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

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.

Study Overview

• Status: Unknown
• Conditions: Pregnancy Complications; Postpartum Hemorrhage

Detailed Description

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.

• Study Type: Observational
• Enrollment (Anticipated): 15000

Contacts and Locations

• Study Contact: Name: Tao Duan, Ph.D; Phone Number: 13371985019; Email: tduan@yahoo.com
• Study Contact Backup: Name: Jing Hua, Ph.D; Phone Number: 13661504752; Email: szhuaj@hotmail.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 201204
      • Recruiting
      • Shanghai first maternity and infant hospital
      • Contact: Jing Hua, Ph.D; Phone Number: 13661504752; Email: szhuaj@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

A total of 20 hospitals from different places of China participated this study. Their annual delivery amount are more than 5000 times and their cesarean section rates are about 40%. The labor progression study include a total of 15,000 puerperae.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

20

Cohorts and Interventions

Group / Cohort
Shanghai First Maternity and Infant Hospital
Dalian Maternity and Child Health Hospital
Beijing Obstetrics and Gynecology Hospital
Shijiazhuang Obstetrics and Gynecology Hospital
The Children and Women's Healthcare of Laiwu City
Suzhou Municipal Hospital
Wenling Women's and Children's Hospital
First Affiliated Hospital of Kunming Medical University
Changsha Hospital for Maternal and Child Health Care
Xinxiang Maternity and Child Health Hospital
Yanshi People's Hospital
The Maternal and Child Health Hospital of Guangxi
Northwest Women and Children's Hospital
Suining Central Hospital
Inner Mongolia Maternity and Child Health Hospital
Fujian Province Maternity and Child Health Hospital
Qinghai Red Cross Hospital
Xinjiang Maternity and Child Health Hospital
Jiangmen Maternity and Child Health Care Hospital
Gansu Provincial Maternity and Child-care Hospital

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
times of uterus contraction	The investigator count the times of uterus contraction in 10 minutes both intrapartum and postpartum.	10 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
fetal heart rate	Normal resting fetal heart rate is approximately 120-160 times per minute.	1 minute
blood pressure	Blood pressure is the pressure exerted by circulating blood upon the walls of blood vessels. It is usually expressed in terms of the systolic (maximum) pressure over diastolic (minimum) pressure and is measured in millimeters of mercury (mmHg). Normal resting systolic (diastolic) blood pressure in an adult is approximately 120 mmHg (80 mmHg), abbreviated "120/80 mmHg".	10 minutes
Apgar scores	The Apgar scale is determined by evaluating the newborn baby on five simple criteria on a scale from zero to two, then summing up the five values thus obtained. The resulting Apgar score ranges from zero to 10.	1 minute and 5minutes

Collaborators and Investigators

• Sponsor: Shanghai First Maternity and Infant Hospital
• Investigators: Principal Investigator: Tao Duan, Ph.D, Shanghai First Maternity and Infant Hospital Tongji University School of Medicine

Study record dates

Study Major Dates

• Study Start: January 1, 2016
• Primary Completion (Anticipated): December 1, 2018
• Study Completion (Anticipated): December 1, 2018

Study Registration Dates

• First Submitted: October 18, 2016
• First Submitted That Met QC Criteria: October 21, 2016
• First Posted (Estimate): October 24, 2016

Study Record Updates

• Last Update Posted (Estimate): October 24, 2016
• Last Update Submitted That Met QC Criteria: October 21, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Obstetric Labor Complications; Puerperal Disorders; Uterine Hemorrhage; Hemorrhage; Pregnancy Complications; Postpartum Hemorrhage
• Other Study ID Numbers: FMIH Duan

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: There are 20 hospitals participated this study, we need get their agreement to share data.