Threatened Abortion in First TrimesterPhase 3NCT02950935
Progesterone in Threatened Abortion
A Phase 3 study testing Progesterone in people with Threatened Abortion in First Trimester, run by IBSA Institut Biochimique SA at 4 sites in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 37 years, women only
- Conditions the study is for
- Threatened Abortion in First Trimester
- What is being tested?
- Progesterone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 4 participants
- Where
- 4 sitesItaly
- Study dates
- 4 Apr 2017to 2 May 2018
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 37 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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);
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- 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.
Who cannot join
- 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);
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- 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.
Trial locations and contacts
4 sites in 1 country.
Italy4 sites
P.O.G. Salesi
Ancona, 60126
"F. Miulli" Regional General Hospital
Bari, BA, 70021
Ospedale Cervesi
Cattolica
Presidio Ospedale S'Anna
Torino, 10126
About this study
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
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.
- Conditions
- Threatened Abortion in First Trimester
- Being tested
- Progesterone, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProgesteroneDrug
subcutaneous injection of progesterone solution will be performed twice à day from onset of threatened abortion symptoms until week 12 of pregnancy.
PlaceboDrug
subcutaneous injection of placebo solution will be performed twice à day from onset of threatened abortion symptoms until week 12 of pregnancy.
| Study group | Role | What they receive |
|---|---|---|
| Progesterone | Experimental | 25 mg of subcutaneous progesterone will be administered twice à day until the 12th week of gestation. Receives: Drug: Progesterone |
| Placebo | Placebo comparator | placebo will be administered twice à day until the 12th week of gestation. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ongoing pregnancy rate at 12 weeks of gestation
Measured: 12 weeks
Secondary outcomes (4)
Reduction of the frequency of uterine contractions;
Measured: 15 days
Pain reduction (using a Numerical Rating Scale);
Measured: 15 days
Reduction of subchorionic haematoma;
Size of subchorionic haematoma will be measured (in mm) at screening and after treatment.
Measured: 15 days
Number of subjects with onset of new threatened abortion
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2016 (estimated)
- Study start4 Apr 2017
- Primary completion2 May 2018
- Study completion2 May 2018
Why it stopped: Difficulty in recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Threatened Abortion in First TrimesterStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- IBSA Institut Biochimique SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02950935
- Sponsor's protocol ID
- 16I-Prg06
- Status last verified
- Jul 2018
- First submitted
- 27 Oct 2016
- Last updated
- 20 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02950935
- Acronym / sponsor ID
- 16I-Prg06
- Conditions
- Threatened Abortion in First Trimester
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulty in recruitment
- Enrolment
- 4 participants (actual)
- Lead sponsor
- IBSA Institut Biochimique SAIndustry (pharma, biotech, devices)
- Study start
- 4 Apr 2017 (actual)
- Primary completion
- 2 May 2018 (actual)
- Study completion
- 2 May 2018 (actual)
- First posted
- 1 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Progesterone | Experimental | Drug: Progesterone25 mg of subcutaneous progesterone will be administered twice à day until the 12th week of gestation. |
| Placebo | Placebo comparator | Drug: Placeboplacebo will be administered twice à day until the 12th week of gestation. |
Who may qualify
- Ages
- 18 to 37 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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);
Key exclusion criteria (14 listed)
- Pregnancy obtained via ART treatment;
- Subchorionic haematoma with >50% placental detachment;
- History of recurrent miscarriage;
- Severe uterine malformations;
- Known hypersensitivity to study medication;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Progesteronesubcutaneous injection of progesterone solution will be performed twice à day from onset of threatened abortion symptoms until week 12 of pregnancy. | Drug | Progesterone |
| Placebosubcutaneous injection of placebo solution will be performed twice à day from onset of threatened abortion symptoms until week 12 of pregnancy. | Drug | Placebo |
Primary outcome
Ongoing pregnancy rate at 12 weeks of gestation
Time frame: 12 weeks
4 secondary outcomes
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
Number of subjects with onset of new threatened abortion
Time frame: 12 weeks
Results and safety
The study was stopped early (reason given: Difficulty in recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2018.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Progesterone in people with Threatened Abortion in First Trimester, run by IBSA Institut Biochimique SA at 4 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 20 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Difficulty in recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ongoing pregnancy rate at 12 weeks of gestation (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2018.