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

• ClinicalTrials.gov Identifier: NCT03210415
• Recruitment Status: Unknown
• First Posted: July 7, 2017
• Last Update Posted: October 29, 2019
• Sponsor: Ministry of Science and Technology of the People´s Republic of China
• Collaborators: First Affiliated Hospital of Chongqing Medical University; Peking University Third Hospital
• Information provided by (Responsible Party): Hongbo Qi, Ministry of Science and Technology of the People´s Republic of China

Study Description

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.

Condition or disease	Intervention/treatment
Preterm Labor	Other: Observational Study Model

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 Design

• Study Type: Observational
• Estimated Enrollment: 1500 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Study on Prevention, Treatment and Mechanism of Preterm Labor for Chinese Pregnant Women ≥35 Years Old
• Actual Study Start Date: August 1, 2017
• Estimated Primary Completion Date: June 30, 2020
• Estimated Study Completion Date: December 30, 2020

Groups and Cohorts

Group/Cohort	Intervention/treatment
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; 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.	Other: Observational Study Model; There is no intervention for the study.

Outcome Measures

Primary Outcome Measures :

1. Morbidity of Preterm birth [ Time Frame: 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 :

1. Social Burden [ Time Frame: 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 .
2. Morbidity of Chorioamnionitis [ Time Frame: 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.
3. Respiratory distress syndrome, ischemic hypoxic encephalopathy, necrotizing enterocolitis, various infections [ Time Frame: 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.
4. Cerebral palsy, chronic lung disease, blindness caused by retinopathy, auditory nerve abnormalities, mental retardation [ Time Frame: 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.

Biospecimen Retention:   Samples With DNA

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

Eligibility Criteria

• Ages Eligible for Study: 35 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Gender Based Eligibility: Yes
• Gender Eligibility Description: study on pregnant women
• Accepts Healthy Volunteers: Yes
• Sampling Method: Probability Sample

Study Population

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

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。

Contacts and Locations

Locations

China, Chongqing

The First Affilliated Hospital of Chongqig Medical University

Chongqing, Chongqing, China, 400010

Sponsors and Collaborators

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

First Affiliated Hospital of Chongqing Medical University

Peking University Third Hospital

Investigators

• Principal Investigator: Hongbo bo Qi, Dr.; First Affiliated Hospital of Chongqing Medical University

More Information

Publications of Results:

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.

• Responsible Party: Hongbo Qi, Principle Investigator, Ministry of Science and Technology of the People´s Republic of China
• ClinicalTrials.gov Identifier: NCT03210415
• Other Study ID Numbers: 2016YFC1000407
• First Posted: July 7, 2017
• Last Update Posted: October 29, 2019
• Last Verified: October 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Hongbo Qi, Ministry of Science and Technology of the People´s Republic of China:

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

Additional relevant MeSH terms:

Premature Birth; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications