Chlorhexidine Vaginal and Infant Wash in Pakistan

Phase 3

Completed

• Conditions: Sepsis; Pregnancy
• Interventions: Procedure: Chlorhexidine vaginal and infant wash

• Registration Number: NCT00121394
• Lead Sponsor: NICHD Global Network for Women's and Children's Health

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.

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 Timeline

• Study Start: 2005-06
• Study First Submitted: 2005-07-15
• Study First Submitted QC: 2005-07-19
• Study First Posted: 2005-07-21
• Primary Completion: 2008-06
• Study Completion: 2008-06
• Status Verified: 2014-07
• Last Update Submitted: 2014-07-29
• Last Update Posted: 2014-07-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 5008

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Chlorhexidine	Chlorhexidine vaginal and infant wash	-

Primary Outcome Measures

Name	Time	Method
Neonatal death or severe sepsis	7 days

Secondary Outcome Measures

Name	Time	Method
Neonatal: receipt of antibiotics, duration of hospitalization, readmission to hospital	7 dats
Maternal: clinical chorioamnionitis, clinical endometritis, urinary tract infection, sepsis, length of hospitalization, readmission to hospital, death	7 days

Trial Locations

Locations (1)

Civil Hospital Karachi; 🇵🇰 Karachi, Pakistan