Recurrent Early Pregnancy LossPhase 3NCT06036576
Thyroxine Therapy for Recurrent Pregnancy Loss in Hypothyroid Women
A Phase 3 study testing Levothyroxine Pill in people with Recurrent Early Pregnancy Loss and Thyroid Diseases, run by Al-Kindy College of Medicine at 1 site in Iraq.
Trial summary
The goal of this clinical trial is to investigate the influence of thyroxine supplementation on pregnancy outcomes in women with varying levels of Thyroid-Stimulating Hormone (TSH), who have experienced recurrent pregnancy loss in the first trimester. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Recurrent Early Pregnancy Loss, Thyroid Diseases
- What is being tested?
- Levothyroxine Pill
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 77 participants
- Where
- 1 siteIraq
- Study dates
- 1 Mar 2022to 20 Jul 2023
- 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 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women aged 18 to 40 years old.
- Diagnosis of recurrent pregnancy loss, defined as two or more pregnancy losses in the first trimester.
- Confirmed thyroid function test results with TSH levels either between 2.5 and 4 or higher than 4.
- Willing and able to give informed consent for participation in the study.
Who cannot join
- Women who are currently taking thyroid medication before the study starts.
- Presence of other causes of recurrent pregnancy loss such as antiphospholipid syndrome, uterine abnormalities, genetic/chromosomal disorders, etc.
- Presence of other severe chronic diseases like heart disease, kidney disease, uncontrolled diabetes, etc.
- Known allergy or intolerance to thyroxine.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Thyroid-Stimulating Hormone Levels and Recurrent Pregnancy Loss: Influence of Thyroxine Supplementation on Pregnancy Outcomes
The goal of this clinical trial is to investigate the influence of thyroxine supplementation on pregnancy outcomes in women with varying levels of Thyroid-Stimulating Hormone (TSH), who have experienced recurrent pregnancy loss in the first trimester. The main questions it aims to answer are:
- Does thyroxine treatment improve pregnancy outcomes in women with TSH levels between 2.5 mU/L and 4 mU/L?
- Is the effect of thyroxine treatment different in women with TSH levels higher than 4 mU/L?
Read more
Participants will be grouped based on their TSH levels, into two groups - those with TSH levels between 2.5 mU/L and 4 mU/L, and those with TSH levels higher than 4 mU/L. They will then be given thyroxine treatment.
Researchers will compare these two groups to see if the pregnancy outcomes differ based on the different TSH levels and thyroxine treatment.
Read the detailed description
This is a prospective clinical trial that aims to investigate the impact of thyroxine supplementation on the outcomes of pregnancies in women who have experienced recurrent pregnancy loss in the first trimester. The study will specifically focus on the role of Thyroid-Stimulating Hormone (TSH) levels in these outcomes.
Participants in the study will include women who have suffered recurrent pregnancy loss in the first trimester and exhibit varying levels of TSH. For the purpose of this research, these participants will be categorized into two groups based on their TSH levels: the first group will consist of women with TSH levels between 2.5 mU/L and 4 mU/L, and the second group will include those with TSH levels higher than 4 mU/L.
All participants will receive thyroxine treatment, with dosages and treatment plans as determined by their respective healthcare providers. The main purpose of this trial is to examine two key questions:
Does thyroxine treatment lead to improved pregnancy outcomes in women with TSH levels between 2.5 mU/L and 4 mU/L? How does the effect of thyroxine treatment on pregnancy outcomes differ in women with TSH levels higher than 4 mU/L? The primary outcomes of interest in this study will be pregnancy success rates, defined as a viable pregnancy beyond the first trimester. Secondary outcomes might include measurements such as gestational age at delivery, birth weight, and any complications that may arise during pregnancy.
This trial aims to provide valuable insights into the potential benefits of thyroxine treatment for women with varying levels of TSH who have experienced recurrent pregnancy loss. The results could contribute to the development of more effective treatment protocols and ultimately improve pregnancy outcomes for these women.
