Progesterone in Threatened Abortion
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|ClinicalTrials.gov Identifier: NCT02950935|
Recruitment Status : Terminated (Difficulty in recruitment)
First Posted : November 1, 2016
Last Update Posted : July 20, 2018
|Condition or disease||Intervention/treatment||Phase|
|Threatened Abortion in First Trimester||Drug: Progesterone Drug: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||4 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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 Pregnancy in Women With Symptoms of Threatened Abortion|
|Actual Study Start Date :||April 4, 2017|
|Actual Primary Completion Date :||May 2, 2018|
|Actual Study Completion Date :||May 2, 2018|
25 mg of subcutaneous progesterone will be administered twice à day until the 12th week of gestation.
subcutaneous injection of progesterone solution will be performed twice à day from onset of threatened abortion symptoms until week 12 of pregnancy.
Placebo Comparator: Placebo
placebo will be administered twice à day until the 12th week of gestation.
subcutaneous injection of placebo solution will be performed twice à day from onset of threatened abortion symptoms until week 12 of pregnancy.
- Ongoing pregnancy rate at 12 weeks of gestation [ Time Frame: 12 weeks ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02950935
|"F. Miulli" Regional General Hospital|
|Bari, BA, Italy, 70021|
|Ancona, Italy, 60126|
|Presidio Ospedale S'Anna|
|Torino, Italy, 10126|