Women and Babies
Current Projects
CONCEPTT Kids International
CONCEPTT Kids International
Neurodevelopmental Outcomes among Offspring of women with Type 1 Diabetes: A Follow up Study of the CONCEPTT Randomized Control Trial
Dr. Jennifer Yamamoto, University of Manitoba
Dr. Lois Donovan, University of Calgary, Richmond Road Diagnostic and Treatment Centre
Dr. Deb Dewey, University of Calgary, The Owerka Centre
Dr. Denice Feig, Mount Sinai Hospital
Dr. Helen Murphy, University of East Anglia, Norwich, UK
Recruitment Status
Recruiting
CONCEPTT was a multicentre randomized controlled trial of continuous glucose monitoring (CGM) in T1D pregnancies. It is the only international cohort that has detailed glycemic measures using CGM in this population. An examination of the impact of maternal glycemia (as measured by CGM) on childhood executive function and behaviour, attention, and social responsiveness has not been performed. CONCEPTT provides a unique opportunity to evaluate the relationship between direct fetal exposure to maternal glucose and these concerning childhood outcomes.
There are 225 eligible participants at 31 sites in Canada, UK, Spain and Italy.
The primary outcome measure is childhood executive function measured by the Global Executive Composite of the Behaviour Rating Inventory of Executive Function – Second Edition (BRIEF2)
ClinicalTrials.gov (NCT#)
NCT05754567
Up to 31 sites in Canada, UK, Spain and Italy
PublicationsNeurocognitive and behavioural outcomes in offspring exposed to maternal pre-existing diabetes: a systematic review and meta-analysis. Link: https://doi.org/10.1007/s00125-019-4923-0
MiTy Tykes
MiTy Tykes - A multi-centre follow up study of the effect of in-utero exposure to metformin in 5-11 year old offspring of mothers in the MiTy Trial
Dr. Denice Feig, Mount Sinai Hospital
Recruitment Status
Recruiting
MiTy Tykes is an international, multi-centre, follow up study examining the offspring born to type 2 diabetic mothers who participated in the MiTy trial where they were treated with either metformin or placebo. The trial seeks to determine whether treatment with metformin during pregnancy leads to a reduction in adiposity as measured by body mass index z-score, other measures of adiposity, and growth trajectory. It will also examine measures of insulin resistance and metabolic syndrome, and Neurodevelopment. The estimated sample size is 220 participants across sites in Canada and Australia.
ClinicalTrials.gov (NCT#) Trial email Trial LocationsCANADA: Toronto, Ontario; London, Ontario; Ottawa, Ontario; Halifax, Nova Scotia; Montreal, Quebec; Quebec City, Quebec; Winnipeg, Manitoba; Edmonton, Alberta; Calgary, Alberta; Vancouver, British Columbia; AUSTRALIA: Campbelltown, New South Wales, Australia; Brisbane, Queensland, Australia.
SNACS
SNACS - Single Dose of Antenatal Corticosteroids (SNACS) Randomized Controlled Trial for Pregnancies at Risk of Preterm Delivery: To Keep Babies and Children Safe
Dr. Sarah McDonald, McMaster University Medical Centre
Dr. Kellie Murphy, Mount Sinai Hospital
Recruitment Status
Recruiting
SNACS is an international, multicenter, randomized, blinded, non- inferiority trial conducted to evaluate the outcomes of administrating a single dose of Antenatal Corticosteroids (Betamethasone) vs the standard double dose, in pregnancies, at increased risk of preterm birth. The primary clinical hypothesis is that the administration of the single does will be non-inferior for the composite outcome compared to the administration of the double dose.
The intended sample size is 3,254.
Primary outcome: A composite outcome of:
1) perinatal mortality (fetal death post-randomization or in hospital neonatal death) or
2) substantial neonatal morbidity [>1 of:
- respiratory morbidity (requiring surfactant <48 hrs of life),
- severe intraventricular hemorrhage (with ventricular distension, post-hemorrhagic ventricular dilation, intraparenchymal haemorrhage or echodense intraparenchymal lesions i.e. Grade 3 or 4),
- severe bowel problem (necrotizing enterocolitis, Stage 2 or 3)].
There are 225 eligible participants at 31 sites in Canada, UK, Spain and Italy.
The primary outcome measure is childhood executive function measured by the Global Executive Composite of the Behaviour Rating Inventory of Executive Function – Second Edition (BRIEF2)
ClinicalTrials.gov (NCT#) Trial email Trial Locations- Canada
- Ontario
- London
- Hamilton
- Toronto
- Kingston
- Ottawa
- British Columbia
- Victoria
- Vancouver
- New Westminster
- Alberta
- Calgary
- Edmonton
- Saskatchewan,
- Saskatoon
- Regina
- Manitoba
- Winnipeg
- Quebec
- Montreal
- Sherbrooke
- New Brunswick
- Fredericton
- Moncton
- Saint John
- Nova Scotia
- Halifax
- Newfoundland and Labrador
- St. John’s
- Ontario
- Australia
- South Australia
- Adelaide
- Melbourne
- Northern Territory
- Tiwi
- New South Wales
- Sydney
- Newcastle
- Queensland
- Townville
- Brisbane
- Tasmania
- South Australia
- Website - https://snacstrial.com/
- X – https://mobile.twitter.com/snacstrial
- Instagram - https://www.instagram.com/snacstrial/
- Facebook - https://www.facebook.com/thesnacstrial/
Completed Projects
CHIPS
CHIPS - Control of Hypertension In Pregnancy Study
Principal investigator
Dr. Laura Magee, Kings College London
Summary
Women with non-severe non-proteinuric pre-existing hypertension (one per cent of deliveries) or gestational hypertension remote from term (two-three per cent of deliveries) represent a highrisk group from both maternal and perinatal perspectives. It is still unclear how best to manage the non-severe hypertension in order to do more good than harm. The placenta does not autoregulate blood flow, so allowing blood pressure (BP) to be higher may improve uteroplacental perfusion, fetal growth, and ultimately, neonatal well-being. Based on our meta-analyses of RCTs, arguments can be made both for and against ‘less tight’ control of BP (allowing for higher BP levels). ‘Less tight’ control may decrease the risk of small for gestational age (SGA) infants, but may also increase the risk of (transient) severe maternal hypertension, antenatal hospitalisation, and proteinuria at delivery. However, there is insufficient evidence on which to base clinical decisions because of reporting bias and between-trial heterogeneity in outcome. Guidelines are founded mainly on expert opinion. The CHIPS Pilot Trial confirmed the importance and feasibility of a definitive RCT. Clinicians complied with the interventions and women were satisfied with their care. ‘Less tight’ (vs. ‘tight’) control resulted in higher dBP, and a more favourable effect on perinatal outcomes.
The purpose of the CHIPS trial was to determine whether ‘less tight’ control (target dBP of 100mmHg) vs. ‘tight’ control (target dBP of 85mmHg) of non-severe maternal hypertension will decrease fetal/neonatal risk without increasing maternal risk.
ClinicalTrials.gov (NCT#)
NCT01192412
Trial Locations
111 sites in 16 countries
Primary outcomes: Pregnancy loss (miscarriage or ectopic pregnancy, pregnancy termination, stillbirth, or neonatal death) or high level neonatal care for >48 hours in the first 28 days of life or prior to primary hospital discharge, whichever is later.
987 participants were enrolled in the trial.
Publications
Magee LA, von Dadelszen P, Singer J, Lee T, Rey E, Ross S, Asztalos E, Murphy KE, Menzies J, Sanchez J, Gafni A, Helewa M, Hutton E, Koren G, Lee SK, Logan AG, Ganzevoort W, Welch R, Thornton JG, Moutquin JM; CHIPS Study Group*. Hypertension. 2016 Nov;68(5):1153-1159. Epub 2016 Sep 12. https://www.ncbi.nlm.nih.gov/pubmed
CONCEPTT
CONCEPTT - Continuous Glucose Monitoring in Women With Type 1 Diabetes in Pregnancy Trial
Principal investigator
Dr. Denice Feig, Mount Sinai Hospital
Dr. Helen Murphy, University of East Anglia, UK
Summary
Background: Women with type 1 diabetes continue to have adverse pregnancy outcomes, including high rates of major congenital malformations, neonatal death, as well as Macrosomia.
Study design: The study will be multi-centre, computer based randomized, open label controlled and conducted as two parallel trials with an intention-to-treat analysis. Pregnant women or women planning pregnancy will be randomized to either receive the Continuous Glucose Monitor (CGM) sensor added to standard therapy or standard therapy of Home Glucose Monitoring (HGM).
