EndometritisNCT06936475
Vaginal Cleansing With Chlorhexidine Versus Iodine for Prevention of Endometritis
A study testing Povidone-Iodine and Chlorhexidine Gluconate in people with Endometritis and Vaginal Cleansing, run by Federal Teaching Hospital Abakaliki at 1 site in Nigeria.
Trial summary
Povidone has been approved for vaginal cleansing in the prevention of endometritis postcaesarean section. chlorhexidine solution which is cheap and readily available as shown to prevent endometritis.The aim of this study is to compare the effectiveness of post-operative vaginal cleansing with povidone-iodine versus… Read more about this study
- Who is it for?
- Ages 15 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Endometritis, Vaginal Cleansing, Post Caesarean
- What is being tested?
- Povidone-Iodine and Chlorhexidine Gluconate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 239 participants
- Where
- 1 siteNigeria
- Study dates
- 1 Jun 2020to 14 Sep 2020
- 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 15 to 45 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- All pregnant women at > 28 weeks gestational age undergoing emergency caesarean section.
- Emergency caesarean sections for women in labour, with ruptured membrane or cord prolapse.
- Pregnant women that gave consent to participate in the study
Who cannot join
- Elective caesarean sections
- Known allergy to povidone iodine or chlorhexidinegluconate
- Diabetes mellitus/ glucose intolerance undergoing elective caesarean section.
- Asymptomatic placenta praevia undergoing elective caesarean section
- Patients who have chorioamnionitis
- Immunosuppressive conditions like AIDS, steroid use
- Patients who have coexisting uterine fibroid.
Trial locations and contacts
1 site in 1 country.
Nigeria1 site
Alex Ekwueme Federal University Teaching Hospital
Abakaliki, Ebonyi State, 480101
About this study
Official title: Post-Caesarean Vaginal Cleansing With Chlorhexidine Gluconate Versus Povidone Iodine for Prevention of Endometritis: A Randomised Controlled Trial
Povidone has been approved for vaginal cleansing in the prevention of endometritis postcaesarean section. chlorhexidine solution which is cheap and readily available as shown to prevent endometritis.The aim of this study is to compare the effectiveness of post-operative vaginal cleansing with povidone-iodine versus chlorhexidinegluconate in reducing post-caesarean maternal endometritis
Read the detailed description
BACKGROUND: Maternal infectious morbidity is a common complication of caesarean section and is the third leading cause of maternal mortality in Nigeria. It accounts for 15% of maternal death worldwide. Post-caesarean maternal infectious morbidity (endometritis) is still a big challenge despite prophylactic antibiotics and other modalities adopted to prevent it. Recently, preoperative vaginal cleansing with povidone-iodine was conditionally recommended in reduction of post-caesarean endometritis by WHO but in some emergent conditions, the practice may not be feasible. There is need to research effective post-caesarean vaginal cleansing antiseptic agents which may offer benefits in such emergent conditions.
AIM: To compare the effectiveness of post-operative vaginal cleansing with povidone-iodine versus chlorhexidinegluconate in reducing post-caesarean maternal endometritis at the Alex Ekwueme Federal University Teaching Hospital Abakaliki (AEFUTHA).
METHODOLOGY: This was a single blinded randomized controlled trial involving two hundred and forty four (244) consenting pregnant women booked for emergency lower segment Caesarean section at AEFUTHA and Mile 4 Hospital, Abakaliki; with 122 women randomized into the Povidone-iodine arm (control arm) and 122 into the Chlorhexidinegluconate arm. Both groups received prophylactic antibiotics and anterior abdominal wall scrubbing. The control group received post-operative vaginal cleansing with Povidone iodine while study group received chlorhexidinegluconate. immediately after skin closure. Subsequently, they were reviewed for endometritis daily till discharge or up to 7 days for patients who had the need to stay up to 7 days or beyond. Data was analyzed using statistical Package for Social Science (IBM SPSS) software (version 24, Chicago II, USA). Continuous variables were presented as mean and standard deviation (Mean ± 2SD), while categorical variables were presented as numbers, frequencies and percentages. Student t test was used for comparison between groups for continuous variables and mean of the two groups. Chi-square test was used for comparison between groups for categorical variables.
- Conditions
- Endometritis, Vaginal Cleansing, Post Caesarean
- Being tested
- Povidone-Iodine, Chlorhexidine Gluconate
- Keywords
- chlorhexidine, Iodine, Endometritis, post caesarean, vaginal cleansing
- Medical subject headings
- Endometritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Povidone-IodineDrug
Also called Povidone
5% povidone iodine
Chlorhexidine GluconateDrug
Also called Chlorhexidine
0.5% chlorhexidine
| Study group | Role | What they receive |
|---|---|---|
| Povidone group | Active comparator | In the povidone group, vaginal cleansing was done with 3 pieces of gauze on a sponge holding forceps soaked in 30ml of 5% povidone-iodine for each patient. The soaked gauze was inserted into the vagina, rotated 360o for 30 seconds from the upper to the lower vaginal wall. This was done when clots had been evacuated from the vagina with dry gauze on a sponge holding forceps according to departmental protocol. Receives: Drug: Povidone-Iodine |
| Chlorhexidine group | Experimental | In the chlorhexidine group, vaginal cleansing was done with 3 pieces of gauze on a sponge holding forceps soaked in 30ml of 0.5% chlorhexidine for each patient. The soaked gauze was inserted into the vagina, rotated 360o for 30 seconds from the upper to the lower vaginal wall. This was done when clots had been evacuated from the vagina with dry gauze on a sponge holding forceps according to departmental protocol. Receives: Drug: Chlorhexidine Gluconate |
What is being measured
The primary outcome is the main question the study is designed to answer.
