Preterm BirthPhase 3NCT01317225
Prevention of Preterm Labor in Patients With a Previous Episode of Threatened Preterm Labor With Progesterone
A Phase 3 study testing 17 α hydroxyprogesterone caproate in people with Preterm Birth and Obstetric Labor, Premature, run by Saint Thomas Hospital, Panama at 1 site in Panama.
Trial summary
The purpose of this study is to determine if the use of 250 mg of intramuscular progesterone biweekly can reduce the incidence of preterm labor in patients with an episode of threatened preterm labor during the current pregnancy. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Preterm Birth, Obstetric Labor, Premature
- What is being tested?
- 17 α hydroxyprogesterone caproate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 sitePanama
- Study dates
- Jun 2011to Aug 2015
- 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 26 and 34 weeks of gestation.
- Cervical length (determined by transvaginal ultrasound) below the 10th percentile for the gestational age.
Who cannot join
- Multiple gestations.
- Maternal pathologies in which preterm termination of pregnancy is required.
Trial locations and contacts
1 site in 1 country.
Panama1 site, 1 recruiting
- Recruiting
Saint Thomas Maternity Hospital
Panama City, Provincia de Panamá
Osvaldo A Reyes, MD (Gyn/Ob), 011(507)65655041, oreyesmaternidad@gmail.com
Rodrigo Velarde, MD (Gyn/Ob), 011(507)66159954, revelarde_14@yahoo.es
About this study
Official title: Use of 17α Hydroxyprogesterone Caproate for the Prevention of Preterm Labor in Patients With a Previous Episode of Threatened Preterm Labor During Current Pregnancy. Double Blind, Randomized, Controlled Trial.
The purpose of this study is to determine if the use of 250 mg of intramuscular progesterone biweekly can reduce the incidence of preterm labor in patients with an episode of threatened preterm labor during the current pregnancy.
Read the detailed description
Preterm birth is one of the main causes of neonatal mortality and morbidity around the world, with serious repercussions on the health system and the families of the preterm baby. Many drugs have been evaluated with the purpose of preventing preterm birth in the patient at risk. One of these drugs is 17 α hydroxyprogesterone caproate. The purpose of this study is to evaluate if the use of biweekly doses of 17 α hydroxyprogesterone caproate in patients hospitalized with the diagnosis of threatened preterm labor, defined as the presence of uterine contractions and a short cervix (below the 10th percentile for the gestational age), can reduce the incidence of preterm birth in this high risk group population.
- Conditions
- Preterm Birth, Obstetric Labor, Premature
- Being tested
- 17 α hydroxyprogesterone caproate, Placebo
- Keywords
- Progesterone, Obstetric labor, premature, Short cervix
- Medical subject headings
- Premature Birth, Obstetric Labor, Premature
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
17 α hydroxyprogesterone caproateDrug
250mg intramuscular (gluteal muscles) biweekly from enrollment until delivery.
PlaceboDrug
Also called Saline solution
250 mg intramuscular (gluteal muscles)biweekly from enrollment until delivery.
| Study group | Role | What they receive |
|---|---|---|
| 17 α hydroxyprogesterone caproate | Experimental | 17α-Hydroxyprogesterone caproate. Receives: Drug: 17 α hydroxyprogesterone caproate |
| Placebo | Placebo comparator | Saline solution. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of preterm birth (before 37 weeks of gestation)
Number of patients that delivered before 37 weeks of pregnancy
Measured: 18 months
Secondary outcomes (2)
Incidence of preterm birth before 35 weeks of pregnancy
To determine if the use of 17 α hydroxyprogesterone caproate can reduce the incidence of preterm birth before 35 weeks of gestation in patients with a previous episode of threatened preterm labor.
