Preterm LaborPhase 3NifedipineNCT02132533
Nifedipine for Acute Tocolysis of Preterm Labor
A Phase 3 study testing Nifedipine in people with Preterm Labor, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to determine if nifedipine treatment of women in preterm labor receiving corticosteroids results in postponement of delivery when compared to placebo. Read more about this study
- Who is it for?
- Ages 16 to 44 years, women only
- Conditions the study is for
- Preterm Labor
- What is being tested?
- Nifedipine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 88 participants
- Where
- 1 siteUnited States
- Study dates
- 5 May 2014to 29 Oct 2018
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 16 to 44 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Between 16 and 44 years of age inclusive
- Singleton pregnancy
- Intact membranes
- Between 28-0/7 weeks and 33-6/7 weeks' gestation inclusive
- Reported or documented uterine activity
- Cervical dilation between 2 cm and 4 cm inclusive
Who cannot join
- Multifetal gestation
- Less than 28 weeks' gestation
- 34 or more weeks' gestation
- Ruptured membranes
- More than 4 cm dilated
- Previously received a course of corticosteroids for fetal lung maturation
Show all 20Show fewer
- Oligohydramnios
- Fetal growth restriction
- Chorioamnionitis or temperature of at least 38.0 degrees Celsius
- Fetal death
- Preeclampsia
- Suspected placental abruption or placenta previa
- Lethal fetal malformation or amniotic fluid index at least 35
- Systolic BP < 90 mmHg or diastolic BP < 50 mmHg
- Baseline tachycardia (pulse >120 after 2 consecutive measurements 30 minutes apart)
- Chronic hypertension treated with antihypertensives in pregnancy
- Seizure disorder or HIV
- Maternal allergy to nifedipine
- Known maternal cardiac disease
- Women who have received progesterone therapy in the second or third trimester for prevention of preterm birth
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine if nifedipine treatment of women in preterm labor receiving corticosteroids results in postponement of delivery when compared to placebo.
- Conditions
- Preterm Labor
- Being tested
- Nifedipine, Placebo, Usual care
- 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
Nifedipine 20 mg orally, then nifedipine 20 mg orally after 90 minutes if still contracting. Continue nifedipine 20 mg orally every 4 hours after the first dose for 48 hours.
PlaceboDrug
Placebo orally, then placebo orally after 90 minutes if still contracting. Continue placebo orally every 4 hours after the first dose for 48 hours.
Usual careOther
Usual evaluation, monitoring and care for women with preterm labor.
| Study group | Role | What they receive |
|---|---|---|
| Nifedipine | Experimental | Women with preterm labor will receive nifedipine. Receives: Drug: Nifedipine; Other: Usual care |
| Placebo | Experimental | Women with preterm labor will receive placebo. Receives: Drug: Placebo; Other: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Preterm Birth
Measured: Less than 37 weeks of gestation
Secondary outcomes (3)
Number of Participants With Preterm Birth
Measured: Within 48 hours of randomization
Number of Participants With Preterm Birth
Measured: At least 2 doses of betamethasone administered prior to delivery
Number of Participants With Preterm Birth
Measured: Within 7 days of randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2014 (estimated)
- Study start5 May 2014
- Primary completion29 Oct 2018
- Study completion29 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Preterm LaborStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Brian M Casey, MD, Study director, Department of Alabama Medical Center, Birmingham, ALDonald D McIntire, PhD, Study director, University of Texas Southwestern Medical CenterKenneth J Leveno, MD, Study director, University of Texas Southwestern Medical CenterChet E Wells, MD, Study director, University of Texas Southwestern Medical CenterJosiah S Hawkins, MD, Principal investigator, Kaiser Medical Center, Oakland, CA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02132533
- Sponsor's protocol ID
- 122013-063
- Acronym
- Nifedipine
- Status last verified
- Dec 2020
- First submitted
- 30 Apr 2014
- Last updated
- 21 Dec 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Wilson A, Hodgetts-Morton VA, Marson EJ, Markland AD, Larkai E, Papadopoulou A, Coomarasamy A, Tobias A, Chou D, Oladapo OT, Price MJ, Morris K, Gallos ID. Tocolytics for delaying preterm birth: a network meta-analysis (0924). Cochrane Database Syst Rev. 2022 Aug 10;8(8):CD014978. doi: 10.1002/14651858.CD014978.pub2.
