Preterm DeliveryPhase 4NCT01031017
Prophylactic Administration of Natural Progesterone in the Prevention of Preterm Delivery in Twin Pregnancies
A Phase 4 study testing progesterone in people with Preterm Delivery, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
Twin pregnancies are at substantial increased risk of preterm delivery. Prophylactic administration of progesterone in singleton pregnancies at risk of preterm delivery has been shown to be effective in reducing the rate of such complication. Read more about this study
- Who is it for?
- Ages 15 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Preterm Delivery
- What is being tested?
- progesterone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 390 participants
- Where
- 1 siteBrazil
- Study dates
- Jun 2007to Jun 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 15 to 50 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Naturally conceived diamniotic twin pregnancies.
- Absence of major fetal abnormalities (such as neural tube defects, abdominal wall defects, cardiac defects, hydrocephalus, malformations that course with polyhydramnios) at the anomaly scan.
- Gestational age between 18 - 21+6weeks at the moment of randomization.
- Patients that are not allergic to the progesterone capsule excipients (arachis oil, soy and lecithin).
- Patients who do not use other medicines that can alter the progesterone effects, such as: barbituric, carbamazepine, hydantoin, rifampicin, betablockers, teofiline or ciclosporin.
- Porphyria, otoscleroses, malignant disease or severe depressive state.
Who cannot join
- Premature rupture of membranes diagnosed at the moment of recruitment.
- Subsequent diagnosis of major fetal abnormalities.
- Twin to twin transfusion syndrome diagnosed during the course of the pregnancy.
- Presence of ovular infection.
- Death of one or both fetuses in any time of the pregnancy.
- Giving up or discontinuing the use of the medication.
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- Elective or iatrogenic premature birth (before 34 weeks).
- Present or past history of thromboembolic disease
- Uterine malformation
- Known or suspected breast or genitals malignancy tumor
- Plan to move to another city during pregnancy
- Placenta Previa
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prophylactic Administration of Natural Progesterone in the Prevention of Preterm Delivery in Twin Pregnancies: A Randomized, Double-Blind, Placebo-Controlled Trial
Twin pregnancies are at substantial increased risk of preterm delivery. Prophylactic administration of progesterone in singleton pregnancies at risk of preterm delivery has been shown to be effective in reducing the rate of such complication. The aim of this study is to investigate the effect of prophylactic administration of natural progesterone in twin pregnancies on the rate of preterm births.
Read the detailed description
In a double-blind, placebo controlled study performed in our Institution, Fonseca et al., investigated the use of micronized natural progesterone, crafted in vaginal capsules of 100mg, for the prevention of preterm delivery. The study involved 142 singleton pregnancies at high risk for premature birth (previous premature birth, cerclage and uterine malformation). The progesterone was introduced from 24 weeks to 34 weeks gestation. The authors observed a significant reduction of premature birth before 37 weeks (28,1% within the placebo group versus 13,8% within the treated group) and below 34 weeks (18,6% within the placebo group versus 2,8% within the treated group). Also, it was observed a reduction in the frequency of the uterine contractions in the progesterone group.
In the only study performed specifically among twin pregnancies, Anna Lisa et al. in 1980, administrated 250mg of 17αOH-PC or placebo (still oil) weekly, in 70 pregnant women with twin pregnancies, beginning before 28 weeks and continuing up to 37 weeks gestation. Seric levels of progesterone, estradiol, estriol, testosterone, and placental lactogenic hormone were also measured weekly. The differences among the achieved results within both groups, according the average in pregnancy duration (36,9 within the treated group, versus 37,3 within the placebo group), the average birthweight and the perimortality rate were not significantly different, as well as the levels of progesterone, estriol, estradiol, testosterone and placental lactogenic hormone. Nevertheless, this study was criticized for starting the use of progesterone at a late stage of pregnancy, in a considerable number of cases.
These studies suggest that in singleton pregnancies with a previous history of preterm birth progesterone treatment may prevent the patients from having subsequent premature births. Nonetheless, the results of these series must not be generalized to all pregnancies at high risk. Additional studies to evaluate the use of progesterone ovules in multiple pregnancies are necessary, as these pregnancies are increasing due to the advanced maternal age at the conception time and also due to the widespread use of assisted reproductive techniques.
