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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03210415
Enrollment
1500
Registered
2017-07-07
Start date
2017-08-01
Completion date
2020-12-30
Last updated
2019-10-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Preterm Labor

Keywords

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

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.

Interventions

OTHERObservational Study Model

There is no intervention for the study.

Sponsors

First Affiliated Hospital of Chongqing Medical University
CollaboratorOTHER
Peking University Third Hospital
CollaboratorOTHER
Ministry of Science and Technology of the People´s Republic of China
Lead SponsorOTHER_GOV

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
35 Years to No maximum
Healthy volunteers
Yes

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。

Design outcomes

Primary

MeasureTime frameDescription
Morbidity of Preterm birth1 yearsPreterm 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

MeasureTime frameDescription
Social Burden1 yearsOutcome 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 .
Morbidity of Chorioamnionitis1 yearsThe 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.
Respiratory distress syndrome, ischemic hypoxic encephalopathy, necrotizing enterocolitis, various infections1 yearsthe 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.
Cerebral palsy, chronic lung disease, blindness caused by retinopathy, auditory nerve abnormalities, mental retardation1 yearsthe 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.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026