Nanovectors to Prevent Placental Passage of Tocolytic Agents

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.

Study Overview

• Status: Unknown
• Conditions: Preterm Labor

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 Type: Observational
• Enrollment (Anticipated): 24

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • Memorial Hermann Hospital Texas Medical Center
      • Contact: Maria Hutchinson, M.S.; Phone Number: 713-500-6421; Email: maria.keefer@uth.tmc.edu
      • Principal Investigator: Jerrie S Refuerzo, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 49 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Pregnant women who will undergo elective cesarean section at term

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Known infection

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Cesarean section; Women with cesarean section

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston

Study record dates

Study Major Dates

• Study Start: July 1, 2014
• Primary Completion (Anticipated): July 1, 2019
• Study Completion (Anticipated): July 1, 2019

Study Registration Dates

• First Submitted: July 23, 2014
• First Submitted That Met QC Criteria: July 23, 2014
• First Posted (Estimate): July 24, 2014

Study Record Updates

• Last Update Posted (Actual): November 2, 2018
• Last Update Submitted That Met QC Criteria: November 1, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Keywords: Indomethacin; Uterine contractions; Nanovectors
• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature
• Other Study ID Numbers: HSC-MS-14-0370