NCT06664554

Brief Summary

Accurate prediction of preterm birth is critical for clinical management to improve the neonatal and maternal outcomes. A clinical challenge remains for current predicting biomarkers due to the complexity and multifactorial nature of underlying causes of preterm birth. This study aims to evaluate the prediction performance of new maternal blood biomarkers (proteomic markers) on the occurrence of preterm birth.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
18,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2021

Typical duration for all trials

Geographic Reach
1 country

5 active sites

Status
completed

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

January 1, 2021

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2024

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 28, 2024

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 29, 2024

Completed
Last Updated

December 5, 2024

Status Verified

December 1, 2024

Enrollment Period

2.5 years

First QC Date

October 28, 2024

Last Update Submit

December 3, 2024

Conditions

Preterm Birth

Keywords

Preterm birthMaternal bloodSerological protein

Outcome Measures

Primary Outcomes (1)

  • Prediction of preterm birth

    The primary outcome is the prediction of preterm birth, defined as pregnancy duration of less than 37 weeks. Preterm birth prediction score is calculated as sum of the z-score of 3 proteins' multiple of median (MoM) values.

    After blood draw during doctor's visit before 37 weeks of gestation

Secondary Outcomes (1)

  • Sensitivity, Specificity, Positive predictive value (PPV), Negative predictive value (NPV)

    After blood draw during doctor's visit before 37 weeks of gestation

Study Arms (2)

Preterm birth

Pregnancy with delivery before 37 weeks of gestational age

Term birth control

Pregnancy with delivery at 37 weeks or later of gestational age

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

General women with pregnancy

You may qualify if:

  • Pregnant women between18 and 45 years of age
  • Single pregnancy
  • Consent to participate in the study

You may not qualify if:

  • Premature rupture of membranes
  • Uterine malformation
  • Fetal malformation
  • Pregestational Diabetes
  • Systemic diseases (chronic kidney disease, autoimmune disease, etc.)
  • Serious medical illness (renal insufficiency, congestive heart disease, chronic respiratory insufficiency, etc.).
  • Suffering from other disease unfavorable to the trial such as metal illness
  • Any maternal or fetal condition that requires termination of pregnancy.
  • Active vaginal bleeding.
  • Multifetal pregnancy with greater than or equal to 2 fetuses.
  • Lack of clinical outcome or incomplete basic information
  • Iatrogenic premature delivery or induced labor
  • Lack of consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Department of Obstetrics and Gynecology, the Eighth Affiliated Hospital, Sun Yat-sen University;

Shenzhen, Guangdong, China

Location

Department of Obstetrics, Shenzhen Maternity and Child Healthcare Hospital

Shenzhen, Guangdong, China

Location

Department of Obstetrics and Gynecology, The Third Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Location

Hunan Provincial Maternal and Child Health Care Hospital

Changsha, Hunan, China

Location

Department of Obstetrics and Gynecology, Qilu Hospital of Shandong University,

Jinan, Shandong, China

Location

Related Publications (2)

  • Romero R, Dey SK, Fisher SJ. Preterm labor: one syndrome, many causes. Science. 2014 Aug 15;345(6198):760-5. doi: 10.1126/science.1251816. Epub 2014 Aug 14.

    PMID: 25124429BACKGROUND

  • Boyle AK, Rinaldi SF, Norman JE, Stock SJ. Preterm birth: Inflammation, fetal injury and treatment strategies. J Reprod Immunol. 2017 Feb;119:62-66. doi: 10.1016/j.jri.2016.11.008. Epub 2016 Dec 2.

    PMID: 28122664BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Qiong Luo, M.D. Ph.D.

    Department of Obstetrics, Women's Hospital of Zhejiang University, School of Medicine, Hangzhou, 310006, China

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D., Ph.D.

Study Record Dates

First Submitted

October 28, 2024

First Posted

October 29, 2024

Study Start

January 1, 2021

Primary Completion

June 30, 2023

Study Completion

June 30, 2024

Last Updated

December 5, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations

CN(5)