Study Summary
This trial will test if an ultrasound-indicated cerclage reduces the incidence of premature birth in asymptomatic women with twin gestations and a short cervix.
Eligible Conditions
- Premature Birth
- Short Cervix Syndrome
- Twin Pregnancy With Antenatal Complications
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 11 Secondary · Reporting Duration: at delivery
Day 28
Neonatal death
Week 6
Maternal death
Day 28
Composite adverse neonatal outcome
at delivery
Birth weight at birth
Chorioamnionitis
Gestational age at spontaneous rupture of membranes
Interval between diagnosis and delivery
Mean gestational age at delivery
Premature rupture of membranes
Preterm delivery less than 34 weeks
Preterm delivery less than <32 weeks, <28 weeks, or <24 weeks
Spontaneous preterm birth rates
Trial Safety
Safety Progress
Trial Design
2 Treatment Groups
Cervical cerclage + vaginal progesterone
1 of 2
Vaginal progesterone
1 of 2
Active Control
200 Total Participants · 2 Treatment Groups
Primary Treatment: Cervical cerclage + vaginal progesterone · No Placebo Group · N/A
Cervical cerclage + vaginal progesterone
Procedure
ActiveComparator Group · 1 Intervention: Cervical cerclage · Intervention Types: ProcedureVaginal progesteroneNoIntervention Group · 1 Intervention: Vaginal progesterone · Intervention Types:
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: at delivery
Who is running the clinical trial?
Thomas Jefferson UniversityLead Sponsor
410 Previous Clinical Trials
135,895 Total Patients Enrolled
8 Trials studying Premature Birth
12,703 Patients Enrolled for Premature Birth
Federico II UniversityOTHER
325 Previous Clinical Trials
102,308 Total Patients Enrolled
15 Trials studying Premature Birth
3,574 Patients Enrolled for Premature Birth
Amanda Roman, MDPrincipal InvestigatorThomas Jefferson University
1 Previous Clinical Trials
30 Total Patients Enrolled
1 Trials studying Premature Birth
30 Patients Enrolled for Premature Birth
Eligibility Criteria
Age 18 - 60 · Female Participants · 4 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You are pregnant with twins who share the same amniotic sac.
You do not have any noticeable symptoms.
References
- Saccone, Gabriele, Orion Rust, Sietske Althuisius, Amanda Roman, and Vincenzo Berghella. 2015. “Cerclage for Short Cervix in Twin Pregnancies: Systematic Review and Meta-analysis of Randomized Trials Using Individual Patient-level Data”. Acta Obstetricia Et Gynecologica Scandinavica. Wiley. doi:10.1111/aogs.12600.
- Romero, R., A. Conde‐Agudelo, W. El‐Refaie, L. Rode, M. L. Brizot, E. Cetingoz, V. Serra, et al.. 2017. “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 in Obstetrics & Gynecology. Wiley. doi:10.1002/uog.17397.
- Hamilton, Brady E., Donna L. Hoyert, Joyce A. Martin, Donna M. Strobino, and Bernard Guyer. 2013. “Annual Summary of Vital Statistics: 2010–2011”. Pediatrics. American Academy of Pediatrics (AAP). doi:10.1542/peds.2012-3769.
- Roman, Amanda, Burton Rochelson, Nathan S. Fox, Matthew Hoffman, Vincenzo Berghella, Vrunda Patel, Ilia Calluzzo, Gabriele Saccone, and Adiel Fleischer. 2015. “Efficacy of Ultrasound-indicated Cerclage in Twin Pregnancies”. American Journal of Obstetrics and Gynecology. Elsevier BV. doi:10.1016/j.ajog.2015.01.031.
- Conde-Agudelo, Agustín, Roberto Romero, Sonia S. Hassan, and Lami Yeo. 2010. “Transvaginal Sonographic Cervical Length for the Prediction of Spontaneous Preterm Birth in Twin Pregnancies: A Systematic Review and Metaanalysis”. American Journal of Obstetrics and Gynecology. Elsevier BV. doi:10.1016/j.ajog.2010.02.064.
