Emergency Cesarean SectionNCT05208515
The Effect of Independent Obstetric Operating Room on Decision-to-delivery Interval for Emergency Cesarean Section
A study testing independent obsteric operating center and general operating center in people with Emergency Cesarean Section, run by Maternal and Child Health Hospital of Foshan at 1 site in China.
Trial summary
The study is to investigate whether the establishing independent obstetric operating centre can shorten the decision-to-delivery interval and improve delivery outcomes of emergency cesarean section. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Emergency Cesarean Section
- What is being tested?
- independent obsteric operating center and general operating center
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2021to 30 Aug 2022
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- over 18 years old, meet the conditions of vaginal delivery, decided to give birth vaginally
Who cannot join
- with missing data
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Maternal and Child Health Hospital of Foshan
Foshan, Guangdong, 528000
Zhengping Liu, MD, 86 757 82969772, liuzphlk81@outlook.com
Dazhi Fan, MD, 86 757 82969772, fandazhigw@163.com
About this study
Official title: A Randomized, Standard-controlled Study of Establishing Independent Obstetric Operating Centre and Decision-to-delivery Interval for Emergency Cesarean Section
The study is to investigate whether the establishing independent obstetric operating centre can shorten the decision-to-delivery interval and improve delivery outcomes of emergency cesarean section.
Read the detailed description
The newest define of decision-to-delivery interval (DDI) is the interval between the time at which the senior obstetrician makes the decision that a caesarean section is required and the time at which the fetus (or first fetus in the case of multiples) is delivered. The recommended DDI by the American College of Obstetricians and Gynecologists and the Royal College of Obstetricians and Gynecologists is within 30 minutes. The 30 minutes rule is also used to measure the overall performance of an obstetric unit in our country. Lower rate of DDI over 30 minutes will improve the outcome of neonatal outcomes.
Affiliated Foshan Maternity \& Child Healthcare Hospital is a tertiary care hospital in south of our country. Obstetric operations in this hospital are used to perform in a big general operating center, which is shared by all departments of the hospital. In December 23, 2020, a new wing of the hospital opened in response to the growing number of patients. In the new wing, an independent obstetric operating center was established to provide health care for obstetric operating. The original and new obstetric units were built according to the same standard. The medical staff shifts between original and new obstetric units every three months. Six months after the new wing of hospital opened, we set off a randomized and controlled trial (RCT). The RCT is aimed to investigate whether the independent obstetric operating center can shorten the DDI, decrease the rate of DDI over 30 minutes and improve neonatal outcomes.
Women who are over 18 years old, meet the conditions of vaginal delivery and decided to give birth vaginally by doctor and patient will be random distributed to original or new obstetric unit from July 1, 2021 to June 30,2022. Women need ECS in original obstetric unit will be send to the general operating center (named standard group), those need ECS in the new wing will be send to the obstetric operating center (named new group). DDI and other related variables of those who need ECS will be recorded. Data of a total of 60 ECS in each group will be collected and analyzed at last. Women who with missing data should be excluded.
- Conditions
- Emergency Cesarean Section
- Being tested
- independent obsteric operating center, general operating center
- Keywords
- independent obstetric operating room, emergency cesarean section, decision-to-delivery interval
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
independent obsteric operating centerOther
send emergency cesarean section needing women from labor room to independent obstetric operating center
general operating centerOther
send emergency cesarean section needing women from labor room to general operating center
| Study group | Role | What they receive |
|---|---|---|
| stardard group | Other | wowen who need emergency cesarean section will be send to the general operating center. Receives: Other: general operating center |
| new group | Experimental | women who need emergency cesarean section will be send to the obstetric operating center Receives: Other: independent obsteric operating center |
What is being measured
The primary outcome is the main question the study is designed to answer.
decision to delivery interval
the interval between the time at which the senior obstetrician makes the decision that a caesarean section is required and the time at which the fetus (or first fetus in the case of multiples) is delivered.
Measured: labor day
transfer time
Time of decision to time of arrival of the patient in theatre
Measured: labor day
anesthetic time
Arrival of the patient in theatres to anaesthetic ready time
Measured: labor day
Operation waiting time
Time at which the anaesthetic is ready to the first skin incision
Measured: labor day
delivery time
Skin incision-to-delivery of the first fetus
Measured: labor day
Secondary outcomes (6)
number of still birth
number of a birth in which the baby is born dead
Measured: labor day
number of neonatal death
number of newborn died after birth
Measured: labor day
first minute Apgar score
Apgar score is a measure of the physical condition of a newborn infant. It is obtained by adding points (2, 1, or 0) for heart rate, respiratory effort, muscle tone, response to stimulation, and skin coloration; a score of ten represents the best possible condition. The 1-minute score determines how well the baby tolerated the birthing process.
Measured: labor day
five minutes Apgar score
Apgar score is a measure of the physical condition of a newborn infant. It is obtained by adding points (2, 1, or 0) for heart rate, respiratory effort, muscle tone, response to stimulation, and skin coloration; a score of ten represents the best possible condition. The 5-minute score tells the health care provider how well the baby is doing outside the mother's womb.
