Chlorhexidine Vaginal and Infant Wash in Pakistan

NCT00121394 | Completed Phase 3 DMC

• 2 other identifiers: GN 09 AU01HD040607
• Study Type: interventional
• Target: 5,008
• Locations: 1 country
• Sites: 1

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.

Conditions

Sepsis; Pregnancy

Keywords

Chlorhexidine; Vaginal wash; Neonatal mortality; Sepsis; Global Network; Maternal and child health; Women's Health; International; Pakistan

Outcome Measures

Primary Outcomes (1)

• Neonatal death or severe sepsis

  7 days

Secondary Outcomes (2)

• 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

Study Arms (1)

Chlorhexidine

EXPERIMENTAL

Procedure: Chlorhexidine vaginal and infant wash

Interventions

Chlorhexidine vaginal and infant wash PROCEDURE

Chlorhexidine

Eligibility Criteria

• Age: 16 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Civil Hospital Karachi

Karachi, Pakistan

Location

Related Publications (2)

• 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.

  PMID: 20502294 DERIVED

• 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.

  PMID: 17978107 DERIVED

Related Links

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

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Robert Goldenberg, M.D.

  Drexel University

  PRINCIPAL INVESTIGATOR

• Sarah Saleem, M.D.

  Aga Khan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2005
• First Posted: July 21, 2005
• Study Start: June 1, 2005
• Primary Completion: June 1, 2008
• Study Completion: June 1, 2008
• Last Updated: July 31, 2014

Record last verified: 2014-07

Locations

PA (1)