Threatened Premature LaborPhase 4PROMISENCT00646802
Vaginal PROgesterone as Maintenance Treatment After an epISode of prEterm Labor (PROMISE Study)
A Phase 4 study testing Progesterone in people with Threatened Premature Labor, run by Hospital Clinic of Barcelona at 12 sites in Spain.
Trial summary
Eligible patients will be informed and asked to enroll in the study at hospital admission. A transvaginal ultrasound examination will be performed to determine cervical length. If an eligible woman accepts to participate, patient will be randomized to one of the study arms assigned in a double blind basis. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Threatened Premature Labor
- What is being tested?
- Progesterone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 265 participants
- Where
- 12 sitesSpain
- Study dates
- Jun 2008to May 2012
- Phase
- Phase 4
- 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 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Pregnant women aged between 18 - 45 years
- Gestational age between 24.0 and before 33.6 gestational weeks
- Singleton pregnancy
- Patients admitted because of preterm labor who have been successfully treated of any tocolytic drugs (β-mimetics drugs, nifedipine, atosiban)
- Ultrasound cervical length at discharge < 25 mm
- Signed patient consent form (CI)
Who cannot join
- Known or suspected infection, premature rupture of membranes or any other pathological gravid maternal or fetal condition coexisting at hospital admission (Pre-eclampsia, RCIU) which may induce iatrogenic labor.
- Present or previous liver disease, present or previous cholestasis gravidarum, abnormal hepatic blood tests.
- With known allergy to progesterone or peanuts (excipient).
- Grade 2 (or upper) renal or liver laboratory abnormalities
- Treated from dependent-hormone malignant cancer (i.e., breast carcinoma...)
- With Diabetes mellitus or insulinized gestational diabetes
Show all 9Show fewer
- Treated with heparin
- Drug abuse
- Inadequate treatment compliance
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
Spain12 sites
Institut Universitari Dexeus
Barcelona, Barcelona, 08028
Hospital Clinic de Barcelona
Barcelona, Barcelona, 08036
Hospital de Basurto
Bilbao, Bilbao, 48013
Hospital Puerta del Mar
Cadiz, Cádiz, 11009
Complejo Hospitalario Universitario Insular-Materno Infantil
Las Palmas de Gran Canaria, Gran Canaria, 35016
Hospital U Gregorio Marañon
Madrid, Madrid, 28009
Hospital Sant joan de Déu de Manresa
Manresa, Barcelona, 08243
Hospital Son Llàtzer
Palma de Mallorca, Balearic Islands, 07198
Corporació Sanitària Parc Taulí
Sabadell, Barcelona, 08208
Hospital Virgen de la Macarena
Seville, Seville, 41009
Hospital de Terrassa. CST
Terrassa, Barcelona, 08227
Hospital Clinico U. Lozano Blesa
Zaragoza, Zaragoza, 50009
About this study
Official title: Vaginal Progesterone as a Maintenance Treatment in Women With Previous Preterm Labor. Randomized, Double Blinded, Placebo-controlled Trial
Eligible patients will be informed and asked to enroll in the study at hospital admission. A transvaginal ultrasound examination will be performed to determine cervical length. If an eligible woman accepts to participate, patient will be randomized to one of the study arms assigned in a double blind basis. Patient will receive the medication (vaginal capsule of progesterone or placebo). The patient will administer herself one vaginal capsule in a daily basis since gestational age of 36 weeks and 6 days as the primary endpoint is to demonstrate that the use of a maintenance treatment with vaginal progesterone is able to reduce the incidence of preterm birth before 34.0 and 37.0 gestational weeks. After delivery, perinatal and neonatal data will be collected.
- Conditions
- Threatened Premature Labor
- Being tested
- Progesterone, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProgesteroneDrug
1 vaginal capsule, 200 mg, once daily since gestation age 36 weeks and 6 days
PlaceboDrug
1 vaginal capsule, once daily since gestational age of 36 weeks and 6 days
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | Progesterone 200 mg Receives: Drug: Progesterone |
| B | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of deliveries before week 34 of gestation
Measured: week 34 of gestation
Secondary outcomes (2)
Median time from randomization to delivery
Measured: delivery
Ultrasound cervical length
Measured: week +5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2008 (estimated)
- Study startJun 2008
- Primary completionMay 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Threatened Premature LaborStudies of the same condition, open and under way.
- More trials run by Hospital Clinic of BarcelonaThe 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 265 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Clinic of Barcelona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Montse Palacio, Hospital Clinic of Barcelona
- Investigators
- Montse Palacio, MD, Principal investigator, Hospital Clinic of Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00646802
- Sponsor's protocol ID
- PROMISE
- Acronym
- PROMISE
- Status last verified
- Aug 2016
- First submitted
- 26 Mar 2008
- Last updated
- 19 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vaginal Progesterone as a Maintenance Treatment in Women With Previous Preterm Labor. Randomized, Double Blinded, Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT00646802
- Acronym / sponsor ID
- PROMISE / PROMISE
- Conditions
- Threatened Premature Labor
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 265 participants (actual)
- Lead sponsor
- Hospital Clinic of BarcelonaUniversity, hospital or other
- Study start
- Jun 2008
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 31 Mar 2008 (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.
Eligible patients will be informed and asked to enroll in the study at hospital admission. A transvaginal ultrasound examination will be performed to determine cervical length. If an eligible woman accepts to participate, patient will be randomized to one of the study arms assigned in a double blind basis. Patient will receive the medication (vaginal capsule of progesterone or placebo). The patient will administer herself one vaginal capsule in a daily basis since gestational age of 36 weeks and 6 days as the primary endpoint is to demonstrate that the use of a maintenance treatment with vaginal progesterone is able to reduce the incidence of preterm birth before 34.0 and 37.0 gestational weeks. After delivery, perinatal and neonatal data will be collected.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Drug: ProgesteroneProgesterone 200 mg |
| B | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Pregnant women aged between 18 - 45 years
- Gestational age between 24.0 and before 33.6 gestational weeks
- Singleton pregnancy
- Patients admitted because of preterm labor who have been successfully treated of any tocolytic drugs (β-mimetics drugs, nifedipine, atosiban)
- Ultrasound cervical length at discharge < 25 mm
Key exclusion criteria (9 listed)
- Known or suspected infection, premature rupture of membranes or any other pathological gravid maternal or fetal condition coexisting at hospital admission (Pre-eclampsia, RCIU) which may induce iatrogenic labor.
- Present or previous liver disease, present or previous cholestasis gravidarum, abnormal hepatic blood tests.
- With known allergy to progesterone or peanuts (excipient).
- Grade 2 (or upper) renal or liver laboratory abnormalities
- Treated from dependent-hormone malignant cancer (i.e., breast carcinoma...)
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 |
|---|---|---|
| Progesterone1 vaginal capsule, 200 mg, once daily since gestation age 36 weeks and 6 days | Drug | A |
| Placebo1 vaginal capsule, once daily since gestational age of 36 weeks and 6 days | Drug | B |
Primary outcome
Proportion of deliveries before week 34 of gestation
Time frame: week 34 of gestation
2 secondary outcomes
Median time from randomization to delivery
Time frame: delivery
Ultrasound cervical length
Time frame: week +5
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 19 Aug 2016.
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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.
Montse Palacio, MD principal investigator
Hospital Clinic of Barcelona
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Progesterone in people with Threatened Premature Labor, run by Hospital Clinic of Barcelona at 12 sites in Spain.
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 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 19 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Spain. 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 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?
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?
Proportion of deliveries before week 34 of gestation (time frame: week 34 of gestation). 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 19 Aug 2016.