Recurrent Pregnancy LossPhase 2NCT02379650
Hydroxychloroquine (HCQ) for Recurrent Pregnancy Loss
A Phase 2 study testing Hydroxychloroquine (HCQ) in people with Recurrent Pregnancy Loss and Miscarriage, run by University of Utah at 2 sites in United States.
Trial summary
Recurrent pregnancy loss (RPL) affects 5% of couples trying to achieve parenthood. Most cases of RPL are unexplained and have no effective treatment to improve the likelihood of a pregnancy resulting in a live birth. This leads to significant patient and provider frustration and emotional stress. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Recurrent Pregnancy Loss, Miscarriage
- What is being tested?
- Hydroxychloroquine (HCQ)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 2 sitesUnited States
- Study dates
- Jul 2016to Jul 2021
- Phase
- Phase 2
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women ages 18 and older
- Planning conception and have experienced 2 or more unexplained pregnancy losses prior to 20 weeks gestation and no more than one live birth
Who cannot join
- Documented antiphospholipd antibodies
- Uterine malformation or parental chromosomal abnormality
- Known lupus or other medical conditions that require treatment with hydroxychloroquine outside of this study protocol
- Any medical contraindications to hydroxychloroquine or aspirin therapy, including liver or kidney disease, pregestational diabetes or known retinopathy
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Intermountain Healthcare
Salt Lake City, Utah, 84107
University of Utah Hospital
Salt Lake City, Utah, 84132
About this study
Official title: RCT Assessing Hydroxychloroquine for Unexplained Recurrent Pregnancy Loss
Recurrent pregnancy loss (RPL) affects 5% of couples trying to achieve parenthood. Most cases of RPL are unexplained and have no effective treatment to improve the likelihood of a pregnancy resulting in a live birth. This leads to significant patient and provider frustration and emotional stress. Hydroxychloroquine (HCQ) is a medication commonly used in pregnancy to treat autoimmune and connective tissue diseases such as systemic lupus erythematosus (SLE). This use has shown that HCQ is very safe in pregnancy. HCQ has anti-inflammatory and anti-thrombotic effects and thus may improve pregnancy outcomes in couples with unexplained RPL. Although some providers are already prescribing HCQ for unexplained RPL, a randomized controlled trial is necessary to determine the true efficacy and safety of this treatment. This study has the potential to establish support for a new treatment option for unexplained RPL.
- Conditions
- Recurrent Pregnancy Loss, Miscarriage
- Being tested
- Hydroxychloroquine (HCQ), Placebo
- Medical subject headings
- Abortion, Spontaneous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydroxychloroquine (HCQ)Drug
Also called Plaquenil®
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Hydroxychloroquine (HCQ) | Experimental | Subjects in the experimental arm will take 400 mg hydroxychloroquine pills every day, starting before they get pregnant and continuing until 36 weeks of pregnancy or until the pregnancy is over. Receives: Drug: Hydroxychloroquine (HCQ) |
| Placebo | Placebo comparator | Subjects in the experimental arm will take placebo pills every day, starting before they get pregnant and continuing until 36 weeks of pregnancy or until the pregnancy is over. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Live Birth
Frequency of pregnancies resulting in live birth
Measured: Duration of gestation (up to 42 weeks)
Secondary outcomes (1)
Adverse Pregnancy Outcomes
Preterm birth, fetal growth restriction, stillbirth, placental insufficiency
Measured: Duration of gestation (up to 42 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2015 (estimated)
- Study startJul 2016
- Primary completionJul 2019 (estimated)
- Study completionJul 2021 (estimated)
Why it stopped: Testing required by FDA for IND approval was too expensive to move forward with conduct of the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Pregnancy LossStudies of the same condition, open and under way.
- More trials run by University of UtahThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Collaborators
- Intermountain Health Care, Inc.
- Responsible party
- Principal investigator, Robert Silver, University of Utah
- Investigators
- Robert Silver, MD, Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02379650
- Sponsor's protocol ID
- 78134
- Status last verified
- Aug 2016
- First submitted
- 28 Feb 2015
- Last updated
- 12 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RCT Assessing Hydroxychloroquine for Unexplained Recurrent Pregnancy Loss
- ClinicalTrials.gov ID
- NCT02379650
- Acronym / sponsor ID
- 78134
- Conditions
- Recurrent Pregnancy Loss, Miscarriage
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Testing required by FDA for IND approval was too expensive to move forward with conduct of the study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Collaborators
- Intermountain Health Care, Inc.
- Study start
- Jul 2016
- Primary completion
- Jul 2019 (estimated)
- Study completion
- Jul 2021 (estimated)
- First posted
- 5 Mar 2015 (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.
Recurrent pregnancy loss (RPL) affects 5% of couples trying to achieve parenthood. Most cases of RPL are unexplained and have no effective treatment to improve the likelihood of a pregnancy resulting in a live birth. This leads to significant patient and provider frustration and emotional stress. Hydroxychloroquine (HCQ) is a medication commonly used in pregnancy to treat autoimmune and connective tissue diseases such as systemic lupus erythematosus (SLE). This use has shown that HCQ is very safe in pregnancy. HCQ has anti-inflammatory and anti-thrombotic effects and thus may improve pregnancy outcomes in couples with unexplained RPL. Although some providers are already prescribing HCQ for unexplained RPL, a randomized controlled trial is necessary to determine the true efficacy and safety of this treatment. This study has the potential to establish support for a new treatment option for unexplained RPL.
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 |
|---|---|---|
| Hydroxychloroquine (HCQ) | Experimental | Drug: Hydroxychloroquine (HCQ)Subjects in the experimental arm will take 400 mg hydroxychloroquine pills every day, starting before they get pregnant and continuing until 36 weeks of pregnancy or until the pregnancy is over. |
| Placebo | Placebo comparator | Drug: PlaceboSubjects in the experimental arm will take placebo pills every day, starting before they get pregnant and continuing until 36 weeks of pregnancy or until the pregnancy is over. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Women ages 18 and older
- Planning conception and have experienced 2 or more unexplained pregnancy losses prior to 20 weeks gestation and no more than one live birth
Key exclusion criteria (4 listed)
- Documented antiphospholipd antibodies
- Uterine malformation or parental chromosomal abnormality
- Known lupus or other medical conditions that require treatment with hydroxychloroquine outside of this study protocol
- Any medical contraindications to hydroxychloroquine or aspirin therapy, including liver or kidney disease, pregestational diabetes or known retinopathy
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 |
|---|---|---|
| Hydroxychloroquine (HCQ)Also: Plaquenil® | Drug | Hydroxychloroquine (HCQ) |
| Placebo | Drug | Placebo |
Primary outcome
Live Birth
Time frame: Duration of gestation (up to 42 weeks)
Frequency of pregnancies resulting in live birth
1 secondary outcome
Adverse Pregnancy Outcomes
Time frame: Duration of gestation (up to 42 weeks)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2016.
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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.
Robert Silver, MD principal investigator
University of Utah
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Hydroxychloroquine (HCQ) in people with Recurrent Pregnancy Loss and Miscarriage, run by University of Utah at 2 sites in United States.
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 2 inclusion and 4 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: withdrawn, as of the sponsor's last update on 12 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 withdrawn before enrolling participants, so there are no results.
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?
Live Birth (time frame: Duration of gestation (up to 42 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 12 Aug 2016.