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

Pregnancy Complications Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02942719
• Other study ID #: FMIH Duan
• Status: Recruiting
• Phase: N/A
• First received: October 18, 2016
• Last updated: October 21, 2016
• Start date: January 2016
• Est. completion date: December 2018

Study information

• Verified date: October 2016
• Source: Shanghai First Maternity and Infant Hospital
• Contact: Tao Duan, Ph.D
• Phone: 13371985019
• Email: tduan[@]yahoo.com
• Is FDA regulated: No
• Health authority: China: Shanghai Municipal Commission of Health and Family Planning
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15000
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hemorrhage
• Postpartum Hemorrhage
• Pregnancy Complications

Locations

Country	Name	City	State
China	Shanghai First Maternity and Infant Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai First Maternity and Infant Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	times of uterus contraction	The investigator count the times of uterus contraction in 10 minutes both intrapartum and postpartum.	10 minutes	No
Secondary	fetal heart rate	Normal resting fetal heart rate is approximately 120-160 times per minute.	1 minute	No
Secondary	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	No
Secondary	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	No