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

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.

Study Overview

• Status: Recruiting
• Conditions: Emergency Cesarean Section
• Intervention / Treatment: Other: general operating center; Other: independent obsteric operating center

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.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Foshan, Guangdong, China, 528000
      • Recruiting
      • Maternal and Child Health Hospital of Foshan
      • Contact: Zhengping Liu, MD; Phone Number: 86 757 82969772; Email: liuzphlk81@outlook.com
      • Contact: Dazhi Fan, MD; Phone Number: 86 757 82969772; Email: fandazhigw@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

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

Exclusion Criteria:

• with missing data

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Maternal and Child Health Hospital of Foshan

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2021
• Primary Completion (Anticipated): June 30, 2022
• Study Completion (Anticipated): August 30, 2022

Study Registration Dates

• First Submitted: December 23, 2021
• First Submitted That Met QC Criteria: January 13, 2022
• First Posted (Actual): January 26, 2022

Study Record Updates

• Last Update Posted (Actual): January 26, 2022
• Last Update Submitted That Met QC Criteria: January 13, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: independent obstetric operating room; emergency cesarean section; decision-to-delivery interval
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Emergencies
• Other Study ID Numbers: MCHHFoshan-2199

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No