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

NCT ID: NCT05878574

Last Updated: 2023-05-26

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 344 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-11-01
• Study Completion Date: 2024-03-31

Brief Summary

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.

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.

Conditions

Recurrent Spontaneous Abortion

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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

Low molecular weight heparin

Intervention Type: DRUG

Continuous use of LMWH for more than 3 months during pregnancy preparation and through pregnancy

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

No interventions assigned to this group

Interventions

Low molecular weight heparin

Continuous use of LMWH for more than 3 months during pregnancy preparation and through pregnancy

Intervention Type: DRUG

Other Intervention Names

LMWH

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Aimin Zhao

OTHER

Sponsor Role: lead

Responsible Party

Aimin Zhao

Director of Obstetrics and Gynecology

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Aimin Zhao, MD

Role: PRINCIPAL_INVESTIGATOR

RenJi Hospital

Locations

Renji Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Daier Yu

Role: CONTACT

sylviatender@163.com

0086+15000732499

Facility Contacts

Daier Yu

Role: primary

sylviatender@163.com

0086+15000732499

Other Identifiers

IIT-2023-0010

Identifier Type: -

Identifier Source: org_study_id