Vaginal ScrubbingNCT03431701
Chlorhexidine Vaginal Cleansing Versus Iodine Prior to C-section and the Rate of Postoperative Infection
A study testing Chlorhexidine, Iodine and Antibiotics in people with Vaginal Scrubbing, run by Makassed General Hospital at 1 site in Lebanon.
Trial summary
Background: Women undergoing cesarean delivery have 5 to 20 fold greater risk for infection and infectious morbidity compared with those undergoing vaginal birth. Endometritis, febrile morbidity, and wound infection are the most frequent complications of post cesarean infections. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Vaginal Scrubbing
- What is being tested?
- Chlorhexidine, Iodine and Antibiotics
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 333 participants
- Where
- 1 siteLebanon
- Study dates
- 8 Feb 2018to 30 Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- all pregnant women who will undergo cesarean delivery
- and willing to sign the informed consent.
Who cannot join
- Known allergy to the antiseptics used
- Infection diagnosis on admission
- Age ≤ 17 years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Chlorhexidine Vaginal Cleansing Versus Iodine Prior to C-section and the Rate of Postoperative Infection: Randomized Clinical Trial
Background: Women undergoing cesarean delivery have 5 to 20 fold greater risk for infection and infectious morbidity compared with those undergoing vaginal birth. Endometritis, febrile morbidity, and wound infection are the most frequent complications of post cesarean infections. Endometritis accounts for 6-27% followed by clinically significant fever, which was reported about 5-24%,while the incidence of wound infection is about 2-9%.Previous studies evaluated whether vaginal cleansing can reduce the incidence of postoperative infectious morbidity. In most of the studies, povidone iodine was used as intervention.
Objectives: The aim of this study is to test the hypothesis that preoperative vaginal cleansing with chlorhexidine would be superior to iodine for the prevention of maternal infectious morbidities including endometritis, fever and wound complications.
Methods: This prospective randomized single blinded controlled trial will be conducted at Makassed General Hospital between February 2018 and January 2019. Total of 300 patients, 150 in each group, will be enrolled. Group 1 patients will receive chlorhexidine vaginal cleansing while group 2 patients will receive iodine prior to C-section. Adverse post infectious morbidities such as endometritis, febrile illness and wound infections will be observed within 30 days of C-section.
Read the detailed description
This prospective randomized single blinded controlled trial will be conducted at Makassed General Hospital between February 2018 and January 2019. All pregnant women who will undergo cesarean delivery and willing to sign the informed consent will be included. Total of 300 patients, 150 in each group, will be enrolled. Group 1 patients will receive chlorhexidine vaginal cleansing while group 2 patients will receive iodine prior to C-section. Adverse post infectious morbidities such as endometritis, febrile illness and wound infections will be observed d within 30 days of C-section.
Vaginal cleansing will be performed in conjunction with the abdominal preparation with foam sponge that contains either chlorhexidine or iodine, sponge will be inserted into the vagina and rotated 360 degrees in the vaginal cavity for about 30 sec. All participants will receive a single body mass index (BMI) based antibiotic dose of cefazolin within 30 minutes prior to the incision.
- Conditions
- Vaginal Scrubbing
- Being tested
- Chlorhexidine, Iodine, Antibiotics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChlorhexidineOther
Vaginal cleansing will be performed in conjunction with the abdominal preparation with foam sponge that contains chlorhexidine. A sponge soaked with chlorhexidine will be inserted into the vagina and rotated 360 degrees in the vaginal cavity for about 30 seconds
IodineOther
Vaginal cleansing will be performed in conjunction with the abdominal preparation with foam sponge that contains iodine. A sponge soaked with iodine will be inserted into the vagina and rotated 360 degrees in the vaginal cavity for about 30 seconds
AntibioticsOther
All participants will receive a single body mass index (BMI) based antibiotic dose of cefazolin or clindamycin within 30 minutes prior to the incision.
