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Infant, Newborn, DiseasesPhase 3NCT00136370

Prevention of Perinatal Sepsis (PoPS): Evaluation of Chlorhexidine Wipes of Birth Canal and Newborn

A Phase 3 study testing Chlorhexidine, Birth canal wipe and sterile water external genital wipe in people with Infant, Newborn, Diseases and Sepsis, run by Centers for Disease Control and Prevention at 1 site in South Africa.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The purpose of this study is to evaluate whether use of the disinfectant chlorhexidine administered to the birth canal during labour and newborn at delivery can protect a woman and her baby from bacterial infections after birth. Read more about this study

Who is it for?
Ages 15 years and older, women onlyHealthy volunteers can take part
What is being tested?
Chlorhexidine, Birth canal wipe and sterile water external genital wipe
Type of treatment
Surgery or procedure
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
8,000 participants
Where
1 siteSouth Africa
Study dates
Apr 2004to Nov 2007
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 15 years and older
  • Women only
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • Pregnant
  • Plan to deliver at Chris Hani Baragwanath Hospital or one of its satellite clinics
  • Plan to remain in Soweto for at least two months after delivery
  • Are able to understand and give informed consent
  • Are at least 15 years old at time of registration

Who cannot join

  • Planned delivery by caesarean section
  • Antenatal ultrasound revealing major fetal congenital anomalies
  • Have known or suspected condition in which vaginal exams are contraindicated, e.g. placenta previa
  • Have a history of allergic reaction to any topical antiseptic solution
  • Present to labour ward with infant born before arrival
  • Present to labour ward with significant vaginal bleeding during labour
Show all 10Show fewer
  • Present with known intrauterine fetal death prior to randomization
  • Subject noted to be in full cervical dilatation or have baby's head on perineum
  • Infant noted to be in face presentation on first vaginal examination
  • Noted to have genital ulcers present on first vaginal examination

Trial locations and contacts

1 site in 1 country.

Clare Cutland, BSc, MBBCh contact

+27-11-989-9894

cutlandc@hivsa.com

Shabir Madhi, MD, PhD contact

+27-11-989-9894

madhis@hivsa.com

South Africa1 site, 1 recruiting

  • Chris Hani Baragwanath Hospital

    Soweto, Gauteng

    Shabir Madhi, MD, PhD, +27-11-989-9894, madhis@hivsa.com

    Clare Cutland, BSc, MBBCh, +27-11-989-9894, cutlandc@hivsa.com

    Recruiting

Other trials in South Africa

About this study

Official title: Preventing Serious Neonatal and Maternal Peripartum Infections in Developing Country Settings With a High Prevalence of HIV Infection: Assessment of the Disease Burden and Evaluation of an Affordable Intervention in Soweto, South Africa

The purpose of this study is to evaluate whether use of the disinfectant chlorhexidine administered to the birth canal during labour and newborn at delivery can protect a woman and her baby from bacterial infections after birth. If effective, this could be used as an inexpensive alternative to antibiotics to prevent newborn infections in resource-poor countries.

Read the detailed description

We are conducting a randomized, controlled clinical trial in Soweto, South Africa to evaluate the efficacy of 0.5% chlorhexidine wipes of the birth canal during labour and of the infant at birth in reducing 1) vertical transmission of leading pathogenic bacteria from mother to child during labour and delivery, and 2) incidence of neonatal sepsis and maternal peripartum infection, in comparison to external genitalia sterile water wipes. In conjunction with this, we will compare vaginal carriage of bacteria commonly associated with neonatal sepsis and maternal peripartum infection among HIV-infected and non-infected pregnant women who deliver at the only public hospital in Soweto, and will characterize the burden of disease and risk factors for maternal peripartum infection and serious neonatal infections in this population by conducting active prospective surveillance.

Being tested
Chlorhexidine, Birth canal wipe, sterile water external genital wipe
Keywords
Chlorhexidine, Prevention, Neonatal sepsis, Peripartum infections
Medical subject headings
Infant, Newborn, Diseases, Sepsis, Puerperal Infection, Neonatal Sepsis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ChlorhexidineDrug

  • Birth canal wipeProcedure or surgery

  • sterile water external genital wipeProcedure or surgery

Study groups in NCT00136370
Study groupRoleWhat they receive
1ExperimentalChlorhexidine Vaginal Wipe
Receives: Drug: Chlorhexidine; Procedure: Birth canal wipe
2Placebo comparatorSterile water external genital wipe
Receives: Procedure: sterile water external genital wipe

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Rates of culture-confirmed or clinical neonatal sepsis, < 3 days of life

  2. Rate of vertical transmission of colonization with group B streptococcus (GBS)

Secondary outcomes (6)

  1. Rates of culture-confirmed or clinical neonatal sepsis (non-nosocomial), 3 to 28 days of life

  2. Rates of serious maternal per partum infections including: endometritis, culture-confirmed post-partum sepsis, and post-partum perineal wound infection

  3. Rates of neonatal hospitalization, < 3 days of life

  4. Rates of neonatal hospitalization, < 28 days of life

  5. Rates of neonatal hospitalization, suspected sepsis

  6. Rate of vertical transmission of colonization with E. coli or Klebsiella species

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Aug 2005 (estimated)
  2. Study startApr 2004
  3. Study completionNov 2007 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
8,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00136370
Sponsor's protocol ID
CDC-NCID-3842
Other IDs
#U50 CCU021960, 02075, RFA CI05-059
Status last verified
Sep 2007
First submitted
25 Aug 2005
Last updated
24 Sep 2007
Results posted
No
Data monitoring committee
Yes

Publications

  • Christensen KK, Christensen P, Dykes AK, Kahlmeter G. Chlorhexidine for prevention of neonatal colonization with group B streptococci. III. Effect of vaginal washing with chlorhexidine before rupture of the membranes. Eur J Obstet Gynecol Reprod Biol. 1985 Apr;19(4):231-6. doi: 10.1016/0028-2243(85)90034-6.

