Preterm BirthPhase 2/3PRECEPETNCT03058536
Progesterone and Cervical Pessary in Twins
A Phase 2/3 study testing Arabin Pessary, Vaginal Progesterone and Arabin Pessary and Progesterone in people with Preterm Birth and Twin Pregnancy With Antenatal Problem, run by Mario Henrique Burlacchini de Carvalho at 1 site in Brazil.
Trial summary
The aim of this randomized control trial is to determine wheter cervical pessary plus vaginal progesterone (400mg) reduce preterm birth less than 34 weeks of gestacion and improve perinatal outcome, among women presenting asyntomatic short cervix, in twin pregnancy. Read more about this study
- Who is it for?
- Ages 16 to 50 years, women only
- Conditions the study is for
- Preterm Birth, Twin Pregnancy With Antenatal Problem
- What is being tested?
- Arabin Pessary, Vaginal Progesterone and Arabin Pessary and Progesterone
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 312 participants
- Where
- 1 siteBrazil
- Study dates
- 21 Feb 2017to Mar 2019
- Phase
- Phase 2/3
- 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 16 to 50 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Twin pregnancy ( dichorionic or monochorionic diamniotic)
- Both fetuses alive
- Asymptomatic short cervix according to gestational age ( measurement less or equal 30 mm between 16 weeks + 0 day and 22 weeks + 0 day, less or equal 25 mm between 22 weeks + 1 day and 24 weeks + 0 day and less or equal 20 mm between 24 weeks + 1 day and 27 weeks + 6 days)
- Gestational age between 16 to 27weeks and 6 days
- Intact membranes
- Informed consent
Who cannot join
- Monoamniotic twins
- Twin Twin transfusion syndrome
- Rupture membranes
- Major malformation or chromosomal abnormality at least one fetus
- Women with Cervical cerclage in the current pregnancy
- Ballooning of membranes outside the cervix into the vagina
Show all 12Show fewer
- Placenta previa
- Treatment with progesterone before randomization
- Allergy of the excipientes of the micronized progesterone
- Labor
- Severe hepatic disfunction, porphyria, otosclerosis, severe depression
- Use of drugs that interfere the effects of progesterone
Trial locations and contacts
1 site in 1 country.
Mario Henrique Burlacchini de Carvalho, PhD contact
Brazil1 site, 1 recruiting
- Recruiting
Hospital das Clinicas da FMUSP
São Paulo, São Paulo
Mario Henrique Burlacchini de Carvalho, PhD, 551126616209, marioburlacchini@uol.com.br
About this study
Official title: Progesterone and Cervical Pessary in Twins : A Prospective and Randomized Study to Prevent Preterm Birth (PRECEPT)
The aim of this randomized control trial is to determine wheter cervical pessary plus vaginal progesterone (400mg) reduce preterm birth less than 34 weeks of gestacion and improve perinatal outcome, among women presenting asyntomatic short cervix, in twin pregnancy.
Read the detailed description
The frequency of twin pregnancies has increased significantly, especially because of the assisted reproduction and advanced maternal age at conception. The twin pregnancies are responsible for 25 % of all preterm birth. Consequently, twin pregnancies are more associated with perinatal mortality and morbidity when compared to single pregnancies. Additionally, the short cervix (< 25 mm) in singleton and twin pregnancies are associated with significantly increased preterm birth.
Randomized controlled trials in singleton pregnancies reported that profilatic cervical cerclage and vaginal progesterone reduce significantly the rate of early preterm birth. In twin pregnancies, vaginal progesterone and profilatic cerclage have been shown to be ineffective in prevention of preterm birth.
However, two individual pacient data meta-analyses reported in a subgroup of women with twin pregancies and short cervix, that vaginal progesterone reduce significantly adverse neonatal outcomes. Nowadays, the effet of cervical pessary is contraditory, mainly in women with short cervix.
This is a randomized prospective trial at São Paulo University Medical School. This trial will involve 312 women with twins pregnancies and short cervix between 16 and 27 weeks and 6 days of gestacional age. Women with twin pregnancy and short cervix ( defined according to the gestacional age ) will be assigned randomly to daily vaginal progesterone (400mg) combined with insertion of cervical pessary, isolated use of daily vaginal progesterone (400mg) isolated insertion of cervical pessary or expectant management (no intervention). The primary outcome is to compare the rate of spontaneous delivery < 34 weeks of gestacion between groups.The secondary outcome is to compare the neonatal adverse outcome between the groups.
