Effect of Vaginal Douching With Betadine Before CS for Prevention of Post Operative Infections

NCT ID: NCT03397615

Last Updated: 2019-07-26

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

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

1200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-03

Study Completion Date

2019-12-31

Brief Summary

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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

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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

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Puerperal Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Betadine douches

subjects received a vaginal preparation with povidone-iodine solution immediately prior to caesarean delivery

Group Type ACTIVE_COMPARATOR

Betadine douches

Intervention Type BEHAVIORAL

subjects received a vaginal preparation with povidone-iodine solution immediately prior to caesarean delivery

Non betadine douches

subjects didnot received a vaginal preparation prior to caesarean delivery

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Betadine douches

subjects received a vaginal preparation with povidone-iodine solution immediately prior to caesarean delivery

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Any patient undergoing CS

Exclusion Criteria

* • 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Ahmed M Maged, MD

professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ahmed Maged, MD

Role: PRINCIPAL_INVESTIGATOR

Professor

Locations

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Kasr Alainy medical school

Cairo, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Ahmed maged, MD

Role: CONTACT

+20201005227404

Heba Wagih, MD

Role: CONTACT

Facility Contacts

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Ahmed Maged, MD

Role: primary

01005227404

Mohamed Nagy, MD

Role: backup

References

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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.

Reference Type DERIVED
PMID: 32335895 (View on PubMed)

Other Identifiers

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16

Identifier Type: -

Identifier Source: org_study_id

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