A Phase 3 interventional study of Chlorhexidine vaginal and infant wash in Sepsis and Pregnancy, sponsored by NICHD Global Network for Women's and Children's Health. Completed at 1 site in Pakistan. Open to female participants aged 16 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-07-31.
Sponsored by NICHD Global Network for Women's and Children's Health · Phase 3, Interventional, and Treatment
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.
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.
1,899 studies on the registry are indexed under Sepsis; 462 are open to participants now.
This study's enrollment of 5,008 is above the median of 105 across 896 interventional studies indexed under Sepsis.
Browse Sepsis studies →NICHD Global Network for Women's and Children's Health is the lead sponsor of 32 studies on the registry; 3 are open to participants now.
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Exclusion Criteria:
Procedure: Chlorhexidine vaginal and infant wash
Neonatal death or severe sepsis
Time frame: 7 days
Maternal: clinical chorioamnionitis, clinical endometritis, urinary tract infection, sepsis, length of hospitalization, readmission to hospital, death
Time frame: 7 days
Neonatal: receipt of antibiotics, duration of hospitalization, readmission to hospital
Time frame: 7 dats
This study is completed, as verified in Jul 2014. You cannot join it, but the record below documents what was studied.
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NICHD Global Network for Women's and Children's Health