Twin Pregnancy Clinical Trial
— Twin-CTBOfficial title:
Obstetric and Neonatal Outcomes of Twin Pregnancy (Twin Conception-To-Birth): A Multicenter International Study
This multicenter study aims at assessing the natural history of twin pregnancy and developing a machine learning-based algorithm to predict clinical outcomes of twin pregnancy during pregnancy and delivery and to determine management strategies that are associated with best maternal and neonatal outcomes. This study will include at least 12 centers from different countries that present at least Europe, South America, Asia, and Africa. Data will be retrospectively collected from January 1st, 2010 to December 31st, 2019.
Status | Not yet recruiting |
Enrollment | 300 |
Est. completion date | March 1, 2022 |
Est. primary completion date | November 1, 2021 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 45 Years |
Eligibility | Inclusion Criteria: 1. Women with twin pregnancy who received their antenatal care and were delivered in the participating institute 2. Compliance to antenatal care visits Exclusion Criteria: 1. Major fetal anomalies of one or both twins 2. Elective miscarriage 3. Authorization to use medical records was not provided by the patient |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Assiut University | Middle East OBGYN graduate education Foundation |
Adinma JI, Agbai AO. Multiple births in Nigerian Igbo women: incidence and outcomes. J Obstet Gynaecol. 1997 Jan;17(1):42-4. — View Citation
Cao K, Verspoor K, Sahebjada S, Baird PN. Evaluating the Performance of Various Machine Learning Algorithms to Detect Subclinical Keratoconus. Transl Vis Sci Technol. 2020 Apr 24;9(2):24. doi: 10.1167/tvst.9.2.24. eCollection 2020 Apr. — View Citation
Carroll SG, Soothill PW, Abdel-Fattah SA, Porter H, Montague I, Kyle PM. Prediction of chorionicity in twin pregnancies at 10-14 weeks of gestation. BJOG. 2002 Feb;109(2):182-6. — View Citation
Huang J, Maguire MG, Ciner E, Kulp MT, Cyert LA, Quinn GE, Orel-Bixler D, Moore B, Ying GS; Vision in Preschoolers (VIP) Study Group. Risk factors for astigmatism in the Vision in Preschoolers Study. Optom Vis Sci. 2014 May;91(5):514-21. doi: 10.1097/OPX.0000000000000242. — View Citation
Kato K, Fujiki K. Multiple Births and Congenital Anomalies in Tokyo Metropolitan Hospitals, 1979-1990. Acta Genet medicae Gemellol twin Res [Internet]. 2014/08/01. 1992;41(4):253-9. Available from: https://www.cambridge.org/core/article/multiple-births-and-congenital-anomalies-in-tokyo-metropolitan-hospitals-19791990/E0EFF17376931D73FB60D91C756B2864
Kong CW, To WWK. The predicting factors and outcomes of caesarean section of the second twin. J Obstet Gynaecol. 2017 Aug;37(6):709-713. doi: 10.1080/01443615.2017.1286466. Epub 2017 Mar 21. — View Citation
Lee YM, Cleary-Goldman J, Thaker HM, Simpson LL. Antenatal sonographic prediction of twin chorionicity. Am J Obstet Gynecol. 2006 Sep;195(3):863-7. — View Citation
Mutihir JE PV. Obstetric outcome of twin pregnancies in Jos, Nigeria. Niger J Clin Pract [Internet]. 2007;10. Available from: https://www.ajol.info/index.php/njcp/article/view/11301
Qin JB, Wang H, Sheng X, Xie Q, Gao S. Assisted reproductive technology and risk of adverse obstetric outcomes in dichorionic twin pregnancies: a systematic review and meta-analysis. Fertil Steril. 2016 May;105(5):1180-1192. doi: 10.1016/j.fertnstert.2015.12.131. Epub 2016 Jan 19. Review. — View Citation
Rodis JF, McIlveen PF, Egan JF, Borgida AF, Turner GW, Campbell WA. Monoamniotic twins: improved perinatal survival with accurate prenatal diagnosis and antenatal fetal surveillance. Am J Obstet Gynecol. 1997 Nov;177(5):1046-9. — View Citation
Rzyska E, Ajay B, Chandraharan E. Safety of vaginal delivery among dichorionic diamniotic twins over 10 years in a UK teaching hospital. Int J Gynaecol Obstet. 2017 Jan;136(1):98-101. doi: 10.1002/ijgo.12017. Epub 2016 Nov 3. — View Citation
* Note: There are 11 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Postpartum hemorrhage | Significant uterine bleeding > 1000 ml | From delivery of the baby to 24 hours postoperative (Total of 24 hours) | |
Primary | perinatal death | Death of the baby during delivery or early neonatal period | From onset of labor to 1 week postnatal | |
Primary | Admission to neonatal intensive care unit (NICU) | Admission of the baby to NICU for observation or intervention | From delivery of the baby to 24 hours postoperative (Total of 24 hours) | |
Primary | Intrauterine fetal death | Death of the fetus any time from 24 weeks to onset of labor |
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