Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202004634203807 Date of Approval: 14/04/2020
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Vaginal Cleaning with Chlorhexidine Solution in Preventing Post-Caesarean Section Infections
Official scientific title Pre-operative Vaginal Cleaning with Chlorhexidine Solution in Preventing Post-Caesarean Section Infections at the Federal Teaching Hospital, Abakaliki: A Randomized Controlled Trial
Brief summary describing the background and objectives of the trial Infection is one of the commonest causes of maternal morbidities and mortality. World Health Organization reported that infection is the third commonest cause of maternal death; it contributes about 15% of maternal deaths. Before the introduction of surgical antisepsis in the 19th century, infection was the most feared complication of caesarean section. In some developing countries today, infection still ranks more than obstetric haemorrhage as a common cause of maternal morbidities and mortality. Any woman is at risk of infection during child birth but women undergoing caesarean section are at higher risk. Various uses of antiseptics, antibiotics and sterilization of surgical instrument have helped reduce post-operative infectious morbidities. Sources of infection are numerous; nosocomial infection, contamination from patient skin flora, haematogenous infection and ascending infection from the vagina. Ascending infection from the lower to upper genital tract is a common but often neglected source of infection. Cleaning the vagina with 1% chlorhexidine antiseptic solution before caesarean section was a cheap, affordable, easily available source of infection control measures in this population. Aim: Investigated the effect of cleaning the vagina of women undergoing caesarean section at Federal Teaching Hospital, Abakaliki and the reduction of post-caesarean infections. Objectives 1. Compared the number of women that developed endometritis in the study and control groups. 2. Compared incidence of surgical incision site infection in the two groups, 3. Compared the duration of hospital stay and financial cost of care in the two groups
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Pregnancy and Childbirth
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 27/02/2018
Actual trial start date 02/07/2018
Anticipated date of last follow up 01/06/2018
Actual Last follow-up date 01/10/2018
Anticipated target sample size (number of participants) 168
Actual target sample size (number of participants) 158
Recruitment status Completed
Publication URL NONE
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group vaginal cleaning with chlorhexidine 1% chlorhexidine solution three times vaginal cleaning with three pieces of gauze soaked in 30 milliliters of 1% chlorhexidine solution in addition to surgical site cleaning with chlorhexidine-alcohol before skin incision. 84
Control Group surgical site cleaning only nil nil received only the surgical site cleaning with chlorhexidine-alcohol before skin incision 84 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Consented pregnant women undergoing emergency caesarean section at FETHA. All unbooked patients undergoing caesarean section after informed consent Patients who have been in labour for four hours or more after hospital admission. Women with features of clinical chorioamnionitis Women with fever (temperature ≥ 38 degree C) Fetal distress as an indication for CS Placenta previa diagnosed on ultrasound Anaemia (pack cell volume less than 21%) Uncontrolled Gestational diabetes mellitus Adult: 19 Year-44 Year 19 Year(s) 45 Year(s) Female
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 08/03/2018 Federal Teaching Hospital research and ethical committee
Ethics Committee Address
Street address City Postal code Country
8 Ejiofor street, Abakaliki Abakaliki 480214 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Secondary Outcome Post-operative wound infection: defined as erythema, tenderness, purulent drainage from the incision site, with or without fever. Post operative fever: defined as temperature equals ≥ 38 degrees C. 4 hourly for 5 days
Primary Outcome Endometritis. Endometritis was suggested clinically in patients with fever, fowl smelling vaginal discharge, uterine sub-involution and tenderness. It was confirmed with endo cervical swab microscopy, culture and sensitivity for all the patients 4 hourly for 5 days
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Federal Teaching Hospital Abakaliki No 8 Ejiofor street, Abakaliki Abakaliki Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Dr Ogah C No 8 Ejiofor street Abakaliki Abakaliki Ebonyi state 0480 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor ogah okechukwu c 6 ejiofor street abakaliki abakaliki 480214 Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
Anikwe chidebe c 6 ejiofor street Abakaliki 480214 Nigeria
Lawani Osaheni L 6 Ejiofor street abakaliki 480214 Nigeria
Ajah leonard O 6 Ejiofor street abakaliki 480214 Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator okechukwu ogah okeyogah2@gmail.com +23480 6 Ejiofor street
City Postal code Country Position/Affiliation
abakaliki 480214 Nigeria consultant
Role Name Email Phone Street address
Scientific Enquiries chidebe anikwe drchideanikwechristian@gmail.com +2348064165965 6 Ejiofor street
City Postal code Country Position/Affiliation
abakaliki 480214 Nigeria consultant
Role Name Email Phone Street address
Public Enquiries Ajah Leonard leookpanku@yahoo.com +2348033920789 6 Ejiofor street
City Postal code Country Position/Affiliation
abakaliki 480214 Nigeria consultant
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data that underlie the result reported in the article after deidentification ( text , tables,figures) Study Protocol Beginning 9 months to end at 36 months following article publication Investigators whose proposed use of the data has been approved by an independent review committee
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes The study showed that the use of 1% chlorhexidine in cleaning the vaginal before emergency caesarean section significantly reduced infectious morbidities like endometritis, decreased hospital stay. It had no effect on surgical site infection. Endo-cervical colonization by micro-organisms was significantly higher in the control 11(14%) in study group versus 41(51)% in control group, (RR) = 0.37,95% CI {0.21 – 0.64}, P 0.0001. Fowl smelling vaginal discharge was 2(2.6%) in study group versus 18(22.5%), (RR) = 9.5, 95% CI {1.30 – 64.55}, P 0.0002. Abdominal tenderness was also higher in the control group 3(3.8%) for study versus 15(30%) for control, (RR) = 2.87, 95% CI {1.00 – 8.21}, P 0.0133. Fever was also lower in the study group but was not statistically significant P value 0.286. 08/04/2020 08/04/2020
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks none
Changes to trial information