The aim of this study is to test the hypothesis that the insertion of a cervical pessary combined with vaginal progesterone, in twin pregnancies with short cervix would reduce the spontaneus preterm birth < 34 weeks' gestation.
- Being tested
- Arabin Pessary, Vaginal Progesterone, Arabin Pessary and Progesterone
- Keywords
- twin short cervix pessary progesterone preterm birth
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arabin PessaryDevice
The cervical pessary will be inserted at the randomization and removed during the 36 week of pregnancy, unless labour occurs sooner.
Vaginal ProgesteroneDrug
Also called Utrogestan
Treatment with 400 mg micronized progesterone daily, until the day of randomization to 36 weeks of pregnancy.
Arabin Pessary and ProgesteroneOther
Arabin Pessary and Progesterone The cervical pessary will be inserted at the randomization and removed during the 36 week of pregnancy, unless labour occurs sooner. Treatment with 400 mg Micronized progesterone daily, until the day of randomization to 36 weeks of pregnancy.
| Study group | Role | What they receive |
|---|---|---|
| Progesterone | Active comparator | 400 mg micronized vaginal progesterone daily from randomization to 36 weeks Receives: Drug: Vaginal Progesterone |
| Arabin Pessary and Progesterone | Active comparator | Arabin Pessary and Natural Micronized Progesterone
400 mg micronized vaginal progesterone daily from randomization to 36 weeks
The device will be placed at randomization and will be removed during the 36th week of gestacional (or earlier if indicated) in combination with vaginal progesterone. Receives: Other: Arabin Pessary and Progesterone |
| Arabin Pessary | Active comparator | The device will be placed at randomization and will be removed during the 36th week of gestacional (or earlier if indicated) without vaginal progesterone use. Receives: Device: Arabin Pessary |
| No intervention | No intervention | Expectant management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Preterm birth
Rate of preterm birth before 34 weeks gestation
Measured: 5 months
Secondary outcomes (2)
Neonatal Complications Rate
Includes necrotizing enterocolitis, intraventricular hemorrhage (grade 3 or higher), respiratory distress syndrome, retinopathy, sepsis, use of mechanical ventilation, time of hospitalization, and neonatal death.
Measured: between birth and 28 days of age
Months from Randomization to delivery interval
Randomization may begin at 16 weeks, and most patient will be delivered between 36 and 38 weeks gestation.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2017
- Study start21 Feb 2017
- Primary completionMar 2019 (estimated)
- Study completionMar 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- 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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 312 twin pregnant women with short cervix between 16 and 27 weeks and 6 days of gestacional age will be randomized in four groups: daily 400mg vaginal progesterone combined with insertion of cervical pessary; isolated use of daily 400mg vaginal progesterone, isolated insertion of cervical pessary or expectant management (no intervention).
- Masking
- None (open label)
- Enrolment
- 312 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mario Henrique Burlacchini de Carvalho
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mario Henrique Burlacchini de Carvalho, University of Sao Paulo
- Investigators
- Mario Henrique Burlacchini de Carvalho, PhD, Principal investigator, Hospital das Clínicas Universidade de São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03058536
- Sponsor's protocol ID
- 1.847.411
- Acronym
- PRECEPET
- Status last verified
- Feb 2017
- First submitted
- 5 Feb 2017
- Last updated
- 15 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Kindinger LM, Poon LC, Cacciatore S, MacIntyre DA, Fox NS, Schuit E, Mol BW, Liem S, Lim AC, Serra V, Perales A, Hermans F, Darzi A, Bennett P, Nicolaides KH, Teoh TG. The effect of gestational age and cervical length measurements in the prediction of spontaneous preterm birth in twin pregnancies: an individual patient level meta-analysis. BJOG. 2016 May;123(6):877-84. doi: 10.1111/1471-0528.13575. Epub 2015 Sep 1.
PubMed 26333191Romero R, Nicolaides K, Conde-Agudelo A, Tabor A, O'Brien JM, Cetingoz E, Da Fonseca E, Creasy GW, Klein K, Rode L, Soma-Pillay P, Fusey S, Cam C, Alfirevic Z, Hassan SS. Vaginal progesterone in women with an asymptomatic sonographic short cervix in the midtrimester decreases preterm delivery and neonatal morbidity: a systematic review and metaanalysis of individual patient data. Am J Obstet Gynecol. 2012 Feb;206(2):124.e1-19. doi: 10.1016/j.ajog.2011.12.003. Epub 2011 Dec 11.