- Conditions
- Preterm Delivery
- Being tested
- progesterone, placebo
- Keywords
- twin pregnancies, preterm delivery, progesterone
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
progesteroneDrug
Also called utrogestan
ovules, 200mg per vagina, once a day from 18 weeks
placeboDrug
placebo
| Study group | Role | What they receive |
|---|---|---|
| placebo | Placebo comparator | group taking placebo Receives: Drug: placebo |
| study group | Active comparator | group taking progesterone Receives: Drug: progesterone |
What is being measured
The primary outcome is the main question the study is designed to answer.
gestational age at delivery
Measured: once at the end of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2009 (estimated)
- Study startJun 2007
- Primary completionMay 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preterm DeliveryStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 390 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria de Lourdes Brizot, University of Sao Paulo
- Investigators
- Maria Brizot, PhD, Principal investigator, Department of Obstetrics, São Paulo University Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01031017
- Sponsor's protocol ID
- 418/04
- Status last verified
- Dec 2014
- First submitted
- 9 Dec 2009
- Last updated
- 4 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prophylactic Administration of Natural Progesterone in the Prevention of Preterm Delivery in Twin Pregnancies: A Randomized, Double-Blind, Placebo-Controlled Trial
- ClinicalTrials.gov ID
- NCT01031017
- Acronym / sponsor ID
- 418/04
- Conditions
- Preterm Delivery
- Keywords
- twin pregnancies, preterm delivery, progesterone
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 390 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- Jun 2007
- Primary completion
- May 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 14 Dec 2009 (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 are at substantial increased risk of preterm delivery. Prophylactic administration of progesterone in singleton pregnancies at risk of preterm delivery has been shown to be effective in reducing the rate of such complication. The aim of this study is to investigate the effect of prophylactic administration of natural progesterone in twin pregnancies on the rate of preterm births.
Detailed description
In a double-blind, placebo controlled study performed in our Institution, Fonseca et al., investigated the use of micronized natural progesterone, crafted in vaginal capsules of 100mg, for the prevention of preterm delivery. The study involved 142 singleton pregnancies at high risk for premature birth (previous premature birth, cerclage and uterine malformation). The progesterone was introduced from 24 weeks to 34 weeks gestation. The authors observed a significant reduction of premature birth before 37 weeks (28,1% within the placebo group versus 13,8% within the treated group) and below 34 weeks (18,6% within the placebo group versus 2,8% within the treated group). Also, it was observed a reduction in the frequency of the uterine contractions in the progesterone group.
In the only study performed specifically among twin pregnancies, Anna Lisa et al. in 1980, administrated 250mg of 17αOH-PC or placebo (still oil) weekly, in 70 pregnant women with twin pregnancies, beginning before 28 weeks and continuing up to 37 weeks gestation. Seric levels of progesterone, estradiol, estriol, testosterone, and placental lactogenic hormone were also measured weekly. The differences among the achieved results within both groups, according the average in pregnancy duration (36,9 within the treated group, versus 37,3 within the placebo group), the average birthweight and the perimortality rate were not significantly different, as well as the levels of progesterone, estriol, estradiol, testosterone and placental lactogenic hormone. Nevertheless, this study was criticized for starting the use of progesterone at a late stage of pregnancy, in a considerable number of cases.
These studies suggest that in singleton pregnancies with a previous history of preterm birth progesterone treatment may prevent the patients from having subsequent premature births. Nonetheless, the results of these series must not be generalized to all pregnancies at high risk. Additional studies to evaluate the use of progesterone ovules in multiple pregnancies are necessary, as these pregnancies are increasing due to the advanced maternal age at the conception time and also due to the widespread use of assisted reproductive techniques.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| placebo | Placebo comparator | Drug: placebogroup taking placebo |
| study group | Active comparator | Drug: progesteronegroup taking progesterone |
Who may qualify
- Ages
- 15 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Naturally conceived diamniotic twin pregnancies.
- Absence of major fetal abnormalities (such as neural tube defects, abdominal wall defects, cardiac defects, hydrocephalus, malformations that course with polyhydramnios) at the anomaly scan.
- Gestational age between 18 - 21+6weeks at the moment of randomization.
- Patients that are not allergic to the progesterone capsule excipients (arachis oil, soy and lecithin).
- Patients who do not use other medicines that can alter the progesterone effects, such as: barbituric, carbamazepine, hydantoin, rifampicin, betablockers, teofiline or ciclosporin.
Key exclusion criteria (12 listed)
- Premature rupture of membranes diagnosed at the moment of recruitment.
- Subsequent diagnosis of major fetal abnormalities.
- Twin to twin transfusion syndrome diagnosed during the course of the pregnancy.
- Presence of ovular infection.
- Death of one or both fetuses in any time of the pregnancy.
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: utrogestanovules, 200mg per vagina, once a day from 18 weeks | Drug | study group |
| placeboplacebo | Drug | placebo |
Primary outcome
gestational age at delivery
Time frame: once at the end of study
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 Dec 2014.
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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.
Maria Brizot, PhD principal investigator
Department of Obstetrics, São Paulo University Medical School
1 site 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 Preterm Delivery, run by University of Sao Paulo at 1 site in Brazil.
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 12 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 Dec 2014. 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 Brazil. 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?
gestational age at delivery (time frame: once at the end of study). 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 4 Dec 2014.