NCT02865993

Brief Summary

The purpose of this study was to evaluate, for the first time in Literature, the effects of betadine washing versus normal saline washing after uterine closure in women undergoing cesarean section (CS) at ≥36 gestational weeks in terms of post CS infections, complication, fever and pain.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2015

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 27, 2016

Completed
19 days until next milestone

First Posted

Study publicly available on registry

August 15, 2016

Completed
Last Updated

August 15, 2016

Status Verified

July 1, 2016

Enrollment Period

6 months

First QC Date

July 27, 2016

Last Update Submit

August 12, 2016

Conditions

Infection; Cesarean Section

Keywords

cesarean sectioncesarean section complicationsbetadine irrigation

Outcome Measures

Primary Outcomes (1)

  • Incidence of postoperative infections

    postoperative infections expressed in number of patients with postoperative infections, such as endometritis or wood infections up to 20 days after cesarean section

    up to 20 days after cesarean section

Study Arms (2)

Betadine Group

OTHER

Patients intra-operatively received intraperitoneal irrigation prior to abdominal closure with low molecular weight povidone-iodine solution ('Betadine LMW') (PVP-I LMW) diluted 50:50 with normal saline.

Other: betadine group

No Betadine Group

OTHER

Patients intra-operatively received intraperitoneal irrigation prior to abdominal closure with only normal saline solution.

Other: no betadine group

Interventions

betadine groupOTHER

Patients intra-operatively received intraperitoneal irrigation prior to abdominal closure with low molecular weight povidone-iodine solution ('Betadine LMW') (PVP-I LMW) diluted 50:50 with normal saline.

Betadine Group
no betadine groupOTHER

Patients intra-operatively received intraperitoneal irrigation prior to abdominal closure with only normal saline solution.

No Betadine Group

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • women aged 18-50 years
  • planned or urgent cesarean section (CS)
  • gestational age \> 36 weeks
  • written informed consent

You may not qualify if:

  • suspected or known allergy to iodine

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

campus bio-medico of Rome

Rome, 00128, Italy

Location

MeSH Terms

Conditions

Infections

Study Officials

  • Roberto Angioli, Professor

    Campus Bio-Medico University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Full Professor

Study Record Dates

First Submitted

July 27, 2016

First Posted

August 15, 2016

Study Start

September 1, 2015

Primary Completion

March 1, 2016

Study Completion

June 1, 2016

Last Updated

August 15, 2016

Record last verified: 2016-07

Locations

IT(1)