Infection; Cesarean SectionPhase 4NCT02693483
Preoperative Vaginal Cleansing With Povidone Iodine and the Risk of Post Cesarean Endometritis
A Phase 4 study testing 10% povidone iodine in people with Infection; Cesarean Section, run by Ain Shams Maternity Hospital at 1 site in Egypt.
Trial summary
Preoperative vaginal cleansing with povidone iodine and the risk of post cesarean endometritis. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infection; Cesarean Section
- What is being tested?
- 10% povidone iodine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 306 participants
- Where
- 1 siteEgypt
- Study dates
- Apr 2015to Oct 2016
- Phase
- Phase 4
- 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 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients 18-40 years of age who will undergo cesarean deliveries.
- Able to communicate well with the investigator \& to comply with the requirements of the entire study.
- Verbal consent obtained from subject and husband / witness before undergoing the study entry (with the understanding that consent may be withdrawn by the patient at any time without prejudice).
Who cannot join
- Patients with allergy to iodine containing solutions.
- Patients with ante-partum hemorrhage.
- Patients with ruptured membranes.
- Patients with any known disease that increases the risk of infection e.g. immunocompromized, those receiving steroids ...etc.
Trial locations and contacts
1 site in 1 country.
About this study
Preoperative vaginal cleansing with povidone iodine and the risk of post cesarean endometritis.
Read the detailed description
Study Population:
Women undergoing cesarean sections will be enrolled in this study after obtaining verbal consent as there are no extra interventional measures that will be undertaken in the study apart from routine investigations and procedures done during cesarean sections, being already approved in signed consent to undergo treatment.
The nature and aim of the work will be fully discussed to all women who will agree to participate in the study. Verbal consent will be obtained from all patients enrolled in the study which is approved by the local ethical committee.
Preoperative evaluation of patients included:
- Medical history taking including:
- Personal (name, age)
- Complaint (in patient word)
- Present history
- Medical history (Diabetes mellitus, Hypertension)
- Past history (any surgeries)
- Family history
- Physical examination including vital data (blood pressure,pulse, temperature)
- Routine hematologic laboratory tests including complete blood picture \& random blood sugar.
- The surgical site will be assessed at least once before cesarean section if the participant presented to emergency department with findings concerning for surgical-site infection.
- Indication for cesarean section.
- Duration of ruptured membranes if found.
- Risk of infection including Diabetes mellitus, immuno-compromised, rupture of membranes and corticosteroid therapy.
Steps:
Patients In the study group (povidone iodine group) patients will be prepared with vaginal cleansing with povidone-iodine along with the usual abdominal scrub. Vaginal cleansing will be done with 3 gauze pieces soaked with 10% povidone iodine in a sterilized bowl and the scrub will be done from the vaginal apex to introitus with attention to the anterior, posterior and lateral vaginal wall. After vaginal cleansing the gloves will be changed to perform the abdominal scrub.
Patients in the control group (no vaginal cleansing group) will not have any vaginal wash (even tap water will not be used).
In both groups, patients will receive preoperative per protocol prophylactic I.V. antibiotics (third generation cephalosporin ) before skin incision.
Operative technique:
During this study all cases will be subjected to exclusion and inclusion criteria. Any risk of infection will be assessed including rupture of membranes, Diabetes mellitus, immune-compromised and corticosteroid therapy….etc. Cesarean section will be performed with estimation of operative duration in time and mean operative blood loss.
Post operative care:
Follow up for temperature of 38°C and greater during first 24 hours of surgery and endometritis will be diagnosed by fever 38.4°C and greater with any of the following (uterine tenderness ,foul smelling lochia or positive C-reactive protein).
Mean hospital stay in days will be determined. N.B: Culture of the upper genital tract are virtually impossible to obtain without contaminating the specimen by the microorganisms in the vagina. Therefore, they rarely add significant information that enhances clinical decision-making.
- Conditions
- Infection; Cesarean Section
- Being tested
- 10% povidone iodine
- Medical subject headings
- Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
10% povidone iodineDrug
Also called betadine
Vaginal cleansing will be done with 3 gauze pieces soaked with 10% povidone iodine in a sterilized bowl and the scrub will be done from the vaginal apex to introitus with attention to the anterior, posterior and lateral vaginal wall
| Study group | Role | What they receive |
|---|---|---|
| povidone iodine | Active comparator | 153 cases undergoing cesarean sections will have preoperative vaginal cleansing with 10% povidone iodine Receives: Drug: 10% povidone iodine |
| no vaginal cleansing | No intervention | 153 cases undergoing cesarean sections |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects with post cesarean endometritis
Number of Subjects with post cesarean endometritis as diagnosed by fever 38.4°C and greater in first 48 hours after cesarean section with any of the following (uterine tenderness, foul smelling lochia or positive C-reactive protein)
Measured: 48 hours
Secondary outcomes (1)
Number of Subjects with allergic reaction to povidone iodine
Number of Subjects with allergic reaction to povidone iodine
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2016 (estimated)
- Study startApr 2015
- Primary completionJun 2016 (estimated)
- Study completionOct 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Infection; Cesarean SectionStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 306 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams Maternity Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amr Ahmed Mahmoud Riad, Ain Shams Maternity Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02693483
- Sponsor's protocol ID
- povidone iodine
- Status last verified
- Feb 2016
- First submitted
- 15 Feb 2016
- Last updated
- 26 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Haas DM, Morgan S, Contreras K, Kimball S. Vaginal preparation with antiseptic solution before cesarean section for preventing postoperative infections. Cochrane Database Syst Rev. 2020 Apr 26;4(4):CD007892. doi: 10.1002/14651858.CD007892.pub7.
