Preterm Birth Prediction by Measurement of Biomarkers in Cervical Vaginal Fluid

NCT03974724 | Unknown

• 1 other identifier: Preterm birth prediction
• Study Type: observational
• Target: 5,000
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine the predictive value of 7 biomarkers cervical vaginal fluid on future preterm birth in pregnant women whose gestational age are 16 to 24 weeks.

Conditions

Preterm Birth

Keywords

Preterm birth; Prediction; Cervical vaginal fluid

Outcome Measures

Primary Outcomes (1)

• Preterm birth

  Preterm birth refers to delivery with the gestational age prior to 37 weeks

  At the time of delivery

Secondary Outcomes (3)

• Neonatal low birth weight(LBW)

  At the time of delivery

• respiratory distress syndrome(RDS)

  At the time of delivery

• neonatal ICU(NICU) admission

  At the time of delivery

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: The investigators aim to recruit asymptomatic pregnant women visit their hospital whose gestational age are between 16 to 24 weeks.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The investigators aim to recruit pregnant women visit their hospital whose gestational age are between 16 to 24 weeks and meet the criteria for inclusion during the study periods. The investigators introduce the study to those pregnant women who visit their hospital early after confirming pregancy till beyond the inclusion gestational age.

You may qualify if:

• Age≥18years
• Between 16-24 weeks gestation
• Signed informed consent
• Note:The investigators also recruit pregnant women who have the following risk factors for preterm birth and meet the criteria for admission: uterine malformation, history of induction, history of premature birth, premature rupture of membranes, history of abortion, history of cervical conization and cervical cerclage, vaginal bleeding, cervical shortening, Multiple pregnancies - twins, triplets, polyhydramnios, smoking, drug use, placenta previa, pregnancy through assisted reproductive technology.

You may not qualify if:

• Rupture of the membrane before sampling
• Manual or ultrasound vaginal examination within 6 hours of sampling
• Vaginal bleeding within 48 hours of sampling (significant vaginal bleeding)
• Therapeutic preterm birth
• Samples of blood contamination
• Progesterone treatment at the time of sampling
• Situations that other researchers believe need to be excluded

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead
• ESCO Beijing Technologies Co., Ltd.: collaborator

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 010, China

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Collect cervical vaginal fluid in posterior fornix in pregnant women whose gestational age are 16 to 24 weeks that enrolled into this study.

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Central Study Contacts

Jinsong Gao, Professor

CONTACT

+8618601106857; gaojsong@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2019
• First Posted: June 5, 2019
• Study Start: May 1, 2019
• Primary Completion: May 1, 2022
• Study Completion: August 1, 2022
• Last Updated: June 5, 2019

Record last verified: 2019-06

Locations

CN (1)