A Randomized Trial of Misoprostol Compared with Manual Vacuum Aspiration for Early Pregnancy Failure

Ganguly, Rajendra Prasad; Mukhopadhyay, Sima; Burman, Sougata Kumar; Patra, Kajal Kumar; Jha, Tulika; Mukherji, Joydev

doi:10.3126/njog.v5i2.5070

Cited by 4 publications

(7 citation statements)

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“…For the six double-blind placebo-controlled trials (Bagratee 2004;Bracken 2014*;Kovavisarach 2005;Lelaidier 1993;Lister 2005;Wood 2002) it was very likely that outcome assessors were blinded for the intervention and detection bias was therefore considered low. This was also the case for two more studies (Ganguly 2010 andSinha 2018) which described outcome assessors were blinded for the intervention. Two more studies used placebo medication, (Herabutya 1997;Kovavisarach 2002) and it is therefore likelier that outcome assessors were blinded for the intervention.…”

Section: Blindingmentioning

confidence: 88%

“…This review has included 43 studies comparing vaginal misoprostol versus expectant management (Trinder 2006), placebo (Bagratee 2004Herabutya 1997;Kovavisarach 2002;Lister 2005;Wood 2002), surgical evacuation (Demetroulis 2001;Fang 2009;Ganguly 2010;Graziosi 2004;Mu ley 2002;Trinder 2006), oral or sublingual misoprostol (Chittacharoen 2003*;Creinin 1997;Dehbashi 2016;Marwah 2016;Ngoc 2004;Rita 2006;Shah 2010*;Sonsanoh 2014;Tang 2003;Tanha 2010a) women with non-viable pregnancies up to a GA of 20 weeks, but made subgroup analyses for first and second trimester pregnancies. These studies are labelled with an asterisk for ease of interpretation.…”

Section: Included Studiesmentioning

confidence: 99%

“…In 30 studies the risk of bias concerning random sequence generation was assessed as being at low risk of bias (Abediasl 2016*;Autry 1999;Ayudhaya 2006;Bagratee 2004;Bracken 2014*;Chittacharoen 2003*;Creinin 1997;Demetroulis 2001;Fang 2009;Ganguly 2010;Gilles 2004;Graziosi 2004;Jain 1996*;Kovavisarach 2005;Kushwah 2009;Lelaidier 1993;Lister 2005;Marwah 2016;Mitwaly 2016*;Mizrachi 2017;Mu ley 2002;Ngoc 2004;Petersen 2013;Saichua 2009;Schreiber 2018;Sinha 2018;Tang 2003;Tang 2006;Tanha 2010a;Wood 2002). These studies mainly used (computer-generated) random number tables.…”

Section: Allocationmentioning

confidence: 99%

“…Most studies used sequentially numbered sealed opaque envelopes, or numbered and sealed packets containing study medication. Furthermore, randomisation using a computer program to guarantee allocation concealment was used (Abediasl 2016*;Autry 1999;Bagratee 2004;Bracken 2014*;Chittacharoen 2003*;Creinin 1997;Demetroulis 2001;Ganguly 2010;Gilles 2004;Graziosi 2004;Kovavisarach 2005;Lelaidier 1993;Lister 2005;Marwah 2016;Mitwaly 2016*;Mizrachi 2017;Mu ley 2002;Ngoc 2004;Petersen 2013;Saichua 2009;Schreiber 2018;Sinha 2018;Sonsanoh 2014;Trinder 2006;Wood 2002). For these studies the risk of bias was considered low risk for allocation concealment.…”

Section: Cochrane Database Of Systematic Reviewsmentioning

confidence: 99%

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Medical treatment for early fetal death (less than 24 weeks)

Lemmers

Verschoor

Kim

et al. 2019

Cochrane Database of Systematic Reviews

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Section: Blindingmentioning

confidence: 88%

Section: Included Studiesmentioning

confidence: 99%

Section: Allocationmentioning

confidence: 99%

Section: Cochrane Database Of Systematic Reviewsmentioning

confidence: 99%

See 2 more Smart Citations

Medical treatment for early fetal death (less than 24 weeks)

Lemmers

Verschoor

Kim

et al. 2019

Cochrane Database of Systematic Reviews

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“…A total of 114 RCTs were included in the review . The PRISMA flow chart in Figure S1 shows study selection.…”

Section: Resultsmentioning

confidence: 99%

Outcomes in prevention and management of miscarriage trials: a systematic review

Smith

Dhillon-Smith

O’Toole

et al. 2018

BJOG

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Background There is a substantial body of research evaluating ways to prevent and manage miscarriage, but all studies do not report on the same outcomes. Objective To review systematically, outcomes reported in existing miscarriage trials. Search strategy MEDLINE, Embase, CINAHL, and Cochrane were searched from inception until January 2017. Selection criteria Randomised controlled trials (RCTs) reporting prevention or management of miscarriage. Miscarriage was defined as a pregnancy loss in the first trimester. Data collection and analysis Data about the study characteristics, primary, and secondary outcomes were extracted. Main results We retrieved 1553 titles and abstracts, from which 208 RCTs were included. For prevention of miscarriage, the most commonly reported primary outcome was live birth and the top four reported outcomes were pregnancy loss/stillbirth (n = 112), gestation of birth (n = 68), birth dimensions (n = 65), and live birth (n = 49). For these four outcomes, 58 specific measures were used for evaluation. For management of miscarriage, the most commonly reported primary outcome was efficacy of treatment. The top four reported outcomes were bleeding (n = 186), efficacy of miscarriage treatment (n = 105), infection (n = 97), and quality of life (n = 90). For these outcomes, 130 specific measures were used for evaluation. Conclusions Our review found considerable variation in the reporting of primary and secondary outcomes along with the measures used to assess them. There is a need for standardised patient‐centred clinical outcomes through the development of a core outcome set; the work from this systematic review will form the foundation of the core outcome set for miscarriage. Tweetable abstract There is disparity in the reporting of outcomes and the measures used to assess them in miscarriage trials.

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