Cesarean Section ComplicationsPhase 3NCT05021315
Vaginal Cleaning Using Povidone Iodine Before CS to Reduce Postoperative Wound Infection
A Phase 3 study testing 10% povidone iodine in people with Cesarean Section Complications and Vaginal Infection, run by Cairo University at 2 sites in Egypt.
Trial summary
The aim of work to assess the effectiveness of preoperative vaginal cleansing with povidone iodine on reduction of post caesarean section wound infection Research questions: Does vaginal cleaning using povidone iodine before cesarean section has effect on reduction of postoperative wound infection?? Read more about this study
- Who is it for?
- Ages 18 to 38 years, women only
- Conditions the study is for
- Cesarean Section Complications, Vaginal Infection, Postoperative Infection
- What is being tested?
- 10% povidone iodine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 800 participants
- Where
- 2 sitesEgypt
- Study dates
- 15 Sep 2021to 15 Oct 2022
- Phase
- Phase 3
- 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 38 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 1. Pregnant women who are 37 weeks gestation or more scheduled for elective cesarean section or those in labor with a limited number of vaginal examinations less than 5 times preoperatively.
- 2. Pregnant women who are 37 weeks gestation or more with rupture of membranes but duration less than 24 hours
- 3. Women consenting to be included in the study.
Who cannot join
- Abnormally invasive placenta and placenta previa.
- Intra-partum fever.
- Prolonged rupture of membranes more than 24 hours
- History of exposure to radiation treatment for cancer.
- History of Gynecological infections (PID).
- History of abdominal infections, e.g., peritonitis.
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- Debilitating diseases like Diabetes mellitus, Thyroid disorders, Cushing disease, abdominal malignancy.
- Obesity is defined as pregnant BMI >30 kg/m2.
- History of wound infection or burst abdomen.
- History suggestive of massive bleeding during previous cesarean section.
- allergy to iodine-containing solutions
- Pregnant women with severe anemia defined as Hb <7 g/dl.
- Cases with intra-abdominal drain deployment are discarded.
- Obstructed labor with numerous vaginal examinations.
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites, 2 recruiting
- Recruiting
faculty of medicine - Cairo university
Cairo, Kasr El Ainy, 11562
mohamed T aneis, MD, 202 23653269, viced.research@cu.edu.eg
waleed M El-khayat, MD
- Recruiting
faculty of medicine, Kasr el ainy hospital, Cairo university
Cairo, 11562
Mohammad A Taymour, MD
About this study
Official title: Effect of Vaginal Cleaning Using Povidone Iodine Before CS to Reduce Postoperative Wound Infection
The aim of work to assess the effectiveness of preoperative vaginal cleansing with povidone iodine on reduction of post caesarean section wound infection
Research questions:
Does vaginal cleaning using povidone iodine before cesarean section has effect on reduction of postoperative wound infection??
- Being tested
- 10% povidone iodine
- Medical subject headings
- Vaginitis
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
50 women who received preoperative vaginal cleansing with 10% povidone iodine.
| Study group | Role | What they receive |
|---|---|---|
| Iodine group | Experimental | 50 women who received preoperative vaginal cleansing with 10% povidone-iodine. Receives: Drug: 10% povidone iodine |
| Control group | No intervention | 50 women who did not receive preoperative vaginal cleansing even with tap water. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative wound complication
Any sign of infection as redness, hotness and tenderness as well as pyrexia occurance in wound postoperative
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2021
- Study start15 Sep 2021
- Primary completion30 Sep 2022 (estimated)
- Study completion15 Oct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cesarean Section ComplicationsStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ahmed nagy shaker ramadan, Cairo University
- Investigators
- Mostafa A Sleem, MD, Principal investigator, Ethical and scientific committee
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05021315
- Sponsor's protocol ID
- 82019
- Status last verified
- Jul 2022
- First submitted
- 20 Aug 2021
- Last updated
- 18 Jul 2022
- 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 18 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Vaginal Cleaning Using Povidone Iodine Before CS to Reduce Postoperative Wound Infection
- ClinicalTrials.gov ID
- NCT05021315
- Acronym / sponsor ID
- 82019
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 15 Sep 2021 (actual)
- Primary completion
- 30 Sep 2022 (estimated)
- Study completion
- 15 Oct 2022 (estimated)
- First posted
- 25 Aug 2021 (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.
The aim of work to assess the effectiveness of preoperative vaginal cleansing with povidone iodine on reduction of post caesarean section wound infection
Research questions:
Does vaginal cleaning using povidone iodine before cesarean section has effect on reduction of postoperative wound infection??
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Iodine group | Experimental | Drug: 10% povidone iodine50 women who received preoperative vaginal cleansing with 10% povidone-iodine. |
| Control group | No intervention | –50 women who did not receive preoperative vaginal cleansing even with tap water. |
Who may qualify
- Ages
- 18 to 38 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 1. Pregnant women who are 37 weeks gestation or more scheduled for elective cesarean section or those in labor with a limited number of vaginal examinations less than 5 times preoperatively.
- 2. Pregnant women who are 37 weeks gestation or more with rupture of membranes but duration less than 24 hours
- 3. Women consenting to be included in the study.
Key exclusion criteria (14 listed)
- Abnormally invasive placenta and placenta previa.
- Intra-partum fever.
- Prolonged rupture of membranes more than 24 hours
- History of exposure to radiation treatment for cancer.
- History of Gynecological infections (PID).
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: Betadine50 women who received preoperative vaginal cleansing with 10% povidone iodine. | Drug | Iodine group |
Primary outcome
Postoperative wound complication
Time frame: 1 week
Any sign of infection as redness, hotness and tenderness as well as pyrexia occurance in wound postoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2022.
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Ultrasound Assessment Of Gastric Volume In Pregnant Women Undergoing Elective Cesarean Section
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Ketamine Pharmacokinetics and Pharmacodynamics for Postpartum Depression and Pain After Cesarean Delivery
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Clinical Impact of Uterine Repair During Cesarean Section With Barbed Suture on the Incidence of Isthmocele
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The Mepilex Cesarean Delivery Trial / MEPIDEL
Surgical Site Infection
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.
Mostafa A Sleem, MD principal investigator
Ethical and scientific committee
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 10% povidone iodine in people with Cesarean Section Complications and Vaginal Infection, run by Cairo University at 2 sites 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 14 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 18 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Mohammed A Taymour, MD (+201006588699, Mohammadtaymour@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative wound complication (time frame: 1 week). 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 18 Jul 2022.