PubMed 22284156Norman JE, Mackenzie F, Owen P, Mactier H, Hanretty K, Cooper S, Calder A, Mires G, Danielian P, Sturgiss S, MacLennan G, Tydeman G, Thornton S, Martin B, Thornton JG, Neilson JP, Norrie J. Progesterone for the prevention of preterm birth in twin pregnancy (STOPPIT): a randomised, double-blind, placebo-controlled study and meta-analysis. Lancet. 2009 Jun 13;373(9680):2034-40. doi: 10.1016/S0140-6736(09)60947-8.
PubMed 19523680Brizot ML, Hernandez W, Liao AW, Bittar RE, Francisco RPV, Krebs VLJ, Zugaib M. Vaginal progesterone for the prevention of preterm birth in twin gestations: a randomized placebo-controlled double-blind study. Am J Obstet Gynecol. 2015 Jul;213(1):82.e1-82.e9. doi: 10.1016/j.ajog.2015.02.021. Epub 2015 Feb 27.
PubMed 25731690Schuit E, Stock S, Rode L, Rouse DJ, Lim AC, Norman JE, Nassar AH, Serra V, Combs CA, Vayssiere C, Aboulghar MM, Wood S, Cetingoz E, Briery CM, Fonseca EB, Worda K, Tabor A, Thom EA, Caritis SN, Awwad J, Usta IM, Perales A, Meseguer J, Maurel K, Garite T, Aboulghar MA, Amin YM, Ross S, Cam C, Karateke A, Morrison JC, Magann EF, Nicolaides KH, Zuithoff NP, Groenwold RH, Moons KG, Kwee A, Mol BW; Global Obstetrics Network (GONet) collaboration. Effectiveness of progestogens to improve perinatal outcome in twin pregnancies: an individual participant data meta-analysis. BJOG. 2015 Jan;122(1):27-37. doi: 10.1111/1471-0528.13032. Epub 2014 Aug 22.
PubMed 25145491Rode L, Klein K, Nicolaides KH, Krampl-Bettelheim E, Tabor A; PREDICT Group. Prevention of preterm delivery in twin gestations (PREDICT): a multicenter, randomized, placebo-controlled trial on the effect of vaginal micronized progesterone. Ultrasound Obstet Gynecol. 2011 Sep;38(3):272-80. doi: 10.1002/uog.9093.
PubMed 21739497Goya M, de la Calle M, Pratcorona L, Merced C, Rodo C, Munoz B, Juan M, Serrano A, Llurba E, Higueras T, Carreras E, Cabero L; PECEP-Twins Trial Group. Cervical pessary to prevent preterm birth in women with twin gestation and sonographic short cervix: a multicenter randomized controlled trial (PECEP-Twins). Am J Obstet Gynecol. 2016 Feb;214(2):145-152. doi: 10.1016/j.ajog.2015.11.012. Epub 2015 Nov 25.
PubMed 26627728Liem S, Schuit E, Hegeman M, Bais J, de Boer K, Bloemenkamp K, Brons J, Duvekot H, Bijvank BN, Franssen M, Gaugler I, de Graaf I, Oudijk M, Papatsonis D, Pernet P, Porath M, Scheepers L, Sikkema M, Sporken J, Visser H, van Wijngaarden W, Woiski M, van Pampus M, Mol BW, Bekedam D. Cervical pessaries for prevention of preterm birth in women with a multiple pregnancy (ProTWIN): a multicentre, open-label randomised controlled trial. Lancet. 2013 Oct 19;382(9901):1341-9. doi: 10.1016/S0140-6736(13)61408-7. Epub 2013 Aug 5.
PubMed 23924878Fox NS, Gupta S, Lam-Rachlin J, Rebarber A, Klauser CK, Saltzman DH. Cervical Pessary and Vaginal Progesterone in Twin Pregnancies With a Short Cervix. Obstet Gynecol. 2016 Apr;127(4):625-630. doi: 10.1097/AOG.0000000000001300.
