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

• Conditions: Pregnancy Complications; Postpartum Hemorrhage

• Registration Number: NCT02942719
• Lead Sponsor: Shanghai First Maternity and Infant Hospital

Brief 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.

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 Timeline

• Study Start: 2016-01
• Status Verified: 2016-10
• Study First Submitted: 2016-10-18
• Study First Submitted QC: 2016-10-21
• Last Update Submitted: 2016-10-21
• Study First Posted: 2016-10-24
• Last Update Posted: 2016-10-24
• Primary Completion: 2018-12
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 15000

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

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
times of uterus contraction	10 minutes	The investigator count the times of uterus contraction in 10 minutes both intrapartum and postpartum.

Secondary Outcome Measures

Name	Time	Method
fetal heart rate	1 minute	Normal resting fetal heart rate is approximately 120-160 times per minute.
Apgar scores	1 minute and 5minutes	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.
blood pressure	10 minutes	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".

Trial Locations

Locations (1)

Shanghai First Maternity and Infant Hospital; 🇨🇳 Shanghai, Shanghai, China