Study on Prevention, Treatment and Mechanism of Preterm Labor for Chinese Pregnant Women ≥35 Years Old

NCT ID: NCT03210415

Last Updated: 2019-10-29

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 1500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-08-01
• Study Completion Date: 2020-12-30

Brief Summary

In China, there's no effective prevention and treatment on preterm birth for pregnant women ≥35 years old, so this study is necessary.

Detailed Description

Because the policy of "Two-child" in China, there are more and more women more than 35 years old choose to have another baby. It is necessary to find out a way to prevent them who is older than 35 from preterm labor. About 1500 pregnant women will be recruited at about gestational age of 14 weeks for this study. All of them will be taken samples (i.e. blood, hair, cervical secretion ) to be saved before and after delivery. After all data collected, the investigators will do analysis of all data and find out strategy and mechanism of preterm labor.

Conditions

Preterm Labor

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Study group

Pregnant women ≥35 years old would have spontaneous preterm labor. There's no intervention in this group, because it's an Observational Study Model.

Observational Study Model

Intervention Type: OTHER

There is no intervention for the study.

Control group

Pregnant women ≥35 years old would not have spontaneous preterm labor. There's no intervention in this group, because it's an Observational Study Model.

Observational Study Model

Intervention Type: OTHER

There is no intervention for the study.

Interventions

Observational Study Model

There is no intervention for the study.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Chinese pregnant women ≥ 35 years old

Exclusion Criteria

• twins or multiple pregnancies, indicated preterm birth, <35 years old, gestational ages ≥ 37 weeks, incomplete data of prenatal care。

• Minimum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

First Affiliated Hospital of Chongqing Medical University

OTHER

Sponsor Role: collaborator

Peking University Third Hospital

OTHER

Sponsor Role: collaborator

Ministry of Science and Technology of the People´s Republic of China

OTHER_GOV

Sponsor Role: lead

Responsible Party

Hongbo Qi

Principle Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hongbo bo Qi, Dr.

Role: PRINCIPAL_INVESTIGATOR

First Affiliated Hospital of Chongqing Medical University

Locations

The First Affilliated Hospital of Chongqig Medical University

Chongqing, Chongqing Municipality, China

Countries

China

References

Blencowe H, Cousens S, Oestergaard MZ, Chou D, Moller AB, Narwal R, Adler A, Vera Garcia C, Rohde S, Say L, Lawn JE. National, regional, and worldwide estimates of preterm birth rates in the year 2010 with time trends since 1990 for selected countries: a systematic analysis and implications. Lancet. 2012 Jun 9;379(9832):2162-72. doi: 10.1016/S0140-6736(12)60820-4.

Reference Type: RESULT

PMID: 22682464 (View on PubMed)

Other Identifiers

2016YFC1000407

Identifier Type: -

Identifier Source: org_study_id