Obstetric Labor, PrematurePhase 3NCT01360034
Nifedipine Versus Indomethacin in the Treatment of Preterm Labour
A Phase 3 study testing Nifedipine and Indomethacin in people with Obstetric Labor, Premature, run by Saint Thomas Hospital, Panama at 1 site in Panama.
Trial summary
The purpose of this study was to compare the effectiveness of nifedipine versus indomethacin as tocolytic for the treatment of preterm labour with short cervix (< 2.5cms). Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Obstetric Labor, Premature
- What is being tested?
- Nifedipine and Indomethacin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 216 participants
- Where
- 1 sitePanama
- Study dates
- Dec 2015to Jun 2016
- Phase
- Phase 3
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Pregnant women between 24 and 34 weeks of gestation.
- Cervical length (determined by transvaginal ultrasound) of 2.5 cms or less
Who cannot join
- All contraindications for tocolysis (fetal distress, abruptio placenta).
- Multiple pregnancy.
- All contraindications for the use of any of the two drugs (indomethacin or nifedipine).
Trial locations and contacts
1 site in 1 country.
Jorge Espinosa, Resident contact
Osvaldo Reyes, MD contact
About this study
Official title: Nifedipine vs. Indomethacin in the Treatment of Preterm Labour and Short Cervix. A Randomized, Controlled Trial.
The purpose of this study was to compare the effectiveness of nifedipine versus indomethacin as tocolytic for the treatment of preterm labour with short cervix (< 2.5cms).
- Conditions
- Obstetric Labor, Premature
- Being tested
- Nifedipine, Indomethacin
- Keywords
- Obstetric labor, premature, Short cervix, Nifedipine, Indomethacin
- 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 as a single dose upon admission and then 10 mg vo every 8 hours for 48 hours.
IndomethacinDrug
Indomethacin: 50 mg vo as a single dose upon admission and then 25 mg vo every 6 hours for 48 hours.
| Study group | Role | What they receive |
|---|---|---|
| Nifedipine | Experimental | 108 patients will receive nifedipine as tocolytic for 48 hours. Receives: Drug: Nifedipine |
| Indomethacin | Experimental | 108 patients will receive indomethacin as tocolytic for 48 hours. Receives: Drug: Indomethacin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of preterm birth (before 48 hours, allowing use of corticosteroids).
Measured: 36 months
Secondary outcomes (2)
Reduction of preterm labour (before 35 weeks).
Measured: 48 months
Adverse effects
To determine the frequency of maternal adverse effects related to the use of both drugs (nifedipine and indomethacin). These include the development of any type of rash, nausea, weakness/hypotension, headache, dyspepsy or bleeding disorders of any kind.
Measured: 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2011 (estimated)
- Study startDec 2015
- Primary completionMay 2016 (estimated)
- Study completionJun 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Obstetric Labor, PrematureStudies of the same condition, open and under way.
- 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
- None (open label)
- Enrolment
- 216 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Saint Thomas Hospital, Panama
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Osvaldo A. Reyes T., Saint Thomas Hospital, Panama
- Investigators
- Jorge Espinosa, Resident, Principal investigator, Saint Thomas Hospital, PanamaOsvaldo Reyes, MD, Principal investigator, Saint Thomas Hospital, Panama
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01360034
- Sponsor's protocol ID
- MHST2011-04
- Status last verified
- Jan 2015
- First submitted
- 20 May 2011
- Last updated
- 5 Jan 2015
- Results posted
- No
- Data monitoring committee
- 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 5 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nifedipine vs. Indomethacin in the Treatment of Preterm Labour and Short Cervix. A Randomized, Controlled Trial.
- ClinicalTrials.gov ID
- NCT01360034
- Acronym / sponsor ID
- MHST2011-04
- Conditions
- Obstetric Labor, Premature
- Keywords
- Obstetric labor, premature, Short cervix, Nifedipine, Indomethacin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 216 participants (estimated)
- Lead sponsor
- Saint Thomas Hospital, PanamaUniversity, hospital or other
- Study start
- Dec 2015
- Primary completion
- May 2016 (estimated)
- Study completion
- Jun 2016 (estimated)
- First posted
- 25 May 2011 (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.
The purpose of this study was to compare the effectiveness of nifedipine versus indomethacin as tocolytic for the treatment of preterm labour with short cervix (< 2.5cms).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nifedipine | Experimental | Drug: Nifedipine108 patients will receive nifedipine as tocolytic for 48 hours. |
| Indomethacin | Experimental | Drug: Indomethacin108 patients will receive indomethacin as tocolytic for 48 hours. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Pregnant women between 24 and 34 weeks of gestation.
- Cervical length (determined by transvaginal ultrasound) of 2.5 cms or less
Key exclusion criteria (3 listed)
- All contraindications for tocolysis (fetal distress, abruptio placenta).
- Multiple pregnancy.
- All contraindications for the use of any of the two drugs (indomethacin or nifedipine).
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 as a single dose upon admission and then 10 mg vo every 8 hours for 48 hours. | Drug | Nifedipine |
| IndomethacinIndomethacin: 50 mg vo as a single dose upon admission and then 25 mg vo every 6 hours for 48 hours. | Drug | Indomethacin |
Primary outcome
Reduction of preterm birth (before 48 hours, allowing use of corticosteroids).
Time frame: 36 months
2 secondary outcomes
Reduction of preterm labour (before 35 weeks).
Time frame: 48 months
Adverse effects
Time frame: 48 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2015.
- 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.
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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.
Jorge Espinosa, Resident contact
Osvaldo Reyes, MD contact
Jorge Espinosa, Resident principal investigator
Saint Thomas Hospital, Panama
Osvaldo Reyes, MD principal investigator
Saint Thomas Hospital, Panama
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 and Indomethacin in people with Obstetric Labor, Premature, run by Saint Thomas Hospital, Panama at 1 site in Panama.
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 2 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 5 Jan 2015. 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 Panama. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jorge Espinosa, Resident (bobbyone-79@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction of preterm birth (before 48 hours, allowing use of corticosteroids). (time frame: 36 months). 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 NCT01360034, 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 5 Jan 2015.