PubMed 26959202Nicolaides KH, Syngelaki A, Poon LC, de Paco Matallana C, Plasencia W, Molina FS, Picciarelli G, Tul N, Celik E, Lau TK, Conturso R. Cervical pessary placement for prevention of preterm birth in unselected twin pregnancies: a randomized controlled trial. Am J Obstet Gynecol. 2016 Jan;214(1):3.e1-9. doi: 10.1016/j.ajog.2015.08.051. Epub 2015 Aug 28.
PubMed 26321037
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Progesterone and Cervical Pessary in Twins : A Prospective and Randomized Study to Prevent Preterm Birth (PRECEPT)
- ClinicalTrials.gov ID
- NCT03058536
- Acronym / sponsor ID
- PRECEPET / 1.847.411
- Keywords
- twin short cervix pessary progesterone preterm birth
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 312 participants (estimated)
- Lead sponsor
- Mario Henrique Burlacchini de CarvalhoUniversity, hospital or other
- Study start
- 21 Feb 2017 (actual)
- Primary completion
- Mar 2019 (estimated)
- Study completion
- Mar 2019 (estimated)
- First posted
- 23 Feb 2017 (actual)
- 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 aim of this randomized control trial is to determine wheter cervical pessary plus vaginal progesterone (400mg) reduce preterm birth less than 34 weeks of gestacion and improve perinatal outcome, among women presenting asyntomatic short cervix, in twin pregnancy.
Detailed description
The frequency of twin pregnancies has increased significantly, especially because of the assisted reproduction and advanced maternal age at conception. The twin pregnancies are responsible for 25 % of all preterm birth. Consequently, twin pregnancies are more associated with perinatal mortality and morbidity when compared to single pregnancies. Additionally, the short cervix (< 25 mm) in singleton and twin pregnancies are associated with significantly increased preterm birth.
Randomized controlled trials in singleton pregnancies reported that profilatic cervical cerclage and vaginal progesterone reduce significantly the rate of early preterm birth. In twin pregnancies, vaginal progesterone and profilatic cerclage have been shown to be ineffective in prevention of preterm birth.
However, two individual pacient data meta-analyses reported in a subgroup of women with twin pregancies and short cervix, that vaginal progesterone reduce significantly adverse neonatal outcomes. Nowadays, the effet of cervical pessary is contraditory, mainly in women with short cervix.
This is a randomized prospective trial at São Paulo University Medical School. This trial will involve 312 women with twins pregnancies and short cervix between 16 and 27 weeks and 6 days of gestacional age. Women with twin pregnancy and short cervix ( defined according to the gestacional age ) will be assigned randomly to daily vaginal progesterone (400mg) combined with insertion of cervical pessary, isolated use of daily vaginal progesterone (400mg) isolated insertion of cervical pessary or expectant management (no intervention). The primary outcome is to compare the rate of spontaneous delivery < 34 weeks of gestacion between groups.The secondary outcome is to compare the neonatal adverse outcome between the groups.
The aim of this study is to test the hypothesis that the insertion of a cervical pessary combined with vaginal progesterone, in twin pregnancies with short cervix would reduce the spontaneus preterm birth < 34 weeks' gestation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- 312 twin pregnant women with short cervix between 16 and 27 weeks and 6 days of gestacional age will be randomized in four groups: daily 400mg vaginal progesterone combined with insertion of cervical pessary; isolated use of daily 400mg vaginal progesterone, isolated insertion of cervical pessary or expectant management (no intervention).
