The Effect of Independent Obstetric Operating Room on Decision-to-delivery Interval for Emergency Cesarean Section
A Randomized, Standard-controlled Study of Establishing Independent Obstetric Operating Centre and Decision-to-delivery Interval for Emergency Cesarean Section
1 other identifier
interventional
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jul 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2021
CompletedFirst Submitted
Initial submission to the registry
December 23, 2021
CompletedFirst Posted
Study publicly available on registry
January 26, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
August 30, 2022
CompletedJanuary 26, 2022
January 1, 2022
12 months
December 23, 2021
January 13, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
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.
labor day
transfer time
Time of decision to time of arrival of the patient in theatre
labor day
anesthetic time
Arrival of the patient in theatres to anaesthetic ready time
labor day
Operation waiting time
Time at which the anaesthetic is ready to the first skin incision
labor day
delivery time
Skin incision-to-delivery of the first fetus
labor day
Secondary Outcomes (6)
number of still birth
labor day
number of neonatal death
labor day
first minute Apgar score
labor day
five minutes Apgar score
labor day
degree of neonatal asphyxia
labor day
- +1 more secondary outcomes
Study Arms (2)
stardard group
OTHERwowen who need emergency cesarean section will be send to the general operating center.
new group
EXPERIMENTALwomen who need emergency cesarean section will be send to the obstetric operating center
Interventions
send emergency cesarean section needing women from labor room to independent obstetric operating center
send emergency cesarean section needing women from labor room to general operating center
Eligibility Criteria
You may qualify if:
- over 18 years old, meet the conditions of vaginal delivery, decided to give birth vaginally
You may not qualify if:
- with missing data
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Maternal and Child Health Hospital of Foshan
Foshan, Guangdong, 528000, China
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director
Study Record Dates
First Submitted
December 23, 2021
First Posted
January 26, 2022
Study Start
July 1, 2021
Primary Completion
June 30, 2022
Study Completion
August 30, 2022
Last Updated
January 26, 2022
Record last verified: 2022-01
Data Sharing
- IPD Sharing
- Will not share