Chlorhexidine Vaginal and Infant Wash in Pakistan

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Randomized Trial of Chlorhexidine Vaginal and Infant Wash to Reduce Neonatal Mortality

Conditions
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Sepsis, Pregnancy

Intervention / Treatment
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* Procedure: Chlorhexidine vaginal and infant wash


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Chlorhexidine<br> | Procedure: Chlorhexidine vaginal and infant wash<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neonatal death or severe sepsis |  | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maternal: clinical chorioamnionitis, clinical endometritis, urinary tract infection, sepsis, length of hospitalization, readmission to hospital, death |  | 7 days | 
| Neonatal: receipt of antibiotics, duration of hospitalization, readmission to hospital |  | 7 dats | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chlorhexidine, Vaginal wash, Neonatal mortality, Sepsis, Global Network, Maternal and child health, Women's Health, International, Pakistan