Chlorhexidine Vaginal and Infant Wash in Pakistan

Pregnancy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00121394
• Other study ID #: GN 09 A
• Secondary ID: U01HD040607
• Status: Completed
• Phase: Phase 3
• First received: July 15, 2005
• Last updated: July 29, 2014
• Start date: June 2005
• Est. completion date: June 2008

Study information

• Verified date: July 2014
• Source: NICHD Global Network for Women's and Children's Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5008
• Est. completion date: June 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 16 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pregnancy
• Sepsis

Intervention

Procedure:
• Chlorhexidine vaginal and infant wash

Locations

Country	Name	City	State
Pakistan	Civil Hospital Karachi	Karachi

Sponsors (7)

Lead Sponsor	Collaborator
NICHD Global Network for Women's and Children's Health	Aga Khan University, Bill and Melinda Gates Foundation, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Global Network for Women's and Children's Health Research, RTI International, University of Alabama at Birmingham

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neonatal death or severe sepsis		7 days	No
Secondary	Maternal: clinical chorioamnionitis, clinical endometritis, urinary tract infection, sepsis, length of hospitalization, readmission to hospital, death		7 days	No
Secondary	Neonatal: receipt of antibiotics, duration of hospitalization, readmission to hospital		7 dats	No

External Links

•   Aga Khan University, Pakistan
•   Global Network for Women's and Children's Health Research
•   Research Triangle Institute International