ISRCTN14163439
Completed
未知
Effectiveness of progesterone to prevent miscarriage in women with early pregnancy bleeding: A randomised placebo-controlled trial (PRISM Trial: PRogesterone In Spontaneous Miscarriage Trial)
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Topic: Reproductive health and childbirth
- Sponsor
- niversity of Birmingham
- Enrollment
- 4153
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
2019 results in https://www.ncbi.nlm.nih.gov/pubmed/31067371 [added 09/05/2019] 2020 cost-effectiveness analysis in https://www.ncbi.nlm.nih.gov/pubmed/32003141(03/02/2020) 2020 results in https://pubmed.ncbi.nlm.nih.gov/32609084/ (added 02/07/2020)
Investigators
Eligibility Criteria
Inclusion Criteria
- •Correct as of 01/02/2017
- •1\. Women presenting with with early pregnancy vaginal bleeding that has occurred within the last 4 days and is in the first 12 weeks of pregnancy
- •2\. Upper Age Limit 39 years
- •3\. Lower Age Limit 18 years
- •Previous inclusion criterion:
- •1\. Women presenting with vaginal bleeding in the first 12 weeks of pregnancy with an intrauterine gestation sac visible on ultrasonography
Exclusion Criteria
- •1\. Women of age less than 18 years or more than 40
- •2\. Women with life\-threatening bleeding
- •3\. Women already taking progesterone supplementation therapy
- •4\. Women with contraindications to progesterone use
Outcomes
Primary Outcomes
Not specified
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Effectiveness of progesterone to prevent miscarriage in women with early pregnancy bleeding: A randomised placebo-controlled trial (PRISM Trial: PRogesterone In Spontaneous Miscarriage Trial)EUCTR2014-002348-42-GBniversity of Birmingham4,153
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