| Arm | Type | Receives |
|---|---|---|
| Progesterone | Active comparator | Drug: Vaginal Progesterone400 mg micronized vaginal progesterone daily from randomization to 36 weeks |
| Arabin Pessary and Progesterone | Active comparator | Other: Arabin Pessary and ProgesteroneArabin Pessary and Natural Micronized Progesterone 400 mg micronized vaginal progesterone daily from randomization to 36 weeks The device will be placed at randomization and will be removed during the 36th week of gestacional (or earlier if indicated) in combination with vaginal progesterone. |
| Arabin Pessary | Active comparator | Device: Arabin PessaryThe device will be placed at randomization and will be removed during the 36th week of gestacional (or earlier if indicated) without vaginal progesterone use. |
| No intervention | No intervention | –Expectant management |
Who may qualify
- Ages
- 16 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Twin pregnancy ( dichorionic or monochorionic diamniotic)
- Both fetuses alive
- Asymptomatic short cervix according to gestational age ( measurement less or equal 30 mm between 16 weeks + 0 day and 22 weeks + 0 day, less or equal 25 mm between 22 weeks + 1 day and 24 weeks + 0 day and less or equal 20 mm between 24 weeks + 1 day and 27 weeks + 6 days)
- Gestational age between 16 to 27weeks and 6 days
- Intact membranes
Key exclusion criteria (12 listed)
- Monoamniotic twins
- Twin Twin transfusion syndrome
- Rupture membranes
- Major malformation or chromosomal abnormality at least one fetus
- Women with Cervical cerclage in the current 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 |
|---|---|---|
| Arabin PessaryThe cervical pessary will be inserted at the randomization and removed during the 36 week of pregnancy, unless labour occurs sooner. | Device | Arabin Pessary |
| Vaginal ProgesteroneAlso: UtrogestanTreatment with 400 mg micronized progesterone daily, until the day of randomization to 36 weeks of pregnancy. | Drug | Progesterone |
| Arabin Pessary and ProgesteroneArabin Pessary and Progesterone The cervical pessary will be inserted at the randomization and removed during the 36 week of pregnancy, unless labour occurs sooner. Treatment with 400 mg Micronized progesterone daily, until the day of randomization to 36 weeks of pregnancy. | Other | Arabin Pessary and Progesterone |
Primary outcome
Preterm birth
Time frame: 5 months
Rate of preterm birth before 34 weeks gestation
2 secondary outcomes
Neonatal Complications Rate
Time frame: between birth and 28 days of age
Months from Randomization to delivery interval
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2017.
- Background: PubMed 26333191Kindinger LM, Poon LC, Cacciatore S, MacIntyre DA, Fox NS, Schuit E, Mol BW, Liem S, Lim AC, Serra V, Perales A, Hermans F, Darzi A, Bennett P, Nicolaides KH, Teoh TG. The effect of gestational age and cervical length measurements in the prediction of spontaneous preterm birth in twin pregnancies: an individual patient level meta-analysis. BJOG. 2016 May;123(6):877-84. doi: 10.1111/1471-0528.13575. Epub 2015 Sep 1.
- Background: PubMed 22284156Romero R, Nicolaides K, Conde-Agudelo A, Tabor A, O'Brien JM, Cetingoz E, Da Fonseca E, Creasy GW, Klein K, Rode L, Soma-Pillay P, Fusey S, Cam C, Alfirevic Z, Hassan SS. Vaginal progesterone in women with an asymptomatic sonographic short cervix in the midtrimester decreases preterm delivery and neonatal morbidity: a systematic review and metaanalysis of individual patient data. Am J Obstet Gynecol. 2012 Feb;206(2):124.e1-19. doi: 10.1016/j.ajog.2011.12.003. Epub 2011 Dec 11.
- Background: PubMed 19523680Norman JE, Mackenzie F, Owen P, Mactier H, Hanretty K, Cooper S, Calder A, Mires G, Danielian P, Sturgiss S, MacLennan G, Tydeman G, Thornton S, Martin B, Thornton JG, Neilson JP, Norrie J. Progesterone for the prevention of preterm birth in twin pregnancy (STOPPIT): a randomised, double-blind, placebo-controlled study and meta-analysis. Lancet. 2009 Jun 13;373(9680):2034-40. doi: 10.1016/S0140-6736(09)60947-8.
- Background: PubMed 25731690Brizot ML, Hernandez W, Liao AW, Bittar RE, Francisco RPV, Krebs VLJ, Zugaib M. Vaginal progesterone for the prevention of preterm birth in twin gestations: a randomized placebo-controlled double-blind study. Am J Obstet Gynecol. 2015 Jul;213(1):82.e1-82.e9. doi: 10.1016/j.ajog.2015.02.021. Epub 2015 Feb 27.
- Background: PubMed 25145491Schuit E, Stock S, Rode L, Rouse DJ, Lim AC, Norman JE, Nassar AH, Serra V, Combs CA, Vayssiere C, Aboulghar MM, Wood S, Cetingoz E, Briery CM, Fonseca EB, Worda K, Tabor A, Thom EA, Caritis SN, Awwad J, Usta IM, Perales A, Meseguer J, Maurel K, Garite T, Aboulghar MA, Amin YM, Ross S, Cam C, Karateke A, Morrison JC, Magann EF, Nicolaides KH, Zuithoff NP, Groenwold RH, Moons KG, Kwee A, Mol BW; Global Obstetrics Network (GONet) collaboration. Effectiveness of progestogens to improve perinatal outcome in twin pregnancies: an individual participant data meta-analysis. BJOG. 2015 Jan;122(1):27-37. doi: 10.1111/1471-0528.13032. Epub 2014 Aug 22.
