Twin Pregnancy With Antenatal ProblemTWIN-UICNCT03340688
Cerclage for Twins With Short Cervical Length ≤ 15mm
A study testing Cervical cerclage in people with Twin Pregnancy With Antenatal Problem and Preterm Birth, run by Thomas Jefferson University at 8 sites in 4 countries.
Trial summary
This is a multicenter randomized study designed to determine if ultrasound indicated cerclage reduces the incidence of spontaneous preterm birth <34 weeks in asymptomatic women with twin gestations and cervical length ≤15mm, diagnosed by transvaginal ultrasound 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 With Antenatal Problem, Preterm Birth, Short Cervix
- What is being tested?
- Cervical cerclage
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 8 sitesin 4 countries
- Study dates
- 22 Jun 2017to Jun 2025
- 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 more than 18 years of age (limits the participants to female gender)
- Diamniotic twin pregnancy
- Asymptomatic
- Transvaginal cervical length ≤ 15 mm between 16-23 6/7 weeks gestation
Who cannot join
- Singleton or higher order than twins multiple gestation
- Transvaginal cervical length >15mm
- Cervical dilation with visible amniotic membranes
- Amniotic membranes prolapsed into the vagina
- Fetal reduction after 14 weeks form higher order
- Monoamniotic twins
Show all 16Show fewer
- Twin-twin transfusion syndrome
- Ruptured membranes
- Major fetal structural anomaly
- Fetal chromosomal abnormality
- Cerclage already in place for other indication
- Active vaginal bleeding
- Clinical chorioamnionitis
- Placenta previa
- Painful regular uterine contractions
- Labor
Trial locations and contacts
8 sites in 4 countries.
8 sites in 4 countries
United States3 sites, 3 recruiting
- Recruiting
Austin Maternal Fetal Medicine St David's Health Care
Austin, Texas, 78758
Sina Haeri, MD
sinahaeri@gmail.com
- Recruiting
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107
Amanda Roman, MD, 215-955-9200, amanda.roman@jefferson.edu
MD
- Not yet recruiting
George Washington University
Washington D.C., District of Columbia, 20052
Alexis Gimovsky, MD, agimovsky@gmail.com
Italy3 sites, 3 recruiting
- Recruiting
Bologna University
Bologna
Giuliana Simonazzi, MD, giuliana.simonazzi@unibo.it
Nicola Rizzo, nicola.rizzo@unibo.it
- Recruiting
University of Brescia
Brescia
Anna Fichera, MD, anna.fichera@gmail.com
Federico Prefumo, MD, federico.prefumo@gmail.com
- Recruiting
Università degli Studi di Napoli "Federico II"
Naples
Gabriele Saccone, MD, gabriele.saccone@libero.it
Pasquale Martinelli, MD, martinel@unina.it
Egypt1 site, 1 recruiting
- Recruiting
The Egyptian IVF Center
Cairo
Mona Aboulghar, MD, monaaboulghar71@gmail.com
Yahia EL faissal, MD, yahiaelfaissal@gmail.com
Spain1 site, 1 recruiting
- Recruiting
University of Barcelona
Barcelona
Núria Baños, MD, NBANOS@clinic.cat
About this study
Official title: Cervical Cerclage for Preventing Spontaneous Preterm Birth in Twin Pregnancies With Transvaginal Ultrasound Cervical Length ≤ 15mm: a Study Protocol for a Randomized Clinical Trial
This is a multicenter randomized study designed to determine if ultrasound indicated cerclage reduces the incidence of spontaneous preterm birth <34 weeks in asymptomatic women with twin gestations and cervical length ≤15mm, diagnosed by transvaginal ultrasound between 16 to 23 6/7 weeks of gestation.
Read the detailed description
Twin pregnancies have 59% 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. The transvaginal cervical length (TVCL) performed before 24 weeks have been determined to be the best tool to identified women with twin pregnancy at risk of preterm birth (PTB). When short TVCL is identified before 24 weeks, the risk of preterm birth is 60%-70% for TVCL ≤25mm and 80%-90% for TVCL ≤15mm. There are a small number of case reports of cervical cerclage in twin pregnancies with cervical length ≤15mm that suggest decreased preterm birth by 80%. The investigators' objective is to determine if ultrasound indicated cerclage in reduces the incidence of spontaneous preterm birth <34 weeks and improve perinatal outcome in asymptomatic women with twin gestations and cervical length ≤15mm between 16 to 23 6/7 weeks of gestation.
- Being tested
- 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.
Cervical cerclageProcedure or surgery
Cervical cerclage indicated by short cervix ≤15mm
| Study group | Role | What they receive |
|---|---|---|
| Cervical cerclage + vaginal progesterone | Active comparator | Cervical cerclage in twin pregnancy with transvaginal cervical length ≤15mm and Daily vaginal progesterone 400mg from diagnosis of short cervix to 36 weeks Receives: Procedure: Cervical cerclage |
| Vaginal progesterone | No intervention | Daily vaginal progesterone 400mg from diagnosis of short cervix to 36 weeks |
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 (11)
Spontaneous preterm birth rates
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 delivery
Premature rupture of membranes
Incidence
Measured: at delivery
Chorioamnionitis
Incidence
Measured: at delivery
Composite adverse neonatal outcome
Includes necrotizing enterocolitis, intraventricular hemorrhage (grade 3 or higher), respiratory distress syndrome, bronchopulmonary dysplasia, retinopathy, blood-culture proven sepsis
Measured: Incidence between birth and 28 days of age
Neonatal death
Incidence
Measured: Between birth and 28 days of age
Maternal death
Incidence
Measured: Between birth and 6 weeks postpartum
Interval between diagnosis and delivery
Mean value (days) through study completion
Measured: at delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2017
- Study start22 Jun 2017
- Primary completionJun 2024 (estimated)
- Study completionJun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Twin Pregnancy With Antenatal ProblemStudies of the same condition, open and under way.
