Twin Pregnancy, Antepartum Condition or ComplicationTWIN-PEICNCT02490384
Physical Exam Indicated Cerclage in Twin Gestations
A study testing Physical exam indicated cerclage in people with Twin Pregnancy, Antepartum Condition or Complication and Preterm Birth, run by Thomas Jefferson University at 11 sites in 3 countries.
Trial summary
This is a multicenter randomized study designed to determine if physical exam indicated cerclage reduces the incidence of spontaneous preterm birth <34 weeks in asymptomatic women with twin gestations and dilated cervix, diagnosed by pelvic exam between 16 to 23 6/7 weeks of gestation. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Twin Pregnancy, Antepartum Condition or Complication, Preterm Birth, Cervical Dilation Premature
- What is being tested?
- Physical exam indicated cerclage
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 11 sitesin 3 countries
- Study dates
- Jun 2015to 12 Dec 2019
- Phase
- Interventional
- 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 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Pregnant women older than 18 years of age
- Diamniotic twin pregnancy
- Cervical dilation between 1 to 5 cm and/or visible membranes by pelvic exam or speculum exam between at 16-23 6/7 weeks gestation
Who cannot join
- Singleton pregnancy or higher order than twins multiple gestation
- Cervical dilation more than 5 cm
- Amniotic membranes prolapsed beyond external os into the vagina, unable to visualize cervical tissue
- More than 24 weeks of gestation
- Multifetal reduction after 14 weeks
- Monoamniotic twins
Show all 16Show fewer
- Twin-twin transfusion syndrome
- Ruptured amniotic membranes at the time of diagnosis of dilated cervix
- Major fetal structural anomaly
- Fetal chromosomal abnormality
- Cerclage already in place for other indications
- Active vaginal bleeding
- Suspicion of clinical or biochemical chorioamnionitis
- Painful regular uterine contractions
- Labor (progressing cervical dilation)
- Placenta previa
Trial locations and contacts
11 sites in 3 countries.
11 sites in 3 countries
United States7 sites
Albany Medical Center
Albany, New York, 12208
Austin Maternal Fetal Medicine St David's Health Care
Austin, Texas, 78758
Wright State University
Dayton, Ohio, 45409
Columbia University Medical Center
New York, New York, 10032
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107
University of Rochester Medical Center
Rochester, New York, 14642
George Washington University
Washington D.C., District of Columbia, 20037
Italy3 sites
Bologna University
Bologna
University of Brescia
Brescia
Università degli Studi di Napoli "Federico II"
Naples
About this study
Official title: Randomized Control Trial Physical Exam Indicated Cerclage in Twin Gestations
This is a multicenter randomized study designed to determine if physical exam indicated cerclage reduces the incidence of spontaneous preterm birth <34 weeks in asymptomatic women with twin gestations and dilated cervix, diagnosed by pelvic exam between 16 to 23 6/7 weeks of gestation.
Read the detailed description
Twin pregnancies have 58% incidence of preterm delivery (before 37 weeks of gestation), with increased perinatal mortality and neonatal morbidity. No therapy has proven effective in preventing preterm birth in twins. When cervical dilation is identified before 24 weeks in singleton pregnancies, the risk of preterm birth is 90%-100%; based on a small series of cases, approximately 50% of twin gestations with cervical dilation will be delivered prior to viability (24 weeks) and the risk of preterm birth prior to 34 and 37 weeks was 85% and 100%. Cervical dilation is the worst prognostic factor for preterm birth. There are a small number of case reports of cervical cerclage in twin pregnancies with a dilated cervix that suggest similar outcomes to those in singleton pregnancies. The investigators' objective is to determine if physical exam indicated cerclage reduces the incidence of spontaneous preterm birth <34 weeks and improve perinatal outcome in asymptomatic women with twin gestations and dilated cervix (1 to 5 cm) between 16 to 23 6/7 weeks of gestation.
