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

Further Study Details: 

Primary Outcomes: Neonatal death or severe sepsis at 7 days
Secondary Outcomes: 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
Expected Total Enrollment:  1000

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 feasibility study, chlorhexidine wash and placebo will be randomly administered to women in labor and newborn infants in a civil 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 1000 women will be randomized, 800 in the hospital and 200 in the community. 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. Safety and side effects will be assessed for the first 100 women. If side effects are reported, the dosage will be reduced to 0.4% for the next 100 women.

Ages Eligible for Study:  16 Years and above,  Genders Eligible for Study:  Female

Accepts Healthy Volunteers

Criteria

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
• Known multiple gestation

Please refer to this study by ClinicalTrials.gov identifier  NCT00121394

Nancy Moss, Ph.D.       mossn@mail.nih.gov

Pakistan
      Civil Hospital Karachi, Karachi,  Pakistan; Recruiting

Study chairs or principal investigators

Robert Goldenberg, M.D.,  Principal Investigator,  Univeristy of Alabama at Birmingham   

Study ID Numbers:  GN 09 A; U01 HD40607
Record last reviewed:  July 2005
Last Updated:  July 25, 2005
Record first received:  July 20, 2005
ClinicalTrials.gov Identifier:  NCT00121394
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-07-26