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Nanovectors to Prevent Placental Passage of Tocolytic Agents

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ClinicalTrials.gov Identifier: NCT02199756
Recruitment Status : Recruiting
First Posted : July 24, 2014
Last Update Posted : November 2, 2018
Sponsor:
Information provided by (Responsible Party):
Jerrie Refuerzo, The University of Texas Health Science Center, Houston

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.

Condition or disease
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
Estimated Enrollment : 24 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Development of Nanovectors to Prevent Placental Passage of a Tocolytic Agent
Study Start Date : July 2014
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : July 2019

Group/Cohort
Cesarean section
Women with cesarean section



Primary Outcome Measures :
  1. 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.


Biospecimen Retention:   Samples Without DNA
Uterine biopsy


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Ages Eligible for Study:   18 Years to 49 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Pregnant women who will undergo elective cesarean section at term
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Known infection

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02199756


Contacts
Contact: Jerrie S Refuerzo, M.D. 713-500-6416 jerrie.s.refuerzo@uth.tmc.edu

Locations
United States, Texas
Memorial Hermann Hospital Texas Medical Center Recruiting
Houston, Texas, United States, 77030
Contact: Maria Hutchinson, M.S.    713-500-6421    maria.keefer@uth.tmc.edu   
Principal Investigator: Jerrie S Refuerzo, M.D.         
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Investigators
Principal Investigator: Jerrie S Refuerzo, M.D. The University of Texas Health Science Center, Houston

Responsible Party: Jerrie Refuerzo, Associate Professor, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT02199756     History of Changes
Other Study ID Numbers: HSC-MS-14-0370
First Posted: July 24, 2014    Key Record Dates
Last Update Posted: November 2, 2018
Last Verified: November 2018

Keywords provided by Jerrie Refuerzo, The University of Texas Health Science Center, Houston:
Uterine contractions
Indomethacin
Nanovectors

Additional relevant MeSH terms:
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Tocolytic Agents
Reproductive Control Agents
Physiological Effects of Drugs