Primary outcomes: Pre-pregnancy Group: Maternal glycemic control as measured by HbA1c at 24 weeks. If the patient becomes pregnant, then HbA1c will be measured post-confirmation of a positive pregnancy test and will contribute to the primary outcome.
Sample size: 324 women (110 pre-pregnant and 214 pregnant)
ClinicalTrials.gov (NCT#)
NCT01788527
Trial email
Conceptt@sunnybrook.ca
Trial Locations
31 (US, Canada, Ireland, Italy, Spain, UK)
Publications
CONCEPTT: Continuous Glucose Monitoring in Women with Type 1 Diabetes in Pregnancy Trial: A multi-center, multi-national, randomized controlled trial - Study protocol. BMC Pregnancy and Childbirth.
https://bmcpregnancychildbirth.biomedcentral.com/articles/10.1186/s12884-016-0961-5
Continuous glucose monitoring in pregnant women with type 1 diabetes (CONCEPTT): a multicentre international randomised controlled trial. The Lancet. https://doi.org/10.1016/S0140-6736(17)32400-5
Continuous glucose monitoring in pregnant women with Type 1 diabetes: benefits for mothers, using pumps or pens, and their babies. Diabetic Medicine. https://doi.org/10.1111/dme.13585
Commentary: Maternal and child health - Real-time continuous glucose monitoring improves glycaemic variability and neonatal outcomes in pregnant women with type 1 diabetes; first published as 10.1136/bmjebm-2018-110927. BMJ EBM. http://dx.doi.org/10.1136/bmjebm-2018-110927
Pumps or Multiple Daily Injections in Pregnancy Involving Type 1 Diabetes: A Prespecified Analysis of the CONCEPTT Randomized Trial. Diabetes Care. https://doi.org/10.2337/dc18-1437
f.Dietary Intakes of Women with Type 1 Diabetes Before and During Pregnancy: A pre-specified secondary subgroup analysis among CONCEPTT participants. Article ID: DME13937. Diabetic Medicine. https://doi.org/10.1111/dme.13937
Modelling potential cost savings from use of real-time continuous glucose monitoring in pregnant women with type 1 diabetes. Diabetic Medicine. https://www.ncbi.nlm.nih.gov/pubmed/31162713
RESPONSE TO COMMENT ON FEIG ET AL. Pumps or Multiple Daily Injections in Pregnancy Involving Type 1 Diabetes: A Prespecified Analysis of the CONCEPTT Randomized Trial. Diabetes Care 2018;41:2471–2479. Diabetic Medicine. https://doi.org/10.2337/dci19-0013
Maternal Glycaemic Control and Risk of Neonatal Hypoglycaemia in Type 1 Diabetes Pregnancy– A secondary analysis of the CONCEPTT Trial. Diabetic Medicine. https://doi.org/10.1111/dme.13988
Dietary Patterns of Insulin Pump and Multiple Daily Injection Users During Type 1 Diabetes Pregnancy. Diabetes Care. https://doi.org/10.2337/dc19-1908
Continuous Glucose Monitoring in Pregnancy: Importance of Analyzing Temporal Profiles to Understand Clinical Outcomes https://doi.org/10.2337/dc19-2527
Which growth standards should be used to identify large- and small-for-gestational age infants of mothers with type 1 diabetes? A pre-specified analysis of the CONCEPTT trial https://doi.org/10.21203/rs.3.rs-27918/v2
Novel biochemical markers of glycemia to predict pregnancy outcomes in women with type 1 diabetes. https://doi.org/10.2337/dc20-2360
Can placental growth factors explain birthweight variation in offspring of women with type 1 diabetes? https://doi.org/10.1007/s00125-021-05438-y
Continuous glucose monitoring Time-in-Range and HbA1c targets in pregnant women with type 1 diabetes
https://doi.org/10.1089/dia.2021.0073
The Cost Implications of Continuous Glucose Monitoring in Pregnant Women with Type 1 Diabetes in Three Canadian Provinces: A Post-Hoc Cost Analysis of the CONCEPTT Trial https://doi.org/10.9778/cmajo.20200128
Reappearance of C-Peptide During the Third Trimester of Pregnancy in Type 1 Diabetes: Pancreatic Regeneration or Fetal Hyperinsulinism?
