Preterm BirthPhase 3NCT00480402
Natural Progesterone and Preterm Birth in Twins
A Phase 3 study testing 200 mg of Progesterone and 400 mg Progesterone in people with Preterm Birth, run by Instituto Valenciano de Infertilidad, IVI VALENCIA at 1 site in Spain.
Trial summary
To assess the effectiveness of natural progesterone supplementation in preventing preterm births in twins. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Preterm Birth
- What is being tested?
- 200 mg of Progesterone and 400 mg Progesterone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 290 participants
- Where
- 1 siteSpain
- Study dates
- Jan 2006to Jun 2007
- 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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Bichorionic biamniotic twin pregnant women
- = or > 18 years old
Who cannot join
- Single pregnancy or monochorionic twin pregnancy or triplets
- Chronic hepatic pathology, previous alterations in hepatic analysis during anti-contraceptive treatment; or gestational cholestasis in in previous pregnancies.Basal alterations in hepatic analysis profile.
- Profylactic cerclage until week 14.
- Basal alterations in renal analysis profile
- Local allergy to micronized natural progesterone
- Genital pathology not allowing for correct absorption of medication
Show all 9Show fewer
- Fetal anomoly diagnosed after sonograph week 12 and/or 20.
- Smokers of more than 10 cigarettes/day
- Consumers of illegal substances
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Eficacia de Los Suplementos de Progesterona Natural en la prevención Del Parto pretérmino Gemelar
To assess the effectiveness of natural progesterone supplementation in preventing preterm births in twins.
Read the detailed description
Objective: To assess the effectiveness of natural progesterone supplementation in preventing preterm births in twins.
Study Design: National multicenter randomized double blind controlled clinical trial.
Setting: Six tertiary hospitals in the east of Spain (communities of Valencia and Murcia): Instituto Universitario IVI Valencia, Hospital Universitario La Fe (Valencia), Hospital Universitario Dr. Peset (Valencia), Hospital General Universitario (Alicante), Hospital Vega Baja de Orihuela (Alicante) y Hospital Virgen de la Arrixaca (Murcia).
Population: 246 bichorionic biamniotic twin pregnant women divided in three groups according to the allocated randomized treatment: (I) placebo (N=82); (II) 200 mg progesterone (N=82); and (III) 400 mg progesterone (N=82).
Methods: All participant women will self-administer two vaginal pessaries at bedtime containing the allocated treatment. Vaginal pessaries will be identical externally but will contain either placebo or 200 mg of natural progesterone (Laboratorios Effik, Madrid, Spain). The treatment will be applied from the 20th week until the 34th week (or until delivery if it occurred earlier). Control visits will be performed at 24, 28, 32 and 34 weeks. Pregnancies will be managed according to each local protocol. An external statistical analysis will be performed on intention to treat basis.
Main outcome measure: Preterm birth rate (<37 weeks). Secondary outcome measures: very preterm birth rate (<32 weeks); cervical length measured by vaginal ultrasound at each control visit; need for tocolytic treatments; rate of preterm premature rupture of membranes; and perinatal morbidity and mortality.
Estimated period of study: 2006-2008.
- Conditions
- Preterm Birth
- Being tested
- 200 mg of Progesterone, 400 mg Progesterone, Placebo
- Keywords
- preterm birth, progesterone, twins, Preterm birth in twin gestations
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
200 mg of ProgesteroneDrug
Administration of 200 mg of Progesterone
400 mg ProgesteroneDrug
Administration of 400 mg Progesterone
PlaceboDrug
Administration of a Placebo
| Study group | Role | What they receive |
|---|---|---|
| 400 mg Progesterone | Experimental | Approximately one third of the bichorionic biamniotic twin pregnant women randomized to the 400 mg Progesterone Group vaginal pessaries arm. Receives: Drug: 400 mg Progesterone |
| 200 mg Progesterone Group | Experimental | Approximately one third of the bichorionic biamniotic twin pregnant women randomized to the 200 mg Progesterone Group vaginal pessaries arm. Receives: Drug: 200 mg of Progesterone |
| Placebo | Active comparator | Approximately one third of the bichoronic biamniotic twin pregnant women were randomized to the placebo vaginal pessaries arm. Receives: Drug: Placebo |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2007 (estimated)
- Study startJan 2006
- Primary completionJun 2007
- Study completionJun 2007
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 290 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Valenciano de Infertilidad, IVI VALENCIA
- Sponsor type
- University, hospital or other
- Investigators
- Vicente Serra, MDPhD, Study director, Instituto Valenciano de la Infertilidad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00480402
- Sponsor's protocol ID
- VLC-VS-0405-507-23
- Status last verified
- Apr 2013
- First submitted
- 28 May 2007
- Last updated
- 4 Apr 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Eficacia de Los Suplementos de Progesterona Natural en la prevención Del Parto pretérmino Gemelar
- ClinicalTrials.gov ID
- NCT00480402
- Acronym / sponsor ID
- VLC-VS-0405-507-23
- Conditions
- Preterm Birth
- Keywords
- preterm birth, progesterone, twins, Preterm birth in twin gestations
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 290 participants (actual)
- Lead sponsor
- Instituto Valenciano de Infertilidad, IVI VALENCIAUniversity, hospital or other
- Study start
- Jan 2006
- Primary completion
- Jun 2007 (actual)
- Study completion
- Jun 2007 (actual)
- First posted
- 30 May 2007 (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.