PubMed 35947046Hawkins JS, Wells CE, Casey BM, McIntire DD, Leveno KJ. Nifedipine for Acute Tocolysis of Preterm Labor: A Placebo-Controlled Randomized Trial. Obstet Gynecol. 2021 Jul 1;138(1):73-78. doi: 10.1097/AOG.0000000000004436.
PubMed 34259466
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nifedipine for Acute Tocolysis of Preterm Labor
- ClinicalTrials.gov ID
- NCT02132533
- Acronym / sponsor ID
- Nifedipine / 122013-063
- Conditions
- Preterm Labor
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- 5 May 2014 (actual)
- Primary completion
- 29 Oct 2018 (actual)
- Study completion
- 29 Oct 2018 (actual)
- First posted
- 7 May 2014 (estimated)
- Results
- Posted 21 Feb 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine if nifedipine treatment of women in preterm labor receiving corticosteroids results in postponement of delivery when compared to placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nifedipine | Experimental | Drug: Nifedipine, Other: Usual careWomen with preterm labor will receive nifedipine. |
| Placebo | Experimental | Drug: Placebo, Other: Usual careWomen with preterm labor will receive placebo. |
Who may qualify
- Ages
- 16 to 44 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Between 16 and 44 years of age inclusive
- Singleton pregnancy
- Intact membranes
- Between 28-0/7 weeks and 33-6/7 weeks' gestation inclusive
- Reported or documented uterine activity
Key exclusion criteria (20 listed)
- Multifetal gestation
- Less than 28 weeks' gestation
- 34 or more weeks' gestation
- Ruptured membranes
- More than 4 cm dilated
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 |
|---|---|---|
| NifedipineNifedipine 20 mg orally, then nifedipine 20 mg orally after 90 minutes if still contracting. Continue nifedipine 20 mg orally every 4 hours after the first dose for 48 hours. | Drug | Nifedipine |
| PlaceboPlacebo orally, then placebo orally after 90 minutes if still contracting. Continue placebo orally every 4 hours after the first dose for 48 hours. | Drug | Placebo |
| Usual careUsual evaluation, monitoring and care for women with preterm labor. | Other | Nifedipine, Placebo |
Primary outcome
Number of Participants With Preterm Birth
Time frame: Less than 37 weeks of gestation
3 secondary outcomes
Number of Participants With Preterm Birth
Time frame: Within 48 hours of randomization
Number of Participants With Preterm Birth
Time frame: At least 2 doses of betamethasone administered prior to delivery
Number of Participants With Preterm Birth
Time frame: Within 7 days of randomization
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35947046Wilson A, Hodgetts-Morton VA, Marson EJ, Markland AD, Larkai E, Papadopoulou A, Coomarasamy A, Tobias A, Chou D, Oladapo OT, Price MJ, Morris K, Gallos ID. Tocolytics for delaying preterm birth: a network meta-analysis (0924). Cochrane Database Syst Rev. 2022 Aug 10;8(8):CD014978. doi: 10.1002/14651858.CD014978.pub2.
- Derived from this study: PubMed 34259466Hawkins JS, Wells CE, Casey BM, McIntire DD, Leveno KJ. Nifedipine for Acute Tocolysis of Preterm Labor: A Placebo-Controlled Randomized Trial. Obstet Gynecol. 2021 Jul 1;138(1):73-78. doi: 10.1097/AOG.0000000000004436.
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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.
Brian M Casey, MD study director
Department of Alabama Medical Center, Birmingham, AL
Donald D McIntire, PhD study director
University of Texas Southwestern Medical Center
Kenneth J Leveno, MD study director
University of Texas Southwestern Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Nifedipine in people with Preterm Labor, run by University of Texas Southwestern Medical Center at 1 site 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 6 inclusion and 20 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 21 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Feb 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Preterm Birth (time frame: Less than 37 weeks of gestation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02132533, which also lists 2 linked publications.
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 21 Dec 2020.