Preterm LaborPhase 4NCT02438371
Nifedipine or Nifedipine Plus Indomethacin for Treatment of Acute Preterm Labor
A Phase 4 study testing Nifedipine and Indomethacin in people with Preterm Labor, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial summary
Tocolytic agents are used for the treatment of preterm labor. It is unclear whether combination treatments of two tocolytic agents are more effective in stopping preterm labor compared to one. Therefore, the investigators propose a comparative effective trial of nifedipine plus indomethacin vs. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Preterm Labor
- What is being tested?
- Nifedipine and Indomethacin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteUnited States
- Study dates
- May 2015to 10 Oct 2019
- Phase
- Phase 4
- 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 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- We will include pregnant women between 22 0/7 to 31 6/7 weeks gestation who present with regular uterine contractions defined as at least one contraction every 10 minutes for 30 minutes with at least one of the following:
- cervical change of at least 1 cm or
- cervical dilation of 2 cm at the time of initial exam or
- positive fetal fibronectin and transvaginal cervical length <2.5 cm
Who cannot join
- We will exclude pregnant women with any contraindication to tocolysis:
- clinical chorioamnionitis (defined as a temperature of >100.4 F and any of the following: fundal tenderness, maternal tachycardia, fetal tachycardia or purulent vaginal discharge)
- non reassuring fetal heart tones
- suspected placental abruption
- preterm premature rupture of membranes
- prior tocolytic treatment during the past 48 hours
- known adverse effect to indomethacin or nifedipine
- already receiving nifedipine for chronic hypertension
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Hermann Hospital Texas Medical Center
Houston, Texas, 77030
About this study
Official title: Nifedipine Alone or Nifedipine Plus Indomethacin for Treatment of Acute Preterm Labor: An Open Label, Randomized Comparative Effectiveness Controlled Trial
Tocolytic agents are used for the treatment of preterm labor. It is unclear whether combination treatments of two tocolytic agents are more effective in stopping preterm labor compared to one. Therefore, the investigators propose a comparative effective trial of nifedipine plus indomethacin vs. nifedipine alone for the treatment of preterm labor
Read the detailed description
The investigators current treatment for preterm labor has not been shown to be effective in prolonging pregnancy sufficiently to improve neonatal outcomes and other treatment strategies are needed. Multiple examples demonstrate that multi-agent treatments are routine clinical practice in other fields of medicine including chemotherapeutics for cancer, multi-therapeutics for myocardial infarction and broad spectrum antibiotics for pneumonia. At this time, it is unclear if a combination of tocolytic medications for preterm labor is more advantageous for women. If pregnancy is prolonged with combined tocolytic therapy, this could directly influence the treatment of preterm labor and potentially improve neonatal outcomes. There currently are no trials of combination regimens using widely used tocolytic agents, such as nifedipine and indomethacin. Thus, we propose a comparative effective trial of nifedipine plus indomethacin vs. nifedipine alone for the treatment of preterm labor
- Conditions
- Preterm Labor
- Being tested
- Nifedipine, Indomethacin
- Keywords
- pregnancy, preterm labor, tocolysis
- 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 Procardia
IndomethacinDrug
| Study group | Role | What they receive |
|---|---|---|
| Nifedipine | Active comparator | Participants will receive nifedipine 10 mg orally every 20 minutes for 3 doses, then nifedipine 10 mg every 6 hours for a total of 48 hours. Receives: Drug: Nifedipine |
| Nifedipine plus Indomethacin | Active comparator | Participants will receive will receive nifedipine 10 mg orally every 20 minutes for 3 doses, then nifedipine 10 mg every 6 hours for a total of 48 hours, as well as indomethacin 100 mg orally, then indomethacin 50 mg orally every 6 hours for a total of 48 hours. Receives: Drug: Nifedipine; Drug: Indomethacin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Maternal Participants Who Achieve 48 Hours of Pregnancy Prolongation
Measured: 48 hours after administration of tocolytic agent
Secondary outcomes (27)
