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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05748743
Other study ID # CK62721303
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 18, 2020
Est. completion date February 25, 2021

Study information

Verified date February 2023
Source Hung Vuong Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study aimed to investigate the effectiveness of glove changing in reducing complications of cesarean deliveries in Vietnam.


Description:

In Vietnam, the rate of Cesarean section (CS) is very high, ranging from 40-50%. Despite that, there are very limited publications concerning the risk factors, complications, and management of surgical site infection (SSI) following CS. Our study is the first to investigate the effectiveness of glove changing in reducing the incidence of post-operative infections in Vietnam. Specifically, the aims of this study are 1) to evaluate whether changing gloves during CS reduces complications and SSI, and 2) to identify other factors that are associated with complications and SSI.


Recruitment information / eligibility

Status Completed
Enrollment 678
Est. completion date February 25, 2021
Est. primary completion date February 25, 2021
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion criteria - pregnant women were 18 years old or higher; - pregnant women had cesarean surgery performed at Hung Vuong hospital; - pregnant women lived close to Ho Chi Minh city and agreed to return for postpartum care one-month post-surgery. Exclusion criteria - pregnant women had fever during labor; - pregnant women had systemic infectious conditions; - pregnant women had surgical site infection SSI or sexually infectious conditions; - pregnant women had ongoing internal conditions such as pre-eclampsia, severe anemia, American Society of Anesthesiologists (ASA) = 3, New York Heart Association (NYHA) class 3 or above, pulmonary edema, or severe asthma.

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
glove changing
Surgical gloves were changed prior to abdominal closure during Cesarean section to evaluate its effectiveness in reducing wound complications after surgery

Locations

Country Name City State
Vietnam Hung Vuong hospital Ho Chi Minh City

Sponsors (1)

Lead Sponsor Collaborator
Hung Vuong Hospital

Country where clinical trial is conducted

Vietnam, 

Outcome

Type Measure Description Time frame Safety issue
Primary Wound complications Seroma, hematoma, wound separation, and wound infection Within 4 weeks after surgery
Secondary Surgical site infection Fever, swelling, redness, and pain surrounding the incisional area Within 4 weeks after surgery
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