The Establishment and Application of the New Labor Progress Centered System of Reducing Cesarean Section Rates in China

NCT ID: NCT02942719

Last Updated: 2016-10-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

15000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-01-31

Study Completion Date

2018-12-31

Brief Summary

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1. To describe the average labor curve and establish new labor progression standards.
2. Cesarean section rates: Based on big data, the investigator will introduce the international advanced Robson class method and identify the appropriate level of cesarean section rate for each type population.
3. Establishment of "Chinese maternal-fetal medical collaboration network" and APP to promote natural childbirth.

Detailed Description

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1. To describe the average labor curve and establish new labor progression standards. The investigator will investigate the current characteristics of obstetric population and the labor progression with obstetric intervention in China. The investigator compare the different effects of traditional labor progression management model, new labor progression management model and active labor progression management model on labor outcomes. Based on the best outcomes of maternity and infants, the investigator will establish and modify new labor progression which is suitable for Chinese.
2. Cesarean section rates: Based on big data, the investigator will introduce the international advanced Robson class method and identify the appropriate level of cesarean section rate for each type population.the investigator compare cesarean section rates of different level hospitals and evaluate the effects of reducing cesarean section rates. The investigator also analyze the risk factors of cesarean section rates of the ten Robson classification, which will provide basis for reducing cesarean section rates under the new strategy.
3. Establishment of "Chinese maternal-fetal medical collaboration network" and mobile application software (APP) to promote natural childbirth: The investigator establish perinatal data center using the hospital information system (HIS) system of hospital. The investigator predict the cesarean section rates and relative factors using the Robson classification method, and propose the new strategy of reducing cesarean section rates. Meanwhile, the investigator develop the quality management system toolkit which can help clinicians standardize behavior and improve obstetric safety.

Conditions

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Pregnancy Complications Postpartum Hemorrhage

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Shanghai First Maternity and Infant Hospital

No interventions assigned to this group

Dalian Maternity and Child Health Hospital

No interventions assigned to this group

Beijing Obstetrics and Gynecology Hospital

No interventions assigned to this group

Shijiazhuang Obstetrics and Gynecology Hospital

No interventions assigned to this group

The Children and Women's Healthcare of Laiwu City

No interventions assigned to this group

Suzhou Municipal Hospital

No interventions assigned to this group

Wenling Women's and Children's Hospital

No interventions assigned to this group

First Affiliated Hospital of Kunming Medical University

No interventions assigned to this group

Changsha Hospital for Maternal and Child Health Care

No interventions assigned to this group

Xinxiang Maternity and Child Health Hospital

No interventions assigned to this group

Yanshi People's Hospital

No interventions assigned to this group

The Maternal and Child Health Hospital of Guangxi

No interventions assigned to this group

Northwest Women and Children's Hospital

No interventions assigned to this group

Suining Central Hospital

No interventions assigned to this group

Inner Mongolia Maternity and Child Health Hospital

No interventions assigned to this group

Fujian Province Maternity and Child Health Hospital

No interventions assigned to this group

Qinghai Red Cross Hospital

No interventions assigned to this group

Xinjiang Maternity and Child Health Hospital

No interventions assigned to this group

Jiangmen Maternity and Child Health Care Hospital

No interventions assigned to this group

Gansu Provincial Maternity and Child-care Hospital

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

1. Chinese pregnant women
2. singleton
3. head position
4. 37 weeks + 0 day - 41weeks + 6 days
5. primipara
6. low-risk pregnancy
7. vaginal delivery willingness
8. vaginal cervix \<7 cm after labor

Exclusion Criteria

1. multiple pregnancy
2. non-head position
3. stillbirth
4. selective cesarean section
5. prenatal cesarean section
6. age \<18 years
7. previous childbirth history
8. pregnancy complications
9. important fetal malformations.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Shanghai First Maternity and Infant Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Tao Duan, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Shanghai First Maternal and Infant Health Hospital affiliated to Tongji University Medical School

Locations

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Shanghai First Maternity and Infant Hospital

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Tao Duan, Ph.D

Role: CONTACT

13371985019

Jing Hua, Ph.D

Role: CONTACT

13661504752

Facility Contacts

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Jing Hua, Ph.D

Role: primary

13661504752

Other Identifiers

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FMIH Duan

Identifier Type: -

Identifier Source: org_study_id

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