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. 2019 Nov 20;2019(11):CD003511. doi: 10.1002/14651858.CD003511.pub5

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:
  • as soon as pregnancy was confirmed; or

  • not later than 10th week of gestation; or

  • not later than the earliest previous miscarriage.


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