Clinical Trials Logo
  1. Home
  2. Endometritis
  3. NCT03442218
  4. Details
NCT03442218 Clinical Trial

Use of Antiseptic Solution for Vaginal Wash Before Cesarean Section

Endometritis Clinical Trial

Official title:
Use fo Antiseptic Solution for Vaginal Wash Before Cesarean Section in Patients With Premature Rupture of Membranes. A Randomized, Double Blind, Controlled Trial.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03442218
Other study ID # MHST2014-20
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 1, 2017
Est. completion date February 28, 2018

Study information
Verified date December 2019
Source Saint Thomas Hospital, Panama
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To evaluate the rate of infections after cesarean sections in patients with premature rupture of membranes after vaginal wash either with an antiseptic solution (clorhexidine solution) vs. saline solution (placebo).

Recruitment information / eligibility
Status Completed
Enrollment 203
Est. completion date February 28, 2018
Est. primary completion date August 31, 2017
Accepts healthy volunteers No
Gender Female
Age group N/A and older
Eligibility Inclusion Criteria:

- Women with gestation between 34 and 41 6/7 weeks.

- Premature rupture of membranes (> 6 hours).

- Use of prophylactic antibiotic 1 hour previous to cesarean section.

Exclusion Criteria:

- Any source of infection diagnosed previous to surgery.

- Fever of unknown origin previous to surgery.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Clorhexidine
Vaginal wash with clorhexidine solution previous to cesarean section in patients with premature rupture of membranes.
• Saline solution
Vaginal wash with saline solution previous to cesarean section in patients with premature rupture of membranes.

Locations
Country Name City State
Panama Saint Thomas Maternity Hospital Panama

Sponsors (2)
Lead Sponsor Collaborator
Saint Thomas Hospital, Panama Sistema Nacional de Investigación (SNI) - Panamá

Country where clinical trial is conducted

Panama, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of cases of endometritis after cesarean section Endometritis 15 days
Secondary Number of cases of cesarean site infection Operative site infection 15 days
Secondary Number of cases of fever (38°C or above) in the puerperium Puerperal fever 15 days
See also
  Status Clinical Trial Phase
Recruiting NCT05049395 - HFNO Reducing the Incidence of Hypoxia for Hysteroscopy Sedated With Propofol N/A
Terminated NCT00386477 - Vaginal Cleansing at Cesarean Delivery to Reduce Infection: A Randomized, Controlled Trial N/A
Terminated NCT04163679 - Vaginal Preparation and Azithromycin to Reduce Post Cesarean Infections N/A
Recruiting NCT03960970 - Two-drug Antibiotic Prophylaxis in Scheduled Cesarean Deliveries Phase 2
Completed NCT03459599 - Antibiotic Prophylaxis in Ragged Placental Membranes N/A
Completed NCT01762098 - Chronic Endometritis in Patients With Recurrent Miscarriages or Repeated Implantation Failures in In-vitro Fertilization N/A
Withdrawn NCT01721616 - Comparison Study of Cefazolin Versus Cefazolin Plus Azithromycin Prophylaxis in Post-Cesarean Endometritis Phase 4
Completed NCT01464840 - The Pharmacokinetics of Azithromycin Prophylaxis for Cesarean Delivery N/A
Completed NCT01235546 - Study of Effectiveness and Safety of Azithromycin-based Extended-spectrum Prophylaxis to Prevent Post Cesarean Infection N/A
Recruiting NCT04307069 - Management of Prelabor Rupture of the Membranes at Term N/A
Terminated NCT01587495 - Pharmacokinetics and Safety of Ertapenem in the Postpartum Period Phase 1
Not yet recruiting NCT01945450 - Prophylactic Antibiotics for Manual Removal of Retained Placenta in Vaginal Birth: a Randomized Controlled Trial N/A
Completed NCT00547170 - Doxycycline Prophylaxis at Vacuum Aspiration Trial Phase 4
Completed NCT00501033 - A Prospective Comparative Study of Induction of Labor With a Cervical Ripening Double Balloon vs Foley Catheter N/A
Completed NCT00500019 - Uterine Flora During Elective and Urgent Cesarean Sections N/A
Completed NCT00330278 - Timing of Prophylactic Antibiotics for Cesarean Sections N/A
Completed NCT00603603 - Controlled Clinical Trial of Supplemental Oxygen for the Prevention of Post-Cesarean Infectious Morbidity N/A
Completed NCT00858832 - Reduction of Endometritis After Cesarean Section With the Routine Use of Methergine N/A
Recruiting NCT04197167 - Mid-Infrared Spectroscopy as a Real Time Diagnostic Tool for Chronic Endometritis N/A
Completed NCT02402907 - STRIPES Study: Study To Reduce Infection Post cEsarean Section N/A