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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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05208515
Enrollment
100
Registered
2022-01-26
Start date
2021-07-01
Completion date
2022-08-30
Last updated
2022-01-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Emergency Cesarean Section

Keywords

independent obstetric operating room, emergency cesarean section, decision-to-delivery interval

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.

Interventions

OTHERindependent obsteric operating center

send emergency cesarean section needing women from labor room to independent obstetric operating center

OTHERgeneral operating center

send emergency cesarean section needing women from labor room to general operating center

Sponsors

Maternal and Child Health Hospital of Foshan
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* with missing data

Design outcomes

Primary

MeasureTime frameDescription
transfer timelabor dayTime of decision to time of arrival of the patient in theatre
decision to delivery intervallabor daythe 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.
anesthetic timelabor dayArrival of the patient in theatres to anaesthetic ready time
Operation waiting timelabor dayTime at which the anaesthetic is ready to the first skin incision
delivery timelabor daySkin incision-to-delivery of the first fetus

Secondary

MeasureTime frameDescription
number of still birthlabor daynumber of a birth in which the baby is born dead
number of newborn transferred to NICUFrom delivery to one week after deliverynumber of newborn transferred to neonatal intensive care unit
number of neonatal deathlabor daynumber of newborn died after birth
first minute Apgar scorelabor dayApgar 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 scorelabor dayApgar 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 asphyxialabor dayneonatal asphyxia is divied into no (8\ 10), mild(4\ 7) and sever(0\ 3) accroding to the Apgar score evaluated in one minute.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026