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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02942719
Other study ID # FMIH Duan
Secondary ID
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


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
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