- Conditions
- Twin Pregnancy, Antepartum Condition or Complication, Preterm Birth, Cervical Dilation Premature
- Being tested
- Physical exam indicated cerclage
- Keywords
- Cervical cerclage
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical exam indicated cerclageProcedure or surgery
Cervical cerclage
| Study group | Role | What they receive |
|---|---|---|
| Physical exam indicated cerclage | Active comparator | Cerclage Receives: Procedure: Physical exam indicated cerclage |
| Expectant management | No intervention | No cerclage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Preterm delivery less than 34 weeks
Incidence of preterm birth less than 34 weeks (any indication)
Measured: at delivery
Secondary outcomes (5)
Spontaneous preterm birth less than 34
Incidence of spontaneous preterm birth less than 34 weeks
Measured: at delivery
Preterm delivery less than <32 weeks, <28 weeks, or <24 weeks
Incidence of preterm birth less than <32 weeks, <28 weeks, or <24 weeks
Measured: at delivery
Mean gestational age at delivery
Mean value of gestational age at delivery (weeks)
Measured: at delivery
Birth weight at birth
Mean value (grams)
Measured: at delivery
Gestational age at spontaneous rupture of membranes
Mean value (weeks) through study completion
Measured: at presentation of rupture membranes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2015 (estimated)
- Study startJun 2015
- Primary completionDec 2019
- Study completion12 Dec 2019
Why it stopped: due to significant decrease of perinatal mortality in the cerclage group
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Twin Pregnancy, Antepartum Condition or ComplicationStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Collaborators
- Columbia University, Federico II University, Albany Medical College, University of Rochester, George Washington University, Wright State University, Baystate Medical Center, Università degli Studi di Brescia, University of Bologna, University Hospital, Geneva, University of Warsaw, Maternal Fetal Medicine Associates
- Responsible party
- Sponsor
- Investigators
- Amanda Roman, MD, Principal investigator, amanda.roman@jefferson.edu
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02490384
- Sponsor's protocol ID
- ThomasJeffersonU
- Acronym
- TWIN-PEIC
- Status last verified
- Apr 2020
- First submitted
- 29 Jun 2015
- Last updated
- 27 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: De identified data
Publications
Hamilton BE, Hoyert DL, Martin JA, Strobino DM, Guyer B. Annual summary of vital statistics: 2010-2011. Pediatrics. 2013 Mar;131(3):548-58. doi: 10.1542/peds.2012-3769. Epub 2013 Feb 11.
PubMed 23400611Goldenberg RL, Iams JD, Miodovnik M, Van Dorsten JP, Thurnau G, Bottoms S, Mercer BM, Meis PJ, Moawad AH, Das A, Caritis SN, McNellis D. The preterm prediction study: risk factors in twin gestations. National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network. Am J Obstet Gynecol. 1996 Oct;175(4 Pt 1):1047-53. doi: 10.1016/s0002-9378(96)80051-2.
PubMed 8885774Conde-Agudelo A, Romero R, Hassan SS, Yeo L. Transvaginal sonographic cervical length for the prediction of spontaneous preterm birth in twin pregnancies: a systematic review and metaanalysis. Am J Obstet Gynecol. 2010 Aug;203(2):128.e1-12. doi: 10.1016/j.ajog.2010.02.064. Epub 2010 Jun 23.
PubMed 20576253Rouse DJ, Caritis SN, Peaceman AM, Sciscione A, Thom EA, Spong CY, Varner M, Malone F, Iams JD, Mercer BM, Thorp J, Sorokin Y, Carpenter M, Lo J, Ramin S, Harper M, Anderson G; National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network. A trial of 17 alpha-hydroxyprogesterone caproate to prevent prematurity in twins. N Engl J Med. 2007 Aug 2;357(5):454-61. doi: 10.1056/NEJMoa070641.
