Preterm LaborNCT02090920
Individualized Dosing of Nifedipine For Tocolysis in Preterm Labor
An observational study of Preterm Labor, run by Indiana University at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Preterm Labor
- What is being tested?
- Nifedipine
- Type of treatment
- Pill or oral medicine
- How many people
- 20 participants
- Where
- 2 sitesUnited States
- Study dates
- Jul 2011to Apr 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Pregnant Women with preterm labor who have been prescribed immediate release nifedipine and admitted at Eskenazi Health Hospital or Indiana University Methodist Hospital.
Who may be able to join
- Pregnant women 18 years of age or older
- Diagnosed with preterm labor (defined as 1-3 uterine contractions per 10 minute interval for at least 60 minutes with evidence of change in cervical dilation and/or effacement)
- Prescribed nifedipine as a tocolytic agent
- Signed informed consent
Who cannot join
- Multifetal gestation
- Cervical dilation of 5 cm or greater
- Ruptured uterine membranes
- Any medical or obstetrical condition that would contraindicate tocolytic therapy including placental abruption; placenta previa; nonreassuring fetal status; uterine growth restriction; severe congenital abnormalities
- Administration of medications known to interact with CYP3A (a human gene) other than betamethasone or dexamethasone as indicated for stimulating fetal lung maturation, within the past 24 hours unless approved by study investigators
- Administered a potent mechanism-based CYP3A inhibitor (e.g. erythromycin, clarithromycin) in past 48 hours
Show all 9Show fewer
- History of allergy or hypersensitivity to nifedipine
- History of taking grapefruit or grapefruit juice by mouth within the last 24 hours
- Known current hepatic or renal disease
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Eskenazi Health
Indianapolis, Indiana, 46202
IU Health Methodist
Indianapolis, Indiana, 46202
About this study
Official title: Individualized Dosing of Nifedipine for Tocolysis in Preterm Labor
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.
Read the 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
- Conditions
- Preterm Labor
- Being tested
- Nifedipine
- Medical subject headings
- Obstetric Labor, Premature
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NifedipineDrug
Also called Adalat, Nifediac, Nifedical, Procardia, Procardia XL
Nifedipine 10 mg immediate release tablet by mouth loading dose Nifedipine administered orally every 15-20 minutes for the first hour to a maximum loading dose of 30 mg, followed by a maintenance dose of 10-20 mg immediate release nifedipine administered orally every 6 hours
| Study group | Role | What they receive |
|---|---|---|
| Nifedipine | Nifedipine 10 mg immediate release tablet by mouth loading dose Nifedipine administered orally every 15-20 minutes for the first hour to a maximum loading dose of 30 mg, followed by a maintenance dose of 10-20 mg immediate release nifedipine administered orally every 6 hours Receives: Drug: Nifedipine |
What is being measured
The primary outcome is the main question the study is designed to answer.
prevention of delivery for 48 hours with attainment of uterine quiescence
The primary study outcome is prevention of delivery for 48 hours with attainment of uterine quiescence, defined by 12 hours of six or fewer contractions per hour and no further cervical change. Failure of the primary outcome occurs if, in the first 48 hours, patients deliver, rupture membranes, experience recurrent preterm labor, continue to contract or experience cervical change, or required the use of alternate tocolytics. Secondary outcomes include time to uterine quiescence (≤6 contractions/hour), birth weight, gestational age at delivery, maternal and neonatal adverse effects.
Measured: One Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2014 (estimated)
- Study startJul 2011
- Primary completionMay 2016
- Study completionApr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preterm LaborStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara Quinney, Indiana University
- Investigators
- Sara Quinney, PharmD, PhD, Principal investigator, Indiana University Clinical Pharmacology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02090920
- Sponsor's protocol ID
- 1106006106
- Status last verified
- Jun 2019
- First submitted
- 3 Mar 2014
- Last updated
- 26 Jun 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Individualized Dosing of Nifedipine for Tocolysis in Preterm Labor
- ClinicalTrials.gov ID
- NCT02090920
- Acronym / sponsor ID
- 1106006106
- Conditions
- Preterm Labor
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- May 2016 (actual)
- Study completion
- Apr 2019 (actual)
- First posted
- 18 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nifedipine | – | Drug: NifedipineNifedipine 10 mg immediate release tablet by mouth loading dose Nifedipine administered orally every 15-20 minutes for the first hour to a maximum loading dose of 30 mg, followed by a maintenance dose of 10-20 mg immediate release nifedipine administered orally every 6 hours |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Pregnant Women with preterm labor who have been prescribed immediate release nifedipine and admitted at Eskenazi Health Hospital or Indiana University Methodist Hospital.
Key inclusion criteria (4 listed)
- Pregnant women 18 years of age or older
- Diagnosed with preterm labor (defined as 1-3 uterine contractions per 10 minute interval for at least 60 minutes with evidence of change in cervical dilation and/or effacement)
- Prescribed nifedipine as a tocolytic agent
- Signed informed consent
Key exclusion criteria (9 listed)
- Multifetal gestation
- Cervical dilation of 5 cm or greater
- Ruptured uterine membranes
- Any medical or obstetrical condition that would contraindicate tocolytic therapy including placental abruption; placenta previa; nonreassuring fetal status; uterine growth restriction; severe congenital abnormalities
- Administration of medications known to interact with CYP3A (a human gene) other than betamethasone or dexamethasone as indicated for stimulating fetal lung maturation, within the past 24 hours unless approved by study investigators
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NifedipineAlso: Adalat, Nifediac, Nifedical, Procardia, Procardia XLNifedipine 10 mg immediate release tablet by mouth loading dose Nifedipine administered orally every 15-20 minutes for the first hour to a maximum loading dose of 30 mg, followed by a maintenance dose of 10-20 mg immediate release nifedipine administered orally every 6 hours | Drug | Nifedipine |
Primary outcome
prevention of delivery for 48 hours with attainment of uterine quiescence
Time frame: One Year
The primary study outcome is prevention of delivery for 48 hours with attainment of uterine quiescence, defined by 12 hours of six or fewer contractions per hour and no further cervical change. Failure of the primary outcome occurs if, in the first 48 hours, patients deliver, rupture membranes, experience recurrent preterm labor, continue to contract or experience cervical change, or required the use of alternate tocolytics. Secondary outcomes include time to uterine quiescence (≤6 contractions/hour), birth weight, gestational age at delivery, maternal and neonatal adverse effects.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sara Quinney, PharmD, PhD principal investigator
Indiana University Clinical Pharmacology
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Preterm Labor, run by Indiana University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
prevention of delivery for 48 hours with attainment of uterine quiescence (time frame: One Year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2019.