| Study group | Role | What they receive |
|---|---|---|
| Group chlorhexidine | Experimental | Patients will receive chlorhexidine abdominal and vaginal scrubbing Receives: Other: Chlorhexidine; Other: Antibiotics |
| Group iodine | Active comparator | Patients will receive iodine abdominal and vaginal scrubbing Receives: Other: Iodine; Other: Antibiotics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Infectious morbidities
post cesarean infectious morbidities: endometritis, febrile morbidity and wound infection
Measured: Within 30 days
Secondary outcomes (2)
Length of hospital stay
Length of hospital stay after delivery
Measured: Within 30 days
Readmission to the hospital
Percentage of patients readmitted to the hospital
Measured: Within 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2018
- Study start8 Feb 2018
- Primary completion30 Jun 2019
- Study completion30 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vaginal ScrubbingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 333 participants (actual)
Sponsor and investigators
- Lead sponsor
- Makassed General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Manal Hubeish, Makassed General Hospital
- Investigators
- Manal Hubesih, MD, Principal investigator, Makassed General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03431701
- Sponsor's protocol ID
- 01022018
- Status last verified
- Sep 2019
- First submitted
- 5 Feb 2018
- Last updated
- 27 Sep 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chlorhexidine Vaginal Cleansing Versus Iodine Prior to C-section and the Rate of Postoperative Infection: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03431701
- Acronym / sponsor ID
- 01022018
- Conditions
- Vaginal Scrubbing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 333 participants (actual)
- Lead sponsor
- Makassed General HospitalUniversity, hospital or other
- Study start
- 8 Feb 2018 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 13 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background: Women undergoing cesarean delivery have 5 to 20 fold greater risk for infection and infectious morbidity compared with those undergoing vaginal birth. Endometritis, febrile morbidity, and wound infection are the most frequent complications of post cesarean infections. Endometritis accounts for 6-27% followed by clinically significant fever, which was reported about 5-24%,while the incidence of wound infection is about 2-9%.Previous studies evaluated whether vaginal cleansing can reduce the incidence of postoperative infectious morbidity. In most of the studies, povidone iodine was used as intervention.
Objectives: The aim of this study is to test the hypothesis that preoperative vaginal cleansing with chlorhexidine would be superior to iodine for the prevention of maternal infectious morbidities including endometritis, fever and wound complications.
Methods: This prospective randomized single blinded controlled trial will be conducted at Makassed General Hospital between February 2018 and January 2019. Total of 300 patients, 150 in each group, will be enrolled. Group 1 patients will receive chlorhexidine vaginal cleansing while group 2 patients will receive iodine prior to C-section. Adverse post infectious morbidities such as endometritis, febrile illness and wound infections will be observed within 30 days of C-section.
Detailed description
This prospective randomized single blinded controlled trial will be conducted at Makassed General Hospital between February 2018 and January 2019. All pregnant women who will undergo cesarean delivery and willing to sign the informed consent will be included. Total of 300 patients, 150 in each group, will be enrolled. Group 1 patients will receive chlorhexidine vaginal cleansing while group 2 patients will receive iodine prior to C-section. Adverse post infectious morbidities such as endometritis, febrile illness and wound infections will be observed d within 30 days of C-section.
Vaginal cleansing will be performed in conjunction with the abdominal preparation with foam sponge that contains either chlorhexidine or iodine, sponge will be inserted into the vagina and rotated 360 degrees in the vaginal cavity for about 30 sec. All participants will receive a single body mass index (BMI) based antibiotic dose of cefazolin within 30 minutes prior to the incision.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group chlorhexidine | Experimental | Other: Chlorhexidine, Other: AntibioticsPatients will receive chlorhexidine abdominal and vaginal scrubbing |
| Group iodine | Active comparator | Other: Iodine, Other: AntibioticsPatients will receive iodine abdominal and vaginal scrubbing |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- all pregnant women who will undergo cesarean delivery
- and willing to sign the informed consent.
Key exclusion criteria (3 listed)
- Known allergy to the antiseptics used
- Infection diagnosis on admission
- Age ≤ 17 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ChlorhexidineVaginal cleansing will be performed in conjunction with the abdominal preparation with foam sponge that contains chlorhexidine. A sponge soaked with chlorhexidine will be inserted into the vagina and rotated 360 degrees in the vaginal cavity for about 30 seconds | Other | Group chlorhexidine |
| IodineVaginal cleansing will be performed in conjunction with the abdominal preparation with foam sponge that contains iodine. A sponge soaked with iodine will be inserted into the vagina and rotated 360 degrees in the vaginal cavity for about 30 seconds | Other | Group iodine |
| AntibioticsAll participants will receive a single body mass index (BMI) based antibiotic dose of cefazolin or clindamycin within 30 minutes prior to the incision. | Other | Group chlorhexidine, Group iodine |
Primary outcome
Infectious morbidities
Time frame: Within 30 days
post cesarean infectious morbidities: endometritis, febrile morbidity and wound infection
2 secondary outcomes
Length of hospital stay
Time frame: Within 30 days
Readmission to the hospital
Time frame: Within 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2019.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Manal Hubesih, MD principal investigator
Makassed General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chlorhexidine, Iodine and Antibiotics in people with Vaginal Scrubbing, run by Makassed General Hospital at 1 site in Lebanon.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Lebanon. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Infectious morbidities (time frame: Within 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2019.