Fetal HIV Transmission Risk and Duration of Membrane Rupture
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Purpose
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.
| Condition |
|---|
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Human Immunodeficiency Virus HIV |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Retrospective |
| Official Title: | Duration of Rupture of Membranes and Risk of Fetal Transmission of HIV in Optimally Managed HIV Positive Mothers |
- 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)
- 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)
| Enrollment: | 210 |
| Study Start Date: | January 2009 |
| Study Completion Date: | December 2010 |
| Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
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HIV Positive Women
HIV positive women in two downtown Toronto, Ontario academic-affiliated hospitals
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Detailed Description:
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.
Eligibility| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Total of 210 women from two downtown Toronto, Ontario academic-affiliated hospitals
Inclusion Criteria:
- all HIV positive women from January 2000
Exclusion Criteria:
- women not on HAART and who were not receiving intrapartum intravenous zidovudine
Contacts and Locations| Canada, Ontario | |
| St. Michael's Hospital | |
| Toronto, Ontario, Canada, M5B 1W8 | |
| Principal Investigator: | Mark Yudin, MD | St. Michael's Hospital, Toronto |
More Information
No publications provided
| Responsible Party: | St. Michael's Hospital, Toronto |
| ClinicalTrials.gov Identifier: | NCT01616823 History of Changes |
| Other Study ID Numbers: | REB File # 10-232 |
| Study First Received: | February 29, 2012 |
| Last Updated: | June 8, 2012 |
| Health Authority: | Canada: Ethics Review Committee |
Keywords provided by St. Michael's Hospital, Toronto:
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Human immunodeficiency virus (HIV) positive women |
Additional relevant MeSH terms:
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Acquired Immunodeficiency Syndrome HIV Infections Immunologic Deficiency Syndromes Rupture Lentivirus Infections Retroviridae Infections RNA Virus Infections |
Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Slow Virus Diseases Immune System Diseases Wounds and Injuries |
ClinicalTrials.gov processed this record on May 16, 2013