PubMed 17671253Schuit E, Stock S, Groenwold RH, Maurel K, Combs CA, Garite T, Spong CY, Thom EA, Rouse DJ, Caritis SN, Saade GR, Zachary JM, Norman JE, Rode L, Klein K, Tabor A, Cetingoz E, Morrison JC, Magann EF, Briery CM, Serra V, Perales A, Meseguer J, Nassar AH, Lim AC, Moons KG, Kwee A, Mol BW. Progestogens to prevent preterm birth in twin pregnancies: an individual participant data meta-analysis of randomized trials. BMC Pregnancy Childbirth. 2012 Mar 15;12:13. doi: 10.1186/1471-2393-12-13.
PubMed 22420582Romero 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 22284156Saccone G, Rust O, Althuisius S, Roman A, Berghella V. Cerclage for short cervix in twin pregnancies: systematic review and meta-analysis of randomized trials using individual patient-level data. Acta Obstet Gynecol Scand. 2015 Apr;94(4):352-8. doi: 10.1111/aogs.12600. Epub 2015 Mar 1.
PubMed 25644964Roman A, Rochelson B, Fox NS, Hoffman M, Berghella V, Patel V, Calluzzo I, Saccone G, Fleischer A. Efficacy of ultrasound-indicated cerclage in twin pregnancies. Am J Obstet Gynecol. 2015 Jun;212(6):788.e1-6. doi: 10.1016/j.ajog.2015.01.031. Epub 2015 Jan 28.
PubMed 25637840Rebarber A, Bender S, Silverstein M, Saltzman DH, Klauser CK, Fox NS. Outcomes of emergency or physical examination-indicated cerclage in twin pregnancies compared to singleton pregnancies. Eur J Obstet Gynecol Reprod Biol. 2014 Feb;173:43-7. doi: 10.1016/j.ejogrb.2013.11.016. Epub 2013 Nov 28.
PubMed 24321466Gupta M, Emary K, Impey L. Emergency cervical cerclage: predictors of success. J Matern Fetal Neonatal Med. 2010 Jul;23(7):670-4. doi: 10.3109/14767050903387011.
PubMed 19883267Zanardini C, Pagani G, Fichera A, Prefumo F, Frusca T. Cervical cerclage in twin pregnancies. Arch Gynecol Obstet. 2013 Aug;288(2):267-71. doi: 10.1007/s00404-013-2758-3. Epub 2013 Feb 21.
PubMed 23430029Miller ES, Rajan PV, Grobman WA. Outcomes after physical examination-indicated cerclage in twin gestations. Am J Obstet Gynecol. 2014 Jul;211(1):46.e1-5. doi: 10.1016/j.ajog.2014.03.034. Epub 2014 Mar 18.
PubMed 24657791Berghella V, Roman A. Cerclage in twins: we can do better! Am J Obstet Gynecol. 2014 Jul;211(1):5-6. doi: 10.1016/j.ajog.2014.03.037. No abstract available.
PubMed 24972530Liem 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 23924878Althuisius SM, Dekker GA, Hummel P, van Geijn HP; Cervical incompetence prevention randomized cerclage trial. Cervical incompetence prevention randomized cerclage trial: emergency cerclage with bed rest versus bed rest alone. Am J Obstet Gynecol. 2003 Oct;189(4):907-10. doi: 10.1067/s0002-9378(03)00718-x.
PubMed 14586323
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Control Trial Physical Exam Indicated Cerclage in Twin Gestations
- ClinicalTrials.gov ID
- NCT02490384
- Acronym / sponsor ID
- TWIN-PEIC / ThomasJeffersonU
- Conditions
- Twin Pregnancy, Antepartum Condition or Complication, Preterm Birth, Cervical Dilation Premature
- Keywords
- Cervical cerclage
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: due to significant decrease of perinatal mortality in the cerclage group
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Thomas Jefferson UniversityUniversity, hospital or other
- Collaborators
- Columbia University, Federico II University, Albany Medical College, University of Rochester, George Washington University, Wright State University, Baystate Medical Center, Università degli Studi di Brescia, University of Bologna, University Hospital, Geneva, University of Warsaw, Maternal Fetal Medicine Associates
- Study start
- Jun 2015 (actual)
- Primary completion
- Dec 2019 (actual)
- Study completion
- 12 Dec 2019 (actual)
- First posted
- 3 Jul 2015 (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.
