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
|Condition or disease|
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|
|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|
Women with cesarean section
- 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
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
|Contact: Jerrie S Refuerzo, M.D.||firstname.lastname@example.org|
|United States, Texas|
|Memorial Hermann Hospital Texas Medical Center||Recruiting|
|Houston, Texas, United States, 77030|
|Contact: Maria Hutchinson, M.S. 713-500-6421 email@example.com|
|Principal Investigator: Jerrie S Refuerzo, M.D.|
|Principal Investigator:||Jerrie S Refuerzo, M.D.||The University of Texas Health Science Center, Houston|