NCT02690129.

Trial name or title	Vaginal progesterone for treatment of threatened miscarriage; randomised clinical trial
Methods	RCT intervention model: parallel assignment Masking: single (participant)
Participants	290 women age: 20 years‐35 years Inclusion criteria: pregnant < 24 weeks pregnant presented with bleeding with or without pain, with single viable fetus (confirmed by U/S examination) and accepting to participate in the trial. Exclusion criteria: currently under medication for any chronic diseases, hypersensitivity to progesterone, congenital fetal anomaly, on hormonal treatment in the current pregnancy and women conceived via assisted reproduction technique
Interventions	Intervention group: (progesterone group): complete bed rest for first 48‐72 hours. Single daily dose of natural micronised progesterone (Prontogest ® 200 mg) at bedtime for 15 days. If needed, a pain killer as Indomethacin 50 mg/rectally twice daily up to control of uterine pain. Complete abstaining from sexual activity or strenuous effort. Rh‐ve women will be given a shot of anti‐D immunoglobulin 300 uG/IM if they continue to bleed; after 12 weeks' gestation or if undergo surgical evacuation. Control group: (placebo): will follow the same plan of management without progesterone support.
Outcomes	Primary outcome: miscarriage rate up to 28 weeks of gestation Secondary outcome: gestational age at delivery or termination of pregnancy
Starting date	Feb 2016
Contact information	Omar M Shaaban, MD Address: Faculty of Medicine Assiut, Egypt Tel:+201223971457 Email:omshaaban2000@yahoo.com
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