Povidone IodineNCT06950229
Povidone Iodine Versus Normal Saline in Preoperative Vaginal Cleansing Before Caesarean Section
A study testing Povidone-Iodine and Normal Saline in people with Povidone Iodine and Normal Saline, run by Federal Teaching Hospital Abakaliki at 1 site in Nigeria.
Trial summary
Post-caesarean maternal infectious morbidity is still a big challenge despite prophylactic antibiotics and preoperative vaginal cleansing with povidone-iodine use in reduction of post-caesarean endometritis.Povidone iodine has been found to cause significant irritation to the vaginal mucosa especially in females with… 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
- Povidone Iodine, Normal Saline, Pre-operative
- What is being tested?
- Povidone-Iodine and Normal Saline
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 224 participants
- Where
- 1 siteNigeria
- Study dates
- 6 Oct 2020to 9 Mar 2021
- 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 consenting parturient for either elective or emergency caesarean section after the age of viability
Who cannot join
- Women with known allergy to topical povidone-iodine.
- Women with presence of pre-existing vaginal irritation symptoms as itching, burning, swelling and vaginal pain.
- Antepartum haemorrhage (Placenta praevia).
- Cord prolapse
- Clinical evidence of Chorioamnionitis
- Face presentation with ruptured membranes to avoid contact of fetal face with iodine.
- Women with immunosupression due to HIV/AIDS, Diabetes Miletus or chronic use of steroids.
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: Efficacy and Safety of Povidone Iodine Versus Normal Saline in Preoperative Vaginal Cleansing Before Caesarean Section: A Randomized Controlled Trial
Post-caesarean maternal infectious morbidity is still a big challenge despite prophylactic antibiotics and preoperative vaginal cleansing with povidone-iodine use in reduction of post-caesarean endometritis.Povidone iodine has been found to cause significant irritation to the vaginal mucosa especially in females with iodine hypersensitivity necessitating the study of efficacy of normal saline which has minimal side effects in the prevention of post caesarean complications
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 and account for 15% of maternal death worldwide. Post-caesarean maternal infectious morbidity is still a big challenge despite prophylactic antibiotics and other modalities adopted to prevent it. Recently, preoperative vaginal cleansing with povidone-iodine (PI) was recommended in reduction of post-caesarean endometritis, but this may lead to significant irritation to the vaginal mucosa resulting from allergic reactions in females with iodine hypersensitivity. Normal saline (NS) is an effective cleaning solution and doesn't have allergic effect on healthy tissues. It is accessible, non-irritant, and less expensive in contrast to povidone iodine.
AIM: To compare the difference in the incidence of postoperative vaginal irritation symptoms and the rate of postoperative infections after using Povidone iodine versus Normal saline solution in vaginal cleansing before caesarean section at the Alex Ekwueme Federal University Teaching Hospital Abakaliki.
METHODOLOGY: This was a randomized controlled trial involving two hundred and twenty four (224) consenting pregnant women undergoing caesarean section in AE-FUTHA. These women were grouped into two arms; group 1 (Vaginal cleansing with povidone iodine) and group 2 (vaginal cleansing with normal saline solution). Both groups received prophylactic antibiotics and anterior abdominal wall scrubbing. Subsequently, the researcher and assistant reviewed the patients for infectious
morbidity daily during ward rounds till discharge and vaginal irritation symptoms 24hours postoperatively, and daily during ward round till discharge.
DATA ANALYSIS: Data was analyzed using statistical Package for Social Science (IBM SPSS) software (version 20, Chicago II, USA). Continuous variables were presented as mean and standard deviation (Mean ± SD), while categorical variables were presented as numbers, frequencies and percentages. Student t- test (t-test) was used for comparison between groups for quantitative variables while the chi- square was performed for comparing categorical variables. Relative risk and 95% confidence interval were calculated for outcome measures. A difference with a P value of < 0.05 was taken to be statistically significant.
