Recurrent MiscarriageNCT05267678
Nutritional Deficiency and Recurrent Miscarriage
An observational study of Recurrent Miscarriage, run by Westlake University at 1 site in China.
Trial summary
This prospective cohort study primarily aims to examine the association between blood niacin levels and recurrent miscarriage. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Recurrent Miscarriage
- How many people
- 499 participants
- Where
- 1 siteChina
- Study dates
- 28 Jan 2023to 1 Jul 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 40 years
- Women only
- No healthy volunteers
- Adult
Study population: Pregnant women with history of recurrent miscarriage
Who may be able to join
- 18-40years old, female
- Positive blood human chorionic gonadotropin test
- Naturally pregnant
- History of recurrent miscarriage (2 or more consecutive spontaneous miscarriage within 28 weeks of gestation)
- Willing to participate in this study with informed consent
Who cannot join
- Women whose confirmed cause of recurrent miscarriage has nothing to do with nutritional deficiencies, including chromosomal abnormalities, abnormal uterine anatomy, immune system diseases, blood diseases, etc.
- Women with Hepatitis B, syphilis, HIV/AIDS and other infectious diseases.
- Women with serious conditions, such as schizophrenia, tumors, heart failure
Trial locations and contacts
1 site in 1 country.
Danyang WANG, MPH contact
China1 site, 1 recruiting
- Recruiting
Peking Union Medical College Hospital, Peking Union Medical College and Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100730
Hongjun SHI, PhD, 86-0571-85271192, shihongjun@westlake.edu.cn
About this study
Official title: A Cohort Study Investigating Nutritional Deficiency Among Pregnant Women With History of Recurrent Miscarriage
This prospective cohort study primarily aims to examine the association between blood niacin levels and recurrent miscarriage.
Read the detailed description
Recurrent miscarriage is affecting around 5% women at reproductive age. And the underlying causes remain undetermined in 50%-70% of cases. Although animal models and linkage analysis according to family studies have identified that niacin deficiency can lead to congenital malformations and recurrent miscarriage. Evidence based on population is lacking with regard to the effect of blood niacin levels on recurrent miscarriage. We intend to enroll 499 pregnant women confirmed by a positive blood human chorionic gonadotropin test and with history of unexplained recurrent miscarriage. By testing their blood niacin levels and following up to the end of first-trimester pregnancy, this study aims to examine the role of niacin levels in preventing miscarriages among women with history of recurrent miscarriage.
- Conditions
- Recurrent Miscarriage
- Being tested
- No intervention
- Medical subject headings
- Abortion, Habitual
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
This is an observational study without any intervention
| Study group | Role | What they receive |
|---|---|---|
| Pregnant women with history of recurrent miscarriage | Not described Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with miscarriage
pregnancy outcomes are confirmed by electronic hospital records or self-reported by participants
Measured: 6-13(+6) weeks of gestation
Gestation week at miscarriage
pregnancy outcomes are confirmed by electronic hospital records or self-reported by participants
Measured: 6-13(+6) weeks of gestation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2022
- Study start28 Jan 2023
- Primary completion1 Apr 2024 (estimated)
- Study completion1 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent MiscarriageStudies 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
- 499 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Westlake University
- Sponsor type
- University, hospital or other
- Collaborators
- Peking Union Medical College Hospital
- Responsible party
- Sponsor
- Investigators
- Hongjun Shi, PhD, Principal investigator, Westlake University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05267678
- Sponsor's protocol ID
- 20220215SHJ001
- Status last verified
- May 2023
- First submitted
- 21 Feb 2022
- Last updated
- 1 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cohort Study Investigating Nutritional Deficiency Among Pregnant Women With History of Recurrent Miscarriage
- ClinicalTrials.gov ID
- NCT05267678
- Acronym / sponsor ID
- 20220215SHJ001
- Conditions
- Recurrent Miscarriage
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 499 participants (estimated)
- Lead sponsor
- Westlake UniversityUniversity, hospital or other
- Collaborators
- Peking Union Medical College Hospital
- Study start
- 28 Jan 2023 (actual)
- Primary completion
- 1 Apr 2024 (estimated)
- Study completion
- 1 Jul 2024 (estimated)
- First posted
- 4 Mar 2022 (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.
This prospective cohort study primarily aims to examine the association between blood niacin levels and recurrent miscarriage.
Detailed description
Recurrent miscarriage is affecting around 5% women at reproductive age. And the underlying causes remain undetermined in 50%-70% of cases. Although animal models and linkage analysis according to family studies have identified that niacin deficiency can lead to congenital malformations and recurrent miscarriage. Evidence based on population is lacking with regard to the effect of blood niacin levels on recurrent miscarriage. We intend to enroll 499 pregnant women confirmed by a positive blood human chorionic gonadotropin test and with history of unexplained recurrent miscarriage. By testing their blood niacin levels and following up to the end of first-trimester pregnancy, this study aims to examine the role of niacin levels in preventing miscarriages among women with history of recurrent miscarriage.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pregnant women with history of recurrent miscarriage | – | Other: No intervention |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Pregnant women with history of recurrent miscarriage
Key inclusion criteria (5 listed)
- 18-40years old, female
- Positive blood human chorionic gonadotropin test
- Naturally pregnant
- History of recurrent miscarriage (2 or more consecutive spontaneous miscarriage within 28 weeks of gestation)
- Willing to participate in this study with informed consent
Key exclusion criteria (3 listed)
- Women whose confirmed cause of recurrent miscarriage has nothing to do with nutritional deficiencies, including chromosomal abnormalities, abnormal uterine anatomy, immune system diseases, blood diseases, etc.
- Women with Hepatitis B, syphilis, HIV/AIDS and other infectious diseases.
- Women with serious conditions, such as schizophrenia, tumors, heart failure
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 |
|---|---|---|
| No interventionThis is an observational study without any intervention | Other | Pregnant women with history of recurrent miscarriage |
Primary outcome
Number of participants with miscarriage
Time frame: 6-13(+6) weeks of gestation
pregnancy outcomes are confirmed by electronic hospital records or self-reported by participants
Gestation week at miscarriage
Time frame: 6-13(+6) weeks of gestation
pregnancy outcomes are confirmed by electronic hospital records or self-reported by participants
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2023.
- Individual participant dataSharing planned: Undecided
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Efficacy of Recombinant Human G-CSF in Women With Unexplained Recurrent Miscarriage
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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.
Danyang WANG, MPH contact
Hongjun Shi, PhD principal investigator
Westlake University
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 Miscarriage, run by Westlake University 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 5 inclusion and 3 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 1 Jun 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 Hongjun Shi, PhD (86-0571-85271192, shihongjun@westlake.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with miscarriage (time frame: 6-13(+6) weeks of gestation). The study lists 2 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 1 Jun 2023.