Number of Maternal Participants Who Achieve 7 Days of Pregnancy Prolongation
Measured: 7 days after administration of tocolytic agent
Number of Days From First Dose of Tocolytic Agent to Delivery
Length of time from tocolytic initiation to the time of delivery
Measured: from time of tocolytic initiation to the time of delivery (from about 1 day to about 2 months)
Neonatal Birthweight
Measured: at the time of birth
Neonatal Sex
Measured: at the time of birth
Number of Neonates Who Were Admitted to the Neonatal Intensive Care Unit (NICU)
Measured: from birth until hospital discharge or day 120 of life (whichever occurs first)
Neonatal Length of Stay in NICU
Measured: from birth until hospital discharge or day 120 of life (whichever occurs first)
Neonatal Length of Hospital Stay
Measured: from birth until hospital discharge or day 120 of life (whichever occurs first)
Number of Neonatal Deaths
Measured: from birth until hospital discharge or day 120 of life (whichever occurs first)
Number of Neonates With Intraventricular Hemorrhage Diagnosed Using Cranial Ultrasonography
Measured: from birth until hospital discharge or day 120 of life (whichever occurs first)
Number of Neonates With Necrotizing Enterocolitis
Measured: from birth until hospital discharge or day 120 of life (whichever occurs first)
Number of Neonates With Culture-positive Sepsis
Measured: from birth until hospital discharge or day 120 of life (whichever occurs first)
Number of Neonates With Seizures
Measured: from birth until hospital discharge or day 120 of life (whichever occurs first)
Number of Neonates Who Needed Mechanical Ventilation
Measured: from birth until hospital discharge or day 120 of life (whichever occurs first)
Neonatal Duration of Ventilator Use
Measured: from birth until hospital discharge or day 120 of life (whichever occurs first)
Number of Neonates Who Received Continuous Positive Airway Pressure (CPAP)
Measured: from birth until hospital discharge or day 120 of life (whichever occurs first)
Number of Maternal Participants Who Delivered by Cesarean Delivery
Measured: at the the time of birth
Number of Maternal Participants Who Had Clinical Chorioamnionitis
Measured: from time of tocolytic initiation to the time of delivery (from about 1 day to about 2 months)
Number of Maternal Participants Who Had Preterm Premature Rupture of Membranes (PPROM)
Measured: from time of tocolytic initiation to the time of delivery (from about 1 day to about 2 months)
Number of Maternal Participants Who Had Preeclampsia
Measured: from time of tocolytic initiation to the time of delivery (from about 1 day to about 2 months)
Number of Maternal Participants Who Needed Blood Transfusion
Measured: from time of birth to time of discharge from hospital (about 2-3 days)
Number of Maternal Participants With Headache
Measured: from time of tocolytic initiation to the time of hospital discharge (from about 2 days to about 2 months)
Number of Maternal Participants With Nausea
Measured: from time of tocolytic initiation to the time of hospital discharge (from about 2 days to about 2 months)
Number of Maternal Participants With Vomiting
Measured: from time of tocolytic initiation to the time of hospital discharge (from about 2 days to about 2 months)
Number of Maternal Participants With Acid Reflux
Measured: from time of tocolytic initiation to the time of hospital discharge (from about 2 days to about 2 months)
Number of Maternal Participants With Hypotension
Measured: from time of tocolytic initiation to the time of hospital discharge (from about 2 days to about 2 months)
Number of Maternal Participants With Tachycardia
Measured: from time of tocolytic initiation to the time of hospital discharge (from about 2 days to about 2 months)
Number of Maternal Participants With Syncope
Measured: from time of tocolytic initiation to the time of hospital discharge (from about 2 days to about 2 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2015 (estimated)
- Study startMay 2015
- Primary completion10 Oct 2019
- Study completion10 Oct 2019
Why it stopped: Study halted due to slow recruitment
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 (1)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 The University of Texas Health Science Center, HoustonThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jerrie Refuerzo, The University of Texas Health Science Center, Houston
- Investigators
- Maria Hutchinson, M.S., Study director, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02438371
- Sponsor's protocol ID
- HSC-MS-15-0134