- Conditions
- Recurrent Early Pregnancy Loss, Thyroid Diseases
- Being tested
- Levothyroxine Pill
- Keywords
- Miscarriage, Hypothyroidism, Thyroid Stimulating Hormone, Thyroxin
- Medical subject headings
- Abortion, Habitual, Thyroid Diseases, Abortion, Spontaneous, Hypothyroidism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Levothyroxine PillDrug
Also called Euthyrox 50 Mcg Tablet, Merck
all participants will receive levothyroxine treatment of 1.6 micrograms per kg per day early in the morning on empty stomach.
| Study group | Role | What they receive |
|---|---|---|
| Thyroid Stimulating Hormone 2.5-4 mU/L | Active comparator | This arm consists of participants who have experienced recurrent pregnancy loss in the first trimester and have TSH levels ranging between 2.5 mU/L and 4 mU/L. These participants will receive levothyroxine treatment of 1.6 micrograms per kg per day Receives: Drug: Levothyroxine Pill |
| Thyroid Stimulating Hormone more than 4 mU/L | Active comparator | This arm consists of participants who have experienced recurrent pregnancy loss in the first trimester and have TSH levels more than 4 mU/L. These participants will receive levothyroxine treatment of 1.6 micrograms per kg per day Receives: Drug: Levothyroxine Pill |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pregnancy Success Rate
The primary outcome measure will be the rate of successful pregnancies, defined as a viable pregnancy beyond the first trimester, among participants in each group. This outcome will be compared between the two groups to determine the impact of thyroxine treatment on successful pregnancies in women with varying levels of TSH.
Measured: Assessed at the end of the first trimester (approximately 12 weeks of gestation) for each participant.
Secondary outcomes (2)
Gestational Age at Delivery
The gestational age at delivery will be recorded and compared between the two groups. This metric provides information about whether thyroxine treatment affects the timing of delivery in this population.
Measured: Assessed at the time of delivery for each participant.
Birth Weight
The birth weight of the baby will be measured and compared between the two groups. This can provide further information on the potential effects of thyroxine treatment on pregnancy outcomes.
Measured: Assessed at the time of delivery for each participant.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2023
- Study start1 Mar 2022
- Primary completion30 May 2023
- Study completion20 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Early Pregnancy LossStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Kindy College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Al-Elwyiah Maternity Teaching Hospital
- Responsible party
- Sponsor
- Investigators
- Sarah Al-Musawi, C.A.B.O.G, Study chair, Al-Kindy College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06036576
- Sponsor's protocol ID
- 15 Al-KindyCM
- Status last verified
- Feb 2022
- First submitted
- 7 Sep 2023
- Last updated
- 14 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thyroid-Stimulating Hormone Levels and Recurrent Pregnancy Loss: Influence of Thyroxine Supplementation on Pregnancy Outcomes
- ClinicalTrials.gov ID
- NCT06036576
- Acronym / sponsor ID
- 15 Al-KindyCM
- Conditions
- Recurrent Early Pregnancy Loss, Thyroid Diseases
- Keywords
- Miscarriage, Hypothyroidism, Thyroid Stimulating Hormone, Thyroxin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Al-Kindy College of MedicineUniversity, hospital or other
- Collaborators
- Al-Elwyiah Maternity Teaching Hospital
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 30 May 2023 (actual)
- Study completion
- 20 Jul 2023 (actual)
- First posted
- 14 Sep 2023 (actual)
- 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 goal of this clinical trial is to investigate the influence of thyroxine supplementation on pregnancy outcomes in women with varying levels of Thyroid-Stimulating Hormone (TSH), who have experienced recurrent pregnancy loss in the first trimester. The main questions it aims to answer are:
- Does thyroxine treatment improve pregnancy outcomes in women with TSH levels between 2.5 mU/L and 4 mU/L?
- Is the effect of thyroxine treatment different in women with TSH levels higher than 4 mU/L?
Participants will be grouped based on their TSH levels, into two groups - those with TSH levels between 2.5 mU/L and 4 mU/L, and those with TSH levels higher than 4 mU/L. They will then be given thyroxine treatment.
Researchers will compare these two groups to see if the pregnancy outcomes differ based on the different TSH levels and thyroxine treatment.
Detailed description
This is a prospective clinical trial that aims to investigate the impact of thyroxine supplementation on the outcomes of pregnancies in women who have experienced recurrent pregnancy loss in the first trimester. The study will specifically focus on the role of Thyroid-Stimulating Hormone (TSH) levels in these outcomes.
