HealthyNCT03614312
Placenta Development Study
An observational study of Healthy, run by Arkansas Children's Hospital Research Institute at 1 site in United States.
Trial summary
This study will help us learn more about how the placenta develops. 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
- Healthy
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Apr 2018to 22 Dec 2021
- 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
Who may be able to join
- BMI - 18-25 kg/m2
- at least 18 years of age
- singleton pregnancy
- less than 36 weeks and plan to deliver in the Little Rock/North Little Rock Area
Who cannot join
- Women with pre-existing medical conditions (e.g. diabetes, hypertension, pre-eclampsia, STD, gestational diabetes)
- Women who are using recreational drugs, tobacco, or alcohol during their pregnancy.
- Women who plan on keeping their placenta following delivery for non-medical reasons.
Trial locations and contacts
1 site in 1 country.
United States1 site
Arkansas Children's Nutrition Center
Little Rock, Arkansas, 72202
About this study
Official title: Epigenetic Mechanisms Underlying Trophoblast Syncytialization
This study will help us learn more about how the placenta develops.
Read the detailed description
The primary purpose of this study is to understand the epigenetic signaling events in placental trophoblast development.
- Conditions
- Healthy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| BMI 18-25 Pregnant Women | BMI 18-25 less than 36 weeks pregnant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants that placental syncytial fusion involves epigenetic changes in histone modifications
Number of participants that histone acetyltransferases eszymes, CBP and p300 affect syncytial fusion
Measured: 40 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2018
- Study start17 Apr 2018
- Primary completion22 Dec 2021
- Study completion22 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arkansas Children's Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03614312
- Sponsor's protocol ID
- 206617
- Status last verified
- Dec 2023
- First submitted
- 5 Mar 2018
- Last updated
- 20 Dec 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 20 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epigenetic Mechanisms Underlying Trophoblast Syncytialization
- ClinicalTrials.gov ID
- NCT03614312
- Acronym / sponsor ID
- 206617
- Conditions
- Healthy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Arkansas Children's Hospital Research InstituteUniversity, hospital or other
- Study start
- 17 Apr 2018 (actual)
- Primary completion
- 22 Dec 2021 (actual)
- Study completion
- 22 Dec 2021 (actual)
- First posted
- 3 Aug 2018 (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.
This study will help us learn more about how the placenta develops.
Detailed description
The primary purpose of this study is to understand the epigenetic signaling events in placental trophoblast development.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BMI 18-25 Pregnant Women | – | –BMI 18-25 less than 36 weeks pregnant |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Pregnant
Key inclusion criteria (4 listed)
- BMI - 18-25 kg/m2
- at least 18 years of age
- singleton pregnancy
- less than 36 weeks and plan to deliver in the Little Rock/North Little Rock Area
Key exclusion criteria (3 listed)
- Women with pre-existing medical conditions (e.g. diabetes, hypertension, pre-eclampsia, STD, gestational diabetes)
- Women who are using recreational drugs, tobacco, or alcohol during their pregnancy.
- Women who plan on keeping their placenta following delivery for non-medical reasons.
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
Number of participants that placental syncytial fusion involves epigenetic changes in histone modifications
Time frame: 40 weeks
Number of participants that histone acetyltransferases eszymes, CBP and p300 affect syncytial fusion
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 20 Dec 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Healthy, run by Arkansas Children's Hospital Research Institute 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 4 inclusion and 3 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 20 Dec 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 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?
Number of participants that placental syncytial fusion involves epigenetic changes in histone modifications (time frame: 40 weeks). 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 20 Dec 2023; AzTrials last refreshed its copy on 27 Oct 2026.