Clinical trial NCT00121394: Chlorhexidine Vaginal and Infant Wash in Pakistan
Official title: Randomized Trial of Chlorhexidine Vaginal and Infant Wash to Reduce Neonatal Mortality
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Sepsis
Pregnancy
Keywords: Chlorhexidine
Vaginal wash
Neonatal mortality
Sepsis
Global Network
Maternal and child health
Women's Health
International
Pakistan
Lead sponsor: NICHD Global Network for Women's and Children's Health
Sponsor class: NETWORK
Collaborators: name: Global Network for Women's and Children's Health Research
name: Bill and Melinda Gates Foundation
name: RTI International
name: University of Alabama at Birmingham
name: Aga Khan University
name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2005-07-21
Enrollment: 5008
Sex: FEMALE
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Neonatal death or severe sepsis
timeFrame: 7 days
Secondary outcomes:
measure: Maternal: clinical chorioamnionitis, clinical endometritis, urinary tract infection, sepsis, length of hospitalization, readmission to hospital, death
timeFrame: 7 days
measure: Neonatal: receipt of antibiotics, duration of hospitalization, readmission to hospital
timeFrame: 7 dats
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Civil Hospital Karachi
Study officials:
affiliation: Drexel University
name: Robert Goldenberg, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Aga Khan University
name: Sarah Saleem, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Saleem S, Rouse DJ, McClure EM, Zaidi A, Reza T, Yahya Y, Memon IA, Khan NH, Memon G, Soomro N, Pasha O, Wright LL, Moore J, Goldenberg RL. Chlorhexidine vaginal and infant wipes to reduce perinatal mortality and morbidity: a randomized controlled trial. Obstet Gynecol. 2010 Jun;115(6):1225-1232. doi: 10.1097/AOG.0b013e3181e00ff0.
citation: Saleem S, Reza T, McClure EM, Pasha O, Moss N, Rouse DJ, Bartz J, Goldenberg RL. Chlorhexidine vaginal and neonatal wipes in home births in Pakistan: a randomized controlled trial. Obstet Gynecol. 2007 Nov;110(5):977-85. doi: 10.1097/01.AOG.0000285653.17869.26.