Low Birth Weight InfantsNCT03187938
Alkaline Phosphatase Level in Pregnancy and Its Association With Birth Weight
An observational study of Low Birth Weight Infants, run by TriHealth Inc. at 1 site in United States.
Trial summary
Alkaline phosphatase is known to be produced by syncytiotrophoblasts in the placenta and its levels are normally increased in pregnancy. Therefore, it would be reasonable to hypothesize that alkaline phosphatase would be low to low normal in cases of low birth weight / intrauterine growth restriction (IUGR)/ placental… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Low Birth Weight Infants
- What is being tested?
- Testing of Alkaline Phosphatase Levels
- How many people
- 292 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Jun 2017to 5 Aug 2019
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Pregnant women, aged 18 and older, who are seen for their prenatal care and who are between 24w0d and 28w6d weeks gestation.
Who may be able to join
- Patients enrolled between 24w0d and 28w6d weeks gestational age will be included. The blood specimen of the patients enrolled will be held until delivery.
Who cannot join
- Multiple gestations
- Known congenital malformations (any, except Pyelectasis)
- Chronic hypertension
- Inflammatory bowel disease (IBD)
- Gall bladder disease
- Active bone disease (ie, skeletal dysplasia, healing fracture)
Show all 9Show fewer
- Active liver disease (ie, hepatitis, cholestasis, cholelithiasis (gallstones))
- Pre-existing type 1 and 2 Diabetes
- Early-onset IUGR
Trial locations and contacts
1 site in 1 country.
United States1 site
Good Samaritan TriHealth Hospital
Cincinnati, Ohio, 45220
About this study
Alkaline phosphatase is known to be produced by syncytiotrophoblasts in the placenta and its levels are normally increased in pregnancy. Therefore, it would be reasonable to hypothesize that alkaline phosphatase would be low to low normal in cases of low birth weight / intrauterine growth restriction (IUGR)/ placental insufficiency.
Read the detailed description
The purpose of this study will be to determine if alkaline phosphatase can be used as a predictor for suboptimal fetal growth, placental insufficiency and low birth weight (birth weight less than 2500 grams). It will also help determine if alkaline phosphatase can be used as a screening tool for low birth weight/IUGR at the time of the 24 to 28 week labs.
- Conditions
- Low Birth Weight Infants
- Being tested
- Testing of Alkaline Phosphatase Levels
- Keywords
- Alkaline Phosphatase, Pregnancy, Suboptimal fetal growth, Placental insufficiency, Low birth weight, IUGR
- Medical subject headings
- Placental Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Testing of Alkaline Phosphatase LevelsDiagnostic test
Testing of alkaline phosphatase levels at the time of the 24w0d to 28w6d week labs.
| Study group | Role | What they receive |
|---|---|---|
| Pregnant women at 24-28 weeks gestation | Pregnant women, aged 18 and older, who are seen for their prenatal care and who are between 24w0d and 28w6d weeks gestation.Their alkaline phosphatase levels will be tested in this study. Receives: Diagnostic Test: Testing of Alkaline Phosphatase Levels |
What is being measured
The primary outcome is the main question the study is designed to answer.
Birth Weight at Delivery
Birth Weight at Delivery
Measured: At Delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2017
- Study start14 Jun 2017
- Primary completion5 Aug 2019
- Study completion5 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Birth Weight InfantsStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 292 participants (actual)
Sponsor and investigators
- Lead sponsor
- TriHealth Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Donna Lambers, MD, Principal investigator, TriHealth Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03187938
- Sponsor's protocol ID
- 16-095
- Status last verified
- Aug 2019
- First submitted
- 13 Jun 2017
- Last updated
- 28 Aug 2019
- 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 28 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alkaline Phosphatase Level in Pregnancy and Its Association With Birth Weight
- ClinicalTrials.gov ID
- NCT03187938
- Acronym / sponsor ID
- 16-095
- Conditions
- Low Birth Weight Infants
- Keywords
- Alkaline Phosphatase, Pregnancy, Suboptimal fetal growth, Placental insufficiency, Low birth weight, IUGR
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 292 participants (actual)
- Lead sponsor
- TriHealth Inc.University, hospital or other
- Study start
- 14 Jun 2017 (actual)
- Primary completion
- 5 Aug 2019 (actual)
- Study completion
- 5 Aug 2019 (actual)
- First posted
- 15 Jun 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.
Alkaline phosphatase is known to be produced by syncytiotrophoblasts in the placenta and its levels are normally increased in pregnancy. Therefore, it would be reasonable to hypothesize that alkaline phosphatase would be low to low normal in cases of low birth weight / intrauterine growth restriction (IUGR)/ placental insufficiency.
Detailed description
The purpose of this study will be to determine if alkaline phosphatase can be used as a predictor for suboptimal fetal growth, placental insufficiency and low birth weight (birth weight less than 2500 grams). It will also help determine if alkaline phosphatase can be used as a screening tool for low birth weight/IUGR at the time of the 24 to 28 week labs.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pregnant women at 24-28 weeks gestation | – | Diagnostic Test: Testing of Alkaline Phosphatase LevelsPregnant women, aged 18 and older, who are seen for their prenatal care and who are between 24w0d and 28w6d weeks gestation.Their alkaline phosphatase levels will be tested in this study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Pregnant women, aged 18 and older, who are seen for their prenatal care and who are between 24w0d and 28w6d weeks gestation.
Key inclusion criteria (1 listed)
- Patients enrolled between 24w0d and 28w6d weeks gestational age will be included. The blood specimen of the patients enrolled will be held until delivery.
Key exclusion criteria (9 listed)
- Multiple gestations
- Known congenital malformations (any, except Pyelectasis)
- Chronic hypertension
- Inflammatory bowel disease (IBD)
- Gall bladder disease
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 |
|---|---|---|
| Testing of Alkaline Phosphatase LevelsTesting of alkaline phosphatase levels at the time of the 24w0d to 28w6d week labs. | Diagnostic test | Pregnant women at 24-28 weeks gestation |
Primary outcome
Birth Weight at Delivery
Time frame: At Delivery
Birth Weight at Delivery
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 28 Aug 2019.
- 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.
Donna Lambers, MD principal investigator
TriHealth Inc.
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 Low Birth Weight Infants, run by TriHealth Inc. at 1 site 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 1 inclusion and 9 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 28 Aug 2019. 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 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. 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?
Birth Weight at Delivery (time frame: At Delivery). 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 28 Aug 2019; AzTrials last refreshed its copy on 6 Nov 2026.