Prospective Study of BMD and Ca-P Metabolism in RSA Patients: LMWH Use Versus Control

May 18, 2023 updated by: Aimin Zhao

Prospective Cohort Study of Bone Mineral Density and Calcium-phosphorus Metabolism in RSA Patients: Low Molecular Weight Heparin Use Versus Control

The goal of this prospective observational study is to learn about the effect of low molecular weight heparin (LMWH) application on bone mineral density (BMD) and on calcium-phosphorus metabolism in patients with recurrent spontaneous abortion (RSA), and to compare the degree of bone loss and changes in blood calcium and phosphorus in RSA patients and in control groups with normal pregnancy. By monitoring ultrasound BMD and serum indicators related to maternal bone formation and Ca-P metabolism, the association mechanism between long-term use of LMWH, maternal Ca-P regulation and bone loss will be constructed, so as to contribute to clinical treatment and lifestyle guidance during pregnancy in RSA patients.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Women who meet the inclusion criteria at the outpatient clinic of Renji Hospital are recruited in this study from November 2022 to December 2023. Basic information of all subjects is recorded, including number of miscarriages, duration of breastfeeding, comorbidities, and intake of nutritional supplements. Subjects' medication use during the study is recorded as well. Subjects will undergo ultrasound BMD at six time points: before and after medication during pregnancy preparation, at 10, 24, 32 weeks of pregnancy, and at 42 days postpartum. Peripheral blood will also be collected at the time points above to measure serum osteocalcin, blood calcium, blood phosphorus, 25(OH) D, thyroid hormone, and parathyroid hormone levels. Subjects will be followed up to 42 days postpartum to observe pregnancy outcomes and health conditions of the newborn.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
344

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200127
        • Recruiting
        • Renji Hospital, Shanghai Jiaotong University School of Medicine
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

All women with a need for pregnancy preparation or a confirmed pregnancy who meet the inclusion criteria from November 2022 to December 2023 at the outpatient clinic of Renji Hospital.

Description

Inclusion Criteria:

  • Age between 18 to 45 years.
  • Female who needs to prepare for pregnancy or have a confirmed pregnancy
  • normal karyotype of chromosomes.
  • normal uterine anatomy under pelvic ultrasound examination.
  • Cooperation in completing blood sample collection, testing and ultrasound examination.
  • no serious medical or surgical comorbidities.
  • Sign the informed consent form.

Exclusion Criteria:

  • Presence of diseases affecting calcium metabolism, including primary hyperparathyroidism, Cushing's disease, chronic liver, kidney and gastrointestinal (e.g., celiac disease) disorders and rheumatoid arthritis.
  • Known HIV positive and / or screening visit, HBsAg or HCV antibody positive.
  • The malignant tumors occurred in the past 5 years (except for the skin squamous basal cell carcinoma which has been resected and considered cured). Subjects who developed malignancies five years ago should provide evidence of remission or cure. Subjects with a history of cervical cancer who had undergone conization or cure in the past 3 years were eligible.
  • Patients with a history of chronic infection such as Mycoplasma, chlamydia, Cryptococcus and invasive fungal infection should be discussed with the main researchers.
  • History of active tuberculosis (TB) or evidence of previous TB infection. Subjects with a history of potential TB infection should also be excluded, unless there is a documented evidence that they have completed appropriate anti TB treatment in accordance with CDC guidelines or local regulations before screening. In addition, subjects were strictly forbidden to have any clinical symptoms / signs of active TB.
  • Presence of pregnancy contraindications.

Study Plan

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

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
LMWH group
Continuous use of low molecular weight heparin for more than 3 months during pregnancy preparation and during pregnancy with a history of more than 2 consecutive miscarriages before 28 weeks of gestation
Drug: Low molecular weight heparin
Continuous use of LMWH for more than 3 months during pregnancy preparation and through pregnancy
Other Names:
  • LMWH
control group
No use of low molecular weight heparin during pregnancy preparation and throughout pregnancy and history of more than 2 consecutive miscarriages before 28 weeks of gestation

