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

M

Maternal and Child Health Hospital of Foshan

Status

Unknown

Conditions

Emergency Cesarean Section

Treatments

Other: general operating center
Other: independent obsteric operating center

Study type

Interventional

Funder types

Other

Identifiers

NCT05208515
MCHHFoshan-2199

Details and patient eligibility

About

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.

Full 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.

Enrollment

100 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

  • with missing data

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

100 participants in 2 patient groups

stardard group
Other group
Description:
wowen who need emergency cesarean section will be send to the general operating center.
Treatment:
Other: general operating center
new group
Experimental group
Description:
women who need emergency cesarean section will be send to the obstetric operating center
Treatment:
Other: independent obsteric operating center

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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