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

NCT ID: NCT05208515

Last Updated: 2022-01-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-01

Study Completion Date

2022-08-30

Brief Summary

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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

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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.

Conditions

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Emergency Cesarean Section

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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stardard group

wowen who need emergency cesarean section will be send to the general operating center.

Group Type OTHER

general operating center

Intervention Type OTHER

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

new group

women who need emergency cesarean section will be send to the obstetric operating center

Group Type EXPERIMENTAL

independent obsteric operating center

Intervention Type OTHER

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

Interventions

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independent obsteric operating center

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

Intervention Type OTHER

general operating center

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* with missing data
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Maternal and Child Health Hospital of Foshan

OTHER

Sponsor Role lead

Responsible Party

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Zhengping Liu, MD

Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Maternal and Child Health Hospital of Foshan

Foshan, Guangdong, China

Site Status RECRUITING

Countries

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China

Facility Contacts

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Zhengping Liu, MD

Role: primary

86 757 82969772

Dazhi Fan, MD

Role: backup

86 757 82969772

Other Identifiers

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MCHHFoshan-2199

Identifier Type: -

Identifier Source: org_study_id

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