Study | Reason for exclusion |
---|---|
Australia 2009 | This study was comparing 3 different regimens for third stage management after second‐trimester intravaginal misoprostol termination. |
Austria 1983 | No clinically relevant outcomes reported. Healthy women delivering at term who had a normal duration of labour (< 12 hours) and without the use of oxytocics before delivery were recruited. Immediately following the separation of the placenta, a twin catheter was introduced into the cavity for intrauterine pressure measurement which was recorded on the cardiotocograph. The women were randomised to receive methergin (methylergometrine) 0.2 mg, or oxytocin 2 IU, or sulprostone 0.5 mg or saline, all administered intramuscularly. Sulprostone had the quickest onset of action and strongest increase in uterine contractility whereas methergin had the longest duration of action on uterine contractility. |
Canada 2004 | Not a randomised controlled trial. A nested study within a randomised controlled trial to look at peripheral blood flow and temperature changes in women receiving misoprostol or oxytocin. |
China 1997 | This trial was reported as randomised but no details of the method of randomisation were given. The 2 study groups were not balanced (260 versus 100), and they were further randomised into subgroups. |
China 1998 | Randomised controlled trial of misoprostol versus oxytocin in caesarean section births only. Data are not presented in a form that can be extracted for the meta‐analysis. |
China 1998b | This trial randomised 80 women to 1 mg carboprost methylate intravaginally versus sublingually vs ergometrine IV. The data were not in a form suitable for extraction for this meta‐analysis. |
China 2000 | This trial randomised 102 women to receive 200 mcg rectal misoprostol versus Pitocin, however, there were not enough information in the article for the assessment of the methodology. |
China 2001 | This trial randomised 348 women into 4 groups of misoprostol 200, 400, and 600 micrograms orally, and oxytocin 20 units intramuscularly. Data were presented only in means, and were not presented in a form suitable for extraction and inclusion in this meta‐analysis. |
China 2002 | This study only includes women with pregnancy‐induced hypertension syndrome. |
China 2003c | This study included only women with failure of induction and was excluded because there was very little information on the methodology and the outcomes were not reported properly. |
China 2003d | This study was excluded because there was no information provided on the paper in regards to the methodology of the study (randomisation, allocation concealment, blinding, etc). |
China 2004b | Randomised, double blind trial of 298 low‐risk women delivering vaginally in Hong Kong, China. Oral misoprostol vs IV oxytocin. The trial is excluded because the number of women in each group are not described and the report is available as an abstract. The authors have not responded to the request for additional information and clarification. There was no statistically significant difference in blood loss > 500 and 1000 mL. Additional oxytocics were used in 25.2 vs 7.5% in the misoprostol and oxytocin groups respectively. |
China 2004c | Data are not in a usable format. Randomised controlled trial comparing misoprostol 400 mcg + syntometrine vs syntometrine. The author contacted but no response. |
Egypt 1999 | 140 women were allocated to receive either 2 different doses of rectal misoprostol or 5 units of oxytocin and 0.2 mg ergometrine intramuscularly. There is no indication of any randomised comparison between the groups. |
Hungary 1979 | The reason for exclusion is that the data are not presented in a usable form. The study is a randomised comparison of 1 mg intramyometrial prostaglandin F2alpha (47 women), 0.2 mg intravenous ergometrine (50) and no treatment (43). Prostaglandin F2alpha reduced the blood loss in the third stage of labour significantly when compared with ergometrine and no treatment. |
India 1988a | 60 women were allocated to 125 microgram PGF2alpha intramuscularly or no uterotonic. There is no indication of any randomised comparison between the 2 groups. |
India 1988b | Multicentre study carried out in 4 centres. Of these, 2 employed a random allocation scheme and 2 used a sequential scheme. The reason for exclusion is that the results are presented together and it is not possible to extract data for those utilising random allocation. |
India 2000a | There are no data that can be extracted to evaluate the validity of the methods used and the outcome data in this study from the conference abstract. When the study is published in full it will be evaluated again. |
India 2000b | There are no data that can be extracted to evaluate the validity of the methods used and the outcome data in this study from the conference abstract. When the study is published in full it will be evaluated again. |
India 2000c | There are no data that can be extracted to evaluate the validity of the methods used and the outcome data in this study from the conference abstract. When the study is published in full it will be evaluated again. |
