Recurrent Spontaneous AbortionNCT05878574
Prospective Study of BMD and Ca-P Metabolism in RSA Patients: LMWH Use Versus Control
An observational study of Recurrent Spontaneous Abortion, run by Aimin Zhao at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Recurrent Spontaneous Abortion
- What is being tested?
- Low molecular weight heparin
- How many people
- 344 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2022to Mar 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Renji Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, 200127
Daier Yu, 0086+15000732499, sylviatender@163.com
About this study
Official title: 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.
Read the 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
- Being tested
- Low molecular weight heparin
- Medical subject headings
- Abortion, Spontaneous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low molecular weight heparinDrug
Also called LMWH
Continuous use of LMWH for more than 3 months during pregnancy preparation and through pregnancy
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
ultrasound BMD before medication during pregnancy preparation
use ultrasound to test heel bone mineral density before medication during pregnancy preparation
Measured: 4 weeks
ultrasound BMD after medication during pregnancy preparation
use ultrasound to test heel bone mineral density after medication during pregnancy preparation
Measured: up to 16 weeks
ultrasound BMD at 10th weeks of pregnancy
use ultrasound to test heel bone mineral density at 10th weeks of pregnancy
Measured: up to 26 weeks
ultrasound BMD at 24th weeks of pregnancy
use ultrasound to test heel bone mineral density at 24th weeks of pregnancy
Measured: 40 weeks
ultrasound BMD at 32nd weeks of pregnancy
use ultrasound to test heel bone mineral density at 32nd weeks of pregnancy
Measured: 1 year
ultrasound BMD at postpartum
use ultrasound to test heel bone mineral density at postpartum
Measured: up to 1 year and 2 months
Secondary outcomes (19)
osteocalcin before medication during pregnancy preparation
use peripheral blood test to detect N-terminal mid-molecular fragment of serum osteocalcin before medication during pregnancy preparation
Measured: 4 weeks
osteocalcin after medication during pregnancy preparation
use peripheral blood test to detect N-terminal mid-molecular fragment of serum osteocalcin after medication during pregnancy preparation
Measured: up to 16 weeks
osteocalcin at 10th weeks of pregnancy
use peripheral blood test to detect N-terminal mid-molecular fragment of serum osteocalcin at 10th weeks of pregnancy
Measured: up to 26 weeks
osteocalcin at 24th weeks of pregnancy
use peripheral blood test to detect N-terminal mid-molecular fragment of serum osteocalcin at 24th weeks of pregnancy
Measured: 40 weeks
osteocalcin at 32nd weeks of pregnancy
use peripheral blood test to detect N-terminal mid-molecular fragment of serum osteocalcin at 32nd weeks of pregnancy
Measured: 1 year
osteocalcin at postpartum
use peripheral blood test to detect N-terminal mid-molecular fragment of serum osteocalcin at postpartum
Measured: up to 1 year and 2 months
calcium before medication during pregnancy preparation
use peripheral blood test to detect calcium level before medication during pregnancy preparation
Measured: 4 weeks
calcium after medication during pregnancy preparation
use peripheral blood test to detect calcium level after medication during pregnancy preparation
Measured: up to 16 weeks
calcium at 10th weeks of pregnancy
use peripheral blood test to detect calcium level at 10th weeks of pregnancy
Measured: up to 26 weeks
calcium at 24th weeks of pregnancy
use peripheral blood test to detect calcium level at 24th weeks of pregnancy
Measured: 40 weeks
calcium at 32nd weeks of pregnancy
use peripheral blood test to detect calcium level at 32nd weeks of pregnancy
Measured: 1 year
calcium at postpartum
use peripheral blood test to detect calcium level at postpartum
Measured: up to 1 year and 2 months
PTH before medication during pregnancy preparation
use peripheral blood test to detect parathyroid hormone level before medication during pregnancy preparation
Measured: 4 weeks
PTH after medication during pregnancy preparation
use peripheral blood test to detect parathyroid hormone level after medication during pregnancy preparation
Measured: up to 16 weeks
PTH at 10th weeks of pregnancy
use peripheral blood test to detect parathyroid hormone level at 10th weeks of pregnancy
Measured: up to 26 weeks
PTH at 24th weeks of pregnancy
use peripheral blood test to detect parathyroid hormone level at 24th weeks of pregnancy
Measured: 40 weeks
PTH at 32nd weeks of pregnancy
use peripheral blood test to detect parathyroid hormone level at 32nd weeks of pregnancy
Measured: 1 year
PTH at postpartum
use peripheral blood test to detect parathyroid hormone level at postpartum
Measured: up to 1 year and 2 months
live bitrh
A live baby born after 23 weeks of gestation
