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Nanovectors to Prevent Placental Passage of Tocolytic Agents

Development of Nanovectors to Prevent Placental Passage of a Tocolytic Agent

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02199756
Enrollment
24
Registered
2014-07-24
Start date
2014-07-31
Completion date
2019-07-31
Last updated
2018-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Preterm Labor

Keywords

Uterine contractions, Indomethacin, Nanovectors

Brief 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. 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.

Interventions

None listed

Sponsors

The University of Texas Health Science Center, Houston
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 49 Years
Healthy volunteers
Yes

Inclusion criteria

* Pregnant women undergoing elective cesarean section who are greater than 37 weeks

Exclusion criteria

* Known infection

Design outcomes

Primary

MeasureTime frameDescription
Uterine contractions3 hoursUterine 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.

Countries

United States

Contacts

Primary ContactJerrie S Refuerzo, M.D.
jerrie.s.refuerzo@uth.tmc.edu713-500-6416

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026