EECV2
EECV2 - Early External Cephalic Version 2 Trial
Principal investigator
Dr. Eileen Hutton, McMaster University
Summary
Between 3-4 per cent of all term pregnancies will be breech. Recent research indicates that it is safest for babies in a breech presentation to be born by CS. Although most women would prefer a vaginal birth (VB), they will choose CS when there is a medical indication. Most physicians now recommend CS for breech pregnancies. CS remains the largest contributing factor to maternal mortality and serious maternal morbidity associated with birth, and the scar resulting from CS complicates all subsequent pregnancies. Research evidence supports turning breech babies using a technique called external cephalic version (ECV) beginning at 37 weeks gestation to significantly lower the CS rate and thus reduce adverse outcomes for women. Although ECV at term is effective, the procedure is often unsuccessful.
The purpose of the EECV2 trial was to determine for women with a fetus in breech presentation, does early external cephalic version (ECV) (at 340/7-356/7 weeks) versus delayed ECV (not before 370/7 weeks) increase or decrease the likelihood of caesarean section (CS)?
EECV2 was a multicentre randomised controlled trial design, with stratification for centre and parity. Participants were randomized to early ECV at 34-35 weeks or delayed ECV at ≥37 weeks.
Primary outcome was to measure rate of caesarian section.
ClinicalTrials.gov (NCT#)
NCT00141687
Trial Locations
68 centres in 21 countries.
Sample size: 1543
Publications
Hutton EK, Hannah ME, Ross SJ, Delisle MF, Carson GD, Windrim R, Ohlsson A, Willan AR, Gafni A, Sylvestre G, Natale R, Barrett Y, Pollard JK, Dunn MS, Turtle P; Early ECV2 Trial Collaborative Group. BJOG. 2011 Apr;118(5):564-77. doi: 10.1111/j.1471-0528.2010.02837.x. Epub 2011 Feb 4. https://www.ncbi.nlm.nih.gov/pubmed
EMPOWER
EMPOWER - Enhancing Breast Milk Production with Domperidone in Mothers of Preterm Neonates
Principal investigator
Dr. Elizabeth Asztalos, Sunnybrook Health Sciences Centre
Summary
EMPOWER is a multi-centre, double-masked, randomised controlled trial designed to determine if the administration of Domperidone compared to placebo will increase breast milk production without any signs of harm over a two or four week period.
The primary research question asks: In mothers of preterm infants 231/7 to 296/7 completed weeks gestation at birth who are pumping to provide expressed breast milk for their infant(s) and are identified as having an inadequate milk supply, does the administration of Domperidone compared to placebo increase breast milk volume without any signs of harm over a 2 or 4 week period?
The primary outcome is the difference between the two groups in achieving a 50 per cent increase in breast milk volume at the end of the first two-week period (mean day 14 volume- mean day volume at entry day 0).
ClinicalTrials.gov (NCT#)
NCT01512225
Trial Locations
8
Sample size: 90
Publications
Asztalos EV, Campbell-Yeo M, da Silva OP, Ito S, Kiss A, Knoppert D; EMPOWER Study Collaborative Group. J Hum Lact. 2017 Feb;33(1):181-187. doi: 10.1177/0890334416680176. Epub 2017 Jan 20.
https://pubmed.ncbi.nlm.nih.gov/28107101/
MACS
MACS - Multiple Courses of Antenatal Corticosteroids for Preterm Birth Study
Principal investigator
Dr. Kellie Murphy, Mount Sinai Hospital
Summary
For women at increased risk of preterm birth, the benefits of a single course of antenatal corticosteroids (ACS) are well-established. These include a reduction in neonatal respiratory distress syndrome (RDS) intraventricular haemorrhage (IVH), neonatal mortality, and the need for surfactant therapy. These benefits have been demonstrated to begin 24 hours post treatment and continue up to seven days. Extrapolating these benefits, many physicians have suggested that weekly courses be given to women who remain at increased risk of preterm birth. In some centres, the practice of giving multiple courses of ACS has become routine. The study is a multicentre, double-masked randomized controlled trial (RCT). Randomization is stratified by gestational age and participating centre.
