Obstetric and Neonatal Outcomes of Twin Pregnancy

NCT ID: NCT04588597

Last Updated: 2020-10-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-11-01

Study Completion Date

2022-03-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Twin Pregnancy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Middle-East OBGYN Graduate Education Foundation

OTHER

Sponsor Role collaborator

Assiut University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Sherif Abdelkarim Mohammed Shazly

M.B.B.Ch, M.S.c in Gynecology and Obstetrics

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Sherif A Shazly, M.Sc

Role: PRINCIPAL_INVESTIGATOR

Assiut University

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Sherif A Shazly, M.Sc

Role: CONTACT

+15075131392

Mohamed A Salah

Role: CONTACT

0201223987685

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 26801066 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24727825 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15511763 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 17668709 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28099698 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28325122 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 1342133 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9396891 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11905430 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16949427 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32818085 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Twin-CTB

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Twin Pregnancy Cohort
NCT05144321 ACTIVE_NOT_RECRUITING
Covid-19 Infection in Pregnancy
NCT04869202 COMPLETED