- Conditions
- Povidone Iodine, Normal Saline, Pre-operative
- Being tested
- Povidone-Iodine, Normal Saline
- Keywords
- Povidone Iodine, Normal Saline, Caesarean section, vaginal cleansing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Povidone-IodineDrug
Hundred (100) ml of 5% povidone iodine was poured into a sterilized bowl (galipot). Three pieces of gauze held with sponge holding forceps was dipped into the sterilized bowl containing 100mls of 5% povidone iodine and was allowed to be well soaked with 5% povidone iodine and thereafter used to swab the vulva in 360 degrees. one gram of ceftriaxone and 500mg of metronidazole was given prior to the procedure.
Normal SalineDrug
Hundred (100) ml of Normal saline was poured into a sterilized bowl (galipot). Three pieces of gauze held with sponge holding forceps was dipped into the sterilized bowl containing 100mls of Normal Saline and was allowed to be well soaked with Normal saline and thereafter used to swab the vulva in 360 degrees. one gram of ceftriaxone and 500 mg of metronidazole was given prior to the procedure.
| Study group | Role | What they receive |
|---|---|---|
| Povidone group | Active comparator | Hundred (100) ml of 5% povidone iodine was poured into a sterilized bowl (galipot). Three pieces of gauze held with sponge holding forceps was dipped into the sterilized bowl containing 100mls of 5% povidone iodine and was allowed to be well soaked with 5% povidone iodine and thereafter used to swab the vulva in 360 degrees. one gram of ceftriaxone and 500mg of metronidazole was given prior to the procedure. Receives: Drug: Povidone-Iodine |
| Normal Saline | Experimental | Hundred (100) ml of Normal saline was poured into a sterilized bowl (galipot). Three pieces of gauze held with sponge holding forceps was dipped into the sterilized bowl containing 100mls of Normal saline and was allowed to be well soaked with Normal saline and thereafter used to swab the vulva in 360 degrees. one gram of ceftriaxone and 500mg of metronidazole was given prior to the procedure. Receives: Drug: Normal Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post caesarean endometritis.
Patient that has at least two or more of the following signs and symptoms with no other recognized cause: fever greater than or equal to 380c, abdominal pain, uterine tenderness and purulent drainage from the uterus
Measured: 24 hours
Post operative vaginal irritation
presence of symptoms like itching, burning, swelling and vaginal pain following the vaginal cleansing with either 5% povidone iodine or normal saline solution.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2025
- Study start6 Oct 2020
- Primary completion9 Mar 2021
- Study completion9 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Povidone IodineStudies 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 224 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
- NCT06950229
- Sponsor's protocol ID
- AE-FUTHA/REC/VOL3/2020/069
- Status last verified
- Apr 2025
- First submitted
- 22 Apr 2025
- Last updated
- 2 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Povidone Iodine Versus Normal Saline in Preoperative Vaginal Cleansing Before Caesarean Section: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06950229
- Acronym / sponsor ID
- AE-FUTHA/REC/VOL3/2020/069
- Conditions
- Povidone Iodine, Normal Saline, Pre-operative
- Keywords
- Povidone Iodine, Normal Saline, Caesarean section, vaginal cleansing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 224 participants (actual)
- Lead sponsor
- Federal Teaching Hospital AbakalikiOther government
- Study start
- 6 Oct 2020 (actual)
- Primary completion
- 9 Mar 2021 (actual)
- Study completion
- 9 Mar 2021 (actual)
- First posted
- 30 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.
Post-caesarean maternal infectious morbidity is still a big challenge despite prophylactic antibiotics and preoperative vaginal cleansing with povidone-iodine use in reduction of post-caesarean endometritis.Povidone iodine has been found to cause significant irritation to the vaginal mucosa especially in females with iodine hypersensitivity necessitating the study of efficacy of normal saline which has minimal side effects in the prevention of post caesarean complications
Detailed description
BACKGROUND: Maternal infectious morbidity is a common complication of caesarean section and is the third leading cause of maternal mortality in Nigeria and account for 15% of maternal death worldwide. Post-caesarean maternal infectious morbidity is still a big challenge despite prophylactic antibiotics and other modalities adopted to prevent it. Recently, preoperative vaginal cleansing with povidone-iodine (PI) was recommended in reduction of post-caesarean endometritis, but this may lead to significant irritation to the vaginal mucosa resulting from allergic reactions in females with iodine hypersensitivity. Normal saline (NS) is an effective cleaning solution and doesn't have allergic effect on healthy tissues. It is accessible, non-irritant, and less expensive in contrast to povidone iodine.
