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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03397615
Other study ID # 16
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 3, 2019
Est. completion date December 2019

Study information

Verified date July 2019
Source Cairo University
Contact Ahmed maged, MD
Phone +20201005227404
Email dr_ahmedmaged08@kasralainy.edu.eg
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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


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


Recruitment information / eligibility

Status Recruiting
Enrollment 1200
Est. completion date December 2019
Est. primary completion date December 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 40 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Betadine douches
subjects received a vaginal preparation with povidone-iodine solution immediately prior to caesarean delivery

Locations

Country Name City State
Egypt Kasr Alainy medical school Cairo

Sponsors (1)

Lead Sponsor Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Postpartum endometritis a clinical diagnosis, usually involving fever, uterine fundal tenderness, or prurulent lochia requiring antibiotic therapy. 6 weeks after Cesarean section
Secondary Postoperative wound infection erythema, tenderness, prurulent drainage from the incision site, with or without fever, requiring antibiotic therapy 6 weeks after Cesarean section
Secondary Postoperative fever temperature higher than 38 degrees C 3 weeks after Cesarean section
See also
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Recruiting NCT00136370 - Prevention of Perinatal Sepsis (PoPS): Evaluation of Chlorhexidine Wipes of Birth Canal and Newborn Phase 3