Participants in the study will include women who have suffered recurrent pregnancy loss in the first trimester and exhibit varying levels of TSH. For the purpose of this research, these participants will be categorized into two groups based on their TSH levels: the first group will consist of women with TSH levels between 2.5 mU/L and 4 mU/L, and the second group will include those with TSH levels higher than 4 mU/L.
All participants will receive thyroxine treatment, with dosages and treatment plans as determined by their respective healthcare providers. The main purpose of this trial is to examine two key questions:
Does thyroxine treatment lead to improved pregnancy outcomes in women with TSH levels between 2.5 mU/L and 4 mU/L? How does the effect of thyroxine treatment on pregnancy outcomes differ in women with TSH levels higher than 4 mU/L? The primary outcomes of interest in this study will be pregnancy success rates, defined as a viable pregnancy beyond the first trimester. Secondary outcomes might include measurements such as gestational age at delivery, birth weight, and any complications that may arise during pregnancy.
This trial aims to provide valuable insights into the potential benefits of thyroxine treatment for women with varying levels of TSH who have experienced recurrent pregnancy loss. The results could contribute to the development of more effective treatment protocols and ultimately improve pregnancy outcomes for these women.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Thyroid Stimulating Hormone 2.5-4 mU/L | Active comparator | Drug: Levothyroxine PillThis arm consists of participants who have experienced recurrent pregnancy loss in the first trimester and have TSH levels ranging between 2.5 mU/L and 4 mU/L. These participants will receive levothyroxine treatment of 1.6 micrograms per kg per day |
| Thyroid Stimulating Hormone more than 4 mU/L | Active comparator | Drug: Levothyroxine PillThis arm consists of participants who have experienced recurrent pregnancy loss in the first trimester and have TSH levels more than 4 mU/L. These participants will receive levothyroxine treatment of 1.6 micrograms per kg per day |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Women aged 18 to 40 years old.
- Diagnosis of recurrent pregnancy loss, defined as two or more pregnancy losses in the first trimester.
- Confirmed thyroid function test results with TSH levels either between 2.5 and 4 or higher than 4.
- Willing and able to give informed consent for participation in the study.
Key exclusion criteria (4 listed)
- Women who are currently taking thyroid medication before the study starts.
- Presence of other causes of recurrent pregnancy loss such as antiphospholipid syndrome, uterine abnormalities, genetic/chromosomal disorders, etc.
- Presence of other severe chronic diseases like heart disease, kidney disease, uncontrolled diabetes, etc.
- Known allergy or intolerance to thyroxine.
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 |
|---|---|---|
| Levothyroxine PillAlso: Euthyrox 50 Mcg Tablet, Merckall participants will receive levothyroxine treatment of 1.6 micrograms per kg per day early in the morning on empty stomach. | Drug | Thyroid Stimulating Hormone 2.5-4 mU/L, Thyroid Stimulating Hormone more than 4 mU/L |
Primary outcome
Pregnancy Success Rate
Time frame: Assessed at the end of the first trimester (approximately 12 weeks of gestation) for each participant.
The primary outcome measure will be the rate of successful pregnancies, defined as a viable pregnancy beyond the first trimester, among participants in each group. This outcome will be compared between the two groups to determine the impact of thyroxine treatment on successful pregnancies in women with varying levels of TSH.
2 secondary outcomes
Gestational Age at Delivery
Time frame: Assessed at the time of delivery for each participant.
Birth Weight
Time frame: Assessed at the time of delivery for each participant.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2023.
- Individual participant dataSharing planned: No
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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.
Sarah Al-Musawi, C.A.B.O.G study chair
Al-Kindy College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Levothyroxine Pill in people with Recurrent Early Pregnancy Loss and Thyroid Diseases, run by Al-Kindy College of Medicine at 1 site in Iraq.
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 4 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: finished, as of the sponsor's last update on 14 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iraq. 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. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Pregnancy Success Rate (time frame: Assessed at the end of the first trimester (approximately 12 weeks of gestation) for each participant.). 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 14 Sep 2023.