Recurrent Pregnancy LossNCT05205044
Evaluation of Apelin-13 and Apelin-36 in Women With Recurrent Pregnancy Loss
An observational study of Recurrent Pregnancy Loss, run by Ain Shams University at 2 sites in Egypt.
Trial summary
Lower Apelin levels are associated with hypertensive disorders with pregnancy, yet no studies investigated its levels in recurrent pregnancy loss Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Recurrent Pregnancy Loss
- What is being tested?
- Apelin-13, Apelin-36
- How many people
- 88 participants
- Where
- 2 sitesEgypt
- Study dates
- 23 Jan 2022to 30 Jan 2023
- 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 18 to 40 years
- Women only
- Adult
Study population: Pregnant females in first trimester
Who may be able to join
- pregnant women in first trimester
- negative antiphospholipid markers
- normal karyotype
Who cannot join
- multiple pregnancy
- fetal malformations
- maternal diseases
- smoking or alcohol use
- history of or risk factors for preterm labor
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites
Ain Shams University Maternity Hospital
Cairo, Cairo/القاهرة, 71350
AinShams Maternity Hospital
Cairo, 002
About this study
Official title: Evaluation of Apelin-13 and Apelin-36 Concentrations in Women With Primary Unexplained Recurrent Pregnancy Loss
Lower Apelin levels are associated with hypertensive disorders with pregnancy, yet no studies investigated its levels in recurrent pregnancy loss
- Conditions
- Recurrent Pregnancy Loss
- Being tested
- Apelin-13, Apelin-36
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Apelin-13, Apelin-36Diagnostic test
Serum levels of Apelin-13 and Apelin-36
| Study group | Role | What they receive |
|---|---|---|
| Recurrent pregnancy loss | Not described Receives: Diagnostic Test: Apelin-13, Apelin-36 | |
| Healthy | Not described Receives: Diagnostic Test: Apelin-13, Apelin-36 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Apelin-13 and Apelin-36
Serum levels of Apelin-13 and Apelin-36
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2022
- Study start23 Jan 2022
- Primary completion30 Jan 2023
- Study completion30 Jan 2023
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 Ain Shams UniversityThe 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
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05205044
- Sponsor's protocol ID
- MS 672/2021
- Status last verified
- Feb 2023
- First submitted
- 11 Jan 2022
- Last updated
- 14 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Apelin-13 and Apelin-36 Concentrations in Women With Primary Unexplained Recurrent Pregnancy Loss
- ClinicalTrials.gov ID
- NCT05205044
- Acronym / sponsor ID
- MS 672/2021
- Conditions
- Recurrent Pregnancy Loss
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 23 Jan 2022 (actual)
- Primary completion
- 30 Jan 2023 (actual)
- Study completion
- 30 Jan 2023 (actual)
- First posted
- 24 Jan 2022 (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.
Lower Apelin levels are associated with hypertensive disorders with pregnancy, yet no studies investigated its levels in recurrent pregnancy loss
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Recurrent pregnancy loss | – | Diagnostic Test: Apelin-13, Apelin-36 |
| Healthy | – | Diagnostic Test: Apelin-13, Apelin-36 |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- Pregnant females in first trimester
Key inclusion criteria (3 listed)
- pregnant women in first trimester
- negative antiphospholipid markers
- normal karyotype
Key exclusion criteria (5 listed)
- multiple pregnancy
- fetal malformations
- maternal diseases
- smoking or alcohol use
- history of or risk factors for preterm labor
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 |
|---|---|---|
| Apelin-13, Apelin-36Serum levels of Apelin-13 and Apelin-36 | Diagnostic test | Healthy, Recurrent pregnancy loss |
Primary outcome
Apelin-13 and Apelin-36
Time frame: 1 year
Serum levels of Apelin-13 and Apelin-36
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 Feb 2023.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Recurrent Pregnancy Loss, run by Ain Shams University at 2 sites in Egypt.
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 3 inclusion and 5 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 Feb 2023. 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 Egypt. 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.
What does the primary outcome measure?
Apelin-13 and Apelin-36 (time frame: 1 year). 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 Feb 2023.