The trial set out to determine if for women at 25 to 32 weeks gestational age, 14 or more days following a single course of antenatal corticosteroids (ACS), who remain at increased risk of preterm birth: compared to placebo, are multiple courses of ACS every 14 days, until 33 weeks, effective in reducing the risk of perinatal or neonatal mortality or significant neonatal morbidity?
The primary outcome is perinatal or neonatal mortality (until 28 days of age or hospital discharge, whichever is later), or significant neonatal morbidity (one or more of the following: respiratory distress syndrome [RDS], bronchopulmonary dysplasia, grade three or four intraventricular haemorrhage (IVH), periventricular leukomalacia or necrotizing enterocolitis).
Sample size: 1858
ClinicalTrials.gov (NCT#)
NCT00187382
Trial email
macs@sw.ca
Trial Locations
80
Publications
- Multiple courses of antenatal corticosteroids for preterm birth (MACS): a randomised controlled trial. Murphy KE, Hannah ME, Willan AR, Hewson SA, Ohlsson A, Kelly EN, Matthews SG, Saigal S, Asztalos E, Ross S, Delisle MF, Amankwah K, Guselle P, Gafni A, Lee SK, Armson BA; MACS Collaborative Group. Lancet. 2008 Dec 20;372(9656):2143-51. doi: 10.1016/S0140-6736(08)61929-7. https://www.ncbi.nlm.nih.gov/pubmed/19101390
- Maternal side-effects after multiple courses of antenatal corticosteroids (MACS): the three-month follow-up of women in the randomized controlled trial of MACS for preterm birth study. Murphy KE, Hannah ME, Willan AR, Ohlsson A, Kelly EN, Matthews SG, Saigal S, Asztalos E, Ross S, Delisle MF, Tomat L, Amankwah K, Guselle P, Gafni A, Lee SK, Armson BA; MACS Collaborative Group.J Obstet Gynaecol Can. 2011 Sep;33(9):909-21.
https://www.ncbi.nlm.nih.gov/pubmed/21923988 - Multiple courses of antenatal corticosteroids for preterm birth study: 2-year outcomes. Asztalos EV, Murphy KE, Hannah ME, Willan AR, Matthews SG, Ohlsson A, Kelly EN, Saigal S, Ross S, Delisle MF, Amankwah K, Guselle P, Gafni A, Lee SK, Armson BA, Sananes R, Tomat L; Multiple Courses of Antenatal Corticosteroids for Preterm Birth Study Collaborative Group. Pediatrics. 2010 Nov;126(5):e1045-55. doi: 10.1542/peds.2010-0857. Epub 2010 Oct 18. https://www.ncbi.nlm.nih.gov/pubmed
MACS-5
MACS-5 - Multiple Courses of Antenatal Corticosteroids for Preterm Birth Study: Outcomes in Children at 5 Years of Age
Principal investigator
Dr. Elizabeth Asztalos, Sunnybrook Health Sciences Centre
Summary
This is the follow up study of children born to participants of the MACS trial. All children alive at 5 years of age underwent the five-year assessment, which included a neurologic assessment to determine the presence of cerebral palsy and any hearing/visual difficulties and the completion of two parent questionnaires. The institutions were encouraged to contact the families of all surviving children even if no contact had been made at 18 to 24 months of age. The target date for the visit was the child’s fifth chronological birthday; completing the assessments within four months of the target date was encouraged, but efforts to locate and assess the children continued beyond this age when necessary.
Intervention: Single and multiple courses of antenatal corticosteroid therapy.
The primary outcome was a composite of death or survival with a neurodevelopmental disability in at least one of the following domains: neuromotor (nonambulatory cerebral palsy), neurosensory (blindness, deafness, or need for visual or hearing aids), or neurocognitive/neurobehavioural function (abnormal attention, memory, or behaviour).
1728 children participated and 1719 children contributed to the primary outcome.
