampsia

    postpartum forty-two days

Study Arms (2)

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

calciumDRUG
calcium Acalcium B

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • first prenatal visit after 16 weeks' gestation;severe anemia;other Underlying medical conditions which need treatment first (such as uncontrolled hyperthyreosis )

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Chengdu, China

RECRUITING

MeSH Terms

Conditions

Pre-Eclampsia

Interventions

Calcium

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-InducedPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

Metals, Alkaline EarthElementsInorganic ChemicalsMetalsBlood Coagulation FactorsBiological Factors

Central Study Contacts

peng chen

CONTACT

cpyxwd007@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 1, 2013

First Posted

March 7, 2013

Study Start

October 1, 2013

Primary Completion

November 1, 2015

Last Updated

August 25, 2015

Record last verified: 2014-04

Locations

CN(1)