ObesityMIFONCT01935076
miRNA in Fetal Overgrowth
An observational study of Obesity, run by University of Pennsylvania at 1 site in United States.
Trial summary
The purpose of this study is to determine whether placental and umbilical cord blood miRNA expression is altered in women with obesity with macrosomic neonates to when compared to miRNA expression from control patients. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Obesity
- What is being tested?
- Neonatal exposure to maternal obesity
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 82 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2013to Feb 2014
- 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 45 years
- Women only
- No healthy volunteers
- Adult
Study population: All patients delivering in the labor and delivery unit at the Hospital of the University of Pennsylvania.
Who may be able to join
- singleton pregnancy
- prenatal care \& delivery at the Hospital of the University of Pennsylvania system
- Normal glucose tolerance test results (less than 120 mg/dl)
Who cannot join
- Multiple gestation
- under 18 years old, or over 45 years old
- chronic hypertension
- preeclampsia
- chronic steroid use
- diabetes
Show all 10Show fewer
- major fetal anomaly
- connective tissue disorder requiring medication
- active HIV
- Hepatitis C
Trial locations and contacts
1 site in 1 country.
United States1 site
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: Placental miRNA (microRNA) Profile in Fetal Overgrowth Related to Maternal Obesity Study
The purpose of this study is to determine whether placental and umbilical cord blood miRNA expression is altered in women with obesity with macrosomic neonates to when compared to miRNA expression from control patients.
Read the detailed description
MicroRNA's are a class of non-coding RNA's that function as translational repressors and are thought to modulate tissue development, proliferation, differentiation and function. Differential expression of certain placental miRNA's has been associated with preeclampsia.
The fetal origins of adult disease hypothesis suggests that risk factors from intrauterine environmental exposures affect the fetus' development during sensitive periods, and increases the risk of specific diseases in adult life. Our aim is to understand factors that predispose fetuses to fetal overgrowth in utero, especially in women with obesity. The objective of the study is to identify miRNA which are differentially expressed in the placenta and cord blood of pregnancies that are affected by fetal macrosomia to determine factors that may predispose fetuses to fetal overgrowth.
- Conditions
- Obesity
- Being tested
- Neonatal exposure to maternal obesity
- Keywords
- Maternal obesity, Macrosomic, miRNA, Fetal overgrowth
- Medical subject headings
- Obesity, Pregnancy in Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neonatal exposure to maternal obesityBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Obese mother/ Macrosomic baby | Obese mother that delivers a macrosomic neonate to understand the effects neonatal exposure to maternal obesity. Receives: Behavioral: Neonatal exposure to maternal obesity | |
| Obese mother/ normal weight baby | Obese mother that delivers a normal weight neonate to understand effects neonatal exposure to maternal obesity. Receives: Behavioral: Neonatal exposure to maternal obesity | |
| Normal weight mother/ Macrosomic baby | Normal weight mother that delivers a macrosomic neonate | |
| Normal weight mother/ Normal weight baby | Normal weight mother who delivered a normal weight neonate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fetal Overgrowth
Placental and cord blood samples will be studied for miRNA expression. The objective of the study is to identify miRNA which are differentially expressed in the placenta and cord blood of pregnancies that are affected by fetal macrosomia to determine factors that may predispose fetuses to fetal overgrowth.
Measured: Delivery date to up to 6 weeks post partum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2013 (estimated)
- Study startJan 2013
- Primary completionFeb 2014
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Celeste Durnwald, University of Pennsylvania
- Investigators
- Celeste P Durnwald, MD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01935076
- Sponsor's protocol ID
- 817124
- Acronym
- MIFO
- Status last verified
- May 2014
- First submitted
- 19 Aug 2013
- Last updated
- 26 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Placental miRNA (microRNA) Profile in Fetal Overgrowth Related to Maternal Obesity Study
- ClinicalTrials.gov ID
- NCT01935076
- Acronym / sponsor ID
- MIFO / 817124
- Conditions
- Obesity
- Keywords
- Maternal obesity, Macrosomic, miRNA, Fetal overgrowth
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 4 Sep 2013 (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.
The purpose of this study is to determine whether placental and umbilical cord blood miRNA expression is altered in women with obesity with macrosomic neonates to when compared to miRNA expression from control patients.
Detailed description
MicroRNA's are a class of non-coding RNA's that function as translational repressors and are thought to modulate tissue development, proliferation, differentiation and function. Differential expression of certain placental miRNA's has been associated with preeclampsia.
The fetal origins of adult disease hypothesis suggests that risk factors from intrauterine environmental exposures affect the fetus' development during sensitive periods, and increases the risk of specific diseases in adult life. Our aim is to understand factors that predispose fetuses to fetal overgrowth in utero, especially in women with obesity. The objective of the study is to identify miRNA which are differentially expressed in the placenta and cord blood of pregnancies that are affected by fetal macrosomia to determine factors that may predispose fetuses to fetal overgrowth.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Obese mother/ Macrosomic baby | – | Behavioral: Neonatal exposure to maternal obesityObese mother that delivers a macrosomic neonate to understand the effects neonatal exposure to maternal obesity. |
| Obese mother/ normal weight baby | – | Behavioral: Neonatal exposure to maternal obesityObese mother that delivers a normal weight neonate to understand effects neonatal exposure to maternal obesity. |
| Normal weight mother/ Macrosomic baby | – | –Normal weight mother that delivers a macrosomic neonate |
| Normal weight mother/ Normal weight baby | – | –Normal weight mother who delivered a normal weight neonate |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- All patients delivering in the labor and delivery unit at the Hospital of the University of Pennsylvania.
Key inclusion criteria (3 listed)
- singleton pregnancy
- prenatal care \& delivery at the Hospital of the University of Pennsylvania system
- Normal glucose tolerance test results (less than 120 mg/dl)
Key exclusion criteria (10 listed)
- Multiple gestation
- under 18 years old, or over 45 years old
- chronic hypertension
- preeclampsia
- chronic steroid use
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 |
|---|---|---|
| Neonatal exposure to maternal obesity | Behavioural | Obese mother/ Macrosomic baby, Obese mother/ normal weight baby |
Primary outcome
Fetal Overgrowth
Time frame: Delivery date to up to 6 weeks post partum
Placental and cord blood samples will be studied for miRNA expression. The objective of the study is to identify miRNA which are differentially expressed in the placenta and cord blood of pregnancies that are affected by fetal macrosomia to determine factors that may predispose fetuses to fetal overgrowth.
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 26 May 2014.
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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.
Celeste P Durnwald, MD principal investigator
University of Pennsylvania
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 Obesity, run by University of Pennsylvania 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 3 inclusion and 10 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 26 May 2014. 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?
Fetal Overgrowth (time frame: Delivery date to up to 6 weeks post partum). 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 26 May 2014; AzTrials last refreshed its copy on 31 Oct 2026.