Clinical Trial: Progesterone in Threatened Abortion
Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional
Official Title: Prospective, Double-blind, Randomised, Placebo Controlled, Phase III Clinical Study Assessing the Efficacy of Natural Progesterone 25 mg/Bid Administered Subcutaneously in the Maintenance of Early Pre
Brief Summary: The main objective of this study will be to assess the efficacy of natural progesterone at a daily dose of 25 mg/bid in the maintenance of early pregnancy in women with symptoms of threatened abortion. The secondary objectives will be the efficacy of progesterone in reducing both pain and uterine contractions.
Detailed Summary:
Sponsor: IBSA Institut Biochimique SA
Current Primary Outcome: Ongoing pregnancy rate at 12 weeks of gestation [ Time Frame: 12 weeks ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Reduction of the frequency of uterine contractions; [ Time Frame: 15 days ]
- Pain reduction (using a Numerical Rating Scale); [ Time Frame: 15 days ]
- Reduction of subchorionic haematoma; [ Time Frame: 15 days ]Size of subchorionic haematoma will be measured (in mm) at screening and after treatment.
- Number of subjects with onset of new threatened abortion [ Time Frame: 12 weeks ]
Original Secondary Outcome: Same as current
Information By: IBSA Institut Biochimique SA
Dates:
Date Received: October 27, 2016
Date Started: March 2017
Date Completion: November 2019
Last Updated: October 31, 2016
Last Verified: October 2016
