Nanovectors to Prevent Placental Passage of Tocolytic Agents

NCT ID: NCT02199756

Last Updated: 2018-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

24 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-07-31

Study Completion Date

2019-07-31

Brief Summary

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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

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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.

Conditions

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Preterm Labor

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Cesarean section

Women with cesarean section

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Known infection
Minimum Eligible Age

18 Years

Maximum Eligible Age

49 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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The University of Texas Health Science Center, Houston

OTHER

Sponsor Role lead

Responsible Party

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Jerrie Refuerzo

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jerrie S Refuerzo, M.D.

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center, Houston

Locations

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Memorial Hermann Hospital Texas Medical Center

Houston, Texas, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Jerrie S Refuerzo, M.D.

Role: CONTACT

713-500-6416

Facility Contacts

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Maria Hutchinson, M.S.

Role: primary

713-500-6421

Other Identifiers

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HSC-MS-14-0370

Identifier Type: -

Identifier Source: org_study_id

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