Measured: labor day
degree of neonatal asphyxia
neonatal asphyxia is divied into no (8~10), mild(4~7) and sever(0~3) accroding to the Apgar score evaluated in one minute.
Measured: labor day
number of newborn transferred to NICU
number of newborn transferred to neonatal intensive care unit
Measured: From delivery to one week after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2022
- Study start1 Jul 2021
- Primary completion30 Jun 2022 (estimated)
- Study completion30 Aug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Emergency Cesarean SectionStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maternal and Child Health Hospital of Foshan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhengping Liu, MD, Maternal and Child Health Hospital of Foshan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05208515
- Sponsor's protocol ID
- MCHHFoshan-2199
- Status last verified
- Jan 2022
- First submitted
- 23 Dec 2021
- Last updated
- 26 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Standard-controlled Study of Establishing Independent Obstetric Operating Centre and Decision-to-delivery Interval for Emergency Cesarean Section
- ClinicalTrials.gov ID
- NCT05208515
- Acronym / sponsor ID
- MCHHFoshan-2199
- Conditions
- Emergency Cesarean Section
- Keywords
- independent obstetric operating room, emergency cesarean section, decision-to-delivery interval
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Maternal and Child Health Hospital of FoshanUniversity, hospital or other
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 30 Jun 2022 (estimated)
- Study completion
- 30 Aug 2022 (estimated)
- First posted
- 26 Jan 2022 (actual)
- 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.
The study is to investigate whether the establishing independent obstetric operating centre can shorten the decision-to-delivery interval and improve delivery outcomes of emergency cesarean section.
Detailed description
The newest define of decision-to-delivery interval (DDI) is the interval between the time at which the senior obstetrician makes the decision that a caesarean section is required and the time at which the fetus (or first fetus in the case of multiples) is delivered. The recommended DDI by the American College of Obstetricians and Gynecologists and the Royal College of Obstetricians and Gynecologists is within 30 minutes. The 30 minutes rule is also used to measure the overall performance of an obstetric unit in our country. Lower rate of DDI over 30 minutes will improve the outcome of neonatal outcomes.
Affiliated Foshan Maternity \& Child Healthcare Hospital is a tertiary care hospital in south of our country. Obstetric operations in this hospital are used to perform in a big general operating center, which is shared by all departments of the hospital. In December 23, 2020, a new wing of the hospital opened in response to the growing number of patients. In the new wing, an independent obstetric operating center was established to provide health care for obstetric operating. The original and new obstetric units were built according to the same standard. The medical staff shifts between original and new obstetric units every three months. Six months after the new wing of hospital opened, we set off a randomized and controlled trial (RCT). The RCT is aimed to investigate whether the independent obstetric operating center can shorten the DDI, decrease the rate of DDI over 30 minutes and improve neonatal outcomes.
Women who are over 18 years old, meet the conditions of vaginal delivery and decided to give birth vaginally by doctor and patient will be random distributed to original or new obstetric unit from July 1, 2021 to June 30,2022. Women need ECS in original obstetric unit will be send to the general operating center (named standard group), those need ECS in the new wing will be send to the obstetric operating center (named new group). DDI and other related variables of those who need ECS will be recorded. Data of a total of 60 ECS in each group will be collected and analyzed at last. Women who with missing data should be excluded.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| stardard group | Other | Other: general operating centerwowen who need emergency cesarean section will be send to the general operating center. |
| new group | Experimental | Other: independent obsteric operating centerwomen who need emergency cesarean section will be send to the obstetric operating center |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- over 18 years old, meet the conditions of vaginal delivery, decided to give birth vaginally
Key exclusion criteria (1 listed)
- with missing data
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| independent obsteric operating centersend emergency cesarean section needing women from labor room to independent obstetric operating center | Other | new group |
| general operating centersend emergency cesarean section needing women from labor room to general operating center | Other | stardard group |
Primary outcome
decision to delivery interval
Time frame: labor day
the interval between the time at which the senior obstetrician makes the decision that a caesarean section is required and the time at which the fetus (or first fetus in the case of multiples) is delivered.
transfer time
Time frame: labor day
Time of decision to time of arrival of the patient in theatre
anesthetic time
Time frame: labor day
Arrival of the patient in theatres to anaesthetic ready time
Operation waiting time
Time frame: labor day
Time at which the anaesthetic is ready to the first skin incision
delivery time
Time frame: labor day
Skin incision-to-delivery of the first fetus
6 secondary outcomes
number of still birth
Time frame: labor day
number of neonatal death
Time frame: labor day
first minute Apgar score
Time frame: labor day
five minutes Apgar score
Time frame: labor day
degree of neonatal asphyxia
Time frame: labor day
number of newborn transferred to NICU
Time frame: From delivery to one week after delivery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2022.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing independent obsteric operating center and general operating center in people with Emergency Cesarean Section, run by Maternal and Child Health Hospital of Foshan 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 1 inclusion and 1 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 26 Jan 2022. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
decision to delivery interval (time frame: labor day). The study lists 5 primary outcomes in all. 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 26 Jan 2022.