- Background: PubMed 21739497Rode L, Klein K, Nicolaides KH, Krampl-Bettelheim E, Tabor A; PREDICT Group. Prevention of preterm delivery in twin gestations (PREDICT): a multicenter, randomized, placebo-controlled trial on the effect of vaginal micronized progesterone. Ultrasound Obstet Gynecol. 2011 Sep;38(3):272-80. doi: 10.1002/uog.9093.
- Background: PubMed 26627728Goya M, de la Calle M, Pratcorona L, Merced C, Rodo C, Munoz B, Juan M, Serrano A, Llurba E, Higueras T, Carreras E, Cabero L; PECEP-Twins Trial Group. Cervical pessary to prevent preterm birth in women with twin gestation and sonographic short cervix: a multicenter randomized controlled trial (PECEP-Twins). Am J Obstet Gynecol. 2016 Feb;214(2):145-152. doi: 10.1016/j.ajog.2015.11.012. Epub 2015 Nov 25.
- Background: PubMed 23924878Liem S, Schuit E, Hegeman M, Bais J, de Boer K, Bloemenkamp K, Brons J, Duvekot H, Bijvank BN, Franssen M, Gaugler I, de Graaf I, Oudijk M, Papatsonis D, Pernet P, Porath M, Scheepers L, Sikkema M, Sporken J, Visser H, van Wijngaarden W, Woiski M, van Pampus M, Mol BW, Bekedam D. Cervical pessaries for prevention of preterm birth in women with a multiple pregnancy (ProTWIN): a multicentre, open-label randomised controlled trial. Lancet. 2013 Oct 19;382(9901):1341-9. doi: 10.1016/S0140-6736(13)61408-7. Epub 2013 Aug 5.
- Background: PubMed 26959202Fox NS, Gupta S, Lam-Rachlin J, Rebarber A, Klauser CK, Saltzman DH. Cervical Pessary and Vaginal Progesterone in Twin Pregnancies With a Short Cervix. Obstet Gynecol. 2016 Apr;127(4):625-630. doi: 10.1097/AOG.0000000000001300.
- Background: PubMed 26321037Nicolaides KH, Syngelaki A, Poon LC, de Paco Matallana C, Plasencia W, Molina FS, Picciarelli G, Tul N, Celik E, Lau TK, Conturso R. Cervical pessary placement for prevention of preterm birth in unselected twin pregnancies: a randomized controlled trial. Am J Obstet Gynecol. 2016 Jan;214(1):3.e1-9. doi: 10.1016/j.ajog.2015.08.051. Epub 2015 Aug 28.
- Individual participant dataSharing planned: No
Related trials for Preterm Birth
Not yet recruitingObservational study
Effect of Antenatal Dexamethasone on Postnatal Adrenal Hormones in Preterm Neonates
Preterm Birth Infants
RecruitingPhase 3
Preeclampsia Intervention Netherlands
Pre-Eclampsia Onset Less Than 37 Weeks, Pre-Eclampsia
Not yet recruiting
Eye Covering and White Noise During Nasogastric Tube Insertion in Preterm Infants
Preterm Infants
Recruiting
Protocol-driven Nutrition in Preterm Infants
Preterm Infants
Recruiting
Controlled Remote Monitoring and Optimization of Oxygen Therapy in Preterm Infants
BPD - Bronchopulmonary Dysplasia, Pulmonary Hypertension
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.
Mario Henrique Burlacchini de Carvalho, PhD contact
Mario Henrique Burlacchini de Carvalho, PhD principal investigator
Hospital das Clínicas Universidade de São Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Arabin Pessary, Vaginal Progesterone and Arabin Pessary and Progesterone in people with Preterm Birth and Twin Pregnancy With Antenatal Problem, run by Mario Henrique Burlacchini de Carvalho 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: status not confirmed, as of the sponsor's last update on 15 Mar 2017. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Mario Henrique Burlacchini de Carvalho, PhD (+55 11 26616209 ext. 3183, mario.burlacchini@hc.fm.usp.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Preterm birth (time frame: 5 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03058536, which also lists 10 linked publications.
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 15 Mar 2017.