Swyer 1953.
Methods | Unit of randomization: pregnancy
Method of randomization of allocation: there were 2 centers in this study. 1 allocated by alternation. It was stated in the paper that the other center used "randomisation". However, method of randomization was not given.
Timing of randomization: before 12 weeks' gestation
Blinding: unclear
Power calculation: no
Number of centers: 2 113 women were enrolled, 0 women were excluded, 113 women were analyzed Source of funding: not stated |
|
Participants | Women having had ≥ 2 consecutive miscarriages before 12 weeks' gestation Exclusions: women with any other known complicating factor (positive Wassermann reaction, extensive cervical tear, uterine malformation, associated medical disease, etc) Age: not stated Location: London, UK Timing and duration: not stated |
|
Interventions | 6 x 25 mg progesterone pellets inserted within the gluteal muscle either:
Control: no treatment Duration: unclear |
|
Outcomes | Miscarriage
Preterm delivery
Stillbirth Live birth rate |
|
Notes | Dates of study: not stated Funding sources: stated that an author was grateful to Organon Laboratories, Ltd for "generous supplies of progesterone implants" Declarations of interest: not stated but it did state that "one of us (D.D.) is grateful" to Dr. Tindall of Organon but no details of why only that author was grateful were given. |
|
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Not stated |
Allocation concealment (selection bias) | High risk | There were 2 centers in this study. 1 allocated by alternation. It was stated in the paper that the other center used "randomisation" |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Not stated but unlikely that knowledge of assignment would influence outcomes |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Not stated but unlikely that knowledge of assignment would influence outcomes |
Incomplete outcome data (attrition bias) All outcomes | Low risk | None |
Selective reporting (reporting bias) | Low risk | None |
Other bias | Low risk | None noted |
hCG: human chorionic gonadotropin;IM: intramuscular; IU: international unit: LBW: low birthweight; NIHR: National Institute for Health Research; PPROM: preterm premature rupture of the membranes; SGA: small‐for‐gestational age