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

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

Status: Unknown

Conditions: Preterm Labor

Treatments: Other: Observational Study Model

Study type: Observational

Funder types: Other

Identifiers

NCT03210415

2016YFC1000407

Details and patient eligibility

About

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

Full 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.

Enrollment: 1,500 estimated patients

Sex: Female

Ages: 35+ years old

Volunteers: Accepts Healthy Volunteers

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。

Trial design

1,500 participants in 2 patient groups

Study group

Description:

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

Treatment:

Other: Observational Study Model

Control group

Description:

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.

Treatment:

Other: Observational Study Model