Chlorhexidine Vaginal and Infant Wash in Pakistan
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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 | Intervention |
---|---|
Sepsis Pregnancy |
Procedure: Chlorhexidine vaginal and infant wash |
Study Type: | Interventional |
Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Diagnostic |
Official Title: | Randomized Trial of Chlorhexidine Vaginal and Infant Wash to Reduce Neonatal Mortality |
- Neonatal death or severe sepsis at 7 days
- Maternal: clinical chorioamnionitis, clinical endometritis, urinary tract infection, sepsis, length of hospitalization, readmission to hospital, death
- Neonatal: receipt of antibiotics, duration of hospitalization, readmission to hospital
Estimated Enrollment: | 5000 |
Study Start Date: | June 2005 |
Study Completion Date: | June 2008 |
Primary Completion Date: | June 2008 (Final data collection date for primary outcome measure) |
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.
Ages Eligible for Study: | 16 Years and older |
Genders 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
Pakistan | |
Civil Hospital Karachi | |
Karachi, Pakistan |
Principal Investigator: | Robert Goldenberg, M.D. | Drexel University |
Principal Investigator: | Sarah Saleem, M.D. | The Aga Khan University |
Additional Information:
No publications provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: | NCT00121394 History of Changes |
Other Study ID Numbers: | GN 09 A, U01 HD40607 |
Study First Received: | July 15, 2005 |
Last Updated: | October 28, 2008 |
Health Authority: | United States: Federal Government |
Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
Chlorhexidine Vaginal wash Neonatal mortality Sepsis Global Network |
Maternal and child health Women's Health International Pakistan |
Additional relevant MeSH terms:
Sepsis Infection Systemic Inflammatory Response Syndrome Inflammation Pathologic Processes Chlorhexidine Chlorhexidine gluconate |
Anti-Infective Agents, Local Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Disinfectants Dermatologic Agents |
ClinicalTrials.gov processed this record on October 16, 2012