The Effect of Independent Obstetric Operating Room on Decision-to-delivery Interval for Emergency Cesarean Section

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Randomized, Standard-controlled Study of Establishing Independent Obstetric Operating Centre and Decision-to-delivery Interval for Emergency Cesarean Section

Conditions
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Emergency Cesarean Section

Intervention / Treatment
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* Other: independent obsteric operating center
* Other: general operating center


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: over 18 years old, meet the conditions of vaginal delivery, decided to give birth vaginally Exclusion Criteria: with missing data

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: stardard group<br>wowen who need emergency cesarean section will be send to the general operating center. | Other: general operating center<br>* send emergency cesarean section needing women from labor room to general operating center<br>|
| Experimental: new group<br>women who need emergency cesarean section will be send to the obstetric operating center | Other: independent obsteric operating center<br>* send emergency cesarean section needing women from labor room to independent obstetric operating center<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of still birth | number of a birth in which the baby is born dead | labor day | 
| number of neonatal death | number of newborn died after birth | 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. | 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. | 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. | labor day | 
| number of newborn transferred to NICU | number of newborn transferred to neonatal intensive care unit | From delivery to one week after delivery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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independent obstetric operating room, emergency cesarean section, decision-to-delivery interval