This is a multicenter randomized study designed to determine if physical exam indicated cerclage reduces the incidence of spontaneous preterm birth <34 weeks in asymptomatic women with twin gestations and dilated cervix, diagnosed by pelvic exam between 16 to 23 6/7 weeks of gestation.
Detailed description
Twin pregnancies have 58% incidence of preterm delivery (before 37 weeks of gestation), with increased perinatal mortality and neonatal morbidity. No therapy has proven effective in preventing preterm birth in twins. When cervical dilation is identified before 24 weeks in singleton pregnancies, the risk of preterm birth is 90%-100%; based on a small series of cases, approximately 50% of twin gestations with cervical dilation will be delivered prior to viability (24 weeks) and the risk of preterm birth prior to 34 and 37 weeks was 85% and 100%. Cervical dilation is the worst prognostic factor for preterm birth. There are a small number of case reports of cervical cerclage in twin pregnancies with a dilated cervix that suggest similar outcomes to those in singleton pregnancies. The investigators' objective is to determine if physical exam indicated cerclage reduces the incidence of spontaneous preterm birth <34 weeks and improve perinatal outcome in asymptomatic women with twin gestations and dilated cervix (1 to 5 cm) between 16 to 23 6/7 weeks of gestation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Physical exam indicated cerclage | Active comparator | Procedure: Physical exam indicated cerclageCerclage |
| Expectant management | No intervention | –No cerclage |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Pregnant women older than 18 years of age
- Diamniotic twin pregnancy
- Cervical dilation between 1 to 5 cm and/or visible membranes by pelvic exam or speculum exam between at 16-23 6/7 weeks gestation
Key exclusion criteria (16 listed)
- Singleton pregnancy or higher order than twins multiple gestation
- Cervical dilation more than 5 cm
- Amniotic membranes prolapsed beyond external os into the vagina, unable to visualize cervical tissue
- More than 24 weeks of gestation
- Multifetal reduction after 14 weeks
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 |
|---|---|---|
| Physical exam indicated cerclageCervical cerclage | Procedure or surgery | Physical exam indicated cerclage |
Primary outcome
Preterm delivery less than 34 weeks
Time frame: at delivery
Incidence of preterm birth less than 34 weeks (any indication)
5 secondary outcomes
Spontaneous preterm birth less than 34
Time frame: at delivery
Preterm delivery less than <32 weeks, <28 weeks, or <24 weeks
Time frame: at delivery
Mean gestational age at delivery
Time frame: at delivery
Birth weight at birth
Time frame: at delivery
Gestational age at spontaneous rupture of membranes
Time frame: at presentation of rupture membranes
Results and safety
The study was stopped early (reason given: due to significant decrease of perinatal mortality in the cerclage group). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2020.
- Background: PubMed 23400611Hamilton BE, Hoyert DL, Martin JA, Strobino DM, Guyer B. Annual summary of vital statistics: 2010-2011. Pediatrics. 2013 Mar;131(3):548-58. doi: 10.1542/peds.2012-3769. Epub 2013 Feb 11.
- Background: PubMed 8885774Goldenberg RL, Iams JD, Miodovnik M, Van Dorsten JP, Thurnau G, Bottoms S, Mercer BM, Meis PJ, Moawad AH, Das A, Caritis SN, McNellis D. The preterm prediction study: risk factors in twin gestations. National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network. Am J Obstet Gynecol. 1996 Oct;175(4 Pt 1):1047-53. doi: 10.1016/s0002-9378(96)80051-2.
- Background: PubMed 20576253Conde-Agudelo A, Romero R, Hassan SS, Yeo L. Transvaginal sonographic cervical length for the prediction of spontaneous preterm birth in twin pregnancies: a systematic review and metaanalysis. Am J Obstet Gynecol. 2010 Aug;203(2):128.e1-12. doi: 10.1016/j.ajog.2010.02.064. Epub 2010 Jun 23.
