|- candidate number||16550|
|- NTR Number||NTR4363|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||24-feb-2014|
|- Secondary IDs||n/a n/a|
|- Public Title||TeMpOH-3 |
|- Scientific Title||Prophylactic radiological interventions to prevent major obstetric haemorrhage in patients at high risk of abnormally invasive placenta |
|- ACRONYM||TeMpOH-3 |
|- hypothesis||Prophylactic radiological interventions do prevent major obstetric haemorrhage in patients at high risk of abnormally invasive placenta |
|- Healt Condition(s) or Problem(s) studied|
|- Inclusion criteria||The study is a cohort study, carried out in patients at high risk of abnormally invasive placenta who underwent an elective caesarean delivery between January 2008 and January 2013 in the Netherlands.|
|- Exclusion criteria||Women who had an emergency caesarean delivery.|
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||Single arm|
|- planned startdate ||1-mrt-2014|
|- planned closingdate||1-mrt-2014|
|- Target number of participants||750|
|- Interventions||Profylactic radiological interventions.|
|- Primary outcome||Major obstetric haemorrhage = Obstetric haemorrhage requiring at least four units of red blood cells < 24 hours after delivery |
|- Secondary outcome||- The total amounts of used blood products in patients: the number of transfused units of RBCs, plasma (and platelets)
- (Severe) maternal morbidity, defined as peripartum hysterectomy or need for other interventions, ICU admission and length of hospitalization.
- Complications related to the radiological interventions, and complications related to surgical procedures.
- Maternal mortality.|
|- Trial web site||http://www.studies-obsgyn.nl/TeMpOH-3|
|- CONTACT FOR PUBLIC QUERIES||Arts-onderzoeker Valérie Harskamp|
|- CONTACT for SCIENTIFIC QUERIES||Arts-onderzoeker Valérie Harskamp|
|- Sponsor/Initiator ||Sanquin Blood Bank (Stichting Sanquin Bloedvoorziening)|
(Source(s) of Monetary or Material Support)
|Sanquin Bloodbank Amsterdam|
|- Brief summary||Major obstetric haemorrhage (MOH) is worldwide the most important cause of severe maternal morbidity and mortality. Abnormally invasive placenta (AIP), covers placenta accreta, increta and percreta, and is considered as a severe pregnancy complication that is frequently associated with major and potentially life threatening postpartum haemorrhage. The most important risk factors for AIP include advanced maternal age, placenta praevia and previous caesarean sections or other uterine surgeries.
Prophylactic placement of catheters for intraoperative balloon occlusion or embolisation of the internal iliac artery in patients at high risk of AIP may prevent the occurrence of MOH. However, this technique is not routinely performed as there is currently too scarce evidence addressing its benefits and risks.
Objectives: To assess the effect of preoperative, prophylactic arterial catheterization on the occurrence of MOH and its sequelae in patients at high risk of AIP who undergo an elective caesarean delivery, compared to omission of this intervention.
Study design: Nationwide, retrospective cohort study.
Study population: This cohort study will be carried out in patients at high risk of abnormally invasive placenta who underwent an elective caesarean delivery between January 2008 and January 2013 in the Netherlands.
Abnormally invasive placenta covers placenta accreta, increta and percreta. In our study, women with a placenta praevia, in combination with at least one previous caesarean section, are considered as patients at high risk of AIP.
|- Main changes (audit trail)||19-3-2014: trial overgezet naar website - LH|
|- RECORD||24-feb-2014 - 21-mrt-2014|