A randomized double-blind controlled trial of the use of dydrogesterone in women with threatened miscarriage in the first trimester: study protocol for a randomized controlled trial

Table 1 The schedule of enrollment, interventions and assessments^a

	Study period
	Enrollment	Allocation	Post-allocation			Close-out
Timepoint^b	3/2016 until present	0	Weekly until 12 completed gestational weeks or 1 week after bleeding has stopped, whichever is longer	20 weeks	Until delivery	24th month
Enrollment:
Eligibility screen	X
Informed consent	X
(List other procedures)
Allocation		X
Interventions:
(Dydrogesterone)			X
(Placebo)			X
(List other study groups)
Assessments:
Pelvic scan, serum hCG and progesterone			X
(Primary outcome)				X
(Secondary outcomes)					X	X

^aRecommended content can be displayed using various schematic formats. See SPIRIT 2013 Explanation and Elaboration for examples from protocols [27]
^bList of specific timepoints in this row
hCG human chorionic gonadotropin

ISSN: 1745-6215