Nanovectors to Prevent Placental Passage of Tocolytic Agents

Preterm Labor Clinical Trial

Official title:

Development of Nanovectors to Prevent Placental Passage of a Tocolytic Agent

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02199756
• Other study ID #: HSC-MS-14-0370
• Status: Recruiting
• Start date: July 2014
• Est. completion date: July 2019

Study information

• Verified date: November 2018
• Source: The University of Texas Health Science Center, Houston
• Contact: Jerrie S Refuerzo, M.D.
• Phone: 713-500-6416
• Email: jerrie.s.refuerzo[@]uth.tmc.edu
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: July 2019
• Est. primary completion date: July 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 49 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Known infection

Related Conditions & MeSH terms

• Obstetric Labor, Premature
• Preterm Labor

Locations

Country	Name	City	State
United States	Memorial Hermann Hospital Texas Medical Center	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	3 hours