Recurrent MiscarriagesNCT00180804
Maternal KIR and Fetal HLA-C Genes in Recurrent Miscarriages
An observational study of Recurrent Miscarriages, run by Imperial College London at 1 site in United Kingdom.
Trial summary
For implantation of developing conceptus, placental cells need to invade mother's uterus to access maternal blood supply in a control manner. We have found a combination of maternal immune genes (the KIR family) and fetal genes (HLA-C) strongly associated with pre-eclampsia where placenta does not implant adequately. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Recurrent Miscarriages
- How many people
- 400 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Apr 2005to 31 Aug 2005
- Phase
- Observational
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Couples with 3 or more unexplained miscarriages
Who cannot join
- Previous livebirths, parental karyotypic abnormalities, thrombophilic defects, uterine structural abnormalities
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Combination of Maternal KIR and Fetal HLA-C Genes in Recurrent Miscarriages
For implantation of developing conceptus, placental cells need to invade mother's uterus to access maternal blood supply in a control manner. We have found a combination of maternal immune genes (the KIR family) and fetal genes (HLA-C) strongly associated with pre-eclampsia where placenta does not implant adequately. The aim of this research is to investigate these two genes family in women suffering with recurrent miscarriages and find a possible link between them.
Read the detailed description
Little is known about reasons for early pregnancy failures. It is believed that some pathology leading to defective implantation of fetus in maternal uterus may lead to recurrent early miscarriages. This project arises from previous work on pre-eclampsia where we found combination of maternal immune genes (KIR) with their ligand (HLA-C) in the fetus was strongly associated with the disease. We will tissue type the fetus, mother and father in cases of unexplained miscarriages. We hope that genetic findings in recurrent miscarriage will lead to new insights, prevention and treatment.
- Conditions
- Recurrent Miscarriages
- Medical subject headings
- Abortion, Habitual
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startApr 2005
- Study completion31 Aug 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent MiscarriagesStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe 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
- Observational
- Time perspective
- Other
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ashley Moffett, MRCP, Principal investigator, University of Cambridge, UKRaj Rai, MRCOG, Principal investigator, Imperial College LondonPreeti Jindal, MRCOG, Principal investigator, St. Mary's NHS Trust, LondonWinnie Lo, Principal investigator, St. Mary's NHS Trust, London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00180804
- Sponsor's protocol ID
- 05/MRE02/20
- Status last verified
- Oct 2023
- First submitted
- 13 Sep 2005
- Last updated
- 16 Oct 2023
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combination of Maternal KIR and Fetal HLA-C Genes in Recurrent Miscarriages
- ClinicalTrials.gov ID
- NCT00180804
- Acronym / sponsor ID
- 05/MRE02/20
- Conditions
- Recurrent Miscarriages
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Study start
- Apr 2005
- Study completion
- 31 Aug 2005 (actual)
- First posted
- 16 Sep 2005 (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.
For implantation of developing conceptus, placental cells need to invade mother's uterus to access maternal blood supply in a control manner. We have found a combination of maternal immune genes (the KIR family) and fetal genes (HLA-C) strongly associated with pre-eclampsia where placenta does not implant adequately. The aim of this research is to investigate these two genes family in women suffering with recurrent miscarriages and find a possible link between them.
Detailed description
Little is known about reasons for early pregnancy failures. It is believed that some pathology leading to defective implantation of fetus in maternal uterus may lead to recurrent early miscarriages. This project arises from previous work on pre-eclampsia where we found combination of maternal immune genes (KIR) with their ligand (HLA-C) in the fetus was strongly associated with the disease. We will tissue type the fetus, mother and father in cases of unexplained miscarriages. We hope that genetic findings in recurrent miscarriage will lead to new insights, prevention and treatment.
Study design
- Time perspective
- Other
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Couples with 3 or more unexplained miscarriages
Key exclusion criteria (1 listed)
- Previous livebirths, parental karyotypic abnormalities, thrombophilic defects, uterine structural abnormalities
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 16 Oct 2023.
Related trials for Recurrent Miscarriages
Not yet recruitingObservational study
Cervical Length Reference Range at 28-34 Weeks in Singleton Pregnancies
Preterm Birth, Cervical Length
Not yet recruitingPhase 3
Efficacy of Progesterone and Low Molecular Weight Heparin in Recurrent Pregnancy Loss
Pregnancy Loss, Pregnancy Loss, Early
Not yet recruitingPhase 4
Azithromycin for Cerclage Prophylaxis
Cervical Insufficiency
Not yet recruiting
Personalized Care for Prenatal Stress Reduction & Prevention of Preterm Birth (PTB) Disparities
Preterm Birth Complication, Preterm Birth
Not yet recruitingObservational study
Cohort Study on the Levels of Placental Growth Factor and Nucleosomes in Early Pregnancy and Adverse Pregnancy Outcomes
Preeclampsia, Premature Birth
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.
Ashley Moffett, MRCP principal investigator
University of Cambridge, UK
Raj Rai, MRCOG principal investigator
Imperial College London
Preeti Jindal, MRCOG principal investigator
St. Mary's NHS Trust, London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Recurrent Miscarriages, run by Imperial College London at 1 site in United Kingdom.
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 1 inclusion and 1 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 16 Oct 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 United Kingdom. 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.
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.
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 16 Oct 2023.