ResearchGynecologyBleeding patterns after misoprostol vs surgical treatment of early pregnancy failure: results from a randomized trial
Section snippets
Materials and Methods
We enrolled 652 women in a randomized, noninferiority trial between March 2002 and March 2004 to test whether misoprostol is an effective alternative to curettage for the treatment of EPF. The trial included 4 clinical centers: Columbia University, University of Miami, University of Pennsylvania, and University of Pittsburgh. The institutional review board of each institution approved the study. Details of the conduct of the trial and the main study results are reported elsewhere.2 Before this
Results
Six hundred fifty-two women with EPF were enrolled in the trial from March 2002 to March 2004. Baseline pregnancy and demographic characteristics were similar between the 2 groups (Table 1). In the curettage group (n = 161 women), 89 women (55%) received electric vacuum aspiration, and 68 women (42%) received manual vacuum aspiration; the study site investigators chose the surgical technique. Three participants who were assigned to curettage, and 2 participants who were assigned to misoprostol
Comment
By all assessment measures, women who were treated with misoprostol for EPF bled more heavily and for a longer duration than did women who were treated with curettage. Clinically significant blood loss after misoprostol was more likely to occur in younger women and parous women and in pregnancies at higher gestational ages but was unrelated to the type of EPF. More women who were treated with misoprostol described their bleeding as unacceptable and sought additional medical care because of
Acknowledgment
We thank the following persons and institutions for their participation in the NICHD Management of Early Pregnancy Failure Trial: assistance with study concept and design, T. Nansel (NICHD); assistance with acquisition of data, C. Robilotto (Columbia University), M. Diro, F. Doyle, N. Vazquez (University of Miami), T. Bader, K. Timbers, A. Hummel, L. Martino (University of Pennsylvania), B. Harwood, R. Guido, L. Reid (University of Pittsburgh); and assistance with data analysis, X.K. Huang
References (20)
- et al.
Spontaneous abortion: A randomized, controlled trial comparing surgical evacuation with conservative management using misoprostol
Fertil Steril
(1999) - et al.
Misoprostol for medical evacuation of early pregnancy failure
Obstet Gynecol
(1997) Spontaneous abortions: Epidemiology
- et al.
A comparison of medical management with misoprostol and surgical management for early pregnancy failure
N Engl J Med
(2005) - et al.
Medical termination of missed abortion
J Obstet Gynaecol
(2002) - et al.
Randomised clinical trial of medical evacuation and surgical curettage for incomplete miscarriage
BMJ
(1995) - et al.
A prospective randomized control trial comparing medical and surgical treatment for early pregnancy failure
Hum Reprod
(2001) - et al.
Misoprostol versus curettage in women with early pregnancy failure after initial expectant management: A randomized trial
Hum Reprod
(2004) - et al.
Management of missed abortion: Comparison of medical treatment with either mifepristone + misoprostol or misoprostol alone with surgical evacuation: A multi-center trial in Copenhagen county, Denmark
Acta Obstet Gynecol Scand
(2002) - et al.
Spontaneous abortion: Expectant management, medical treatment or surgical evacuation
Acta Obstet Gynecol Scand
(2002)
Cited by (43)
Vaginal Bleeding Before 20 Weeks Gestation
2023, Obstetrics and Gynecology Clinics of North AmericaThe effect of mifepristone pretreatment on bleeding and pain during medical management of early pregnancy loss
2021, ContraceptionCitation Excerpt :However, these likely underestimate true durations of bleeding due to their short follow-up periods. Davis et al. found that 90% of participants using misoprostol 800 mcg vaginally for EPL reported any bleeding after 1 week, with 1/3 reporting heavy bleeding, and half of participants reported any bleeding between days 15 and 30 after misoprostol administration [2]. Our results were comparable and had similar limitations, as we collected data prospectively until ultrasound confirmation of the gestational sac expulsion; as a result, neither of our studies adequately measured total bleeding duration.
MisoREST: Surgical versus expectant management in women with an incomplete evacuation of the uterus after misoprostol treatment for miscarriage: A cohort study
2017, European Journal of Obstetrics and Gynecology and Reproductive BiologyCitation Excerpt :In 5–50% of the women treated with misoprostol, such ultrasound indicates an incomplete evacuation of the uterus [2,3,5,8–11]. Although women generally have few symptoms, and in spite of the limited value of ultrasound in determining the presence of intra uterine pregnancy remnants, this finding often leads to an additional curettage, which reduces the initial advantage of non-invasive therapy [15,16]. This is of concern since curettage is more expensive and bears the risk of short- and long term complications such as cervical tears, uterine perforation, infection, intra-uterine adhesions (Asherman’s syndrome) and an increased risk of preterm birth in the subsequent pregnancy [17,18].
Fertility and obstetric outcomes after curettage versus expectant management in randomised and non-randomised women with an incomplete evacuation of the uterus after misoprostol treatment for miscarriage
2017, European Journal of Obstetrics and Gynecology and Reproductive BiologyA randomized controlled trial of daily text messages versus monthly paper diaries to collect bleeding data after intrauterine device insertion
2015, ContraceptionCitation Excerpt :In contrast, when assigned to text messages, such women provided a quantity of answers similar to the generally more educated participants recruited from the Faculty Practice. Diary responses in the paper group were lower than reported in other studies [25–29]. However, we made little effort to collect paper diary data with only one reminder per month.
Funded by contracts (N01-HD-1-3321, N01-HD-3322, N01-HD-3323, N01-HD-3324, and N01-HD-3325) with the National Institute of Child Health and Human Development, National Institutes of Health.
Cite this article as: Davis AR, Hendlish SK, Westhoff C, et al. Bleeding patterns after misoprostol vs surgical treatment of early pregnancy failure: results from a randomized trial. Am J Obstet Gynecol 2007;196:31.e1-31.e7.