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

Emergency Cesarean Section Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05208515
• Other study ID #: MCHHFoshan-2199
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2021
• Est. completion date: August 30, 2022

Study information

• Verified date: January 2022
• Source: Maternal and Child Health Hospital of Foshan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: August 30, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• with missing data

Related Conditions & MeSH terms

• Emergencies
• Emergency Cesarean Section

Intervention

Other:
• independent obsteric operating center
send emergency cesarean section needing women from labor room to independent obstetric operating center
• general operating center
send emergency cesarean section needing women from labor room to general operating center

Locations

Country	Name	City	State
China	Maternal and Child Health Hospital of Foshan	Foshan	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Maternal and Child Health Hospital of Foshan

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	transfer time	Time of decision to time of arrival of the patient in theatre	labor day
Primary	anesthetic time	Arrival of the patient in theatres to anaesthetic ready time	labor day
Primary	Operation waiting time	Time at which the anaesthetic is ready to the first skin incision	labor day
Primary	delivery time	Skin incision-to-delivery of the first fetus	labor day
Secondary	number of still birth	number of a birth in which the baby is born dead	labor day
Secondary	number of neonatal death	number of newborn died after birth	labor day
Secondary	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
Secondary	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
Secondary	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
Secondary	number of newborn transferred to NICU	number of newborn transferred to neonatal intensive care unit	From delivery to one week after delivery