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

NCT03210415 | Unknown DMC

• 1 other identifier: 2016YFC1000407
• Study Type: observational
• Target: 1,500
• Locations: 1 country
• Sites: 1

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.

Conditions

Preterm Labor

Keywords

Preterm Labor; China; Pregnant Women; ≥35 Years Old

Outcome Measures

Primary Outcomes (1)

• Morbidity of Preterm birth

  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.

  1 years

Secondary Outcomes (4)

• Social Burden

  1 years

• Morbidity of Chorioamnionitis

  1 years

• Respiratory distress syndrome, ischemic hypoxic encephalopathy, necrotizing enterocolitis, various infections

  1 years

• Cerebral palsy, chronic lung disease, blindness caused by retinopathy, auditory nerve abnormalities, mental retardation

  1 years

Study Arms (2)

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.

Other: Observational Study Model

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.

Other: Observational Study Model

Interventions

Observational Study Model OTHER

There is no intervention for the study.

Control group; Study group

Eligibility Criteria

• Age: 35 Years+
• Gender Eligibility Details: study on pregnant women
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Chinese pregnant women ≥ 35 years old with spontaneous preterm birth between 28-37 weeks of gestation.

You may qualify if:

• Chinese pregnant women ≥ 35 years old

You may not qualify if:

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

Sponsors & Collaborators

• Ministry of Science and Technology of the People´s Republic of China: lead
• First Affiliated Hospital of Chongqing Medical University: collaborator
• Peking University Third Hospital: collaborator

Study Sites (1)

The First Affilliated Hospital of Chongqig Medical University

Chongqing, Chongqing Municipality, 400010, China

Location

Related Publications (1)

• 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.

  PMID: 22682464 RESULT

Biospecimen

Retention: SAMPLES WITH DNA

blood, urine, hair, cervical secretion，saliva，amniotic fluid, placenta

MeSH Terms

Conditions

Obstetric Labor, Premature

Condition Hierarchy (Ancestors)

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

Study Officials

• Hongbo bo Qi, Dr.

  First Affiliated Hospital of Chongqing Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: May 4, 2017
• First Posted: July 7, 2017
• Study Start: August 1, 2017
• Primary Completion: June 30, 2020
• Study Completion: December 30, 2020
• Last Updated: October 29, 2019

Record last verified: 2019-10

Locations

CN (1)