ClinicalTrials.gov (NCT#)
NCT00187382
Trial email
macs@sw.ca
Trial Locations
80
Publications
Multiple courses of antenatal corticosteroids for preterm birth study: outcomes in children at 5 years of age (MACS-5). Asztalos EV, Murphy KE, Willan AR, Matthews SG, Ohlsson A, Saigal S, Armson BA, Kelly EN, Delisle MF, Gafni A, Lee SK, Sananes R, Rovet J, Guselle P, Amankwah K, Saleem M, Sanchez J; MACS-5 Collaborative Group. JAMA Pediatr. 2013 Dec;167(12):1102-10. doi: 10.1001/jamapediatrics.2013.2764. https://www.ncbi.nlm.nih.gov/pubmed
MiTy
MiTy - Metformin in Women With Type 2 Diabetes in Pregnancy Trial)
Principal investigator
Dr. Denice Feig, Mount Sinai Hospital
Summary
The trial was a phase III, multi-site, randomized, double-masked placebo-controlled trial of metformin or placebo in addition to their usual insulin regimen, in women diagnosed with type 2 diabetes in pregnancy, between 6+0 and 22+6 weeks gestation. The analysis was conducted using an intention-to-treat approach.
ClinicalTrials.gov (NCT#)
NCT01353391
Trial email
MiTy@sunnybrook.ca
Trial Locations
29
Primary outcome: a composite of pregnancy loss (miscarriage, termination, stillbirth, neonatal death), preterm birth, birth injury, moderate/severe respiratory distress, neonatal hypoglycemia, and NICU admission > 24 hours.
Sample size: 502
Publications
Feig DS, Murphy K, Asztalos E, Tomlinson G, Sanchez J, Zinman B, Ohlsson A, Ryan EA, Fantus IG, Armson AB, Lipscombe LL, Barrett JF; MiTy Collaborative Group. Metformin in women with type 2 diabetes in pregnancy (MiTy): a multi-center randomized controlled trial. BMC Pregnancy Childbirth. 2016 Jul 19;16(1):173. doi: 10.1186/s12884-016-0954-4.
Feig DS, Donovan LE, Zinman B, Sanchez JJ, Asztalos E, Ryan EA, Fantus IG, Hutton E, Armson AB, Lipscombe LL, Simmons D, Barrett JFR, Karanicolas PJ, Tobin S, McIntyre HD, Tian SY, Tomlinson G, Murphy KE; MiTy Collaborative Group. Metformin in women with type 2 diabetes in pregnancy (MiTy): a multicentre, international, randomised, placebo-controlled trial. Lancet Diabetes Endocrinol. 2020 Oct;8(10):834-844. doi: 10.1016/S2213-8587(20)30310-7. Erratum in: Lancet Diabetes Endocrinol. 2020 Nov;8(11):e6. PMID: 32946820.
MiTy Kids
MiTy Kids - Metformin in Women with Type 2 Diabetes in Pregnancy Kids Trial
Principal investigator
Dr. Denice Feig, Mount Sinai Hospital
Summary
MiTy Kids is an international, multi-centre follow up study to the MiTy Trial. The trial seeks to determine whether treatment with metformin during pregnancy, in women with type 2 diabetes, leads to a reduction in adiposity as measured by BMI z-score and sum of skinfold thickness in the offspring at 2 years of age.
ClinicalTrials.gov (NCT#)
NCT01832181
Trial email
MiTyKids@sunnybrook.ca
Trial Locations
CANADA: Toronto, Ontario; London, Ontario; Ottawa, Ontario; Kingston, Ontario; Halifax, Nova Scotia; Montreal, Quebec; Quebec City, Quebec; Winnipeg, Manitoba; Edmonton, Alberta; Calgary, Alberta; Vancouver, British Columbia; Victoria, British Columbia, St. John’s, Newfoundland; Regina, Saskatchewan; AUSTRALIA: Campbelltown, New South Wales, Australia; Brisbane, Queensland, Australia.
TBT
The term breech trial (TBT) - Planned caesarean section versus planned vaginal birth for breech presentation at term: a randomised multicentre trial
Principal investigator
Mary Hannah
Summary
For 3-4 per cent of pregnancies, the fetus will be in the breech presentation at term. For most of these women, the approach to delivery is controversial. We did a randomised trial to compare a policy of planned caesarean section with a policy of planned vaginal birth for selected breech-presentation pregnancies.
Women with a singleton fetus in a frank or complete breech presentation were randomly assigned planned caesarean section or planned vaginal birth. Women having a vaginal breech delivery had an experienced clinician at the birth. Mothers and infants were followed-up to six weeks post partum.
The primary outcomes were perinatal mortality, neonatal mortality, or serious neonatal morbidity; and maternal mortality or serious maternal morbidity.