    PubMed 3891445

  • Taha TE, Biggar RJ, Broadhead RL, Mtimavalye LA, Justesen AB, Liomba GN, Chiphangwi JD, Miotti PG. Effect of cleansing the birth canal with antiseptic solution on maternal and newborn morbidity and mortality in Malawi: clinical trial. BMJ. 1997 Jul 26;315(7102):216-9; discussion 220. doi: 10.1136/bmj.315.7102.216.

    PubMed 9253269

  • Kollee LA, Speyer I, van Kuijck MA, Koopman R, Dony JM, Bakker JH, Wintermans RG. Prevention of group B streptococci transmission during delivery by vaginal application of chlorhexidine gel. Eur J Obstet Gynecol Reprod Biol. 1989 Apr;31(1):47-51. doi: 10.1016/0028-2243(89)90025-7.

    PubMed 2653894

  • Burman LG, Christensen P, Christensen K, Fryklund B, Helgesson AM, Svenningsen NW, Tullus K. Prevention of excess neonatal morbidity associated with group B streptococci by vaginal chlorhexidine disinfection during labour. The Swedish Chlorhexidine Study Group. Lancet. 1992 Jul 11;340(8811):65-9. doi: 10.1016/0140-6736(92)90393-h.

    PubMed 1352011

  • Adriaanse AH, Kollee LA, Muytjens HL, Nijhuis JG, de Haan AF, Eskes TK. Randomized study of vaginal chlorhexidine disinfection during labor to prevent vertical transmission of group B streptococci. Eur J Obstet Gynecol Reprod Biol. 1995 Aug;61(2):135-41. doi: 10.1016/0301-2115(95)02134-s.

    PubMed 7556834

  • Rouse DJ, Hauth JC, Andrews WW, Mills BB, Maher JE. Chlorhexidine vaginal irrigation for the prevention of peripartal infection: a placebo-controlled randomized clinical trial. Am J Obstet Gynecol. 1997 Mar;176(3):617-22. doi: 10.1016/s0002-9378(97)70557-x.

    PubMed 9077616

  • Stray-Pedersen B, Bergan T, Hafstad A, Normann E, Grogaard J, Vangdal M. Vaginal disinfection with chlorhexidine during childbirth. Int J Antimicrob Agents. 1999 Aug;12(3):245-51. doi: 10.1016/s0924-8579(99)00068-0.

    PubMed 10461843

  • Facchinetti F, Piccinini F, Mordini B, Volpe A. Chlorhexidine vaginal flushings versus systemic ampicillin in the prevention of vertical transmission of neonatal group B streptococcus, at term. J Matern Fetal Neonatal Med. 2002 Feb;11(2):84-8. doi: 10.1080/jmf.11.2.84.88.

    PubMed 12375548

  • Cutland CL, Schrag SJ, Zell ER, Kuwanda L, Buchmann E, Velaphi SC, Groome MJ, Adrian PV, Madhi SA; PoPS trial team. Maternal HIV infection and vertical transmission of pathogenic bacteria. Pediatrics. 2012 Sep;130(3):e581-90. doi: 10.1542/peds.2011-1548. Epub 2012 Aug 6.

    PubMed 22869824

  • Schrag SJ, Cutland CL, Zell ER, Kuwanda L, Buchmann EJ, Velaphi SC, Groome MJ, Madhi SA; PoPS Trial Team. Risk factors for neonatal sepsis and perinatal death among infants enrolled in the prevention of perinatal sepsis trial, Soweto, South Africa. Pediatr Infect Dis J. 2012 Aug;31(8):821-6. doi: 10.1097/INF.0b013e31825c4b5a.

    PubMed 22565291

  • Cutland CL, Madhi SA, Zell ER, Kuwanda L, Laque M, Groome M, Gorwitz R, Thigpen MC, Patel R, Velaphi SC, Adrian P, Klugman K, Schuchat A, Schrag SJ; PoPS Trial Team. Chlorhexidine maternal-vaginal and neonate body wipes in sepsis and vertical transmission of pathogenic bacteria in South Africa: a randomised, controlled trial. Lancet. 2009 Dec 5;374(9705):1909-16. doi: 10.1016/S0140-6736(09)61339-8. Epub 2009 Oct 19.

    PubMed 19846212

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Chlorhexidine, Birth canal wipe and sterile water external genital wipe in people with Infant, Newborn, Diseases and Sepsis, run by Centers for Disease Control and Prevention at 1 site in South Africa.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 24 Sep 2007. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Clare Cutland, BSc, MBBCh (+27-11-989-9894, cutlandc@hivsa.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rates of culture-confirmed or clinical neonatal sepsis, < 3 days of life. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00136370, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2007.

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