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. 2018 Aug 6;2018(8):CD005943. doi: 10.1002/14651858.CD005943.pub5

El‐Zibdeh 2009.

Methods Design: quasi‐experimental
Recruitment method: pregnant women consecutively presented to the clinic during study period
Method of randomisation: according to the day of the week the women attended the clinic; women attending on Saturday, Monday, and Wednesday were assigned to intervention group and those attending on Sunday, Tuesday, and Thursday were assigned to the control group
Setting: Amman Islamic Hospital clinic
Participants Inclusion: women with threatened miscarriage (mild or moderate vaginal bleeding during the first trimester of pregnancy)
Exclusion: presence of a systemic illness or fever, the suspected passage of any fetal or pregnancy materials, and the absence of a normal gestational sac at 5 weeks gestational age, a yolk sac at 5.5–6 weeks gestational age, an embryo at 6–6.5 weeks gestational age or cardiac activity at 7 weeks gestational age
Particpants randomised: 146
Interventions Intervention group: (86 women) synthetic progesterone, dydrogesterone, oral 10 mg twice daily. Until 1 week after the bleeding stopped. Standard supportive care, including iron, folic acid and multivitamin supplements and bed rest
Control group: (60 women) no treatment. Standard supportive care, including iron, folic acid and multivitamin supplements and bed rest
Outcomes Miscarriage
Preterm delivery
Fetal structural malformations, including genital malformations
Maternal hypertension
Intra‐uterine growth restriction
APH
Notes Journal: Maturitas
Year of publication: 2009
Country: Jordan
Income status of the country: lower‐middle‐income
Source of funding: Solvay Pharmaceuticals
Conflict of interest: no actual or potential conflict
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) High risk According to the day of the week the women presented to the clinic. Women attending the clinic on Saturday, Monday or Wednesday were allocated to the intervention group and those attending on Sunday, Tuesday or Thursday were allocated to the control group.
Allocation concealment (selection bias) High risk The randomisation was performed by the attending physician, who also gave the treatment to the women.
Blinding of participants and personnel (performance bias) 
 All outcomes High risk No blinding of the participants and study personnel
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Blinding was ensured for the outcome assessors.
Incomplete outcome data (attrition bias) 
 All outcomes Low risk No loss to follow‐up
Selective reporting (reporting bias) Low risk All the prespecified outcomes were addressed.
Other bias High risk The difference in the number of participants recruited to experimental and the control groups (86 versus 60) might have introduced bias.