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

Ismail 2017.

Methods Unit of randomization: pregnancy
 Method of randomization: computer‐generated tables
 Timing of randomization: before trying to conceive
 Power calculation: yes, needed 350 in each arm
 Blinding: yes (double)
 Number of centers: 1 ‐ Recurrent Miscarriage Clinic of Assiut Women's Health Hospital
700 women randomized, 675 women analyzed
Source of funding: not stated
Participants All women who presented to the clinic, "regular marital life with the same partner". Not specifically stated the inclusion criteria or definition of recurrent miscarriage but assumed it is similar to others based on other text as at least 3 unexplained miscarriages.
Exclusion: known cause of recurrent miscarriage, antiphospholipid antibody syndrome, consanguinity
 Age: 20‐39
Location: Egypt
Interventions 400 mg progesterone pessary suppositories twice daily
Control: matched placebo pessaries manufactured to look identical
Treatment began immediately after documentation of ovulation using ultrasound. Continued until 28 weeks of gestation. Stopped if did not become pregnant that cycle ‐ allowed up to 6 cycles
Outcomes Miscarriage rate (primary), viable pregnancy > 20 weeks, live birth rate, vaginal bleeding, preterm delivery, cytokine levels
Notes Dates of study: September 2012‐November 2015
Funding sources: NIHR‐HTA, UK
Declarations of interest: the trial authors reported "no conflicts of interest".
This study will remain in awaiting classification pending clarification regarding the study data.
Since publication of the 2018 update of this review, we have been advised that the Ismail 2017 study is currently the subject of an investigation by the Journal of Maternal‐Fetal & Neonatal Medicine. Consequently, we have now moved this study from 'included studies' to 'studies awaiting classification' until the outcome of the investigation is known.