Measured: 18 months
Incidence of preterm birth before 32 weeks of pregnancy
To determine if the use of 17 α hydroxyprogesterone caproate can reduce the incidence of preterm birth before 32 weeks of gestation in patients with a previous episode of threatened preterm labor.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2011 (estimated)
- Study startJun 2011
- Primary completionJul 2015 (estimated)
- Study completionAug 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preterm BirthStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 80 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
- Osvaldo A Reyes, MD (Gyn/Ob), Principal investigator, Saint Thomas Maternity HospitalRodrigo Velarde, MD (Gyn/Ob), Principal investigator, Saint Thomas Maternity Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01317225
- Sponsor's protocol ID
- MHST2011-01
- Status last verified
- Jan 2015
- First submitted
- 16 Mar 2011
- Last updated
- 6 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of 17α Hydroxyprogesterone Caproate for the Prevention of Preterm Labor in Patients With a Previous Episode of Threatened Preterm Labor During Current Pregnancy. Double Blind, Randomized, Controlled Trial.
- ClinicalTrials.gov ID
- NCT01317225
- Acronym / sponsor ID
- MHST2011-01
- Conditions
- Preterm Birth, Obstetric Labor, Premature
- Keywords
- Progesterone, Obstetric labor, premature, Short cervix
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Saint Thomas Hospital, PanamaUniversity, hospital or other
- Study start
- Jun 2011
- Primary completion
- Jul 2015 (estimated)
- Study completion
- Aug 2015 (estimated)
- First posted
- 17 Mar 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 is to determine if the use of 250 mg of intramuscular progesterone biweekly can reduce the incidence of preterm labor in patients with an episode of threatened preterm labor during the current pregnancy.
Detailed description
Preterm birth is one of the main causes of neonatal mortality and morbidity around the world, with serious repercussions on the health system and the families of the preterm baby. Many drugs have been evaluated with the purpose of preventing preterm birth in the patient at risk. One of these drugs is 17 α hydroxyprogesterone caproate. The purpose of this study is to evaluate if the use of biweekly doses of 17 α hydroxyprogesterone caproate in patients hospitalized with the diagnosis of threatened preterm labor, defined as the presence of uterine contractions and a short cervix (below the 10th percentile for the gestational age), can reduce the incidence of preterm birth in this high risk group population.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 17 α hydroxyprogesterone caproate | Experimental | Drug: 17 α hydroxyprogesterone caproate17α-Hydroxyprogesterone caproate. |
| Placebo | Placebo comparator | Drug: PlaceboSaline solution. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Pregnant women between 26 and 34 weeks of gestation.
- Cervical length (determined by transvaginal ultrasound) below the 10th percentile for the gestational age.
Key exclusion criteria (2 listed)
- Multiple gestations.
- Maternal pathologies in which preterm termination of pregnancy is required.
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 |
|---|---|---|
| 17 α hydroxyprogesterone caproate250mg intramuscular (gluteal muscles) biweekly from enrollment until delivery. | Drug | 17 α hydroxyprogesterone caproate |
| PlaceboAlso: Saline solution250 mg intramuscular (gluteal muscles)biweekly from enrollment until delivery. | Drug | Placebo |
Primary outcome
Incidence of preterm birth (before 37 weeks of gestation)
Time frame: 18 months
Number of patients that delivered before 37 weeks of pregnancy
2 secondary outcomes
Incidence of preterm birth before 35 weeks of pregnancy
Time frame: 18 months
Incidence of preterm birth before 32 weeks of pregnancy
Time frame: 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2015.
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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.
Osvaldo A Reyes, MD (Gyn/Ob) principal investigator
Saint Thomas Maternity Hospital
Rodrigo Velarde, MD (Gyn/Ob) principal investigator
Saint Thomas Maternity Hospital
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 17 α hydroxyprogesterone caproate in people with Preterm Birth and 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 2 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 6 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. Some participants in this study may receive a placebo. 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 Osvaldo A Reyes, MD (Gyn/Ob) (011(507)65655041, oreyesmaternidad@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of preterm birth (before 37 weeks of gestation) (time frame: 18 months). 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 6 Jan 2015.