- Background: PubMed 17671253Rouse DJ, Caritis SN, Peaceman AM, Sciscione A, Thom EA, Spong CY, Varner M, Malone F, Iams JD, Mercer BM, Thorp J, Sorokin Y, Carpenter M, Lo J, Ramin S, Harper M, Anderson G; National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network. A trial of 17 alpha-hydroxyprogesterone caproate to prevent prematurity in twins. N Engl J Med. 2007 Aug 2;357(5):454-61. doi: 10.1056/NEJMoa070641.
- Background: PubMed 22420582Schuit E, Stock S, Groenwold RH, Maurel K, Combs CA, Garite T, Spong CY, Thom EA, Rouse DJ, Caritis SN, Saade GR, Zachary JM, Norman JE, Rode L, Klein K, Tabor A, Cetingoz E, Morrison JC, Magann EF, Briery CM, Serra V, Perales A, Meseguer J, Nassar AH, Lim AC, Moons KG, Kwee A, Mol BW. Progestogens to prevent preterm birth in twin pregnancies: an individual participant data meta-analysis of randomized trials. BMC Pregnancy Childbirth. 2012 Mar 15;12:13. doi: 10.1186/1471-2393-12-13.
- 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 25644964Saccone G, Rust O, Althuisius S, Roman A, Berghella V. Cerclage for short cervix in twin pregnancies: systematic review and meta-analysis of randomized trials using individual patient-level data. Acta Obstet Gynecol Scand. 2015 Apr;94(4):352-8. doi: 10.1111/aogs.12600. Epub 2015 Mar 1.
- Background: PubMed 25637840Roman A, Rochelson B, Fox NS, Hoffman M, Berghella V, Patel V, Calluzzo I, Saccone G, Fleischer A. Efficacy of ultrasound-indicated cerclage in twin pregnancies. Am J Obstet Gynecol. 2015 Jun;212(6):788.e1-6. doi: 10.1016/j.ajog.2015.01.031. Epub 2015 Jan 28.
- Background: PubMed 24321466Rebarber A, Bender S, Silverstein M, Saltzman DH, Klauser CK, Fox NS. Outcomes of emergency or physical examination-indicated cerclage in twin pregnancies compared to singleton pregnancies. Eur J Obstet Gynecol Reprod Biol. 2014 Feb;173:43-7. doi: 10.1016/j.ejogrb.2013.11.016. Epub 2013 Nov 28.
- Background: PubMed 19883267Gupta M, Emary K, Impey L. Emergency cervical cerclage: predictors of success. J Matern Fetal Neonatal Med. 2010 Jul;23(7):670-4. doi: 10.3109/14767050903387011.
- Background: PubMed 23430029Zanardini C, Pagani G, Fichera A, Prefumo F, Frusca T. Cervical cerclage in twin pregnancies. Arch Gynecol Obstet. 2013 Aug;288(2):267-71. doi: 10.1007/s00404-013-2758-3. Epub 2013 Feb 21.
- Background: PubMed 24657791Miller ES, Rajan PV, Grobman WA. Outcomes after physical examination-indicated cerclage in twin gestations. Am J Obstet Gynecol. 2014 Jul;211(1):46.e1-5. doi: 10.1016/j.ajog.2014.03.034. Epub 2014 Mar 18.
- Individual participant dataSharing planned: Yes. De identified data
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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.
Amanda Roman, MD principal investigator
amanda.roman@jefferson.edu
11 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical exam indicated cerclage in people with Twin Pregnancy, Antepartum Condition or Complication and Preterm Birth, run by Thomas Jefferson University at 11 sites in 3 countries.
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 3 inclusion and 16 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: stopped early, as of the sponsor's last update on 27 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States, Italy, Poland. 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.
Are results available for this study?
The study was stopped early (reason given: due to significant decrease of perinatal mortality in the cerclage group). 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 less than 34 weeks (time frame: at delivery). 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 NCT02490384, which also lists 17 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 27 Apr 2020.