Pregnancy ComplicationsNCT02942719
The Establishment and Application of the New Labor Progress Centered System of Reducing Cesarean Section Rates in China
An observational study of Pregnancy Complications and Postpartum Hemorrhage, run by Shanghai First Maternity and Infant Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy Complications, Postpartum Hemorrhage
- How many people
- 15,000 participants
- Where
- 1 siteChina
- Study dates
- Jan 2016to Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Chinese pregnant women
- singleton
- head position
- 37 weeks + 0 day - 41weeks + 6 days
- primipara
- low-risk pregnancy
- vaginal delivery willingness
- vaginal cervix <7 cm after labor
Who cannot join
- multiple pregnancy
- non-head position
- stillbirth
- selective cesarean section
- prenatal cesarean section
- age <18 years
Show all 9Show fewer
- previous childbirth history
- pregnancy complications
- important fetal malformations.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai First Maternity and Infant Hospital
Shanghai, Shanghai Municipality, 201204
Jing Hua, Ph.D, 13661504752, szhuaj@hotmail.com
About this study
- To describe the average labor curve and establish new labor progression standards.
- 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.
- Establishment of "Chinese maternal-fetal medical collaboration network" and APP to promote natural childbirth.
Read the detailed description
- 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.
- 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.
- 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
- Pregnancy Complications, Postpartum Hemorrhage
- Medical subject headings
- Pregnancy Complications, Postpartum Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Shanghai First Maternity and Infant Hospital | Not described | |
| Dalian Maternity and Child Health Hospital | Not described | |
| Beijing Obstetrics and Gynecology Hospital | Not described | |
| Shijiazhuang Obstetrics and Gynecology Hospital | Not described | |
| The Children and Women's Healthcare of Laiwu City | Not described | |
| Suzhou Municipal Hospital | Not described | |
| Wenling Women's and Children's Hospital | Not described | |
| First Affiliated Hospital of Kunming Medical University | Not described | |
| Changsha Hospital for Maternal and Child Health Care | Not described | |
| Xinxiang Maternity and Child Health Hospital | Not described | |
| Yanshi People's Hospital | Not described | |
| The Maternal and Child Health Hospital of Guangxi | Not described | |
| Northwest Women and Children's Hospital | Not described | |
| Suining Central Hospital | Not described | |
| Inner Mongolia Maternity and Child Health Hospital | Not described | |
| Fujian Province Maternity and Child Health Hospital | Not described | |
| Qinghai Red Cross Hospital | Not described | |
| Xinjiang Maternity and Child Health Hospital | Not described | |
| Jiangmen Maternity and Child Health Care Hospital | Not described | |
| Gansu Provincial Maternity and Child-care Hospital | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
times of uterus contraction
The investigator count the times of uterus contraction in 10 minutes both intrapartum and postpartum.
Measured: 10 minutes
Secondary outcomes (3)
fetal heart rate
Normal resting fetal heart rate is approximately 120-160 times per minute.
Measured: 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".
Measured: 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.
Measured: 1 minute and 5minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2016 (estimated)
- Study startJan 2016
- Primary completionDec 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy ComplicationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 15,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai First Maternity and Infant Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tao Duan, Ph.D, Principal investigator, Shanghai First Maternal and Infant Health Hospital affiliated to Tongji University Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02942719
- Sponsor's protocol ID
- FMIH Duan
- Status last verified
- Oct 2016
- First submitted
- 18 Oct 2016
- Last updated
- 24 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided: There are 20 hospitals participated this study, we need get their agreement to share data.
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Establishment and Application of the New Labor Progress Centered System of Reducing Cesarean Section Rates in China
- ClinicalTrials.gov ID
- NCT02942719
- Acronym / sponsor ID
- FMIH Duan
- Conditions
- Pregnancy Complications, Postpartum Hemorrhage
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 15,000 participants (estimated)
- Lead sponsor
- Shanghai First Maternity and Infant HospitalUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 24 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- To describe the average labor curve and establish new labor progression standards.
- 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.
- Establishment of "Chinese maternal-fetal medical collaboration network" and APP to promote natural childbirth.
Detailed description
- 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.
- 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.
- 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 20
| Arm | Type | Receives |
|---|---|---|
| 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 | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (8 listed)
- Chinese pregnant women
- singleton
- head position
- 37 weeks + 0 day - 41weeks + 6 days
- primipara
Key exclusion criteria (9 listed)
- multiple pregnancy
- non-head position
- stillbirth
- selective cesarean section
- prenatal cesarean section
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
times of uterus contraction
Time frame: 10 minutes
The investigator count the times of uterus contraction in 10 minutes both intrapartum and postpartum.
3 secondary outcomes
fetal heart rate
Time frame: 1 minute
blood pressure
Time frame: 10 minutes
Apgar scores
Time frame: 1 minute and 5minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2016.
- Individual participant dataSharing planned: Undecided. There are 20 hospitals participated this study, we need get their agreement to share data.
Related trials for Pregnancy Complications
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
Population Pharmacokinetics of Temocillin in Acute Enterobacterial Pyelonephritis in Children
Pyelonephritis
Active, not recruitingPhase 3
A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011)
Carcinoma, Renal Cell
Recruiting
Safety and Performance of UCon Patch Electrode
Urinary Incontinence, Urinary Incontinence, Urge
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tao Duan, Ph.D principal investigator
Shanghai First Maternal and Infant Health Hospital affiliated to Tongji University Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy Complications and Postpartum Hemorrhage, run by Shanghai First Maternity and Infant Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tao Duan, Ph.D (13371985019, tduan@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
times of uterus contraction (time frame: 10 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2016.