Fetal HIV Transmission Risk and Duration of Membrane Rupture

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
St. Michael's Hospital, Toronto
ClinicalTrials.gov Identifier:
NCT01616823
First received: February 29, 2012
Last updated: June 8, 2012
Last verified: September 2011

February 29, 2012
June 8, 2012
January 2009
December 2009   (final data collection date for primary outcome measure)
Mode of delivery [ Time Frame: Ten years ] [ Designated as safety issue: No ]
In optimally managed HIV+ women with undetectable viral loads and on HAART, receiving intrapartum IV ZDV, the risk of vertical transmission of HIV is independent of the length of time of rupture of membranes (as a secondary measure)
Same as current
Complete list of historical versions of study NCT01616823 on ClinicalTrials.gov Archive Site
Median length of time of membrane rupture [ Time Frame: Ten Years ] [ Designated as safety issue: No ]
In optimally managed HIV+ women with undetectable viral loads and on HAART, receiving intrapartum IV ZDV, the risk of vertical transmission of HIV is independent of the length of time of rupture of membranes (as a secondary measure)
Same as current
Not Provided
Not Provided
 
Fetal HIV Transmission Risk and Duration of Membrane Rupture
Duration of Rupture of Membranes and Risk of Fetal Transmission of HIV in Optimally Managed HIV Positive Mothers

In optimally managed HIV+ women with undetectable viral loads, who are on HAART and also receiving intrapartum IV ZDV, the risk of vertical transmission of HIV is independent of the length of time of rupture of membranes.

In developed countries, HIV infection is now considered a chronic disease and thus the life expectancy of people infected with HIV is approaching that of the general population. Therefore many HIV positive women are choosing to pursue pregnancies. An important concern for antenatal and intrapartum management is decreasing the risk of vertical transmission. With the use of highly active antiretroviral therapy (HAART) and intrapartum IV zidovudine (ZDV) the risk of transmission is decreased significantly, however there is some debate surrounding optimal mode of delivery. Possible mechanisms leading to perinatal transmission include transfusion of the mother's blood to the fetus during labour contractions, infection after rupture of membranes and direct contact of the fetus with infected secretions or blood from the maternal genital tract.

When maternal viral load is detectable, The Society of Obstetricians and Gynaecologists of Canada (SOGC) and other governing bodies recommend that elective cesarean section be performed for delivery as there is a 12-fold increased risk of perinatal transmission. However, the evidence suggests that for women at very low risk of transmission, such as those with an undetectable viral load and on HAART, the benefit of transmission reduction provided by cesarean section may be negligible.

The question of length of time of rupture of membranes prior to delivery and transmission risk has been a source of controversy, especially in the context of women on suppressive therapy (HAART) with an undetectable viral load. Traditional thinking has stated that the length of time of rupture of membranes should not be longer than 4 hours, as the benefit of cesarean section is lost after this time. However, this thinking is based on data where maternal viral loads were not known and only intrapartum IV ZDV was used. Many practitioners believe that in women with undetectable viral loads, virally suppressed on HAART, the safest route of delivery is vaginal, irrespective of length of time of rupture of membranes.

This is a retrospective cohort study which plans to examine the mode of delivery and median length of time of rupture of membranes for HIV positive women in two downtown academic institutions in Toronto.

Observational
Observational Model: Cohort
Time Perspective: Retrospective
Not Provided
Not Provided
Probability Sample

Total of 210 women from two downtown Toronto, Ontario academic-affiliated hospitals

  • Human Immunodeficiency Virus
  • HIV
Not Provided
HIV Positive Women
HIV positive women in two downtown Toronto, Ontario academic-affiliated hospitals
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
210
December 2010
December 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • all HIV positive women from January 2000

Exclusion Criteria:

  • women not on HAART and who were not receiving intrapartum intravenous zidovudine
Female
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT01616823
REB File # 10-232
No
St. Michael's Hospital, Toronto
St. Michael's Hospital, Toronto
Not Provided
Principal Investigator: Mark Yudin, MD St. Michael's Hospital, Toronto
St. Michael's Hospital, Toronto
September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP