We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

Chlorhexidine Vaginal and Infant Wash in Pakistan

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00121394
Recruitment Status : Completed
First Posted : July 21, 2005
Last Update Posted : July 31, 2014
Information provided by (Responsible Party):

Study Description
Brief Summary:
Infection is a major health problem during birth in Pakistan. This study will look at the possibility of using a septic wash to help improve health during birth in Karachi, Pakistan.

Condition or disease Intervention/treatment Phase
Sepsis Pregnancy Procedure: Chlorhexidine vaginal and infant wash Phase 3

Detailed Description:

Sepsis in mother and infant is a major cause of perinatal morbidity and mortality in low-resource settings. Several studies have investigated the likelihood that an anti-bacterial agent, chlorhexidine, administered during labor and delivery to mother and infant could reduce the risk of infection and of subsequent maternal and infant morbidity and mortality. In this trial, chlorhexidine wash and placebo will be randomly administered to women in labor and newborn infants in a public hospital in Karachi, Pakistan.

Delivery attendants will administer 0.6% chlorhexidine solution every four hours until delivery (4 washes maximum) and one neonatal wash with the same solution. The control group will receive 200 ml of sterile physiologic saline solution. A total of 5000 women will be randomized in the hospital study, 2500 control and 2500 intervention. All women and infants will be evaluated 24 hours post delivery and at a 7-day follow-up. Women who delivered at home will also receive a 28 days post-partum assessment. Women will be carefully monitored for side effects to the dosage. In addition a community-based feasibility trial of 200 patients (100 CHX, 100 control) will be completed.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5008 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Randomized Trial of Chlorhexidine Vaginal and Infant Wash to Reduce Neonatal Mortality
Study Start Date : June 2005
Primary Completion Date : June 2008
Study Completion Date : June 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sepsis
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Chlorhexidine Procedure: Chlorhexidine vaginal and infant wash

Outcome Measures

Primary Outcome Measures :
  1. Neonatal death or severe sepsis [ Time Frame: 7 days ]

Secondary Outcome Measures :
  1. Maternal: clinical chorioamnionitis, clinical endometritis, urinary tract infection, sepsis, length of hospitalization, readmission to hospital, death [ Time Frame: 7 days ]
  2. Neonatal: receipt of antibiotics, duration of hospitalization, readmission to hospital [ Time Frame: 7 dats ]

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Gravidas with living fetus delivering at home in the care of identified study birth attendant (community) or admitted to the identified hospital (Civil Hospital Karachi) for delivery

Exclusion Criteria:

  • Contraindications to cervical exam (e.g., placenta previa)
  • Active genital herpes or vulvovaginal ulceration
  • Known or suspected allergy to chlorhexidine
  • Fetus with face presentation
  • Fetal death
  • Unwilling/unable to give informed consent
  • Less than 16 years of age
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00121394

Civil Hospital Karachi
Karachi, Pakistan
Sponsors and Collaborators
NICHD Global Network for Women's and Children's Health
Global Network for Women's and Children's Health Research
Bill and Melinda Gates Foundation
RTI International
University of Alabama at Birmingham
Aga Khan University
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Principal Investigator: Robert Goldenberg, M.D. Drexel University
Principal Investigator: Sarah Saleem, M.D. The Aga Khan University
More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: NICHD Global Network for Women's and Children's Health
ClinicalTrials.gov Identifier: NCT00121394     History of Changes
Other Study ID Numbers: GN 09 A
U01HD040607 ( U.S. NIH Grant/Contract )
First Posted: July 21, 2005    Key Record Dates
Last Update Posted: July 31, 2014
Last Verified: July 2014

Keywords provided by NICHD Global Network for Women's and Children's Health:
Vaginal wash
Neonatal mortality
Global Network
Maternal and child health
Women's Health

Additional relevant MeSH terms:
Systemic Inflammatory Response Syndrome
Pathologic Processes
Chlorhexidine gluconate
Anti-Infective Agents, Local
Anti-Infective Agents
Dermatologic Agents