post caesarean endometritis
the number of participants that will develop endometritis following use of either agents
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2025
- Study start1 Jun 2020
- Primary completion14 Sep 2020
- Study completion14 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndometritisStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single blinded randomized controlled trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 239 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal Teaching Hospital Abakaliki
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Assumpta Nnenna Nweke, Federal Teaching Hospital Abakaliki
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06936475
- Sponsor's protocol ID
- FETHA/REC/VOL2/2019/294
- Status last verified
- Apr 2025
- First submitted
- 14 Apr 2025
- Last updated
- 1 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This will be made available following publication
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Caesarean Vaginal Cleansing With Chlorhexidine Gluconate Versus Povidone Iodine for Prevention of Endometritis: A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT06936475
- Acronym / sponsor ID
- FETHA/REC/VOL2/2019/294
- Conditions
- Endometritis, Vaginal Cleansing, Post Caesarean
- Keywords
- chlorhexidine, Iodine, Endometritis, post caesarean, vaginal cleansing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 239 participants (actual)
- Lead sponsor
- Federal Teaching Hospital AbakalikiOther government
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 14 Sep 2020 (actual)
- Study completion
- 14 Sep 2020 (actual)
- First posted
- 20 Apr 2025 (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.
Povidone has been approved for vaginal cleansing in the prevention of endometritis postcaesarean section. chlorhexidine solution which is cheap and readily available as shown to prevent endometritis.The aim of this study is to compare the effectiveness of post-operative vaginal cleansing with povidone-iodine versus chlorhexidinegluconate in reducing post-caesarean maternal endometritis
Detailed description
BACKGROUND: Maternal infectious morbidity is a common complication of caesarean section and is the third leading cause of maternal mortality in Nigeria. It accounts for 15% of maternal death worldwide. Post-caesarean maternal infectious morbidity (endometritis) is still a big challenge despite prophylactic antibiotics and other modalities adopted to prevent it. Recently, preoperative vaginal cleansing with povidone-iodine was conditionally recommended in reduction of post-caesarean endometritis by WHO but in some emergent conditions, the practice may not be feasible. There is need to research effective post-caesarean vaginal cleansing antiseptic agents which may offer benefits in such emergent conditions.
AIM: To compare the effectiveness of post-operative vaginal cleansing with povidone-iodine versus chlorhexidinegluconate in reducing post-caesarean maternal endometritis at the Alex Ekwueme Federal University Teaching Hospital Abakaliki (AEFUTHA).
METHODOLOGY: This was a single blinded randomized controlled trial involving two hundred and forty four (244) consenting pregnant women booked for emergency lower segment Caesarean section at AEFUTHA and Mile 4 Hospital, Abakaliki; with 122 women randomized into the Povidone-iodine arm (control arm) and 122 into the Chlorhexidinegluconate arm. Both groups received prophylactic antibiotics and anterior abdominal wall scrubbing. The control group received post-operative vaginal cleansing with Povidone iodine while study group received chlorhexidinegluconate. immediately after skin closure. Subsequently, they were reviewed for endometritis daily till discharge or up to 7 days for patients who had the need to stay up to 7 days or beyond. Data was analyzed using statistical Package for Social Science (IBM SPSS) software (version 24, Chicago II, USA). Continuous variables were presented as mean and standard deviation (Mean ± 2SD), while categorical variables were presented as numbers, frequencies and percentages. Student t test was used for comparison between groups for continuous variables and mean of the two groups. Chi-square test was used for comparison between groups for categorical variables.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Single blinded randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Povidone group | Active comparator | Drug: Povidone-IodineIn the povidone group, vaginal cleansing was done with 3 pieces of gauze on a sponge holding forceps soaked in 30ml of 5% povidone-iodine for each patient. The soaked gauze was inserted into the vagina, rotated 360o for 30 seconds from the upper to the lower vaginal wall. This was done when clots had been evacuated from the vagina with dry gauze on a sponge holding forceps according to departmental protocol. |
| Chlorhexidine group | Experimental | Drug: Chlorhexidine GluconateIn the chlorhexidine group, vaginal cleansing was done with 3 pieces of gauze on a sponge holding forceps soaked in 30ml of 0.5% chlorhexidine for each patient. The soaked gauze was inserted into the vagina, rotated 360o for 30 seconds from the upper to the lower vaginal wall. This was done when clots had been evacuated from the vagina with dry gauze on a sponge holding forceps according to departmental protocol. |
Who may qualify
- Ages
- 15 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- All pregnant women at > 28 weeks gestational age undergoing emergency caesarean section.
- Emergency caesarean sections for women in labour, with ruptured membrane or cord prolapse.
- Pregnant women that gave consent to participate in the study
Key exclusion criteria (7 listed)
- Elective caesarean sections
- Known allergy to povidone iodine or chlorhexidinegluconate
- Diabetes mellitus/ glucose intolerance undergoing elective caesarean section.
- Asymptomatic placenta praevia undergoing elective caesarean section
- Patients who have chorioamnionitis
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 |
|---|---|---|
| Povidone-IodineAlso: Povidone5% povidone iodine | Drug | Povidone group |
| Chlorhexidine GluconateAlso: Chlorhexidine0.5% chlorhexidine | Drug | Chlorhexidine group |
Primary outcome
post caesarean endometritis
Time frame: 7 days
the number of participants that will develop endometritis following use of either agents
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 1 May 2025.
- Individual participant dataSharing planned: No. This will be made available following publication
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Povidone-Iodine and Chlorhexidine Gluconate in people with Endometritis and Vaginal Cleansing, run by Federal Teaching Hospital Abakaliki at 1 site in Nigeria.
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 3 inclusion and 7 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 1 May 2025. 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 Nigeria. 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?
post caesarean endometritis (time frame: 7 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 1 May 2025.