NCT04064931

Brief Summary

The study plans to recruit patients with recurrent miscarriage and detect their niacin, thiamine, vitamin A, vitamin B6, vitamin B12, vitamin D levels in plasma, evaluating if some lack exists.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2019

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

August 20, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 22, 2019

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 12, 2021

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2022

Completed
Last Updated

March 15, 2022

Status Verified

March 1, 2021

Enrollment Period

2.3 years

First QC Date

August 20, 2019

Last Update Submit

March 14, 2022

Conditions

Keywords

recurrent miscarriagevitamins

Outcome Measures

Primary Outcomes (1)

  • Plasma niacin levels in the enrolled population.

    2019-11 to 2020-1

Secondary Outcomes (2)

  • plasma thiamine, vitamin A, vitamin B6, vitamin B12, vitamin D levels of the enrolled population

    2019-11 to 2020-1

  • full exon sequence of the enrolled population

    2019-11 to 2020-1

Study Arms (3)

recurrent abortion

women of childbearing age who have spontaneous abortion within 20 weeks of pregnancy for 2 or more consecutive times.

Diagnostic Test: Detection of niacin and other vitamins in plasma

normal pregnancy history

Women of childbearing age who had a normal pregnancy history and are not in pregnancy status now.

Diagnostic Test: Detection of niacin and other vitamins in plasma

general population

Women of childbearing age in general examination.

Diagnostic Test: Detection of niacin and other vitamins in plasma

Interventions

Detection of niacin and other vitamins in plasma

general populationnormal pregnancy historyrecurrent abortion

Eligibility Criteria

AgeUp to 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

Recurrent abortion population without confirmed diagnosis of known causes

You may qualify if:

  • Research group 1: Recurrent abortion group: women of childbearing age who have spontaneous abortion within 20 weeks of pregnancy for 2 or more consecutive times.
  • Control group: 1) Women of childbearing age who had a normal pregnancy history and are not in pregnancy status now. 2) Women of childbearing age in general examination.

You may not qualify if:

  • patients with confirmed causes unrelated to nutritional deficiencies, including
  • Both husband and wife have been diagnosed with chromosomal abnormalities or fetal chorionic chromosomal abnormalities;
  • The patient has been diagnosed with uterine abnormalities;
  • vaginal bacterial infection or chlamydial infection;
  • antiphospholipid antibody syndrome;
  • Other immune system diseases (hypothyroidism, PCOS, hyperprolactinemia);
  • ovarian function decline (FSH\>10mIU/ml);
  • Cervical insufficiency5.3 Exit criteria:
  • After being selected, the researcher was withdrawn due to various considerations.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking Union Medical College Hospital, Peking Union Medical College and Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100730, China

RECRUITING

MeSH Terms

Conditions

Abortion, Habitual

Condition Hierarchy (Ancestors)

Abortion, SpontaneousPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Qi Yu, Professor

    Peking Union Medical College Hospital

    STUDY DIRECTOR

Central Study Contacts

Qi Yu, Professor

CONTACT

Fangying Chen, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
3 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 20, 2019

First Posted

August 22, 2019

Study Start

August 1, 2019

Primary Completion

November 12, 2021

Study Completion

November 1, 2022

Last Updated

March 15, 2022

Record last verified: 2021-03

Locations