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RCT Investigating Pre-cesarean Vaginal Wash of Chlorhexidine vs Povidone-iodine for Patient With Ruptured Amniotic Membrane.

NCT03925155 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2020-07-07

No results posted yet for this study

Summary

The objective of this study is to investigate if the rate of infectious morbidity is decreased with the use of chlorhexidine or povidone-iodine vaginal scrub before cesarean section after ruptured membranes.

Conditions

  • Cesarean Section Complications

Interventions

DRUG

EZ scrub vaginal chlorhexidine 4% solution

Patients will be randomized to receive one of two solutions. Either chlorhexidine 4% solution or standard of care 10% provodine-iodine vaginal solution

DRUG

10% provodine-iodine vaginal preparation

Patients will be randomized to receive one of two solutions. Either chlorhexidine 4% solution or standard of care 10% provodine-iodine vaginal solution

Sponsors & Collaborators

  • Montefiore Medical Center

    lead OTHER

Principal Investigators

  • Meleen Chuang, MD · Montefiore Medical Center, Dept OB/GYN

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-05-01
Primary Completion
2022-05-01
Completion
2023-05-01
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03925155 on ClinicalTrials.gov