- Status last verified
- Oct 2021
- First submitted
- 5 May 2015
- Last updated
- 24 Nov 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
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 35947046
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nifedipine Alone or Nifedipine Plus Indomethacin for Treatment of Acute Preterm Labor: An Open Label, Randomized Comparative Effectiveness Controlled Trial
- ClinicalTrials.gov ID
- NCT02438371
- Acronym / sponsor ID
- HSC-MS-15-0134
- Conditions
- Preterm Labor
- Keywords
- pregnancy, preterm labor, tocolysis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study halted due to slow recruitment
- Enrolment
- 49 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- May 2015 (actual)
- Primary completion
- 10 Oct 2019 (actual)
- Study completion
- 10 Oct 2019 (actual)
- First posted
- 8 May 2015 (estimated)
- Results
- Posted 24 Nov 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Tocolytic agents are used for the treatment of preterm labor. It is unclear whether combination treatments of two tocolytic agents are more effective in stopping preterm labor compared to one. Therefore, the investigators propose a comparative effective trial of nifedipine plus indomethacin vs. nifedipine alone for the treatment of preterm labor
Detailed description
The investigators current treatment for preterm labor has not been shown to be effective in prolonging pregnancy sufficiently to improve neonatal outcomes and other treatment strategies are needed. Multiple examples demonstrate that multi-agent treatments are routine clinical practice in other fields of medicine including chemotherapeutics for cancer, multi-therapeutics for myocardial infarction and broad spectrum antibiotics for pneumonia. At this time, it is unclear if a combination of tocolytic medications for preterm labor is more advantageous for women. If pregnancy is prolonged with combined tocolytic therapy, this could directly influence the treatment of preterm labor and potentially improve neonatal outcomes. There currently are no trials of combination regimens using widely used tocolytic agents, such as nifedipine and indomethacin. Thus, we propose a comparative effective trial of nifedipine plus indomethacin vs. nifedipine alone for the treatment of preterm labor
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nifedipine | Active comparator | Drug: NifedipineParticipants will receive nifedipine 10 mg orally every 20 minutes for 3 doses, then nifedipine 10 mg every 6 hours for a total of 48 hours. |
| Nifedipine plus Indomethacin | Active comparator | Drug: Nifedipine, Drug: IndomethacinParticipants will receive will receive nifedipine 10 mg orally every 20 minutes for 3 doses, then nifedipine 10 mg every 6 hours for a total of 48 hours, as well as indomethacin 100 mg orally, then indomethacin 50 mg orally every 6 hours for a total of 48 hours. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- We will include pregnant women between 22 0/7 to 31 6/7 weeks gestation who present with regular uterine contractions defined as at least one contraction every 10 minutes for 30 minutes with at least one of the following:
- cervical change of at least 1 cm or
- cervical dilation of 2 cm at the time of initial exam or
- positive fetal fibronectin and transvaginal cervical length <2.5 cm
Key exclusion criteria (8 listed)
- We will exclude pregnant women with any contraindication to tocolysis:
- clinical chorioamnionitis (defined as a temperature of >100.4 F and any of the following: fundal tenderness, maternal tachycardia, fetal tachycardia or purulent vaginal discharge)
- non reassuring fetal heart tones
- suspected placental abruption
- preterm premature rupture of membranes
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: Procardia | Drug | Nifedipine, Nifedipine plus Indomethacin |
| Indomethacin | Drug | Nifedipine plus Indomethacin |
Primary outcome
Number of Maternal Participants Who Achieve 48 Hours of Pregnancy Prolongation
Time frame: 48 hours after administration of tocolytic agent
27 secondary outcomes
Number of Maternal Participants Who Achieve 7 Days of Pregnancy Prolongation
Time frame: 7 days after administration of tocolytic agent
Number of Days From First Dose of Tocolytic Agent to Delivery
Time frame: from time of tocolytic initiation to the time of delivery (from about 1 day to about 2 months)
Neonatal Birthweight
Time frame: at the time of birth
Neonatal Sex
Time frame: at the time of birth
Number of Neonates Who Were Admitted to the Neonatal Intensive Care Unit (NICU)
