PregnanciesPhase 4NCT01927029
Preterm Delivery Prevention in Twins With Progesterone
A Phase 4 study testing Progesterone in people with Pregnancies, run by Universidad del Desarrollo.
Trial summary
Twin pregnancies have very high preterm delivery rate. Until now, no RCT has proven benefit of progesterone in this population. In contrast, singleton pregnancies are treated with this hormone. The objective is to compare 180mg/day progeterone vaginal gel with 180mg/day with placebo, from 18 weeks to 34 weeks. Read more about this study
- Who is it for?
- Ages 14 to 45 years, women only
- Conditions the study is for
- Pregnancies
- What is being tested?
- Progesterone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 213 participants
- Where
- No sites listed yet
- Study dates
- Aug 2013to Dec 2014
- 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 14 to 45 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Monochorionic or Dichorionic twin pregnancies
- 18 weeks to 24 weeks at inclusion.
Who cannot join
- Cerclage before inclusion
- Contractions, rupture of the membranes, cervix dilation,
- Short cervix (15mm or 20mm if there is history of preterm delivery
- Monoamniotic twins, Major malformation, Selective IUGR, TRAP, TTTS.
- Younger than 14 years.
About this study
Official title: Prevención de Parto Prematuro en Gemelares: Ensayo Aleatorio Con Progesterona Vaginal.
Twin pregnancies have very high preterm delivery rate. Until now, no RCT has proven benefit of progesterone in this population. In contrast, singleton pregnancies are treated with this hormone. The objective is to compare 180mg/day progeterone vaginal gel with 180mg/day with placebo, from 18 weeks to 34 weeks. The sample size was calculated and 213 cases in each group are needed to demonstrate a reduction of preterm delivery <34weeks from 13% to 7%.
- Conditions
- Pregnancies
- Being tested
- Progesterone, Placebo
- Keywords
- twin pregnancy, progesterone, preterm delivery, >14 years, Abscense of cerclage,, TTTS, hemorrage,, history of thrombosis., cervix >15mm
- Medical subject headings
- Premature Birth, Fetofetal Transfusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProgesteroneDrug
Also called Progendo gel
Vaginal progesterone gel 180mg/daily is given from second trimester (18 to 24 weeks) until 34 weeks.
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Progesterone | Experimental | Daily administration of vaginal progesterone, 180mg, in gel, from 18 weeks to 34 weeks. Receives: Drug: Progesterone |
| Placebo | Placebo comparator | Placebo Gel, for daily use from 18 weeks to 34 weeks. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Preterm delivery <34 weeks
Spontaneous labor under 34 weeks.
Measured: 14 months
Secondary outcomes (1)
Preterm delivery <37 weeks
Spontaneous delivery under 37 weeks
Measured: 14 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2013 (estimated)
- Study startAug 2013
- Primary completionOct 2014 (estimated)
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnanciesStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 213 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad del Desarrollo
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Padre Hurtado, Hospital San Borja-Arriaran
- Responsible party
- Principal investigator, Masami Yamamoto, Clinica Alemana de Santiago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01927029
- Sponsor's protocol ID
- CAS149
- Status last verified
- Aug 2013
- First submitted
- 19 Aug 2013
- Last updated
- 21 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevención de Parto Prematuro en Gemelares: Ensayo Aleatorio Con Progesterona Vaginal.
- ClinicalTrials.gov ID
- NCT01927029
- Acronym / sponsor ID
- CAS149
- Conditions
- Pregnancies
- Keywords
- twin pregnancy, progesterone, preterm delivery, >14 years, Abscense of cerclage,, TTTS, hemorrage,, history of thrombosis., cervix >15mm
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 213 participants (actual)
- Lead sponsor
- Universidad del DesarrolloUniversity, hospital or other
- Collaborators
- Hospital Padre Hurtado, Hospital San Borja-Arriaran
- Study start
- Aug 2013
- Primary completion
- Oct 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 21 Aug 2013 (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.
Twin pregnancies have very high preterm delivery rate. Until now, no RCT has proven benefit of progesterone in this population. In contrast, singleton pregnancies are treated with this hormone. The objective is to compare 180mg/day progeterone vaginal gel with 180mg/day with placebo, from 18 weeks to 34 weeks. The sample size was calculated and 213 cases in each group are needed to demonstrate a reduction of preterm delivery <34weeks from 13% to 7%.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Progesterone | Experimental | Drug: ProgesteroneDaily administration of vaginal progesterone, 180mg, in gel, from 18 weeks to 34 weeks. |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo Gel, for daily use from 18 weeks to 34 weeks. |
Who may qualify
- Ages
- 14 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Monochorionic or Dichorionic twin pregnancies
- 18 weeks to 24 weeks at inclusion.
Key exclusion criteria (5 listed)
- Cerclage before inclusion
- Contractions, rupture of the membranes, cervix dilation,
- Short cervix (15mm or 20mm if there is history of preterm delivery
- Monoamniotic twins, Major malformation, Selective IUGR, TRAP, TTTS.
- Younger than 14 years.
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 |
|---|---|---|
| ProgesteroneAlso: Progendo gelVaginal progesterone gel 180mg/daily is given from second trimester (18 to 24 weeks) until 34 weeks. | Drug | Progesterone |
| Placebo | Drug | Placebo |
Primary outcome
Preterm delivery <34 weeks
Time frame: 14 months
Spontaneous labor under 34 weeks.
1 secondary outcome
Preterm delivery <37 weeks
Time frame: 14 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2013.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Progesterone in people with Pregnancies, run by Universidad del Desarrollo.
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 5 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 21 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Preterm delivery <34 weeks (time frame: 14 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 21 Aug 2013.