Puerperal InfectionNCT03397615
Effect of Vaginal Douching With Betadine Before CS for Prevention of Post Operative Infections
A study testing Betadine douches in people with Puerperal Infection, run by Cairo University at 1 site in Egypt.
Trial summary
The present study was a prospective randomized controlled trial in which subjects received a vaginal preparation with povidone-iodine solution immediately prior to caesarean delivery or received no vaginal preparation 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
- Puerperal Infection
- What is being tested?
- Betadine douches
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,200 participants
- Where
- 1 siteEgypt
- Study dates
- 3 Jan 2019to Dec 2019
- 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 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Any patient undergoing CS
Who cannot join
- • Betadine allegy.
- Rupture membranes.
- Accidental Hemorrhage.
- H/O suggestive chorioamnionitis ; uterine tenderness, offensive vaginal discharge, fever medical disorders as diabetes, hypertension , cardiac or renal diseqases
Trial locations and contacts
1 site in 1 country.
Heba Wagih, MD contact
Egypt1 site, 1 recruiting
- Recruiting
Kasr Alainy medical school
Cairo, 12151
Ahmed Maged, MD, 01005227404, prof.ahmedmaged@gmail.com
Mohamed Nagy, MD, mnmo75@yahoo.com
About this study
Official title: Effect of Vaginal Douching With Betadine Versus Non Douching Before CS for Prevention of Post Operative Infections
The present study was a prospective randomized controlled trial in which subjects received a vaginal preparation with povidone-iodine solution immediately prior to caesarean delivery or received no vaginal preparation
Read the detailed description
The present study was a prospective randomized controlled trial in which subjects received a vaginal preparation with povidone-iodine solution immediately prior to caesarean delivery or received no vaginal preparation
- Conditions
- Puerperal Infection
- Being tested
- Betadine douches
- Medical subject headings
- Puerperal Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Betadine douchesBehavioural
subjects received a vaginal preparation with povidone-iodine solution immediately prior to caesarean delivery
| Study group | Role | What they receive |
|---|---|---|
| Betadine douches | Active comparator | subjects received a vaginal preparation with povidone-iodine solution immediately prior to caesarean delivery Receives: Behavioral: Betadine douches |
| Non betadine douches | No intervention | subjects didnot received a vaginal preparation prior to caesarean delivery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postpartum endometritis
a clinical diagnosis, usually involving fever, uterine fundal tenderness, or prurulent lochia requiring antibiotic therapy.
Measured: 6 weeks after Cesarean section
Secondary outcomes (2)
Postoperative wound infection
erythema, tenderness, prurulent drainage from the incision site, with or without fever, requiring antibiotic therapy
Measured: 6 weeks after Cesarean section
Postoperative fever
temperature higher than 38 degrees C
Measured: 3 weeks after Cesarean section
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2018
- Study start3 Jan 2019
- Primary completionDec 2019 (estimated)
- Study completionDec 2019 (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 Puerperal InfectionStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed M Maged, MD, Cairo University
- Investigators
- Ahmed Maged, MD, Principal investigator, Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03397615
- Sponsor's protocol ID
- 16
- Status last verified
- Jul 2019
- First submitted
- 6 Jan 2018
- Last updated
- 26 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- 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 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Vaginal Douching With Betadine Versus Non Douching Before CS for Prevention of Post Operative Infections
- ClinicalTrials.gov ID
- NCT03397615
- Acronym / sponsor ID
- 16
- Conditions
- Puerperal Infection
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 3 Jan 2019 (actual)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 12 Jan 2018 (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 present study was a prospective randomized controlled trial in which subjects received a vaginal preparation with povidone-iodine solution immediately prior to caesarean delivery or received no vaginal preparation
Detailed description
The present study was a prospective randomized controlled trial in which subjects received a vaginal preparation with povidone-iodine solution immediately prior to caesarean delivery or received no vaginal preparation
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Betadine douches | Active comparator | Behavioral: Betadine douchessubjects received a vaginal preparation with povidone-iodine solution immediately prior to caesarean delivery |
| Non betadine douches | No intervention | –subjects didnot received a vaginal preparation prior to caesarean delivery |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Any patient undergoing CS
Key exclusion criteria (4 listed)
- • Betadine allegy.
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 |
|---|---|---|
| Betadine douchessubjects received a vaginal preparation with povidone-iodine solution immediately prior to caesarean delivery | Behavioural | Betadine douches |
Primary outcome
Postpartum endometritis
Time frame: 6 weeks after Cesarean section
a clinical diagnosis, usually involving fever, uterine fundal tenderness, or prurulent lochia requiring antibiotic therapy.
2 secondary outcomes
Postoperative wound infection
Time frame: 6 weeks after Cesarean section
Postoperative fever
Time frame: 3 weeks after Cesarean section
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2019.
- 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
Related trials for Puerperal Infection
RecruitingPhase 4
Cabotegravir & Rilpivirine Antiretroviral Therapy in Pregnancy
HIV -1 Infection
Enrolling by invitation
Intervention to Reduce HIV Related Stigma Among Pregnant and Postpartum Women
HIV, HIV - Human Immunodeficiency Virus
Not yet recruiting
Evaluating the Healthy Families PrEP Program for Women at Risk for HIV
HIV, Pregnancy
Recruiting
Integrated Mental Health Care for Pregnant Women With HIV in Kenya: The Tunawiri Study
Human Immunodeficiency Virus, Mental Disorder
Active, not recruiting
Eliminating Severe Maternal Morbidity With Heart Health Doulas Trial
Preeclampsia, Hypertensive Disorder of Pregnancy
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.
Heba Wagih, MD contact
Ahmed Maged, MD principal investigator
Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Betadine douches in people with Puerperal Infection, run by Cairo University 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 1 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 Jul 2019. 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.
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 Ahmed maged, MD (+20201005227404, dr_ahmedmaged08@kasralainy.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postpartum endometritis (time frame: 6 weeks after Cesarean section). 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 NCT03397615, 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 Jul 2019.