Twin; Pregnancy, Affecting Fetus or NewbornNCT05674214
Birth Weight-discordance in Twins Pregnancy: a Multicenter Retrospective Study
An observational study of Twin; Pregnancy, Affecting Fetus or Newborn, run by The Third Affiliated Hospital of Guangzhou Medical University at 1 site in China.
Trial summary
The rate of twin pregnancies in China has increased by 50 percent over the past decade and now stands at about 3 percent. This is significantly higher than the European and American countries. Read more about this study
- Who is it for?
- Ages 1 day to 28 daysHealthy volunteers can take part
- Conditions the study is for
- Twin; Pregnancy, Affecting Fetus or Newborn
- How many people
- 13,440 participants
- Where
- 1 siteChina
- Study dates
- 10 Sep 2020to 25 Nov 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 1 day to 28 days
- All sexes
- Healthy volunteers accepted
- Child
Study population: live twin births
Who may be able to join
- live twin births
- 1. delivered from 2018 to 2020
Who cannot join
- congenital and hereditary diseases
- inherited metabolic diseases
- complex congenital heart disease
- digestive tract malformations
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Occurrence of Liveborn Twins With Birth Weight-discordance and Its Relationship to the Adverse Outcomes: a Multicenter Retrospective Study
The rate of twin pregnancies in China has increased by 50 percent over the past decade and now stands at about 3 percent. This is significantly higher than the European and American countries. There are significant differences in birth weight of some newborns, that is, birth weight-discordance in twin pregnancies (BWDT). BWDT was significantly associated with fetal death, preterm birth, neonatal death, and neonatal complications. Existing studies mainly focus on the perinatal outcomes of mothers and infants with BWDT, or are reported from small samples in developed countries. The investigators are aware of the need to further explore the occurrence of birth weight inconsistency and adverse neonatal outcomes in China with a large sample. Through retrospective study design, the investigators will collect clinical data of live twin births at multiple study sites, investigate the incidence of BWDT, and analyze its adverse outcomes.
Read the detailed description
The investigators adopted a multicenter retrospective case-control study design and enrolled live twin births delivered from 2018 to 2020 in 22 hospitals in 12 provinces in China. Children with congenital and hereditary diseases, such as inherited metabolic diseases, complex congenital heart disease, and digestive tract malformations, were excluded from the study. The investigators collected the following information: (1) General information: maternal age, year of delivery, number of delivery, mode of conception, mode of delivery, chorionic nature, education level, newborn sex; (2) Maternal risk factors associated with intrauterine development: induced abortion ≥2 times, placental disease, uterine tumor, gestational diabetes mellitus, gestational hypertension disease, intrahepatic cholestasis, connective tissue disease, hypothyroidism, and chorionic amnitis; (3) Infant birth outcome: gestational age, birth weight, birth length, birth head circumference, very low birth weight infants, ultra-low birth weight infants, the Apgar score, whether transferred to neonatology department. (4) Information of hospitalization during the neonatal period: Pulmonary surfactant use, duration of oxygen therapy, neonatal complications (i.e., pulmonary hemorrhage, BPD, NEC, PDA, ROP, PVL, IVH, anemia, infection, etc.), feeding status (i.e., duration of milk opening, duration of full feeding, feeding style and feeding materials at full feeding, Time to recovery of birth weight), and discharge outcome (i.e., total hospitalization cost, length of stay, gestational age corrected for discharge, discharge status, discharge physique).
- Keywords
- twins, birth weigh-discordant, occurrence, birth outcomes, multi-center study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| birth weight-discordant group | the birth weight difference within twins is greater than 20% | |
| the birth weight-concordant group | the birth weight difference within twins is less than or equal to 20% |
What is being measured
The primary outcome is the main question the study is designed to answer.
birth outcome
gestational age
Measured: 1 day
neonatal complications
the morbidity of pulmonary hemorrhage, BPD, NEC, PDA, ROP, PVL, IVH, anemia, infection, etc
Measured: 1 month
Secondary outcomes (2)
discharge outcome
total hospitalization cost
Measured: 3 months
discharge outcome
length of stay
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2023
- Study start10 Sep 2020
- Primary completion1 Oct 2022
- Study completion25 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Twin; Pregnancy, Affecting Fetus or NewbornStudies of the same condition, open and under way.
- 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-control
- Time perspective
- Retrospective
- Enrolment
- 13,440 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Third Affiliated Hospital of Guangzhou Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Peking University Third Hospital, The Affiliated Hospital of Inner Mongolia Medical University, The Third Hospital Of BaoGang Group, Lanzhou University Second Hospital, Yan'an University Affiliated Hospital, Xiamen University Women and Children's Hospital, Xinxiang Central Hospital, Central Hospital of Xiaogan, The Affiliated Hospital Of Guizhou Medical University, Sichuan Jinxin Women and Children's Hospital, The First Affiliated Hospital of Shaoyang University, First Affiliated Hospital of Jinan University, First Affiliated Hospital of Shantou University Medical College, Second Affiliated Hospital of Shantou University Medical College, The Second People's Hospital of GuangDong Province, Dongguan People's Hospital, Dongguan Binhai Bay Central Hospital, Zhongshan People's Hospital, Guangdong, China, Huizhou Municipal Central Hospital, Yuebei People's Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05674214
- Sponsor's protocol ID
- ThirdGuangzhouMU_QL Cui
- Status last verified
- Jan 2023
- First submitted
- 30 Nov 2022
- Last updated
- 7 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hiersch L, Barrett J, Aviram A, Mei-Dan E, Yoon EW, Zaltz A, Kingdom J, Melamed N. Patterns of discordant growth and adverse neonatal outcomes in twins. Am J Obstet Gynecol. 2021 Aug;225(2):187.e1-187.e14. doi: 10.1016/j.ajog.2021.01.018. Epub 2021 Jan 25.
PubMed 33508311D'Antonio F, Thilaganathan B, Laoreti A, Khalil A; Southwest Thames Obstetric Research Collaborative (STORK). Birth-weight discordance and neonatal morbidity in twin pregnancy: analysis of STORK multiple pregnancy cohort. Ultrasound Obstet Gynecol. 2018 Nov;52(5):586-592. doi: 10.1002/uog.18916. Epub 2018 Oct 8.
PubMed 29028139Jahanfar S, Lim K, Oviedo-Joekes E. Stillbirth Associated With Birth Weight Discordance in Twin Gestations. J Obstet Gynaecol Can. 2019 Jan;41(1):52-58. doi: 10.1016/j.jogc.2018.02.017. Epub 2018 Oct 10.
PubMed 30316716Miller J, Chauhan SP, Abuhamad AZ. Discordant twins: diagnosis, evaluation and management. Am J Obstet Gynecol. 2012 Jan;206(1):10-20. doi: 10.1016/j.ajog.2011.06.075. Epub 2011 Jun 25.
PubMed 21864822Diaz-Garcia C, Bernard JP, Ville Y, Salomon LJ. Validity of sonographic prediction of fetal weight and weight discordance in twin pregnancies. Prenat Diagn. 2010 Apr;30(4):361-7. doi: 10.1002/pd.2469.
PubMed 20187000D'Antonio F, Odibo AO, Prefumo F, Khalil A, Buca D, Flacco ME, Liberati M, Manzoli L, Acharya G. Weight discordance and perinatal mortality in twin pregnancy: systematic review and meta-analysis. Ultrasound Obstet Gynecol. 2018 Jul;52(1):11-23. doi: 10.1002/uog.18966.
PubMed 29155475D'Antonio F, Khalil A, Dias T, Thilaganathan B; Southwest Thames Obstetric Research Collaborative (STORK). Weight discordance and perinatal mortality in twins: analysis of the Southwest Thames Obstetric Research Collaborative (STORK) multiple pregnancy cohort. Ultrasound Obstet Gynecol. 2013 Jun;41(6):643-8. doi: 10.1002/uog.12412. Epub 2013 Apr 22.
PubMed 23355123
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Occurrence of Liveborn Twins With Birth Weight-discordance and Its Relationship to the Adverse Outcomes: a Multicenter Retrospective Study
- ClinicalTrials.gov ID
- NCT05674214
- Acronym / sponsor ID
- ThirdGuangzhouMU_QL Cui
- Keywords
- twins, birth weigh-discordant, occurrence, birth outcomes, multi-center study
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 13,440 participants (actual)
- Lead sponsor
- The Third Affiliated Hospital of Guangzhou Medical UniversityUniversity, hospital or other
- Collaborators
- Peking University Third Hospital, The Affiliated Hospital of Inner Mongolia Medical University, The Third Hospital Of BaoGang Group, Lanzhou University Second Hospital, Yan'an University Affiliated Hospital, Xiamen University Women and Children's Hospital, Xinxiang Central Hospital, Central Hospital of Xiaogan, The Affiliated Hospital Of Guizhou Medical University, Sichuan Jinxin Women and Children's Hospital, The First Affiliated Hospital of Shaoyang University, First Affiliated Hospital of Jinan University, First Affiliated Hospital of Shantou University Medical College, Second Affiliated Hospital of Shantou University Medical College, The Second People's Hospital of GuangDong Province, Dongguan People's Hospital, Dongguan Binhai Bay Central Hospital, Zhongshan People's Hospital, Guangdong, China, Huizhou Municipal Central Hospital, Yuebei People's Hospital
- Study start
- 10 Sep 2020 (actual)
- Primary completion
- 1 Oct 2022 (actual)
- Study completion
- 25 Nov 2022 (actual)
- First posted
- 6 Jan 2023 (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.
The rate of twin pregnancies in China has increased by 50 percent over the past decade and now stands at about 3 percent. This is significantly higher than the European and American countries. There are significant differences in birth weight of some newborns, that is, birth weight-discordance in twin pregnancies (BWDT). BWDT was significantly associated with fetal death, preterm birth, neonatal death, and neonatal complications. Existing studies mainly focus on the perinatal outcomes of mothers and infants with BWDT, or are reported from small samples in developed countries. The investigators are aware of the need to further explore the occurrence of birth weight inconsistency and adverse neonatal outcomes in China with a large sample. Through retrospective study design, the investigators will collect clinical data of live twin births at multiple study sites, investigate the incidence of BWDT, and analyze its adverse outcomes.
Detailed description
The investigators adopted a multicenter retrospective case-control study design and enrolled live twin births delivered from 2018 to 2020 in 22 hospitals in 12 provinces in China. Children with congenital and hereditary diseases, such as inherited metabolic diseases, complex congenital heart disease, and digestive tract malformations, were excluded from the study. The investigators collected the following information: (1) General information: maternal age, year of delivery, number of delivery, mode of conception, mode of delivery, chorionic nature, education level, newborn sex; (2) Maternal risk factors associated with intrauterine development: induced abortion ≥2 times, placental disease, uterine tumor, gestational diabetes mellitus, gestational hypertension disease, intrahepatic cholestasis, connective tissue disease, hypothyroidism, and chorionic amnitis; (3) Infant birth outcome: gestational age, birth weight, birth length, birth head circumference, very low birth weight infants, ultra-low birth weight infants, the Apgar score, whether transferred to neonatology department. (4) Information of hospitalization during the neonatal period: Pulmonary surfactant use, duration of oxygen therapy, neonatal complications (i.e., pulmonary hemorrhage, BPD, NEC, PDA, ROP, PVL, IVH, anemia, infection, etc.), feeding status (i.e., duration of milk opening, duration of full feeding, feeding style and feeding materials at full feeding, Time to recovery of birth weight), and discharge outcome (i.e., total hospitalization cost, length of stay, gestational age corrected for discharge, discharge status, discharge physique).
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| birth weight-discordant group | – | –the birth weight difference within twins is greater than 20% |
| the birth weight-concordant group | – | –the birth weight difference within twins is less than or equal to 20% |
Who may qualify
- Ages
- 1 day to 28 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- live twin births
Key inclusion criteria (2 listed)
- live twin births
- 1. delivered from 2018 to 2020
Key exclusion criteria (4 listed)
- congenital and hereditary diseases
- inherited metabolic diseases
- complex congenital heart disease
- digestive tract malformations
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
birth outcome
Time frame: 1 day
gestational age
neonatal complications
Time frame: 1 month
the morbidity of pulmonary hemorrhage, BPD, NEC, PDA, ROP, PVL, IVH, anemia, infection, etc
2 secondary outcomes
discharge outcome
Time frame: 3 months
discharge outcome
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2023.
- Results publication: PubMed 33508311Hiersch L, Barrett J, Aviram A, Mei-Dan E, Yoon EW, Zaltz A, Kingdom J, Melamed N. Patterns of discordant growth and adverse neonatal outcomes in twins. Am J Obstet Gynecol. 2021 Aug;225(2):187.e1-187.e14. doi: 10.1016/j.ajog.2021.01.018. Epub 2021 Jan 25.
- Results publication: PubMed 29028139D'Antonio F, Thilaganathan B, Laoreti A, Khalil A; Southwest Thames Obstetric Research Collaborative (STORK). Birth-weight discordance and neonatal morbidity in twin pregnancy: analysis of STORK multiple pregnancy cohort. Ultrasound Obstet Gynecol. 2018 Nov;52(5):586-592. doi: 10.1002/uog.18916. Epub 2018 Oct 8.
- Results publication: PubMed 30316716Jahanfar S, Lim K, Oviedo-Joekes E. Stillbirth Associated With Birth Weight Discordance in Twin Gestations. J Obstet Gynaecol Can. 2019 Jan;41(1):52-58. doi: 10.1016/j.jogc.2018.02.017. Epub 2018 Oct 10.
- Results publication: PubMed 21864822Miller J, Chauhan SP, Abuhamad AZ. Discordant twins: diagnosis, evaluation and management. Am J Obstet Gynecol. 2012 Jan;206(1):10-20. doi: 10.1016/j.ajog.2011.06.075. Epub 2011 Jun 25.
- Results publication: PubMed 20187000Diaz-Garcia C, Bernard JP, Ville Y, Salomon LJ. Validity of sonographic prediction of fetal weight and weight discordance in twin pregnancies. Prenat Diagn. 2010 Apr;30(4):361-7. doi: 10.1002/pd.2469.
- Results publication: PubMed 29155475D'Antonio F, Odibo AO, Prefumo F, Khalil A, Buca D, Flacco ME, Liberati M, Manzoli L, Acharya G. Weight discordance and perinatal mortality in twin pregnancy: systematic review and meta-analysis. Ultrasound Obstet Gynecol. 2018 Jul;52(1):11-23. doi: 10.1002/uog.18966.
- Results publication: PubMed 23355123D'Antonio F, Khalil A, Dias T, Thilaganathan B; Southwest Thames Obstetric Research Collaborative (STORK). Weight discordance and perinatal mortality in twins: analysis of the Southwest Thames Obstetric Research Collaborative (STORK) multiple pregnancy cohort. Ultrasound Obstet Gynecol. 2013 Jun;41(6):643-8. doi: 10.1002/uog.12412. Epub 2013 Apr 22.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Twin; Pregnancy, Affecting Fetus or Newborn, run by The Third Affiliated Hospital of Guangzhou Medical University at 1 site in China.
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 4 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: finished, as of the sponsor's last update on 7 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
birth outcome (time frame: 1 day). The study lists 2 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 NCT05674214, which also lists 7 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 7 Jun 2023.