Obstetric and Neonatal Outcomes of Twin Pregnancy

Twin Pregnancy Clinical Trial

— Twin-CTB  

Official title:

Obstetric and Neonatal Outcomes of Twin Pregnancy (Twin Conception-To-Birth): A Multicenter International Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04588597
• Other study ID #: Twin-CTB
• Status: Not yet recruiting
• Start date: November 1, 2020
• Est. completion date: March 1, 2022

Study information

• Verified date: October 2020
• Source: Assiut University
• Contact: Sherif A Shazly, M.Sc
• Phone: +15075131392
• Email: sherif.shazly.mogge[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

Twin pregnancies carry higher risks of maternal, fetal and neonatal adverse outcomes compared to singleton pregnancy.They are associated with increased perinatal morbidity and mortality, anemia, pregnancy- induced hypertension, increased incidence of cesarean section (CS), postpartum hemorrhage, prematurity and low birth weight and Increased rate of perinatal death. 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. Medical records of eligible women will be reviewed, and data abstraction will be performed using a standardized excel sheet designed for this study. Target data include baseline demographics and clinical data (e.g. age, parity, ethnicity, smoking, IVF pregnancy, history of gynecologic surgeries, type of twin pregnancy, current medical disorders, current obstetric complications, fetal anomalies, administration of antenatal steroids, Placental site, and twin-specific complications). Information from serial ultrasound reports including fetal growth and Doppler studies will be collected and data on fetal intervention will be abstracted. Peripartum data include node of delivery, Method of induction, CS indication, and type of cesarean incision. Clinical outcomes include postpartum hemorrhage, and perinatal death, admission to neonatal intensive care unit (NICU), neonatal need for respiratory support, neonatal intracranial hemorrhage, neonatal respiratory distress syndrome and neonatal hypoxic ischemic encephalopathy. Data will not include any identifiable information. Prediction model will be created using baseline demographic and obstetric features of pregnancy and individual maternal and perinatal complications will be set as outcomes (dependent variables). A composite outcome of major maternal and neonatal outcomes will be created separately.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Twin Pregnancy

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Assiut University	Middle East OBGYN graduate education Foundation

References & Publications (11)

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

Outcome

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