Birth DefectsNCT03725878
Effectiveness of Comprehensive Tertiary Interventions on Incidence and Clinical Outcomes of Birth Defects
A study testing Standard tertiary interventions of birth defects, Additional preconception health care and Additional health care procedures during and after pregnancy in people with Birth Defects, run by Children's Hospital of Fudan University at 1 site in China.
Trial summary
This project is a single blind cluster randomized controlled trial with a purpose of assessing the effectiveness of a comprehensive tertiary interventions (before pregnancy, during pregnancy and after delivery) on the incidence and the clinical outcomes of birth defects in a preparing-for-pregancy population in… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Birth Defects
- What is being tested?
- Standard tertiary interventions of birth defects, Additional preconception health care and Additional health care procedures during and after pregnancy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,808 participants
- Where
- 1 siteChina
- Study dates
- 31 Oct 2018to 10 Sep 2024
- Phase
- Interventional
- 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
Who may be able to join
- Females and their husbands attend pre-pregnancy physical examinations from Minhang distrit and Songjiang distrit in Shanghai.
- Couples who have planned to be pregnant within a year
- Women are between 18 and 45 years old
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
China1 site
Children Hospital of Fudan University
Shanghai, Shanghai Municipality, 201102
About this study
Official title: Effectiveness of Comprehensive Tertiary Interventions on Incidence and Clinical Outcomes of Birth Defects : a Cluster Randomisation Intervention Trial
This project is a single blind cluster randomized controlled trial with a purpose of assessing the effectiveness of a comprehensive tertiary interventions (before pregnancy, during pregnancy and after delivery) on the incidence and the clinical outcomes of birth defects in a preparing-for-pregancy population in Shanghai. The preconception intervention is focused on identifying individuals whose red blood cell folate level is below recommended level for preventing neural tube defects (400ng/ml) or with elevated homocysteine level (over th 80th percentiles, 6.8 µmol/L) , and modifying their folate deficiency status to normal before pregnancy.
Read the detailed description
According to World health Organization (WHO), approximately 3.2 million children are born with birth defect(s) worldwide and the incidence of birth defects in China is 5.6%. Birth defects are the main cause of fetal death, infant mortality and morbidity, and long-term disability. Congenital heart defects, oral clefts, hydrocephalus, neural tube defects and mental retardation are most common birth defects in China. Though the etiology of birth defects is still unknow, many studies indicated that maternal key nutrition factors, especially maternal folic acid status, during periconception played an important role in organogenesis, reducing the incidence of neural tube defects, congenital heart diseases and some other birth defects.
Our project is a single-blind, cluster randomized controlled trial that aim at evaluating whether hospital-based tertiary intervention approaches reduce the incidence of birth defects (compound primary outcomes, including neural tube defects, congenital heart defects, cleft lips and palates, hydrocephalus, alimentary tract malformations or urological deformities) that identified at middle of gestation via ultrasound or clinical observation at birth. Every couple attending premarital check or preconception physical examination from Minhang and Songjiang district in Shanghai will be recruited. Recruited couples are to draw blood samples and invite to complete questionnaires that collecting informations on diet supplementation. Comprehensive interventions before conception are based on serum folate, red blood cell folate, homocysteine, vitamin B12 and fasting glycemic and lipids profiles. Single nucleotide polymorphisms related to folate and homocysteine matalism pathway will be genotyped in participants with sufficient intake of folic acid but unknown deficiency of the nutrients. Venous blood of pregnant women and questionnaires about the supplementation of key nutrients at the first antenatal visit are also obtained. NT examination, Down's screening, and ultrasound examination results are collected during the second trimester (15-24 gestational week), then routine prenatal genetic counseling, assessment, and diagnosis are provided according to the local policy to those pregnant women with positive screen results indicating high risk of fatal birth defects. Newborns with above mentioned birth defects are provided green channel to clinical specialty team for further diagnosis, surgical correction and rehabilitation guidance. Clinical follow up will be conducted till 6-month old for the prognosis of treatment. The current project will provide evidence on the necessity and effectiveness of preconception intervention focusing on sufficient folate nutrition levels in prevention of birth defects.
- Conditions
- Birth Defects
- Being tested
- Standard tertiary interventions of birth defects, Additional preconception health care, Additional health care procedures during and after pregnancy
- Keywords
- Birth Defects, periconception, randomized controlled trial, folate
- Medical subject headings
- Congenital Abnormalities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard tertiary interventions of birth defectsProcedure or surgery
Also called Routine preconception and pregnant health cares
Couples eligible for reproductive policy are entitled to routine health cares including general health cares (health education, medical history inquiry, physical examinations, consulting guidance and pregnancy outcome follow-up) and medical examinations (laboratory examinations, virus screenings and image examinations). But nutrients status are not included in these examinations, such as folate, vitamin B12, and macroelements, et al. Regular antenatal cares are required, such as deformity screening by ultrasound. Routine neonatal screenings are conducted to diagnose infant with birth defect timely.
Additional preconception health careProcedure or surgery
Also called Individualized guide for folic acid supplementary
Various studies have revealed that folate is essential in early embryo development, whereas folate level evaluation in periconception women is not included in routine health cares. Therefore, we evaluate subject's folate level by serum and red blood cell folate examination. By combination of folate supplement obtained by questionnaire,folate level evaluated by examinations and folate metabolism ability evaluated by genotyping key enzymes in folate metabolism, an individualized folic acid supplementary guide is given to subjects. Red blood cell folate concentration >400 ng/ml before pregnancy is recommended.
Additional health care procedures during and after pregnancyProcedure or surgery
Also called Green channels for antenatal care and postnatal care
Fetus with birth defect will be referred to a tertiary hospital to receive genetic assessments and prenatal diagnosis to reduce unnecessary abortions. A 6-months follow up will be conducted to follow children's birth outcomes. It also helps clinical team to give early diagnosis and treatment for children with birth defect to reduce disability and improve life quality of defect children.
| Study group | Role | What they receive |
|---|---|---|
| Interventional | Experimental | Standard tertiary interventions of birth defects; Additional preconception health care; Additional health care procedures during and after pregnancy. Receives: Procedure: Standard tertiary interventions of birth defects; Procedure: Additional preconception health care; Procedure: Additional health care procedures during and after pregnancy |
| Control | Active comparator | Standard tertiary interventions of birth defects; Additional health care procedures during and after pregnancy. Receives: Procedure: Standard tertiary interventions of birth defects; Procedure: Additional health care procedures during and after pregnancy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of total fetal birth defects found during the second trimester, still birth, and neontal birth defects identified after delivery
This is a composite outcome: the total number of fetus defects detected by Down's syndrome screenings, NT examinations and Ultrasound image examinations during the second trimester, stillbirth, and the number of birth defects after delivery diagnosed by clinical team.
(Defects are classified in consistent with our birth defect monitoring policy, which have 24 types of defects: Anencephalus; Spina bifida; Encephalocele; Congenital Hydrocephalus; Cleft Palate; Cleft Lip; Cleft Lip with Cleft Palate; Microtia (including Anotia); Deformity of external ear(s) (except Microtia and Anotia); Esophageal atresia or stenosis; Anorectal atresia (including Congenital Anorectal Malformations); Hypospadia; Ectopocystis; Pes Equinovarus; Polydactylism; Syndactylia; Limb shortening; Congenital Diaphragmatic Hernia; Pcromphalus; Celoschisis; Conjoined Twins; Trisomy 21 syndrome; Congenital heart disease; Others. )
Measured: From the confirmation of pregnant to 28 days after birth
Secondary outcomes (5)
Incidence rate of total abortion because of the affected congenital defects
Reasons of abortion are recorded
Measured: From the confirmation of pregnant to the 28th gestational week
Incidence of death or severe organ dysfunctions
Severe organ dysfunctions were defined based on specialty clinical examinaitons
Measured: From birth to 6 months after delivery ( can be expanding to the end of the 7th month)
Extra medical cost that relates to affecting any birth defects during pregnancy and after birth
Additional medical cost that exceeds normal pregnancies and children within one year old
Measured: From confirmation of pregnancy to one year old after birth
incidence of congenital heart defect
congenital heart defects diagnosed during pregnancy (ultrasound) and after birth( Echocardiography). (Definition see Zhao et al. Lancet 2014)
Measured: from conception to one year old
Total pregnancy loss
artificial abortions without any medical reasons were exluded
Measured: from conception to 28 gestational weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2018
- Study start31 Oct 2018
- Primary completion8 Oct 2023
- Study completion10 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Birth DefectsStudies of the same condition, open and under way.
- More trials run by Children's Hospital of Fudan 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- cluster rondomization with average cluster size =100 pregnancies.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 4,808 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Collaborators
- Minhang Maternal and Children Health Care Hospital, Songjiang Maternal and Children Health Hospital
- Responsible party
- Principal investigator, Guoying huang, Children's Hospital of Fudan University
- Investigators
- Ying G Huang, MD, Ph.D, Study chair, Children's Hospital of Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03725878
- Sponsor's protocol ID
- 2016YFC1000500(6)
- Status last verified
- Feb 2025
- First submitted
- 24 Oct 2018
- Last updated
- 20 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Liu S, Joseph KS, Luo W, Leon JA, Lisonkova S, Van den Hof M, Evans J, Lim K, Little J, Sauve R, Kramer MS; Canadian Perinatal Surveillance System (Public Health Agency of Canada). Effect of Folic Acid Food Fortification in Canada on Congenital Heart Disease Subtypes. Circulation. 2016 Aug 30;134(9):647-55. doi: 10.1161/CIRCULATIONAHA.116.022126.
PubMed 27572879Czeizel AE, Dudas I, Vereczkey A, Banhidy F. Folate deficiency and folic acid supplementation: the prevention of neural-tube defects and congenital heart defects. Nutrients. 2013 Nov 21;5(11):4760-75. doi: 10.3390/nu5114760.
PubMed 24284617Ebadifar A, KhorramKhorshid HR, Kamali K, Salehi Zeinabadi M, Khoshbakht T, Ameli N. Maternal Supplementary Folate Intake, Methylenetetrahydrofolate Reductase (MTHFR) C677T and A1298C Polymorphisms and the Risk of Orofacial Cleft in Iranian Children. Avicenna J Med Biotechnol. 2015 Apr-Jun;7(2):80-4.
PubMed 26140186Li M, Zhang Y, Chen X, Wang D, Ji M, Jiang Y, Dou Y, Ma X, Sheng W, Yan W, Huang G. Effectiveness of community-based folate-oriented tertiary interventions on incidence of fetus and birth defects: a protocol for a single-blind cluster randomized controlled trial. BMC Pregnancy Childbirth. 2020 Aug 20;20(1):475. doi: 10.1186/s12884-020-03154-w.
PubMed 32819312
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Comprehensive Tertiary Interventions on Incidence and Clinical Outcomes of Birth Defects : a Cluster Randomisation Intervention Trial
- ClinicalTrials.gov ID
- NCT03725878
- Acronym / sponsor ID
- 2016YFC1000500(6)
- Conditions
- Birth Defects
- Keywords
- Birth Defects, periconception, randomized controlled trial, folate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4,808 participants (actual)
- Lead sponsor
- Children's Hospital of Fudan UniversityUniversity, hospital or other
- Collaborators
- Minhang Maternal and Children Health Care Hospital, Songjiang Maternal and Children Health Hospital
- Study start
- 31 Oct 2018 (actual)
- Primary completion
- 8 Oct 2023 (actual)
- Study completion
- 10 Sep 2024 (actual)
- First posted
- 31 Oct 2018 (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 project is a single blind cluster randomized controlled trial with a purpose of assessing the effectiveness of a comprehensive tertiary interventions (before pregnancy, during pregnancy and after delivery) on the incidence and the clinical outcomes of birth defects in a preparing-for-pregancy population in Shanghai. The preconception intervention is focused on identifying individuals whose red blood cell folate level is below recommended level for preventing neural tube defects (400ng/ml) or with elevated homocysteine level (over th 80th percentiles, 6.8 µmol/L) , and modifying their folate deficiency status to normal before pregnancy.
Detailed description
According to World health Organization (WHO), approximately 3.2 million children are born with birth defect(s) worldwide and the incidence of birth defects in China is 5.6%. Birth defects are the main cause of fetal death, infant mortality and morbidity, and long-term disability. Congenital heart defects, oral clefts, hydrocephalus, neural tube defects and mental retardation are most common birth defects in China. Though the etiology of birth defects is still unknow, many studies indicated that maternal key nutrition factors, especially maternal folic acid status, during periconception played an important role in organogenesis, reducing the incidence of neural tube defects, congenital heart diseases and some other birth defects.
Our project is a single-blind, cluster randomized controlled trial that aim at evaluating whether hospital-based tertiary intervention approaches reduce the incidence of birth defects (compound primary outcomes, including neural tube defects, congenital heart defects, cleft lips and palates, hydrocephalus, alimentary tract malformations or urological deformities) that identified at middle of gestation via ultrasound or clinical observation at birth. Every couple attending premarital check or preconception physical examination from Minhang and Songjiang district in Shanghai will be recruited. Recruited couples are to draw blood samples and invite to complete questionnaires that collecting informations on diet supplementation. Comprehensive interventions before conception are based on serum folate, red blood cell folate, homocysteine, vitamin B12 and fasting glycemic and lipids profiles. Single nucleotide polymorphisms related to folate and homocysteine matalism pathway will be genotyped in participants with sufficient intake of folic acid but unknown deficiency of the nutrients. Venous blood of pregnant women and questionnaires about the supplementation of key nutrients at the first antenatal visit are also obtained. NT examination, Down's screening, and ultrasound examination results are collected during the second trimester (15-24 gestational week), then routine prenatal genetic counseling, assessment, and diagnosis are provided according to the local policy to those pregnant women with positive screen results indicating high risk of fatal birth defects. Newborns with above mentioned birth defects are provided green channel to clinical specialty team for further diagnosis, surgical correction and rehabilitation guidance. Clinical follow up will be conducted till 6-month old for the prognosis of treatment. The current project will provide evidence on the necessity and effectiveness of preconception intervention focusing on sufficient folate nutrition levels in prevention of birth defects.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- cluster rondomization with average cluster size =100 pregnancies.
| Arm | Type | Receives |
|---|---|---|
| Interventional | Experimental | Procedure: Standard tertiary interventions of birth defects, Procedure: Additional preconception health care, Procedure: Additional health care procedures during and after pregnancyStandard tertiary interventions of birth defects; Additional preconception health care; Additional health care procedures during and after pregnancy. |
| Control | Active comparator | Procedure: Standard tertiary interventions of birth defects, Procedure: Additional health care procedures during and after pregnancyStandard tertiary interventions of birth defects; Additional health care procedures during and after pregnancy. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Females and their husbands attend pre-pregnancy physical examinations from Minhang distrit and Songjiang distrit in Shanghai.
- Couples who have planned to be pregnant within a year
- Women are between 18 and 45 years old
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard tertiary interventions of birth defectsAlso: Routine preconception and pregnant health caresCouples eligible for reproductive policy are entitled to routine health cares including general health cares (health education, medical history inquiry, physical examinations, consulting guidance and pregnancy outcome follow-up) and medical examinations (laboratory examinations, virus screenings and image examinations). But nutrients status are not included in these examinations, such as folate, vitamin B12, and macroelements, et al. Regular antenatal cares are required, such as deformity screening by ultrasound. Routine neonatal screenings are conducted to diagnose infant with birth defect timely. | Procedure or surgery | Control, Interventional |
| Additional preconception health careAlso: Individualized guide for folic acid supplementaryVarious studies have revealed that folate is essential in early embryo development, whereas folate level evaluation in periconception women is not included in routine health cares. Therefore, we evaluate subject's folate level by serum and red blood cell folate examination. By combination of folate supplement obtained by questionnaire,folate level evaluated by examinations and folate metabolism ability evaluated by genotyping key enzymes in folate metabolism, an individualized folic acid supplementary guide is given to subjects. Red blood cell folate concentration >400 ng/ml before pregnancy is recommended. | Procedure or surgery | Interventional |
| Additional health care procedures during and after pregnancyAlso: Green channels for antenatal care and postnatal careFetus with birth defect will be referred to a tertiary hospital to receive genetic assessments and prenatal diagnosis to reduce unnecessary abortions. A 6-months follow up will be conducted to follow children's birth outcomes. It also helps clinical team to give early diagnosis and treatment for children with birth defect to reduce disability and improve life quality of defect children. | Procedure or surgery | Control, Interventional |
Primary outcome
Incidence of total fetal birth defects found during the second trimester, still birth, and neontal birth defects identified after delivery
Time frame: From the confirmation of pregnant to 28 days after birth
This is a composite outcome: the total number of fetus defects detected by Down's syndrome screenings, NT examinations and Ultrasound image examinations during the second trimester, stillbirth, and the number of birth defects after delivery diagnosed by clinical team. (Defects are classified in consistent with our birth defect monitoring policy, which have 24 types of defects: Anencephalus; Spina bifida; Encephalocele; Congenital Hydrocephalus; Cleft Palate; Cleft Lip; Cleft Lip with Cleft Palate; Microtia (including Anotia); Deformity of external ear(s) (except Microtia and Anotia); Esophageal atresia or stenosis; Anorectal atresia (including Congenital Anorectal Malformations); Hypospadia; Ectopocystis; Pes Equinovarus; Polydactylism; Syndactylia; Limb shortening; Congenital Diaphragmatic Hernia; Pcromphalus; Celoschisis; Conjoined Twins; Trisomy 21 syndrome; Congenital heart disease; Others. )
5 secondary outcomes
Incidence rate of total abortion because of the affected congenital defects
Time frame: From the confirmation of pregnant to the 28th gestational week
Incidence of death or severe organ dysfunctions
Time frame: From birth to 6 months after delivery ( can be expanding to the end of the 7th month)
Extra medical cost that relates to affecting any birth defects during pregnancy and after birth
Time frame: From confirmation of pregnancy to one year old after birth
incidence of congenital heart defect
Time frame: from conception to one year old
Total pregnancy loss
Time frame: from conception to 28 gestational weeks
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 20 Feb 2025.
- Background: PubMed 27572879Liu S, Joseph KS, Luo W, Leon JA, Lisonkova S, Van den Hof M, Evans J, Lim K, Little J, Sauve R, Kramer MS; Canadian Perinatal Surveillance System (Public Health Agency of Canada). Effect of Folic Acid Food Fortification in Canada on Congenital Heart Disease Subtypes. Circulation. 2016 Aug 30;134(9):647-55. doi: 10.1161/CIRCULATIONAHA.116.022126.
- Background: PubMed 24284617Czeizel AE, Dudas I, Vereczkey A, Banhidy F. Folate deficiency and folic acid supplementation: the prevention of neural-tube defects and congenital heart defects. Nutrients. 2013 Nov 21;5(11):4760-75. doi: 10.3390/nu5114760.
- Background: PubMed 26140186Ebadifar A, KhorramKhorshid HR, Kamali K, Salehi Zeinabadi M, Khoshbakht T, Ameli N. Maternal Supplementary Folate Intake, Methylenetetrahydrofolate Reductase (MTHFR) C677T and A1298C Polymorphisms and the Risk of Orofacial Cleft in Iranian Children. Avicenna J Med Biotechnol. 2015 Apr-Jun;7(2):80-4.
- Derived from this study: PubMed 32819312Li M, Zhang Y, Chen X, Wang D, Ji M, Jiang Y, Dou Y, Ma X, Sheng W, Yan W, Huang G. Effectiveness of community-based folate-oriented tertiary interventions on incidence of fetus and birth defects: a protocol for a single-blind cluster randomized controlled trial. BMC Pregnancy Childbirth. 2020 Aug 20;20(1):475. doi: 10.1186/s12884-020-03154-w.
- Individual participant dataSharing planned: Undecided
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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.
Ying G Huang, MD, Ph.D study chair
Children's Hospital of Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard tertiary interventions of birth defects, Additional preconception health care and Additional health care procedures during and after pregnancy in people with Birth Defects, run by Children's Hospital of Fudan 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 3 inclusion and 1 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 20 Feb 2025. 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?
Incidence of total fetal birth defects found during the second trimester, still birth, and neontal birth defects identified after delivery (time frame: From the confirmation of pregnant to 28 days after birth). 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 NCT03725878, which also lists 4 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 20 Feb 2025.