Obstetric and Neonatal Outcomes of Twin Pregnancy

NCT04588597 | Unknown

• 1 other identifier: Twin-CTB
• Study Type: observational
• Target: 300
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Twin Pregnancy

Keywords

Twin pregnancy; maternal outcomes; neonatal outcomes; machine learning

Outcome Measures

Primary Outcomes (4)

• Postpartum hemorrhage

  Significant uterine bleeding \> 1000 ml

  From delivery of the baby to 24 hours postoperative (Total of 24 hours)

• perinatal death

  Death of the baby during delivery or early neonatal period

  From onset of labor to 1 week postnatal

• 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)

• Intrauterine fetal death

  Death of the fetus any time from 24 weeks to onset of labor

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

This study will include eligible women from at least 12 centers(anticipated) from different countries that present at least Europe, South America, Asia, and Africa.

You may qualify if:

• Women with twin pregnancy who received their antenatal care and were delivered in the participating institute
• Compliance to antenatal care visits

You may not qualify if:

• Major fetal anomalies of one or both twins
• Elective miscarriage
• Authorization to use medical records was not provided by the patient

Sponsors & Collaborators

• Assiut University: lead
• Middle-East OBGYN Graduate Education Foundation: collaborator

Related Publications (11)

• 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.

  PMID: 26801066 BACKGROUND

• 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.

  PMID: 24727825 BACKGROUND

• Adinma JI, Agbai AO. Multiple births in Nigerian Igbo women: incidence and outcomes. J Obstet Gynaecol. 1997 Jan;17(1):42-4. doi: 10.1080/01443619750114077.

  PMID: 15511763 BACKGROUND

• Mutihir JT, Pam VC. Obstetric outcome of twin pregnancies in Jos, Nigeria. Niger J Clin Pract. 2007 Mar;10(1):15-8.

  PMID: 17668709 BACKGROUND

• 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.

  PMID: 28099698 BACKGROUND

• 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.

  PMID: 28325122 BACKGROUND

• Kato K, Fujiki K. Multiple births and congenital anomalies in Tokyo Metropolitan Hospitals, 1979-1990. Acta Genet Med Gemellol (Roma). 1992;41(4):253-9. doi: 10.1017/s0001566000002117.

  PMID: 1342133 BACKGROUND

• 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. doi: 10.1016/s0002-9378(97)70012-7.

  PMID: 9396891 BACKGROUND

• 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. doi: 10.1111/j.1471-0528.2002.01172.x.

  PMID: 11905430 BACKGROUND

• 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. doi: 10.1016/j.ajog.2006.06.039.

  PMID: 16949427 BACKGROUND

• 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.

  PMID: 32818085 BACKGROUND

Study Officials

• Sherif A Shazly, M.Sc

  Assiut University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sherif A Shazly, M.Sc

CONTACT

+15075131392; sherif.shazly.mogge@gmail.com

Mohamed A Salah

CONTACT

0201223987685; mohamed.ashraf.mogge@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.B.B.Ch, M.S.c in Gynecology and Obstetrics

Study Record Dates

• First Submitted: October 8, 2020
• First Posted: October 19, 2020
• Study Start: November 1, 2020
• Primary Completion: November 1, 2021
• Study Completion: March 1, 2022
• Last Updated: October 19, 2020

Record last verified: 2020-10