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TeMpOH-3

 

Prophylactic radiological interventions to prevent major obstetric Haemorrhage in patients at high risk of abnormally invasive placenta

 

Go to the TeMpOH-3 study website

 

Rationale
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 placenta praevia and previous caesarean sections.
Prophylactic placement of catheters for intraoperative balloon occlusion or embolization 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.

 

Objective
To assess the effect of preoperative, prophylactic arterial catheterization on the occurrence of major obstetric haemorrhage, transfusion requirements, maternal morbidity and mortality in patients at high risk of AIP who undergo an elective caesarean delivery, compared to the 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.
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. Placenta praevia exists when the placental edge is at the margin of the internal os or covers the internal os of the cervix.

 

Methods
The Dutch Hospital Data (DHD)-foundation and the Netherlands Perinatal Registry (PRN)-foundation will generate a list of women coded with placenta praevia and a caesarean section between January 2008 and January 2013.
By reviewing the discharge letters of the patients from above mentioned lists, the research nurses and midwives in the participating hospitals will be asked to identify the women with the diagnosis placenta praevia and at least one previous caesarean section, who underwent an elective caesarean delivery between January 2008 and January 2013. Data on patient and treatment characteristics of selected women will be collected by performing a chart review of patients. Regression analyses will be used to examine the association of prophylactic placement of arterial catheters and the occurrence MOH and other sequelae. Possible adverse events due to the use of balloon catheters will be recorded.

 

Outcome measures
The occurrence of MOH, transfusion requirements, severe maternal morbidity and mortality.

 

Sample size calculation
Between January 2008 and January 2013 there were 909 665 deliveries in the Netherlands. Under the assumption that the incidence of placenta praevia is around 0,3-0,4% in European countries (1), we estimate that around 2500-4000 women were diagnosed with placenta praevia in the Netherlands in the past 5 years. Approximately 20-25% of the patients with a placenta praevia have an obstetrical history with at least one previous caesarean section (2;3). In the Netherlands we estimate to find around 750 patients with placenta praevia, and at least one previous caesarean section, between January 2008 and January 2013.
As there are 89 hospitals with an obstetrical unit in the Netherlands, we expect to include 5 to 15 patients in each hospital. As the management of patients at high risk of abnormally invasive placenta needs a multidisciplinary and specialized approach, the incidence will probably be higher in the university and large teaching hospitals.

 

1. Cresswell JA, Ronsmans C, Calvert C, Filippi V. Prevalence of placenta praevia by world region: a systematic review and meta-analysis. Trop Med Int Health 2013; 18(6):712-724.

2. Hershkowitz R, Fraser D, Mazor M, Leiberman JR. One or multiple previous cesarean sections are associated with similar increased frequency of placenta previa. Eur J Obstet Gynecol Reprod Biol 1995; 62(2):185-188.

3. Rosenberg T, Pariente G, Sergienko R, Wiznitzer A, Sheiner E. Critical analysis of risk factors and outcome of placenta previa. Arch Gynecol Obstet 2011; 284(1):47-51.


Time schedule
Data will be collected from March 2014 till July 2014

 

Projectleader
Mw. Prof. J.G. van der Bom
Clinical epidemiologist, Leiden University Medical Center (LUMC)
Head of Center for Clinical Transfusion Research (Sanquin Research, Leiden)

 

Projectgroup

Mw. Drs. V. Harskamp, Clinical Epidemiology, LUMC

Mw. Dr. K.W.M. Bloemenkamp, Obstetrics and Gynaecology, LUMC
MW. Prof. J.G. van der Bom, Clinical Epidemiology, LUMC & Sanquin Blood Supply
Mw. Drs. D.D.C.A. Henriquez, Obstetrics and Gynaecology, LUMC
Dr. M.G. van Kraaij, Hematology Radboud UMC & Sanquin Blood Supply
Prof. Dr. J. van Roosmalen, Obstetrics and Gynaecology, LUMC
Dr. J.J. Zwart, Obstetrics and Gynaecology, Deventer Ziekenhuis

 

Contact (researcher)
Mw. Drs. V. Harskamp
Albinusdreef 2
2333 ZA Leiden
T: 071-5265639 / 06-26902995
E: 
tempoh3@studies-obsgyn.nl of TeMpOH3@lumc.nl