Ignite Creation Date:
2025-12-25 @ 4:10 AM
Ignite Modification Date:
2026-02-24 @ 1:44 PM
Study NCT ID:
NCT02090920
Status:
COMPLETED
Last Update Posted:
2019-06-26
First Post:
2014-03-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Individualized Dosing of Nifedipine For Tocolysis in Preterm Labor
Sponsor:
Indiana University
Organization:
Study Overview
Official Title:
Individualized Dosing of Nifedipine for Tocolysis in Preterm Labor
Status:
COMPLETED
Status Verified Date:
2019-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study looks at the effects of a mother's genes and other characteristics (mother's age, baby's age, race, and other diseases) on the ability of nifedipine to end contractions and prevent an early delivery. This information will be used to decide what amount of nifedipine women need to best treat preterm contractions.
Detailed Description:
The purpose of this study is to identify the relationship between the amount of nifedipine in a woman's body and its effect on ending preterm (early) labor contractions and delaying delivery by at least 48 hours. The study will also look at the effects of genes (materials passed from parent to child that determine the make-up of the body) and other characteristics (for example mother's age, baby's age, race, and other diseases or drugs) on the ability of nifedipine to end the contractions. We will use this information to decide what amount of nifedipine women need to best treat preterm contractions. This study will also examine the effect of pregnancy on how fast nifedipine is removed from the woman's body.
This study will be conducted on two phases. The first will study women who are starting nifedipine for treatment of preterm labor. Nifedipine dose will be determined by the patient's physician. Blood samples will be obtained from the mother to determine the concentration of nifedipine and its metabolite, oxidized nifedipine, during one dosing interval. A blood sample will also be obtained for DNA isolation to examine variants in genes involved in the nifedipine pathway. We will also collect data on uterine contractions and blood pressure through clinical monitoring. After delivery, maternal and umbilical cord blood samples will be obtained, along with a piece of placenta. Women who take part in the first phase will be asked to return 6-10 weeks after delivery. At that time, she will take a single dose of 10 mg immediate release nifedipine by mouth and blood samples will be collected for up to 6 hours. Blood pressure will also be monitored prior to collection of each blood sample
This study will be conducted on two phases. The first will study women who are starting nifedipine for treatment of preterm labor. Nifedipine dose will be determined by the patient's physician. Blood samples will be obtained from the mother to determine the concentration of nifedipine and its metabolite, oxidized nifedipine, during one dosing interval. A blood sample will also be obtained for DNA isolation to examine variants in genes involved in the nifedipine pathway. We will also collect data on uterine contractions and blood pressure through clinical monitoring. After delivery, maternal and umbilical cord blood samples will be obtained, along with a piece of placenta. Women who take part in the first phase will be asked to return 6-10 weeks after delivery. At that time, she will take a single dose of 10 mg immediate release nifedipine by mouth and blood samples will be collected for up to 6 hours. Blood pressure will also be monitored prior to collection of each blood sample
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: