Preterm LaborNCT03205020
Maternal Serum Amyloid A Levels in Pregnancies Complicated With Preterm Labour.
An observational study of Preterm Labor, run by mona nematallah at 1 site in Egypt.
Trial summary
The aim of the current study is to assess the accuracy of maternal serum amyloid A for prediction of preterm labor in women with threatened preterm labor. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Preterm Labor
- What is being tested?
- serum amyloid a test
- How many people
- 58 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2017to 1 Feb 2018
- How long will I take part?
- 6 Months
- 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 35 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: 58 pregnant women will be recruited
Who may be able to join
- Pregnant women, age 18 - 35.
- Gestational age: 28 - 36+6 weeks.
- Singleton pregnancy.
- No past history of any medical disorder and with no other medical complications during pregnancy
- Nonsmoker.
- Diagnosis of preterm labor is based on the American College of Obstetricians and Gynecologists Guidelines
Show all 11Show fewer
- Criteria of preterm delivery:
- Gestational age: 28 - 36+6 weeks
- Presence of uterine contractions (at least 4 in 20 minutes or 8 in 60 minutes)
- cervical dilation ≥ 4 cm
- Cervical effacement ≥ 80%.
Who cannot join
- Of any patient with the following risk factors for preterm labor:
- Over distended uterus .
- hemorrhage
- Uterine anomalies
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Ain Shams University
Cairo
ahmed hussien, MD, 01061460044
About this study
The aim of the current study is to assess the accuracy of maternal serum amyloid A for prediction of preterm labor in women with threatened preterm labor.
- Conditions
- Preterm Labor
- Being tested
- serum amyloid a test
- Medical subject headings
- Obstetric Labor, Premature
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
serum amyloid a testDiagnostic test
- Women who are diagnosed with preterm labor (28-36 weeks) will be enrolled in this study. Serum samples will be collected from all women before any intervention. All women will be sampled once at the time of admission.
- Venous blood sample (5 c.c) will be taken from each participant for examination of serum amyloid A.
- The collected blood will be centrifuging and serum will be stored to measure the level of amyloid A by (ELISA) technique in clinical pathology department- Ain shams University
| Study group | Role | What they receive |
|---|---|---|
| women with preterm labor | Not described Receives: Diagnostic Test: serum amyloid a test | |
| women delivered at full term | Not described Receives: Diagnostic Test: serum amyloid a test |
What is being measured
The primary outcome is the main question the study is designed to answer.
prevalence of Amyloid A level in women with preterm labour
venous sample will be taken from each participant from onset of labour, Amyloid a level will be calculated
Measured: 6 months
Secondary outcomes (1)
neonatal complications
preterm baby will be examined at neonatal intensive care unit by neonatologist.
- Admission to Neonates intensive care unit.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2017
- Study start1 Jul 2017 (estimated)
- Primary completion1 Jan 2018 (estimated)
- Study completion1 Feb 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preterm LaborStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 58 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- mona nematallah
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, mona nematallah, Ain Shams University
- Investigators
- mona mohamed, MS, Study chair, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03205020
- Sponsor's protocol ID
- amyloid a
- Status last verified
- Jun 2017
- First submitted
- 13 Jun 2017
- Last updated
- 5 Jul 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maternal Serum Amyloid A Levels in Pregnancies Complicated With Preterm Labour.
- ClinicalTrials.gov ID
- NCT03205020
- Acronym / sponsor ID
- amyloid a
- Conditions
- Preterm Labor
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- mona nematallahUniversity, hospital or other
- Study start
- 1 Jul 2017 (estimated)
- Primary completion
- 1 Jan 2018 (estimated)
- Study completion
- 1 Feb 2018 (estimated)
- First posted
- 2 Jul 2017 (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 aim of the current study is to assess the accuracy of maternal serum amyloid A for prediction of preterm labor in women with threatened preterm labor.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| women with preterm labor | – | Diagnostic Test: serum amyloid a test |
| women delivered at full term | – | Diagnostic Test: serum amyloid a test |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- 58 pregnant women will be recruited
Key inclusion criteria (11 listed)
- Pregnant women, age 18 - 35.
- Gestational age: 28 - 36+6 weeks.
- Singleton pregnancy.
- No past history of any medical disorder and with no other medical complications during pregnancy
- Nonsmoker.
Key exclusion criteria (4 listed)
- Of any patient with the following 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 |
|---|---|---|
| serum amyloid a test* Women who are diagnosed with preterm labor (28-36 weeks) will be enrolled in this study. Serum samples will be collected from all women before any intervention. All women will be sampled once at the time of admission. * Venous blood sample (5 c.c) will be taken from each participant for examination of serum amyloid A. * The collected blood will be centrifuging and serum will be stored to measure the level of amyloid A by (ELISA) technique in clinical pathology department- Ain shams University | Diagnostic test | women delivered at full term, women with preterm labor |
Primary outcome
prevalence of Amyloid A level in women with preterm labour
Time frame: 6 months
venous sample will be taken from each participant from onset of labour, Amyloid a level will be calculated
1 secondary outcome
neonatal complications
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2017.
Related trials for Preterm Labor
Not yet recruiting
nCPAP-NAVA-Backup Versus Standard nCPAP for Severe Apnea in Preterm Infants ≤28 Weeks
Apnea of Prematurity
Recruiting
Study of the Influence of Intraperitoneal Insufflation of CO2 by Laparoscopy on the Short-term Evolution of Premature Infants With Ulcerative Necrotizing Enterocolitis
Preterm Birth, Enterocolitis, Necrotizing
RecruitingObservational study
Multidimensional Dynamic Early Warning System for Neonatal Necrotizing Enterocolitis: A Multicenter Clinical Study
NEC - Necrotizing Enterocolitis
Recruiting
Optimization of Saturation Targets And Resuscitation Trial (OptiSTART)
Premature Infants, Bronchopulmonary Dysplasia
RecruitingObservational study
Growing Little PEAPODS Study
Premature Birth, Premature Infant
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.
mona mohamed, MS study chair
Ain Shams University
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 Preterm Labor, run by mona nematallah at 1 site 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 11 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: status not confirmed, as of the sponsor's last update on 5 Jul 2017. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact mona cairo nematallah, MS (01061490044 ext. ain shams, drmonanematallah11@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
prevalence of Amyloid A level in women with preterm labour (time frame: 6 months). 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 5 Jul 2017.