AIM: To compare the difference in the incidence of postoperative vaginal irritation symptoms and the rate of postoperative infections after using Povidone iodine versus Normal saline solution in vaginal cleansing before caesarean section at the Alex Ekwueme Federal University Teaching Hospital Abakaliki.
METHODOLOGY: This was a randomized controlled trial involving two hundred and twenty four (224) consenting pregnant women undergoing caesarean section in AE-FUTHA. These women were grouped into two arms; group 1 (Vaginal cleansing with povidone iodine) and group 2 (vaginal cleansing with normal saline solution). Both groups received prophylactic antibiotics and anterior abdominal wall scrubbing. Subsequently, the researcher and assistant reviewed the patients for infectious
morbidity daily during ward rounds till discharge and vaginal irritation symptoms 24hours postoperatively, and daily during ward round till discharge.
DATA ANALYSIS: Data was analyzed using statistical Package for Social Science (IBM SPSS) software (version 20, Chicago II, USA). Continuous variables were presented as mean and standard deviation (Mean ± SD), while categorical variables were presented as numbers, frequencies and percentages. Student t- test (t-test) was used for comparison between groups for quantitative variables while the chi- square was performed for comparing categorical variables. Relative risk and 95% confidence interval were calculated for outcome measures. A difference with a P value of < 0.05 was taken to be statistically significant.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Povidone group | Active comparator | Drug: Povidone-IodineHundred (100) ml of 5% povidone iodine was poured into a sterilized bowl (galipot). Three pieces of gauze held with sponge holding forceps was dipped into the sterilized bowl containing 100mls of 5% povidone iodine and was allowed to be well soaked with 5% povidone iodine and thereafter used to swab the vulva in 360 degrees. one gram of ceftriaxone and 500mg of metronidazole was given prior to the procedure. |
| Normal Saline | Experimental | Drug: Normal SalineHundred (100) ml of Normal saline was poured into a sterilized bowl (galipot). Three pieces of gauze held with sponge holding forceps was dipped into the sterilized bowl containing 100mls of Normal saline and was allowed to be well soaked with Normal saline and thereafter used to swab the vulva in 360 degrees. one gram of ceftriaxone and 500mg of metronidazole was given prior to the procedure. |
Who may qualify
- Ages
- 15 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- . All consenting parturient for either elective or emergency caesarean section after the age of viability
Key exclusion criteria (7 listed)
- Women with known allergy to topical povidone-iodine.
- Women with presence of pre-existing vaginal irritation symptoms as itching, burning, swelling and vaginal pain.
- Antepartum haemorrhage (Placenta praevia).
- Cord prolapse
- Clinical evidence of 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-IodineHundred (100) ml of 5% povidone iodine was poured into a sterilized bowl (galipot). Three pieces of gauze held with sponge holding forceps was dipped into the sterilized bowl containing 100mls of 5% povidone iodine and was allowed to be well soaked with 5% povidone iodine and thereafter used to swab the vulva in 360 degrees. one gram of ceftriaxone and 500mg of metronidazole was given prior to the procedure. | Drug | Povidone group |
| Normal SalineHundred (100) ml of Normal saline was poured into a sterilized bowl (galipot). Three pieces of gauze held with sponge holding forceps was dipped into the sterilized bowl containing 100mls of Normal Saline and was allowed to be well soaked with Normal saline and thereafter used to swab the vulva in 360 degrees. one gram of ceftriaxone and 500 mg of metronidazole was given prior to the procedure. | Drug | Normal Saline |
Primary outcome
Post caesarean endometritis.
Time frame: 24 hours
Patient that has at least two or more of the following signs and symptoms with no other recognized cause: fever greater than or equal to 380c, abdominal pain, uterine tenderness and purulent drainage from the uterus
Post operative vaginal irritation
Time frame: 24 hours
presence of symptoms like itching, burning, swelling and vaginal pain following the vaginal cleansing with either 5% povidone iodine or normal saline solution.
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 2 May 2025.
- Individual participant dataSharing planned: No
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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 Normal Saline in people with Povidone Iodine and Normal Saline, 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 1 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 2 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: 24 hours). The study lists 2 primary outcomes in all. 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 2 May 2025.