Preterm LaborNCT02199756
Nanovectors to Prevent Placental Passage of Tocolytic Agents
An observational study of Preterm Labor, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial summary
The purpose of the study is to find out whether indomethacin encapsulated within a nanovector can stop contractions in pregnant human uterine tissue. Preterm delivery is a major contributor to newborn deaths. The treatment of preterm labor includes medications that stop contractions within the uterus, or womb. Read more about this study
- Who is it for?
- Ages 18 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Preterm Labor
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2014to Jul 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 to 49 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Pregnant women who will undergo elective cesarean section at term
Who may be able to join
- Pregnant women undergoing elective cesarean section who are greater than 37 weeks
Who cannot join
- Known infection
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Memorial Hermann Hospital Texas Medical Center
Houston, Texas, 77030
Maria Hutchinson, M.S., 713-500-6421, maria.keefer@uth.tmc.edu
Jerrie S Refuerzo, M.D.
About this study
Official title: Development of Nanovectors to Prevent Placental Passage of a Tocolytic Agent
The purpose of the study is to find out whether indomethacin encapsulated within a nanovector can stop contractions in pregnant human uterine tissue. Preterm delivery is a major contributor to newborn deaths. The treatment of preterm labor includes medications that stop contractions within the uterus, or womb. Indomethacin is effective in stopping uterine contractions, but crosses the placenta to the unborn baby causing problems for the baby. Nanovectors are used to direct the delivery of medications. If indomethacin can be delivered directly to the uterus using a nanovector, it may be an ideal medication to treat preterm labor. We hypothesize that nanovectors loaded with indomethacin will reduce uterine contractions.
Read the detailed description
This is a prospective observational study.
Subjects will undergo a biopsy from the middle of the upper margin of the uterine incision measuring 4 x 2 x 2 cm. This will be performed by the managing doctor at the time of cesarean section after delivery of the baby. Once the tissue is obtained, the site will be closed using sutures similar to the usual closure of the uterus at cesarean section. This biopsy will be taken to the laboratory to test whether the nanovector will increase or decrease contractions in the uterus. Once this test is finished, the tissue will be frozen and test for the absence or presence of the nanovector within the tissue.
- Conditions
- Preterm Labor
- Keywords
- Uterine contractions, Indomethacin, Nanovectors
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Cesarean section | Women with cesarean section |
What is being measured
The primary outcome is the main question the study is designed to answer.
Uterine contractions
Uterine biopsies obtained from subjects will be placed in a specimen chamber that measures uterine contractility. Mean contractile intensity will be determined before and after exposure to oxytocin, indomethacin, liposomes and liposome indomethacin.
Measured: 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2014 (estimated)
- Study startJul 2014
- Primary completionJul 2019 (estimated)
- Study completionJul 2019 (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.
- More trials run by The University of Texas Health Science Center, HoustonThe 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
- 24 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jerrie Refuerzo, The University of Texas Health Science Center, Houston
- Investigators
- Jerrie S Refuerzo, M.D., Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02199756
- Sponsor's protocol ID
- HSC-MS-14-0370
- Status last verified
- Nov 2018
- First submitted
- 23 Jul 2014
- Last updated
- 2 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Nanovectors to Prevent Placental Passage of a Tocolytic Agent
- ClinicalTrials.gov ID
- NCT02199756
- Acronym / sponsor ID
- HSC-MS-14-0370
- Conditions
- Preterm Labor
- Keywords
- Uterine contractions, Indomethacin, Nanovectors
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- Jul 2019 (estimated)
- Study completion
- Jul 2019 (estimated)
- First posted
- 24 Jul 2014 (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 the study is to find out whether indomethacin encapsulated within a nanovector can stop contractions in pregnant human uterine tissue. Preterm delivery is a major contributor to newborn deaths. The treatment of preterm labor includes medications that stop contractions within the uterus, or womb. Indomethacin is effective in stopping uterine contractions, but crosses the placenta to the unborn baby causing problems for the baby. Nanovectors are used to direct the delivery of medications. If indomethacin can be delivered directly to the uterus using a nanovector, it may be an ideal medication to treat preterm labor. We hypothesize that nanovectors loaded with indomethacin will reduce uterine contractions.
Detailed description
This is a prospective observational study.
Subjects will undergo a biopsy from the middle of the upper margin of the uterine incision measuring 4 x 2 x 2 cm. This will be performed by the managing doctor at the time of cesarean section after delivery of the baby. Once the tissue is obtained, the site will be closed using sutures similar to the usual closure of the uterus at cesarean section. This biopsy will be taken to the laboratory to test whether the nanovector will increase or decrease contractions in the uterus. Once this test is finished, the tissue will be frozen and test for the absence or presence of the nanovector within the tissue.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cesarean section | – | –Women with cesarean section |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Pregnant women who will undergo elective cesarean section at term
Key inclusion criteria (1 listed)
- Pregnant women undergoing elective cesarean section who are greater than 37 weeks
Key exclusion criteria (1 listed)
- Known infection
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
Uterine contractions
Time frame: 3 hours
Uterine biopsies obtained from subjects will be placed in a specimen chamber that measures uterine contractility. Mean contractile intensity will be determined before and after exposure to oxytocin, indomethacin, liposomes and liposome indomethacin.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2018.
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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.
Jerrie S Refuerzo, M.D. principal investigator
The University of Texas Health Science Center, Houston
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 The University of Texas Health Science Center, Houston 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 1 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 2 Nov 2018. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jerrie S Refuerzo, M.D. (713-500-6416, jerrie.s.refuerzo@uth.tmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Uterine contractions (time frame: 3 hours). 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 2 Nov 2018.