2088 patients were enrolled in this study
Trial Locations
121 centres in 26 countries
Publications
Planned caesarean section versus planned vaginal birth for breech presentation at term: a randomised multicentre trial. Term Breech Trial Collaborative Group. Hannah ME, Hannah WJ, Hewson SA, Hodnett ED, Saigal S, Willan AR. Lancet. 2000 Oct 21;356(9239):1375-83. https://www.ncbi.nlm.nih.gov/pubmed/11052579
Twin Birth Study
TBS - Twin Birth Study
Principal investigator
Dr. Jon Barrett, Sunnybrook Health Sciences Centre
Summary
Twins complicate approximately 2-3 per cent of all births. Twin fetuses that are >2500g at birth are at higher risk of death and neonatal morbidity than singletons of the same birth weight. In addition, the second twin is at higher risk of death and/or serious neonatal morbidity compared with twin A if delivery is vaginal but not if delivery is by caesarean section (CS).
The study aimed to conduct an international multicentre RCT, comparing planned CS to planned VB for twins at 32 to 38 weeks gestation.
Because there is an increase in stillbirth rate after 38 weeks gestation, trial participants were delivered by the planned method of delivery at 38 weeks. Vaginal delivery was conducted by experienced personnel: if twin B is non-vertex the initial options for delivery were: spontaneous or assisted vaginal breech delivery (if breech); total breech extraction with or without internal podalic version; or external cephalic version and vaginal delivery of the fetus as a vertex.
Primary outcomes:
Perinatal or neonatal mortality and/or serious neonatal morbidity (excluding lethal congenital anomalies).
Secondary outcomes:
death or poor neurodevelopmental outcome of the children at 2 years of age; problematic urinary or fecal/flatal incontinence for the mother at two years postpartum.
Other outcomes
maternal death or serious maternal morbidity within 28 days following delivery; maternal satisfaction with method of delivery (three months); breast feeding (three months); maternal quality of life (three months and two years); problematic urinary or fecal/flatal incontinence at three months
Sample size: 2804 women
ClinicalTrials.gov (NCT#)
NCT00187369
Trial email
TBS@sunnybrook.ca
Trial Locations
106 centres in 25 countries.
Publications
- Barrett JFR, Hannah ME, Hutton EK, Willan AR, Allen AC, Armson BA, Gafni A, Joseph KS, Mason D, Ohlsson A, Ross S, Sanchez JJ, Asztalos EV, Twin Birth Study Collaborative Group. A Randomized Trial of Planned Cesarean or Vaginal Birth Delivery for Twin Pregnancy. N Engl J Med 2013; 369: 1295-305. Doi:10.1056/NEJMoa1214939. PMID: 24088091.
- Hutton EK, Hannah ME, Ross S, Joseph KS, Ohlsson A, Asztalos EV, Willan AR, Allen AC, Armson BA, Gafni A, Mangoff K, Sanchez JJ, Barrett JF; Twin Birth Study Collaborative Group. Maternal outcomes at 3 months after planned caesarean section versus planned vaginal birth for twin pregnancies in the Twin Birth Study: a randomised controlled trial. BJOG. 2015 Nov;122(12):1653-62.
- Asztalos EV, Hannah ME, Hutton EK, Willan AR, Allen AC, Armson BA, Gafni A, Joseph KS, Ohlsson A, Ross S, Sanchez JJ, Mangoff, K and Barrett JFR for Twin Birth Study Collaborative Group. Twin Birth Study: 2-year neurodevelopmental follow-up of the randomized trial comparing planned cesarean vs planned vaginal delivery for twin pregnancy. Am J Obstet Gynecol. 2016 Jan; 214(3):371.e - 371.e19.
- Hutton EK, Hannah ME, Willan AR, Ross S, Allen AC, Armson BA, Gafni A, Joseph KS, Mangoff K, Ohlsson A, Sanchez JJ, Asztalos EV, Barrett J; Twin Birth Study Collaborative Group. Urinary stress incontinence and other maternal outcomes 2 years after caesarean or vaginal birth for twin pregnancy: a multicentre randomised trial. BJOG. 2018 Dec;125(13):1682-1690. doi: 10.1111/1471-0528.15407. Epub 2018 Aug 27.