PubMed 32335895
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Vaginal Cleansing With Povidone Iodine and the Risk of Post Cesarean Endometritis
- ClinicalTrials.gov ID
- NCT02693483
- Acronym / sponsor ID
- povidone iodine
- Conditions
- Infection; Cesarean Section
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 306 participants (estimated)
- Lead sponsor
- Ain Shams Maternity HospitalUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- Jun 2016 (estimated)
- Study completion
- Oct 2016 (estimated)
- First posted
- 26 Feb 2016 (estimated)
- 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.
Preoperative vaginal cleansing with povidone iodine and the risk of post cesarean endometritis.
Detailed description
Study Population:
Women undergoing cesarean sections will be enrolled in this study after obtaining verbal consent as there are no extra interventional measures that will be undertaken in the study apart from routine investigations and procedures done during cesarean sections, being already approved in signed consent to undergo treatment.
The nature and aim of the work will be fully discussed to all women who will agree to participate in the study. Verbal consent will be obtained from all patients enrolled in the study which is approved by the local ethical committee.
Preoperative evaluation of patients included:
- Medical history taking including:
- Personal (name, age)
- Complaint (in patient word)
- Present history
- Medical history (Diabetes mellitus, Hypertension)
- Past history (any surgeries)
- Family history
- Physical examination including vital data (blood pressure,pulse, temperature)
- Routine hematologic laboratory tests including complete blood picture \& random blood sugar.
- The surgical site will be assessed at least once before cesarean section if the participant presented to emergency department with findings concerning for surgical-site infection.
- Indication for cesarean section.
- Duration of ruptured membranes if found.
- Risk of infection including Diabetes mellitus, immuno-compromised, rupture of membranes and corticosteroid therapy.
Steps:
Patients In the study group (povidone iodine group) patients will be prepared with vaginal cleansing with povidone-iodine along with the usual abdominal scrub. Vaginal cleansing will be done with 3 gauze pieces soaked with 10% povidone iodine in a sterilized bowl and the scrub will be done from the vaginal apex to introitus with attention to the anterior, posterior and lateral vaginal wall. After vaginal cleansing the gloves will be changed to perform the abdominal scrub.
Patients in the control group (no vaginal cleansing group) will not have any vaginal wash (even tap water will not be used).
In both groups, patients will receive preoperative per protocol prophylactic I.V. antibiotics (third generation cephalosporin ) before skin incision.
Operative technique:
During this study all cases will be subjected to exclusion and inclusion criteria. Any risk of infection will be assessed including rupture of membranes, Diabetes mellitus, immune-compromised and corticosteroid therapy….etc. Cesarean section will be performed with estimation of operative duration in time and mean operative blood loss.
Post operative care:
Follow up for temperature of 38°C and greater during first 24 hours of surgery and endometritis will be diagnosed by fever 38.4°C and greater with any of the following (uterine tenderness ,foul smelling lochia or positive C-reactive protein).
Mean hospital stay in days will be determined. N.B: Culture of the upper genital tract are virtually impossible to obtain without contaminating the specimen by the microorganisms in the vagina. Therefore, they rarely add significant information that enhances clinical decision-making.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| povidone iodine | Active comparator | Drug: 10% povidone iodine153 cases undergoing cesarean sections will have preoperative vaginal cleansing with 10% povidone iodine |
| no vaginal cleansing | No intervention | –153 cases undergoing cesarean sections |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients 18-40 years of age who will undergo cesarean deliveries.
- Able to communicate well with the investigator \& to comply with the requirements of the entire study.
- Verbal consent obtained from subject and husband / witness before undergoing the study entry (with the understanding that consent may be withdrawn by the patient at any time without prejudice).
Key exclusion criteria (4 listed)
- Patients with allergy to iodine containing solutions.
- Patients with ante-partum hemorrhage.
- Patients with ruptured membranes.
- Patients with any known disease that increases the risk of infection e.g. immunocompromized, those receiving steroids ...etc.
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 |
|---|---|---|
| 10% povidone iodineAlso: betadineVaginal cleansing will be done with 3 gauze pieces soaked with 10% povidone iodine in a sterilized bowl and the scrub will be done from the vaginal apex to introitus with attention to the anterior, posterior and lateral vaginal wall | Drug | povidone iodine |
Primary outcome
Number of Subjects with post cesarean endometritis
Time frame: 48 hours
Number of Subjects with post cesarean endometritis as diagnosed by fever 38.4°C and greater in first 48 hours after cesarean section with any of the following (uterine tenderness, foul smelling lochia or positive C-reactive protein)
1 secondary outcome
Number of Subjects with allergic reaction to povidone iodine
Time frame: 48 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2016.
- Derived from this study: PubMed 32335895Haas DM, Morgan S, Contreras K, Kimball S. Vaginal preparation with antiseptic solution before cesarean section for preventing postoperative infections. Cochrane Database Syst Rev. 2020 Apr 26;4(4):CD007892. doi: 10.1002/14651858.CD007892.pub7.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing 10% povidone iodine in people with Infection; Cesarean Section, run by Ain Shams Maternity Hospital at 1 site in Egypt.
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 4 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: status not confirmed, as of the sponsor's last update on 26 Feb 2016. 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 Egypt. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Amr A Riad, MD (01005347179 ext. +2, amr.riad@med.asu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Subjects with post cesarean endometritis (time frame: 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02693483, which also lists 1 linked publication.
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 26 Feb 2016.