- Goldenberg, Robert L., Jay D. Iams, Menachem Miodovnik, J.Peter Van Dorsten, Gary Thurnau, Sidney Bottoms, Brian M. Mercer, et al.. 1996. “The Preterm Prediction Study: Risk Factors in Twin Gestations”. American Journal of Obstetrics and Gynecology. Elsevier BV. doi:10.1016/s0002-9378(96)80051-2.
- Roman, Amanda, Burton Rochelson, Nathan S. Fox, Matthew Hoffman, Vincenzo Berghella, Vrunda Patel, Ilia Calluzzo, Gabriele Saccone, and Adiel Fleischer. 2015. “Efficacy of Ultrasound-indicated Cerclage in Twin Pregnancies”. American Journal of Obstetrics and Gynecology. Elsevier BV. doi:10.1016/j.ajog.2015.01.031.
- Romero, R., A. Conde‐Agudelo, W. El‐Refaie, L. Rode, M. L. Brizot, E. Cetingoz, V. Serra, et al.. 2017. “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 in Obstetrics & Gynecology. Wiley. doi:10.1002/uog.17397.
- Conde-Agudelo, Agustín, Roberto Romero, Sonia S. Hassan, and Lami Yeo. 2010. “Transvaginal Sonographic Cervical Length for the Prediction of Spontaneous Preterm Birth in Twin Pregnancies: A Systematic Review and Metaanalysis”. American Journal of Obstetrics and Gynecology. Elsevier BV. doi:10.1016/j.ajog.2010.02.064.
- Goldenberg, Robert L., Jay D. Iams, Menachem Miodovnik, J.Peter Van Dorsten, Gary Thurnau, Sidney Bottoms, Brian M. Mercer, et al.. 1996. “The Preterm Prediction Study: Risk Factors in Twin Gestations”. American Journal of Obstetrics and Gynecology. Elsevier BV. doi:10.1016/s0002-9378(96)80051-2.
- Hamilton, Brady E., Donna L. Hoyert, Joyce A. Martin, Donna M. Strobino, and Bernard Guyer. 2013. “Annual Summary of Vital Statistics: 2010–2011”. Pediatrics. American Academy of Pediatrics (AAP). doi:10.1542/peds.2012-3769.
- Saccone, Gabriele, Orion Rust, Sietske Althuisius, Amanda Roman, and Vincenzo Berghella. 2015. “Cerclage for Short Cervix in Twin Pregnancies: Systematic Review and Meta-analysis of Randomized Trials Using Individual Patient-level Data”. Acta Obstetricia Et Gynecologica Scandinavica. Wiley. doi:10.1111/aogs.12600.
- Romero 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.
- Saccone 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.
- Goldenberg 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.
- Conde-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.
- 2017. "Cerclage for Twins With Short Cervical Length ≤ 15mm". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03340688.
Frequently Asked Questions
Is this experiment accepting new members at present?
"As per the information provided on clinicaltrials.gov, this trial is currently recruiting participants and was originally posted in June of 2017 with a recent update made to it on April 23rd 2020." - Anonymous Online Contributor
Unverified Answer
Is this study open to geriatric participants?
"This trial's eligibility guidelines specify that participants must be aged 18 to 60 years old. For individuals below this age range, there are 184 studies available and 74 for those above the cutoff." - Anonymous Online Contributor
Unverified Answer
Could I qualify as a participant for this medical trial?
"This clinical trial aims to recruit 200 participants who experienced a premature birth and are between 18-60 years old. Notably, the inclusion criteria necessitates that they must have had a diamniotic twin pregnancy, be asymptomatic, and must identify with female gender." - Anonymous Online Contributor
Unverified Answer
What is the upper limit of participants for this medical experiment?
"Affirmative. Clinicaltrials.gov divulges that this medical trial is presently recruiting, with the first posting dating back to June 22nd 2017 and last updated April 23rd 2020. 200 patients are needed for 3 separate sites." - Anonymous Online Contributor
Unverified Answer