To assess the effectiveness of natural progesterone supplementation in preventing preterm births in twins.
Detailed description
Objective: To assess the effectiveness of natural progesterone supplementation in preventing preterm births in twins.
Study Design: National multicenter randomized double blind controlled clinical trial.
Setting: Six tertiary hospitals in the east of Spain (communities of Valencia and Murcia): Instituto Universitario IVI Valencia, Hospital Universitario La Fe (Valencia), Hospital Universitario Dr. Peset (Valencia), Hospital General Universitario (Alicante), Hospital Vega Baja de Orihuela (Alicante) y Hospital Virgen de la Arrixaca (Murcia).
Population: 246 bichorionic biamniotic twin pregnant women divided in three groups according to the allocated randomized treatment: (I) placebo (N=82); (II) 200 mg progesterone (N=82); and (III) 400 mg progesterone (N=82).
Methods: All participant women will self-administer two vaginal pessaries at bedtime containing the allocated treatment. Vaginal pessaries will be identical externally but will contain either placebo or 200 mg of natural progesterone (Laboratorios Effik, Madrid, Spain). The treatment will be applied from the 20th week until the 34th week (or until delivery if it occurred earlier). Control visits will be performed at 24, 28, 32 and 34 weeks. Pregnancies will be managed according to each local protocol. An external statistical analysis will be performed on intention to treat basis.
Main outcome measure: Preterm birth rate (<37 weeks). Secondary outcome measures: very preterm birth rate (<32 weeks); cervical length measured by vaginal ultrasound at each control visit; need for tocolytic treatments; rate of preterm premature rupture of membranes; and perinatal morbidity and mortality.
Estimated period of study: 2006-2008.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 400 mg Progesterone | Experimental | Drug: 400 mg ProgesteroneApproximately one third of the bichorionic biamniotic twin pregnant women randomized to the 400 mg Progesterone Group vaginal pessaries arm. |
| 200 mg Progesterone Group | Experimental | Drug: 200 mg of ProgesteroneApproximately one third of the bichorionic biamniotic twin pregnant women randomized to the 200 mg Progesterone Group vaginal pessaries arm. |
| Placebo | Active comparator | Drug: PlaceboApproximately one third of the bichoronic biamniotic twin pregnant women were randomized to the placebo vaginal pessaries arm. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Bichorionic biamniotic twin pregnant women
- = or > 18 years old
Key exclusion criteria (9 listed)
- Single pregnancy or monochorionic twin pregnancy or triplets
- Chronic hepatic pathology, previous alterations in hepatic analysis during anti-contraceptive treatment; or gestational cholestasis in in previous pregnancies.Basal alterations in hepatic analysis profile.
- Profylactic cerclage until week 14.
- Basal alterations in renal analysis profile
- Local allergy to micronized natural progesterone
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 |
|---|---|---|
| 200 mg of ProgesteroneAdministration of 200 mg of Progesterone | Drug | 200 mg Progesterone Group |
| 400 mg ProgesteroneAdministration of 400 mg Progesterone | Drug | 400 mg Progesterone |
| PlaceboAdministration of a Placebo | Drug | Placebo |
Primary outcome
Not reported in the source record.
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 4 Apr 2013.
Related trials for Preterm Birth
Not yet recruiting
nCPAP-NAVA-Backup Versus Standard nCPAP for Severe Apnea in Preterm Infants ≤28 Weeks
Apnea of Prematurity
Recruiting
Study of the Influence of Intraperitoneal Insufflation of CO2 by Laparoscopy on the Short-term Evolution of Premature Infants With Ulcerative Necrotizing Enterocolitis
Preterm Birth, Enterocolitis, Necrotizing
Recruiting
Comparing Surfactant Administration Through Supraglottic Airway and Thin Catheter for Preterm Infants
Surfactant, Respiratory Distress Syndrome (Neonatal)
RecruitingObservational study
Multidimensional Dynamic Early Warning System for Neonatal Necrotizing Enterocolitis: A Multicenter Clinical Study
NEC - Necrotizing Enterocolitis
Recruiting
Optimization of Saturation Targets And Resuscitation Trial (OptiSTART)
Premature Infants, Bronchopulmonary Dysplasia
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.
Vicente Serra, MDPhD study director
Instituto Valenciano de la Infertilidad
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 200 mg of Progesterone and 400 mg Progesterone in people with Preterm Birth, run by Instituto Valenciano de Infertilidad, IVI VALENCIA at 1 site 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 2 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 4 Apr 2013. 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 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. 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?
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.
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 4 Apr 2013.