TY - JOUR
T1 - Surgical versus expectant management in women with an incomplete evacuation of the uterus after treatment with misoprostol for miscarriage
T2 - The MisoREST trial
AU - Verschoor, Marianne A.C.
AU - Lemmers, Marike
AU - Bossuyt, Patrick M.
AU - Graziosi, Giuseppe C.M.
AU - Hajenius, Petra J.
AU - Hendriks, Dave J.
AU - van Hooff, Marcel A.H.
AU - van Meurs, Hannah S.
AU - Opmeer, Brent C.
AU - van Tulder, Maurits W.
AU - Bouwma, Liesanne
AU - Catshoek, Ruby
AU - Geomini, Peggy
AU - Klinkert, Ellen R.
AU - Langenveld, Josje
AU - Nieboer, Theodoor E.
AU - van der Ploeg, J. Marinus
AU - Radder, Celine M.
AU - Spinder, Taeke
AU - van der Voet, Lucy F.
AU - Mol, Ben Willem J.
AU - Huirne, Judith A.F.
AU - Ankum, Willem M.
PY - 2013/5/2
Y1 - 2013/5/2
N2 - Background: Medical treatment with misoprostol is a non-invasive and inexpensive treatment option in first trimester miscarriage. However, about 30% of women treated with misoprostol have incomplete evacuation of the uterus. Despite being relatively asymptomatic in most cases, this finding often leads to additional surgical treatment (curettage). A comparison of effectiveness and cost-effectiveness of surgical management versus expectant management is lacking in women with incomplete miscarriage after misoprostol.Methods/Design: The proposed study is a multicentre randomized controlled trial that assesses the costs and effects of curettage versus expectant management in women with incomplete evacuation of the uterus after misoprostol treatment for first trimester miscarriage.Eligible women will be randomized, after informed consent, within 24 hours after identification of incomplete evacuation of the uterus by ultrasound scanning. Women are randomly allocated to surgical or expectant management. Curettage is performed within three days after randomization.Primary outcome is the sonographic finding of an empty uterus (maximal diameter of any contents of the uterine cavity < 10 millimeters) six weeks after study entry. Secondary outcomes are patients' quality of life, surgical outcome parameters, the type and number of re-interventions during the first three months and pregnancy rates and outcome 12 months after study entry.Discussion: This trial will provide evidence for the (cost) effectiveness of surgical versus expectant management in women with incomplete evacuation of the uterus after misoprostol treatment for first trimester miscarriage.Trial registration: Dutch Trial Register: NTR3110.
AB - Background: Medical treatment with misoprostol is a non-invasive and inexpensive treatment option in first trimester miscarriage. However, about 30% of women treated with misoprostol have incomplete evacuation of the uterus. Despite being relatively asymptomatic in most cases, this finding often leads to additional surgical treatment (curettage). A comparison of effectiveness and cost-effectiveness of surgical management versus expectant management is lacking in women with incomplete miscarriage after misoprostol.Methods/Design: The proposed study is a multicentre randomized controlled trial that assesses the costs and effects of curettage versus expectant management in women with incomplete evacuation of the uterus after misoprostol treatment for first trimester miscarriage.Eligible women will be randomized, after informed consent, within 24 hours after identification of incomplete evacuation of the uterus by ultrasound scanning. Women are randomly allocated to surgical or expectant management. Curettage is performed within three days after randomization.Primary outcome is the sonographic finding of an empty uterus (maximal diameter of any contents of the uterine cavity < 10 millimeters) six weeks after study entry. Secondary outcomes are patients' quality of life, surgical outcome parameters, the type and number of re-interventions during the first three months and pregnancy rates and outcome 12 months after study entry.Discussion: This trial will provide evidence for the (cost) effectiveness of surgical versus expectant management in women with incomplete evacuation of the uterus after misoprostol treatment for first trimester miscarriage.Trial registration: Dutch Trial Register: NTR3110.
KW - Curettage
KW - Expectant management
KW - Incomplete evacuation
KW - Miscarriage
KW - Misoprostol
UR - http://www.scopus.com/inward/record.url?scp=84876872647&partnerID=8YFLogxK
U2 - 10.1186/1471-2393-13-102
DO - 10.1186/1471-2393-13-102
M3 - Article
C2 - 23638956
AN - SCOPUS:84876872647
SN - 1471-2393
VL - 13
JO - BMC Pregnancy and Childbirth
JF - BMC Pregnancy and Childbirth
M1 - 102
ER -