India 2001a | This study is reported as randomised double blind but there is no mention of placebos. There is also a discrepancy in the results between the text and the tables. 200 women were assigned either misoprostol orally 400 mcg or methylergometrine. |
India 2005b | The study is reported as a randomised controlled trial comparing carboprost with methylergometrine but the results are analyzed by risk subgroups only and they are imbalanced between the 2 random allocation groups. |
India 2006e | This is a randomised trial (cluster) of an educational intervention to implement active management of the third stage of labour using misoprostol. The control group received standard practice which was 'no special training' and no use of misoprostol. |
India 2006h | This study did not have sufficient information on the risk of bias and exclusion criteria. We have contacted the authors but have not received any response. |
India 2009a | The study was reported in an abstract with not enough information on the methodology and outcomes. No contact information provided for the authors. |
India 2009c | This study had a very high risk of bias on evaluation, therefore we have excluded the study. |
Indonesia 2002 | Data to evaluate the validity of the methods used are not available in this published abstract. When the study is published in full it will be evaluated again. This study involves 196 women undergoing full term vaginal delivery. 98 women were randomly allocated to 600 micrograms of oral misoprostol or 10 IU of oxytocin intramuscularly immediately after the baby was born. The length of the third stage of labour was 8.122 minutes for the misoprostol group and 8.388 minutes for the oxytocin group. Third stage blood loss for the misoprostol and oxytocin group was respectively 144.286 mL and 131.020 mL. Shivering occurred in 13.3% in the misoprostol group and 2.0% in the oxytocin group. |
Israel 1992 | This is a randomised controlled trial comparing intraumbilical PGF2alpha with saline injection. Although a prostaglandin was used for the management of the third stage of labour the mechanism of action may not be comparable to other routes of administration. This paper will be considered for inclusion in another review on the management of the third stage (intraumbilical uterotonics). |
Italy 1988 | Data from this trial were published in an abstract. It is excluded because no full publication of the trial data could be located. |
Japan 1976 | There does not seem to be a randomised comparison between study groups. 4 prostaglandin groups were studied: a. systemic: a.1. intramuscular (gluteal), a.2. continuous intravenous drip infusion, b. local: b.1. transabdominal intramyometrial injection, b.2. transvaginal intramyometrial injection. These groups were compared to ergot alkaloids. Number of participants are also not balanced (46 in prostaglandin vs 13 in ergot group). |
Korea 2007 | The study was reported in an abstract with not enough information on the methodology and outcomes. No contact information provided for the authors. |
Singapore 1990 | The outcome examined in this trial was serum prostaglandin levels. |
Singapore 2001 | This trial has 57 women randomly assigned to receive oral misoprostol 200, 400, 500, 600, or 800 micrograms or ergometrine‐oxytocin. Uterine activity was the main outcome, but side‐effects were also reported. The data are incomplete and not in a suitable form for extraction. |
South Africa 1999 | Data from this trial were published in an abstract. It is excluded because no further publication of complete trial data was located. This trial evaluates treatment of primary postpartum haemorrhage. |
Thailand 2000 | The study was reported in an abstract with not enough information on the methodology and outcomes. No contact information provided for the authors. |
Turkey 2005 | Randomised, placebo‐controlled trial comparing 400 mcg rectal vs 400 mcg vaginal misoprostol vs placebo after delivery of the placenta. Women with haemorrhage were excluded from the analysis after randomisation. Authors contacted for clarification. |
United Kingdom 2001a | Randomised controlled trial of 400 mcg oral misoprostol versus 10 IU IV oxytocin. Primary outcome was 'intraoperative blood loss', which is not 1 of the outcomes for this review. |
USA 1983 | 75 women were randomised to 3e groups of different doses of prostaglandin F2alpha (62.5, 125, 250 microgram intramuscularly). Then another 15 women were sequentially allocated to the same treatment groups, in groups of 5. The randomised and non‐randomised groups have been reported together in the paper to increase the sample size. It is not possible to extract data on the randomised women alone. |
USA 1999 | Data from this trial were published in an abstract. It is excluded because no further publication of the completed trial data was located and the data presented in the abstract are incomplete. |
Yemen 2009 | The study is not a randomised controlled trial. It used a "convenience sample" which was then divided into 2 groups by a "quasi‐random" allocation. |
IU: international unit IV: intravenous vs: versus