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

• Conditions: Preterm Labor
• Interventions: Other: Observational Study Model

• Registration Number: NCT03210415
• Lead Sponsor: Ministry of Science and Technology of the People´s Republic of China

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.

Study Timeline

• Study First Submitted: 2017-05-04
• Study First Submitted QC: 2017-07-03
• Study First Posted: 2017-07-07
• Study Start: 2017-08-01
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-27
• Last Update Posted: 2019-10-29
• Primary Completion: 2020-06-30
• Study Completion: 2020-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 1500

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。

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Morbidity of Preterm birth	1 years	Preterm delivery (PTD) is one of the most common and most serious complications of pregnancy. In China, preterm delivery is defined as delivery after 28 weeks completed but before 37 weeks of gestation. PTD rate varies between 5-18 %. Outcome also varies with the quality of neonatal care. create the highest burden for the society.

Secondary Outcome Measures

Name	Time	Method
Respiratory distress syndrome, ischemic hypoxic encephalopathy, necrotizing enterocolitis, various infections	1 years	the short-term outcomes of the preterm delivery, which will cost money, time and source to beat. The treatment is not satisfactory, but create the highest burden for the society.
Morbidity of Chorioamnionitis	1 years	The main hypothesis of the etiology of spontaneous PTD is ascending infection from the lower genital tract up in the sterile uterus invading the decidua, chorioamniotic membranes, amniotic fluid and, in some cases, the fetus. This is responsible for an inflammatory condition that might trigger myometrial contractions, rupture of the membranes and cervical maturation leading to PTD. Investigations have shown that the amount of bacteria present in the amniotic fluid is correlated to the level of intrauterine inflammation. Inflammation is also related to the presence of bacteria in the amniotic fluid and to histological chorioamnionitis.
Cerebral palsy, chronic lung disease, blindness caused by retinopathy, auditory nerve abnormalities, mental retardation	1 years	the long-term outcomes of the preterm delivery. The main areas that are affected are the respiratory function and the neurodevelopment of these babies due to the early arrest in the lung and brain development, respectively. Moreover, the overall general health of this population is affected in the long-term and ongoing follow up studies are required to provide a better understanding in the field.
Social Burden	1 years	Outcome varies with the quality of neonatal care. create the highest burden for the society. A 2006 report from the Institute of Medicine estimated the annual cost of preterm birth in the United States to be $26.2 billion or more than $51,000 per premature infant .

Trial Locations

Locations (1)

The First Affilliated Hospital of Chongqig Medical University; 🇨🇳 Chongqing, Chongqing, China