- More trials run by Thomas Jefferson UniversityThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Collaborators
- Federico II University
- Responsible party
- Sponsor
- Investigators
- Amanda Roman, MD, Principal investigator, Thomas Jefferson University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03340688
- Sponsor's protocol ID
- 17D.326
- Acronym
- TWIN-UIC
- Status last verified
- Apr 2020
- First submitted
- 8 Nov 2017
- Last updated
- 27 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
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 20576253Saccone 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 25637840Romero R, Conde-Agudelo A, El-Refaie W, Rode L, Brizot ML, Cetingoz E, Serra V, Da Fonseca E, Abdelhafez MS, Tabor A, Perales A, Hassan SS, Nicolaides KH. Vaginal progesterone decreases preterm birth and neonatal morbidity and mortality in women with a twin gestation and a short cervix: an updated meta-analysis of individual patient data. Ultrasound Obstet Gynecol. 2017 Mar;49(3):303-314. doi: 10.1002/uog.17397.
PubMed 28067007
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
- Cervical Cerclage for Preventing Spontaneous Preterm Birth in Twin Pregnancies With Transvaginal Ultrasound Cervical Length ≤ 15mm: a Study Protocol for a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03340688
- Acronym / sponsor ID
- TWIN-UIC / 17D.326
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Thomas Jefferson UniversityUniversity, hospital or other
- Collaborators
- Federico II University
- Study start
- 22 Jun 2017 (actual)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 13 Nov 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.
This is a multicenter randomized study designed to determine if ultrasound indicated cerclage reduces the incidence of spontaneous preterm birth <34 weeks in asymptomatic women with twin gestations and cervical length ≤15mm, diagnosed by transvaginal ultrasound between 16 to 23 6/7 weeks of gestation.
Detailed description
Twin pregnancies have 59% 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. The transvaginal cervical length (TVCL) performed before 24 weeks have been determined to be the best tool to identified women with twin pregnancy at risk of preterm birth (PTB). When short TVCL is identified before 24 weeks, the risk of preterm birth is 60%-70% for TVCL ≤25mm and 80%-90% for TVCL ≤15mm. There are a small number of case reports of cervical cerclage in twin pregnancies with cervical length ≤15mm that suggest decreased preterm birth by 80%. The investigators' objective is to determine if ultrasound indicated cerclage in reduces the incidence of spontaneous preterm birth <34 weeks and improve perinatal outcome in asymptomatic women with twin gestations and cervical length ≤15mm 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 |
|---|---|---|
| Cervical cerclage + vaginal progesterone | Active comparator | Procedure: Cervical cerclageCervical cerclage in twin pregnancy with transvaginal cervical length ≤15mm and Daily vaginal progesterone 400mg from diagnosis of short cervix to 36 weeks |
| Vaginal progesterone | No intervention | –Daily vaginal progesterone 400mg from diagnosis of short cervix to 36 weeks |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Pregnant women more than 18 years of age (limits the participants to female gender)
- Diamniotic twin pregnancy
- Asymptomatic
- Transvaginal cervical length ≤ 15 mm between 16-23 6/7 weeks gestation
Key exclusion criteria (16 listed)
- Singleton or higher order than twins multiple gestation
- Transvaginal cervical length >15mm
- Cervical dilation with visible amniotic membranes
- Amniotic membranes prolapsed into the vagina
- Fetal reduction after 14 weeks form higher order
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 |
|---|---|---|
| Cervical cerclageCervical cerclage indicated by short cervix ≤15mm | Procedure or surgery | Cervical cerclage + vaginal progesterone |
Primary outcome
Preterm delivery less than 34 weeks
Time frame: at delivery
Incidence of preterm birth less than 34 weeks (any indication)
11 secondary outcomes
Spontaneous preterm birth rates
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 delivery
Premature rupture of membranes
Time frame: at delivery
Chorioamnionitis
Time frame: at delivery
Composite adverse neonatal outcome
Time frame: Incidence between birth and 28 days of age
Neonatal death
Time frame: Between birth and 28 days of age
Maternal death
Time frame: Between birth and 6 weeks postpartum
Interval between diagnosis and delivery
Time frame: at delivery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2020.
- Results publication: 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.
- Results publication: 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.
- Results publication: 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.
- Results publication: 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.
- Results publication: 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.
- Results publication: PubMed 28067007Romero R, Conde-Agudelo A, El-Refaie W, Rode L, Brizot ML, Cetingoz E, Serra V, Da Fonseca E, Abdelhafez MS, Tabor A, Perales A, Hassan SS, Nicolaides KH. Vaginal progesterone decreases preterm birth and neonatal morbidity and mortality in women with a twin gestation and a short cervix: an updated meta-analysis of individual patient data. Ultrasound Obstet Gynecol. 2017 Mar;49(3):303-314. doi: 10.1002/uog.17397.
- Individual participant dataSharing planned: Yes
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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
Thomas Jefferson University
8 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cervical cerclage in people with Twin Pregnancy With Antenatal Problem and Preterm Birth, run by Thomas Jefferson University at 8 sites in 4 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 4 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: status not confirmed, 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 8 sites in United States, Italy, Egypt, 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.
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 Amanda Roman, MD (215.955.9200, amanda.roman@jefferson.edu), or a site near the patient. 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 NCT03340688, which also lists 6 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.