Clinical trial NCT05208515: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Emergency Cesarean Section
Keywords: independent obstetric operating room
emergency cesarean section
decision-to-delivery interval
Lead sponsor: Maternal and Child Health Hospital of Foshan
Sponsor class: OTHER
First posted: 2022-01-26
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* over 18 years old, meet the conditions of vaginal delivery, decided to give birth vaginally

Exclusion Criteria:

* with missing data

Primary outcomes:
measure: decision to delivery interval
timeFrame: labor day
measure: transfer time
timeFrame: labor day
measure: anesthetic time
timeFrame: labor day
measure: Operation waiting time
timeFrame: labor day
measure: delivery time
timeFrame: labor day
Secondary outcomes:
measure: number of still birth
timeFrame: labor day
measure: number of neonatal death
timeFrame: labor day
measure: first minute Apgar score
timeFrame: labor day
measure: five minutes Apgar score
timeFrame: labor day
measure: degree of neonatal asphyxia
timeFrame: labor day
measure: number of newborn transferred to NICU
timeFrame: From delivery to one week after delivery
Other outcomes:
Locations:
city: Foshan
country: China
facility: Maternal and Child Health Hospital of Foshan
state: Guangdong
Study officials:
References: