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Preterm Birth Prediction by Measurement of Biomarkers in Cervical Vaginal Fluid (PBMBCVF)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03974724
Recruitment Status : Recruiting
First Posted : June 5, 2019
Last Update Posted : June 5, 2019
ESCO Beijing Technologies Co., Ltd.
Information provided by (Responsible Party):
Peking Union Medical College Hospital

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.

Condition or disease
Preterm Birth

Detailed Description:

Preterm births (PTBs) refers to a delivery with a gestational age prior to 37 weeks, which can be divided into extreme PTBs (<28 weeks), early PTBs (28-32 weeks), and advanced PTBs (32-37 weeks). The prevalence of PTBs is on a global scale, with more than 1 million PTB per year in China (with a prevalence of 7%), ranking the second in the world. PTBs is the main cause of perinatal death. Meanwhile, premature infants are at higher risk of short-term or long-term complications such as respiratory distress syndrome and mental retardation, causing huge economic and mental burdens on families and society. Most PTBs are spontaneous or caused by premature rupture of membranes (PROM) while the precisely reason remains unknown. Effective early prediction of PTBs and timely intervention are key to reducing PTBs and improving adverse pregnancy outcomes. Current prediction methods for PTBs can be divided into the following three categories: risk factor assessment, cervical length measurement, and biomarkers. However, about half of premature pregnant women do not have high-risk factors, and only premature risk factors cannot accurately identify prematurely at-risk populations. Biomarkers such as fetal fibronectin (fFN) have a very high negative predictive value (more than 95%), but positive predictive value is low (with 200 ng/ml as a cut-off value, and fFN predicts a positive predictive value for preterm birth at <34 weeks gestation reaching only 37.7%). Other biomarkers such as hyperphosphorylated insulin-like growth factor binding protein-1 (phIGFBP1) and placenta α1 microglobulin (PAMG-1) were detected, but their predictive effects were still dissatisfactory.

Therefore, there is no currently effective screening method for predicting the occurrence of PTBs. How to accurately predict and diagnose PTBs is still an unsolved problem in obstetrics. Our previous study identified seven biomarkers in cervical vaginal fluid(CVF) that may be associated with preterm birth and preliminary validation in animal experiments, suggesting that biomarkers in selected CVF may be effective predictors of PTBs, but larger samples of clinical trials are required for validation.

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Study Type : Observational
Estimated Enrollment : 5000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Preterm Birth Prediction by Measurement of Biomarkers in Cervical Vaginal Fluid
Actual Study Start Date : May 1, 2019
Estimated Primary Completion Date : May 1, 2022
Estimated Study Completion Date : August 1, 2022

Primary Outcome Measures :
  1. Preterm birth [ Time Frame: At the time of delivery ]
    Preterm birth refers to delivery with the gestational age prior to 37 weeks

Secondary Outcome Measures :
  1. Neonatal low birth weight(LBW) [ Time Frame: At the time of delivery ]
    LBW is defined as birth weigh less than 2500g

  2. respiratory distress syndrome(RDS) [ Time Frame: At the time of delivery ]
    the number of neonatal RDS occurs in participants' newborns

  3. neonatal ICU(NICU) admission [ Time Frame: At the time of delivery ]
    the number of neonates admitted to NICU

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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   The investigators aim to recruit asymptomatic pregnant women visit their hospital whose gestational age are between 16 to 24 weeks.
Accepts Healthy Volunteers:   No
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.

Inclusion Criteria:

  1. Age≥18years
  2. Between 16-24 weeks gestation
  3. 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.

Exclusion Criteria:

  1. Rupture of the membrane before sampling
  2. Manual or ultrasound vaginal examination within 6 hours of sampling
  3. Vaginal bleeding within 48 hours of sampling (significant vaginal bleeding)

Note: exclusion criteria for sample are listed as follow:

After the delivery results are verified, the samples are excluded according to the sample exclusion criteria and the samples that do not meet the criteria are excluded, including:

  1. Therapeutic preterm birth
  2. Samples of blood contamination
  3. Progesterone treatment at the time of sampling
  4. Situations that other researchers believe need to be excluded

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03974724

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Contact: Jinsong Gao, Professor +8618601106857

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China, Beijing
Peking Union Medical College Hospital Recruiting
Beijing, Beijing, China, 010
Contact: Sijian Li, resident    +8618811749581   
Sponsors and Collaborators
Peking Union Medical College Hospital
ESCO Beijing Technologies Co., Ltd.
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Responsible Party: Peking Union Medical College Hospital Identifier: NCT03974724    
Other Study ID Numbers: Preterm birth prediction
First Posted: June 5, 2019    Key Record Dates
Last Update Posted: June 5, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Peking Union Medical College Hospital:
Preterm birth
Cervical vaginal fluid
Additional relevant MeSH terms:
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Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications