Nanovectors to Prevent Placental Passage of Tocolytic Agents
| Status: | Recruiting |
|---|---|
| Conditions: | Women's Studies |
| Therapuetic Areas: | Reproductive |
| Healthy: | No |
| Age Range: | 18 - 49 |
| Updated: | 11/4/2018 |
| Start Date: | July 2014 |
| End Date: | July 2019 |
| Contact: | Jerrie S Refuerzo, M.D. |
| Email: | jerrie.s.refuerzo@uth.tmc.edu |
| Phone: | 713-500-6416 |
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.
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.
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.
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.
Inclusion Criteria:
- Pregnant women undergoing elective cesarean section who are greater than 37 weeks
Exclusion Criteria:
- Known infection
We found this trial at
1
site
Houston, Texas 77030
Principal Investigator: Jerrie S Refuerzo, M.D.
Phone: 713-500-6421
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