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
ultrasound BMD before medication during pregnancy preparation
Time Frame: 4 weeks
use ultrasound to test heel bone mineral density before medication during pregnancy preparation
4 weeks
ultrasound BMD after medication during pregnancy preparation
Time Frame: up to 16 weeks
use ultrasound to test heel bone mineral density after medication during pregnancy preparation
up to 16 weeks
ultrasound BMD at 10th weeks of pregnancy
Time Frame: up to 26 weeks
use ultrasound to test heel bone mineral density at 10th weeks of pregnancy
up to 26 weeks
ultrasound BMD at 24th weeks of pregnancy
Time Frame: 40 weeks
use ultrasound to test heel bone mineral density at 24th weeks of pregnancy
40 weeks
ultrasound BMD at 32nd weeks of pregnancy
Time Frame: 1 year
use ultrasound to test heel bone mineral density at 32nd weeks of pregnancy
1 year
ultrasound BMD at postpartum
Time Frame: up to 1 year and 2 months
use ultrasound to test heel bone mineral density at postpartum
up to 1 year and 2 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
osteocalcin before medication during pregnancy preparation
Time Frame: 4 weeks
use peripheral blood test to detect N-terminal mid-molecular fragment of serum osteocalcin before medication during pregnancy preparation
4 weeks
osteocalcin after medication during pregnancy preparation
Time Frame: up to 16 weeks
use peripheral blood test to detect N-terminal mid-molecular fragment of serum osteocalcin after medication during pregnancy preparation
up to 16 weeks
osteocalcin at 10th weeks of pregnancy
Time Frame: up to 26 weeks
use peripheral blood test to detect N-terminal mid-molecular fragment of serum osteocalcin at 10th weeks of pregnancy
up to 26 weeks
osteocalcin at 24th weeks of pregnancy
Time Frame: 40 weeks
use peripheral blood test to detect N-terminal mid-molecular fragment of serum osteocalcin at 24th weeks of pregnancy
40 weeks
osteocalcin at 32nd weeks of pregnancy
Time Frame: 1 year
use peripheral blood test to detect N-terminal mid-molecular fragment of serum osteocalcin at 32nd weeks of pregnancy
1 year
osteocalcin at postpartum
Time Frame: up to 1 year and 2 months
use peripheral blood test to detect N-terminal mid-molecular fragment of serum osteocalcin at postpartum
up to 1 year and 2 months
calcium before medication during pregnancy preparation
Time Frame: 4 weeks
use peripheral blood test to detect calcium level before medication during pregnancy preparation
4 weeks
calcium after medication during pregnancy preparation
Time Frame: up to 16 weeks
use peripheral blood test to detect calcium level after medication during pregnancy preparation
up to 16 weeks
calcium at 10th weeks of pregnancy
Time Frame: up to 26 weeks
use peripheral blood test to detect calcium level at 10th weeks of pregnancy
up to 26 weeks
calcium at 24th weeks of pregnancy
Time Frame: 40 weeks
use peripheral blood test to detect calcium level at 24th weeks of pregnancy
40 weeks
calcium at 32nd weeks of pregnancy
Time Frame: 1 year
use peripheral blood test to detect calcium level at 32nd weeks of pregnancy
1 year
calcium at postpartum
Time Frame: up to 1 year and 2 months
use peripheral blood test to detect calcium level at postpartum
up to 1 year and 2 months
PTH before medication during pregnancy preparation
Time Frame: 4 weeks
use peripheral blood test to detect parathyroid hormone level before medication during pregnancy preparation
4 weeks
PTH after medication during pregnancy preparation
Time Frame: up to 16 weeks
use peripheral blood test to detect parathyroid hormone level after medication during pregnancy preparation
up to 16 weeks
PTH at 10th weeks of pregnancy
Time Frame: up to 26 weeks
use peripheral blood test to detect parathyroid hormone level at 10th weeks of pregnancy
up to 26 weeks
PTH at 24th weeks of pregnancy
Time Frame: 40 weeks
use peripheral blood test to detect parathyroid hormone level at 24th weeks of pregnancy
40 weeks
PTH at 32nd weeks of pregnancy
Time Frame: 1 year
use peripheral blood test to detect parathyroid hormone level at 32nd weeks of pregnancy
1 year
PTH at postpartum
Time Frame: up to 1 year and 2 months
use peripheral blood test to detect parathyroid hormone level at postpartum
up to 1 year and 2 months
live bitrh
Time Frame: 1 year
A live baby born after 23 weeks of gestation
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Aimin Zhao

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Aimin Zhao, MD, Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2023

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 7, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 18, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 26, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 26, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 18, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IIT-2023-0010

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings