Twin PregnancyTwin-CTBNCT04588597
Obstetric and Neonatal Outcomes of Twin Pregnancy
An observational study of Twin Pregnancy, run by Assiut University.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Twin Pregnancy
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2020to 1 Mar 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
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.
Who may be able to join
- Women with twin pregnancy who received their antenatal care and were delivered in the participating institute
- Compliance to antenatal care visits
Who cannot join
- Major fetal anomalies of one or both twins
- Elective miscarriage
- Authorization to use medical records was not provided by the patient
Trial locations and contacts
No sites are listed yet.
About this study
Official 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.
Read the detailed 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.
- Conditions
- Twin Pregnancy
- Keywords
- Twin pregnancy, maternal outcomes, neonatal outcomes, machine learning
What is being measured
The primary outcome is the main question the study is designed to answer.
Postpartum hemorrhage
Significant uterine bleeding > 1000 ml
Measured: 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
Measured: 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
Measured: From delivery of the baby to 24 hours postoperative (Total of 24 hours)
Intrauterine fetal death
Measured: Death of the fetus any time from 24 weeks to onset of labor
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2020
- Study start1 Nov 2020 (estimated)
- Primary completion1 Nov 2021 (estimated)
- Study completion1 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Twin PregnancyStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Collaborators
- Middle-East OBGYN Graduate Education Foundation
- Responsible party
- Principal investigator, Sherif Abdelkarim Mohammed Shazly, Assiut University
- Investigators
- Sherif A Shazly, M.Sc, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04588597
- Sponsor's protocol ID
- Twin-CTB
- Acronym
- Twin-CTB
- Status last verified
- Oct 2020
- First submitted
- 8 Oct 2020
- Last updated
- 19 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 26801066Huang 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.
PubMed 24727825Adinma 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.
PubMed 15511763Mutihir JT, Pam VC. Obstetric outcome of twin pregnancies in Jos, Nigeria. Niger J Clin Pract. 2007 Mar;10(1):15-8.
PubMed 17668709Rzyska 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.
PubMed 28099698Kong 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.
PubMed 28325122Kato 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.
PubMed 1342133Rodis 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.
PubMed 9396891Carroll 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.
PubMed 11905430Lee 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.
PubMed 16949427Cao 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.
PubMed 32818085
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Obstetric and Neonatal Outcomes of Twin Pregnancy (Twin Conception-To-Birth): A Multicenter International Study
- ClinicalTrials.gov ID
- NCT04588597
- Acronym / sponsor ID
- Twin-CTB / Twin-CTB
- Conditions
- Twin Pregnancy
- Keywords
- Twin pregnancy, maternal outcomes, neonatal outcomes, machine learning
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Collaborators
- Middle-East OBGYN Graduate Education Foundation
- Study start
- 1 Nov 2020 (estimated)
- Primary completion
- 1 Nov 2021 (estimated)
- Study completion
- 1 Mar 2022 (estimated)
- First posted
- 19 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (2 listed)
- Women with twin pregnancy who received their antenatal care and were delivered in the participating institute
- Compliance to antenatal care visits
Key exclusion criteria (3 listed)
- Major fetal anomalies of one or both twins
- Elective miscarriage
- Authorization to use medical records was not provided by the patient
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Postpartum hemorrhage
Time frame: From delivery of the baby to 24 hours postoperative (Total of 24 hours)
Significant uterine bleeding > 1000 ml
perinatal death
Time frame: From onset of labor to 1 week postnatal
Death of the baby during delivery or early neonatal period
Admission to neonatal intensive care unit (NICU)
Time frame: From delivery of the baby to 24 hours postoperative (Total of 24 hours)
Admission of the baby to NICU for observation or intervention
Intrauterine fetal death
Time frame: Death of the fetus any time from 24 weeks to onset of labor
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2020.
- Background: PubMed 26801066Qin 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.
- Background: PubMed 24727825Huang 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.
- Background: PubMed 15511763Adinma 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.
- Background: PubMed 17668709Mutihir JT, Pam VC. Obstetric outcome of twin pregnancies in Jos, Nigeria. Niger J Clin Pract. 2007 Mar;10(1):15-8.
- Background: PubMed 28099698Rzyska 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.
- Background: PubMed 28325122Kong 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.
- Background: PubMed 1342133Kato 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.
- Background: PubMed 9396891Rodis 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.
- Background: PubMed 11905430Carroll 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.
- Background: PubMed 16949427Lee 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.
- Background: PubMed 32818085Cao 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sherif A Shazly, M.Sc principal investigator
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of Twin Pregnancy, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sherif A Shazly, M.Sc (+15075131392, sherif.shazly.mogge@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postpartum hemorrhage (time frame: From delivery of the baby to 24 hours postoperative (Total of 24 hours)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04588597, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2020.