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TeMpOH-3


- candidate number16550
- NTR NumberNTR4363
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR24-feb-2014
- Secondary IDsn/a n/a
- Public TitleTeMpOH-3
- Scientific TitleProphylactic radiological interventions to prevent major obstetric haemorrhage in patients at high risk of abnormally invasive placenta
- ACRONYMTeMpOH-3
- hypothesisProphylactic radiological interventions do prevent major obstetric haemorrhage in patients at high risk of abnormally invasive placenta
- Healt Condition(s) or Problem(s) studied
- Inclusion criteriaThe 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 criteriaWomen who had an emergency caesarean delivery.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeobservational
- planned startdate 1-mrt-2014
- planned closingdate1-mrt-2014
- Target number of participants750
- InterventionsProfylactic radiological interventions.
- Primary outcomeMajor 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.
- Timepointsnone
- Trial web sitehttp://www.studies-obsgyn.nl/TeMpOH-3
- statusplanned
- CONTACT FOR PUBLIC QUERIESArts-onderzoeker Valérie Harskamp
- CONTACT for SCIENTIFIC QUERIESArts-onderzoeker Valérie Harskamp
- Sponsor/Initiator Sanquin Blood Bank (Stichting Sanquin Bloedvoorziening)
- Funding
(Source(s) of Monetary or Material Support)
Sanquin Bloodbank Amsterdam
- Publications
- Brief summaryMajor 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
- RECORD24-feb-2014 - 21-mrt-2014


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