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

NCT05878574 | Unknown FDA Drug

• 1 other identifier: IIT-2023-0010
• Study Type: observational
• Target: 344
• Locations: 1 country
• Sites: 1

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.

Conditions

Recurrent Spontaneous Abortion

Outcome Measures

Primary Outcomes (6)

• ultrasound BMD before medication during pregnancy preparation

  use ultrasound to test heel bone mineral density before medication during pregnancy preparation

  4 weeks

• ultrasound BMD after medication during pregnancy preparation

  use ultrasound to test heel bone mineral density after medication during pregnancy preparation

  up to 16 weeks

• ultrasound BMD at 10th weeks of pregnancy

  use ultrasound to test heel bone mineral density at 10th weeks of pregnancy

  up to 26 weeks

• ultrasound BMD at 24th weeks of pregnancy

  use ultrasound to test heel bone mineral density at 24th weeks of pregnancy

  40 weeks

• ultrasound BMD at 32nd weeks of pregnancy

  use ultrasound to test heel bone mineral density at 32nd weeks of pregnancy

  1 year

• ultrasound BMD at postpartum

  use ultrasound to test heel bone mineral density at postpartum

  up to 1 year and 2 months

Secondary Outcomes (19)

• osteocalcin before medication during pregnancy preparation

  4 weeks

• osteocalcin after medication during pregnancy preparation

  up to 16 weeks

• osteocalcin at 10th weeks of pregnancy

  up to 26 weeks

• osteocalcin at 24th weeks of pregnancy

  40 weeks

• osteocalcin at 32nd weeks of pregnancy

  1 year

Study Arms (2)

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

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

Interventions

Low molecular weight heparin DRUG

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

Also known as: LMWH

LMWH group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Aimin Zhao: lead

Study Sites (1)

Renji Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, 200127, China

RECRUITING

MeSH Terms

Conditions

Abortion, Spontaneous

Interventions

Heparin, Low-Molecular-Weight

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Heparin; Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Officials

• Aimin Zhao, MD

  RenJi Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Daier Yu

CONTACT

0086+15000732499; sylviatender@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director of Obstetrics and Gynecology

Study Record Dates

• First Submitted: May 7, 2023
• First Posted: May 26, 2023
• Study Start: November 1, 2022
• Primary Completion: December 1, 2023
• Study Completion: March 1, 2024
• Last Updated: May 26, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)