Vaginal Cleaning Using Povidone Iodine Before CS to Reduce Postoperative Wound Infection

NCT ID: NCT05021315

Last Updated: 2022-07-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

800 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-15

Study Completion Date

2022-10-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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??

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cesarean Section Complications Vaginal Infection Postoperative Infection

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Iodine group

50 women who received preoperative vaginal cleansing with 10% povidone-iodine.

Group Type EXPERIMENTAL

10% povidone iodine

Intervention Type DRUG

50 women who received preoperative vaginal cleansing with 10% povidone iodine.

Control group

50 women who did not receive preoperative vaginal cleansing even with tap water.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

10% povidone iodine

50 women who received preoperative vaginal cleansing with 10% povidone iodine.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Betadine

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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.

Exclusion Criteria

1. Abnormally invasive placenta and placenta previa.
2. Intra-partum fever.
3. Prolonged rupture of membranes more than 24 hours
4. History of exposure to radiation treatment for cancer.
5. History of Gynecological infections (PID).
6. History of abdominal infections, e.g., peritonitis.
7. Debilitating diseases like Diabetes mellitus, Thyroid disorders, Cushing disease, abdominal malignancy.
8. Obesity is defined as pregnant BMI \>30 kg/m2.
9. History of wound infection or burst abdomen.
10. History suggestive of massive bleeding during previous cesarean section.
11. allergy to iodine-containing solutions
12. Pregnant women with severe anemia defined as Hb \<7 g/dl.
13. Cases with intra-abdominal drain deployment are discarded.
14. Obstructed labor with numerous vaginal examinations.
Minimum Eligible Age

18 Years

Maximum Eligible Age

38 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Cairo University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

ahmed nagy shaker ramadan

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Mostafa A Sleem, MD

Role: PRINCIPAL_INVESTIGATOR

Ethical and scientific committee

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

faculty of medicine - Cairo university

Cairo, Kasr El Ainy, Egypt

Site Status RECRUITING

faculty of medicine, Kasr el ainy hospital, Cairo university

Cairo, , Egypt

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Egypt

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Mohammed A Taymour, MD

Role: CONTACT

+201006588699

Waleed M El-Khayat, MD

Role: CONTACT

01005135542

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

mohamed T aneis, MD

Role: primary

202 23653269

Mohammad A Taymour, MD

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

82019

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

The Skin Prep Study
NCT01472549 COMPLETED NA
Vaginal Microbiota and Post-cesarean SSI
NCT06840041 NOT_YET_RECRUITING