Progesterone in Threatened Abortion

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Threatened Abortion in First Trimester

Intervention / Treatment
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* Drug: Progesterone
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pregnant women attending the emergency room of the study sites with the following characteristics: Able and willing to sign the Subject Informed Consent Form and adhere to the study visit schedule; Age: 18-37 years; BMI: 18-28 kg/m2; Symptoms of threatened abortion (vaginal bleeding , with or without pelvic pain); Ultrasound proof of viable singleton intrauterine pregnancy (positive foetal heart beat); Gestation week ≥6 weeks (5 w +1d) and <12 weeks (11 w + 1d) according to ultrasound dating (CRL); Closed uterine cervix; At the first case of threatened abortion in the current pregnancy. Exclusion Criteria: Pregnancy obtained via ART treatment; Subchorionic haematoma with >50% placental detachment; History of recurrent miscarriage; Severe uterine malformations; Known hypersensitivity to study medication; Neoplasias (known or suspected breast or genital tract cancer); Severe impairment of hepatic or renal function; Use of concomitant medications that might interfere with study evaluations (other hormonal treatment or drugs affecting uterine contractility); Active arterial or venous thromboembolism or severe thrombophlebitis, or a history of these events; Porphyria; A history of idiopathic jaundice, severe pruritus or pemphigoid gestationis during pregnancy; Antiphospholipid syndrome; Diabetes mellitus; Known thyroid diseases or autoimmune conditions.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 37 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Progesterone<br>25 mg of subcutaneous progesterone will be administered twice à day until the 12th week of gestation. | Drug: Progesterone<br>* subcutaneous injection of progesterone solution will be performed twice à day from onset of threatened abortion symptoms until week 12 of pregnancy.<br>|
| Placebo Comparator: Placebo<br>placebo will be administered twice à day until the 12th week of gestation. | Drug: Placebo<br>* subcutaneous injection of placebo solution will be performed twice à day from onset of threatened abortion symptoms until week 12 of pregnancy.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ongoing pregnancy rate at 12 weeks of gestation |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of the frequency of uterine contractions; |  | 15 days | 
| Pain reduction (using a Numerical Rating Scale); |  | 15 days | 
| Reduction of subchorionic haematoma; | Size of subchorionic haematoma will be measured (in mm) at screening and after treatment. | 15 days | 
| Number of subjects with onset of new threatened abortion |  | 12 weeks |