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2023
- Study start1 Nov 2022
- Primary completionDec 2023 (estimated)
- Study completionMar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Spontaneous AbortionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 344 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aimin Zhao
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Aimin Zhao, RenJi Hospital
- Investigators
- Aimin Zhao, MD, Principal investigator, RenJi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05878574
- Sponsor's protocol ID
- IIT-2023-0010
- Status last verified
- May 2023
- First submitted
- 7 May 2023
- Last updated
- 26 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Cohort Study of Bone Mineral Density and Calcium-phosphorus Metabolism in RSA Patients: Low Molecular Weight Heparin Use Versus Control
- ClinicalTrials.gov ID
- NCT05878574
- Acronym / sponsor ID
- IIT-2023-0010
- Conditions
- Recurrent Spontaneous Abortion
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 344 participants (estimated)
- Lead sponsor
- Aimin ZhaoUniversity, hospital or other
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Mar 2024 (estimated)
- First posted
- 26 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LMWH group | – | Drug: Low molecular weight heparinContinuous 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 |
| 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 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low molecular weight heparinAlso: LMWHContinuous use of LMWH for more than 3 months during pregnancy preparation and through pregnancy | Drug | LMWH group |
Primary outcome
ultrasound BMD before medication during pregnancy preparation
Time frame: 4 weeks
use ultrasound to test heel bone mineral density before medication during pregnancy preparation
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
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
ultrasound BMD at 24th weeks of pregnancy
Time frame: 40 weeks
use ultrasound to test heel bone mineral density at 24th weeks of pregnancy
ultrasound BMD at 32nd weeks of pregnancy
Time frame: 1 year
use ultrasound to test heel bone mineral density at 32nd weeks of pregnancy
ultrasound BMD at postpartum
Time frame: up to 1 year and 2 months
use ultrasound to test heel bone mineral density at postpartum
19 secondary outcomes
osteocalcin before medication during pregnancy preparation
Time frame: 4 weeks
osteocalcin after medication during pregnancy preparation
Time frame: up to 16 weeks
osteocalcin at 10th weeks of pregnancy
Time frame: up to 26 weeks
osteocalcin at 24th weeks of pregnancy
Time frame: 40 weeks
osteocalcin at 32nd weeks of pregnancy
Time frame: 1 year
osteocalcin at postpartum
Time frame: up to 1 year and 2 months
calcium before medication during pregnancy preparation
Time frame: 4 weeks
calcium after medication during pregnancy preparation
Time frame: up to 16 weeks
calcium at 10th weeks of pregnancy
Time frame: up to 26 weeks
calcium at 24th weeks of pregnancy
Time frame: 40 weeks
calcium at 32nd weeks of pregnancy
Time frame: 1 year
calcium at postpartum
Time frame: up to 1 year and 2 months
PTH before medication during pregnancy preparation
Time frame: 4 weeks
PTH after medication during pregnancy preparation
Time frame: up to 16 weeks
PTH at 10th weeks of pregnancy
Time frame: up to 26 weeks
PTH at 24th weeks of pregnancy
Time frame: 40 weeks
PTH at 32nd weeks of pregnancy
Time frame: 1 year
PTH at postpartum
Time frame: up to 1 year and 2 months
live bitrh
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2023.
- Individual participant dataSharing planned: No
Related trials for Recurrent Spontaneous Abortion
Not yet recruitingPhase 3
Efficacy of Progesterone and Low Molecular Weight Heparin in Recurrent Pregnancy Loss
Pregnancy Loss, Pregnancy Loss, Early
Not yet recruiting
Personalized Care for Prenatal Stress Reduction & Prevention of Preterm Birth (PTB) Disparities
Preterm Birth Complication, Preterm Birth
Not yet recruitingObservational study
Cohort Study on the Levels of Placental Growth Factor and Nucleosomes in Early Pregnancy and Adverse Pregnancy Outcomes
Preeclampsia, Premature Birth
RecruitingPhase 2
Efficacy of Recombinant Human G-CSF in Women With Unexplained Recurrent Miscarriage
Recurrent Pregnancy Loss, Recurrent Miscarriages
RecruitingPhase 2
Using Placental Pathology to Prevent Recurrent Adverse Pregnancy Outcomes: A Pilot Project
Adverse Pregnancy Outcome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aimin Zhao, MD principal investigator
RenJi Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Recurrent Spontaneous Abortion, run by Aimin Zhao at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Daier Yu (0086+15000732499, sylviatender@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ultrasound BMD before medication during pregnancy preparation (time frame: 4 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2023.