The Effect of Independent Obstetric Operating Room on Decision-to-delivery Interval for Emergency Cesarean Section
Primary Purpose
Emergency Cesarean Section
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
independent obsteric operating center
general operating center
Sponsored by
About this trial
This is an interventional treatment trial for Emergency Cesarean Section focused on measuring independent obstetric operating room, emergency cesarean section, decision-to-delivery interval
Eligibility Criteria
Inclusion Criteria:
- over 18 years old, meet the conditions of vaginal delivery, decided to give birth vaginally
Exclusion Criteria:
- with missing data
Sites / Locations
- Maternal and Child Health Hospital of FoshanRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Experimental
Arm Label
stardard group
new group
Arm Description
wowen who need emergency cesarean section will be send to the general operating center.
women who need emergency cesarean section will be send to the obstetric operating center
Outcomes
Primary Outcome Measures
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.
transfer time
Time of decision to time of arrival of the patient in theatre
anesthetic time
Arrival of the patient in theatres to anaesthetic ready time
Operation waiting time
Time at which the anaesthetic is ready to the first skin incision
delivery time
Skin incision-to-delivery of the first fetus
Secondary Outcome Measures
number of still birth
number of a birth in which the baby is born dead
number of neonatal death
number of newborn died after birth
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.
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.
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.
number of newborn transferred to NICU
number of newborn transferred to neonatal intensive care unit
Full Information
NCT ID
NCT05208515
First Posted
December 23, 2021
Last Updated
January 13, 2022
Sponsor
Maternal and Child Health Hospital of Foshan
1. Study Identification
Unique Protocol Identification Number
NCT05208515
Brief Title
The Effect of Independent Obstetric Operating Room on Decision-to-delivery Interval for Emergency Cesarean Section
Official Title
A Randomized, Standard-controlled Study of Establishing Independent Obstetric Operating Centre and Decision-to-delivery Interval for Emergency Cesarean Section
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2021 (Actual)
Primary Completion Date
June 30, 2022 (Anticipated)
Study Completion Date
August 30, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Maternal and Child Health Hospital of Foshan
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Emergency Cesarean Section
Keywords
independent obstetric operating room, emergency cesarean section, decision-to-delivery interval
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
stardard group
Arm Type
Other
Arm Description
wowen who need emergency cesarean section will be send to the general operating center.
Arm Title
new group
Arm Type
Experimental
Arm Description
women who need emergency cesarean section will be send to the obstetric operating center
Intervention Type
Other
Intervention Name(s)
independent obsteric operating center
Intervention Description
send emergency cesarean section needing women from labor room to independent obstetric operating center
Intervention Type
Other
Intervention Name(s)
general operating center
Intervention Description
send emergency cesarean section needing women from labor room to general operating center
Primary Outcome Measure Information:
Title
decision to delivery interval
Description
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.
Time Frame
labor day
Title
transfer time
Description
Time of decision to time of arrival of the patient in theatre
Time Frame
labor day
Title
anesthetic time
Description
Arrival of the patient in theatres to anaesthetic ready time
Time Frame
labor day
Title
Operation waiting time
Description
Time at which the anaesthetic is ready to the first skin incision
Time Frame
labor day
Title
delivery time
Description
Skin incision-to-delivery of the first fetus
Time Frame
labor day
Secondary Outcome Measure Information:
Title
number of still birth
Description
number of a birth in which the baby is born dead
Time Frame
labor day
Title
number of neonatal death
Description
number of newborn died after birth
Time Frame
labor day
Title
first minute Apgar score
Description
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.
Time Frame
labor day
Title
five minutes Apgar score
Description
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.
Time Frame
labor day
Title
degree of neonatal asphyxia
Description
neonatal asphyxia is divied into no (8~10), mild(4~7) and sever(0~3) accroding to the Apgar score evaluated in one minute.
Time Frame
labor day
Title
number of newborn transferred to NICU
Description
number of newborn transferred to neonatal intensive care unit
Time Frame
From delivery to one week after delivery
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
over 18 years old, meet the conditions of vaginal delivery, decided to give birth vaginally
Exclusion Criteria:
with missing data
Facility Information:
Facility Name
Maternal and Child Health Hospital of Foshan
City
Foshan
State/Province
Guangdong
ZIP/Postal Code
528000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhengping Liu, MD
Phone
86 757 82969772
Email
liuzphlk81@outlook.com
First Name & Middle Initial & Last Name & Degree
Dazhi Fan, MD
Phone
86 757 82969772
Email
fandazhigw@163.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Effect of Independent Obstetric Operating Room on Decision-to-delivery Interval for Emergency Cesarean Section
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