Fetal HIV Transmission Risk and Duration of Membrane Rupture
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT01616823 |
|
Recruitment Status
:
Completed
First Posted
: June 12, 2012
Last Update Posted
: June 12, 2012
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
| Condition or disease |
|---|
| Human Immunodeficiency Virus HIV |
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.
| Study Type : | Observational |
| Actual Enrollment : | 210 participants |
| 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 |
| Study Start Date : | January 2009 |
| Actual Primary Completion Date : | December 2009 |
| Actual Study Completion Date : | December 2010 |
| Group/Cohort |
|---|
|
HIV Positive Women
HIV positive women in two downtown Toronto, Ontario academic-affiliated hospitals
|
- Mode of delivery [ Time Frame: Ten years ]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 ]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)
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | Child, Adult, Senior |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Inclusion Criteria:
- all HIV positive women from January 2000
Exclusion Criteria:
- women not on HAART and who were not receiving intrapartum intravenous zidovudine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01616823
| Canada, Ontario | |
| St. Michael's Hospital | |
| Toronto, Ontario, Canada, M5B 1W8 | |
| Principal Investigator: | Mark Yudin, MD | St. Michael's Hospital, Toronto |
| Responsible Party: | St. Michael's Hospital, Toronto |
| ClinicalTrials.gov Identifier: | NCT01616823 History of Changes |
| Other Study ID Numbers: |
REB File # 10-232 |
| First Posted: | June 12, 2012 Key Record Dates |
| Last Update Posted: | June 12, 2012 |
| Last Verified: | September 2011 |
Keywords provided by St. Michael's Hospital, Toronto:
|
Human immunodeficiency virus (HIV) positive women |
Additional relevant MeSH terms:
|
Immunologic Deficiency Syndromes Acquired Immunodeficiency Syndrome HIV Infections Rupture Immune System Diseases Lentivirus Infections Retroviridae Infections |
RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Slow Virus Diseases Wounds and Injuries |