Suspended

Calcium Supplementation to Prevent Preeclampsia in Sichuan Province of China: a Multi-center, Prospective Random Trial

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What is being tested

calcium

+ calcium

Drug
Who is being recruted

Urogenital Diseases+2

+ Female Urogenital Diseases and Pregnancy Complications

+ Pregnancy Complications

+2 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Prevention Study

Interventional
Study Start: October 2013
See protocol details

Summary

Principal SponsorWest China Second University Hospital
Study Contactpeng chen
Last updated: August 25, 2015
Sourced from a government-validated database.Claim as a partner

Study start date: October 1, 2013

Actual date on which the first participant was enrolled.

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

NCT01806454
Principal SponsorWest China Second University Hospital
Study Contactpeng chen
Last updated: August 25, 2015
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

11000 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Prevention Study

Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Female

Biological sex of participants that are eligible to enroll.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsPregnancy ComplicationsHypertension, Pregnancy-InducedPre-Eclampsia

Criteria

1 inclusion criteria required to participate
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
1 exclusion criteria prevent from participating
first prenatal visit after 16 weeks' gestation;severe anemia;other Underlying medical conditions which need treatment first (such as uncontrolled hyperthyreosis )

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Active Comparator
tablets, 600mg per day,till birth

Group II

Active Comparator
tablets,1200mg per day,till birth

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Chengdu, ChinaOpen in Google Maps
SuspendedOne Study Center