Time frame: from birth until hospital discharge or day 120 of life (whichever occurs first)
Neonatal Length of Stay in NICU
Time frame: from birth until hospital discharge or day 120 of life (whichever occurs first)
Neonatal Length of Hospital Stay
Time frame: from birth until hospital discharge or day 120 of life (whichever occurs first)
Number of Neonatal Deaths
Time frame: from birth until hospital discharge or day 120 of life (whichever occurs first)
Number of Neonates With Intraventricular Hemorrhage Diagnosed Using Cranial Ultrasonography
Time frame: from birth until hospital discharge or day 120 of life (whichever occurs first)
Number of Neonates With Necrotizing Enterocolitis
Time frame: from birth until hospital discharge or day 120 of life (whichever occurs first)
Number of Neonates With Culture-positive Sepsis
Time frame: from birth until hospital discharge or day 120 of life (whichever occurs first)
Number of Neonates With Seizures
Time frame: from birth until hospital discharge or day 120 of life (whichever occurs first)
Number of Neonates Who Needed Mechanical Ventilation
Time frame: from birth until hospital discharge or day 120 of life (whichever occurs first)
Neonatal Duration of Ventilator Use
Time frame: from birth until hospital discharge or day 120 of life (whichever occurs first)
Number of Neonates Who Received Continuous Positive Airway Pressure (CPAP)
Time frame: from birth until hospital discharge or day 120 of life (whichever occurs first)
Number of Maternal Participants Who Delivered by Cesarean Delivery
Time frame: at the the time of birth
Number of Maternal Participants Who Had Clinical Chorioamnionitis
Time frame: from time of tocolytic initiation to the time of delivery (from about 1 day to about 2 months)
Number of Maternal Participants Who Had Preterm Premature Rupture of Membranes (PPROM)
Time frame: from time of tocolytic initiation to the time of delivery (from about 1 day to about 2 months)
Number of Maternal Participants Who Had Preeclampsia
Time frame: from time of tocolytic initiation to the time of delivery (from about 1 day to about 2 months)
Number of Maternal Participants Who Needed Blood Transfusion
Time frame: from time of birth to time of discharge from hospital (about 2-3 days)
Number of Maternal Participants With Headache
Time frame: from time of tocolytic initiation to the time of hospital discharge (from about 2 days to about 2 months)
Number of Maternal Participants With Nausea
Time frame: from time of tocolytic initiation to the time of hospital discharge (from about 2 days to about 2 months)
Number of Maternal Participants With Vomiting
Time frame: from time of tocolytic initiation to the time of hospital discharge (from about 2 days to about 2 months)
Number of Maternal Participants With Acid Reflux
Time frame: from time of tocolytic initiation to the time of hospital discharge (from about 2 days to about 2 months)
Number of Maternal Participants With Hypotension
Time frame: from time of tocolytic initiation to the time of hospital discharge (from about 2 days to about 2 months)
Number of Maternal Participants With Tachycardia
Time frame: from time of tocolytic initiation to the time of hospital discharge (from about 2 days to about 2 months)
Number of Maternal Participants With Syncope
Time frame: from time of tocolytic initiation to the time of hospital discharge (from about 2 days to about 2 months)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2021.
- 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.
- Individual participant dataSharing planned: No
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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.
Maria Hutchinson, M.S. study director
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Nifedipine and Indomethacin in people with Preterm Labor, run by The University of Texas Health Science Center, Houston 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 4 inclusion and 8 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: stopped early, as of the sponsor's last update on 24 Nov 2021. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 24 Nov 2021). 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 Maternal Participants Who Achieve 48 Hours of Pregnancy Prolongation (time frame: 48 hours after administration of tocolytic agent). 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 NCT02438371, which also lists 1 linked publication.
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 24 Nov 2021.