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Chlorhexidine Vaginal and Infant Wash in Pakistan

Information source: NICHD Global Network for Women's and Children's Health
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Sepsis; Pregnancy

Intervention: Chlorhexidine vaginal and infant wash (Procedure)

Phase: Phase 3

Status: Completed

Sponsored by: NICHD Global Network for Women's and Children's Health

Official(s) and/or principal investigator(s):
Robert Goldenberg, M.D., Principal Investigator, Affiliation: Drexel University
Sarah Saleem, M.D., Principal Investigator, Affiliation: The Aga Khan University

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.

Clinical Details

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

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

Primary outcome: Neonatal death or severe sepsis

Secondary outcome:

Maternal: clinical chorioamnionitis, clinical endometritis, urinary tract infection, sepsis, length of hospitalization, readmission to hospital, death

Neonatal: receipt of antibiotics, duration of hospitalization, readmission to hospital

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

Minimum age: 16 Years. Maximum age: N/A. Gender(s): Female.

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

Locations and Contacts

Civil Hospital Karachi, Karachi, Pakistan
Additional Information

Global Network for Women's and Children's Health Research

Research Triangle Institute International

Aga Khan University, Pakistan

Starting date: June 2005
Last updated: July 29, 2014

Page last updated: August 23, 2015

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