Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12615000904572
Ethics application status
Approved
Date submitted
24/07/2015
Date registered
31/08/2015
Date last updated
8/08/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Feasibility trial for PINTO: pre-diabetes in pregnancy, can early intensive management and lifestyle advice improve outcomes?
Scientific title
For pregnant women with a first trimester HbA1c in the pre-diabetes range, does intensive management including blood sugar monitoring to maintain normoglycaemia, compared to standard weight gain and dietary advice, improve pregnancy outcome. A feasibility trial for PINTO.
Secondary ID [1] 286889 0
nil
Universal Trial Number (UTN)
U1111-1162-3277
Trial acronym
PINTO feasibility study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prediabetes in pregnancy 295695 0
Condition category
Condition code
Reproductive Health and Childbirth 295979 295979 0 0
Antenatal care
Metabolic and Endocrine 296089 296089 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Group B – Intervention group

Attend a diabetes in pregnancy clinic, from before 14 weeks' gestation, in combination with standard care from their usual lead maternity carer (community midwife or obstetrician).

Commence blood sugar monitoring four to six times daily, fasting and one hour after all meals, using a finger prick and handheld glucose monitoring device.

Attend one 1-hr group lifestyle education session (dietary, weight-gain and exercise advice) with our clinic dietitian. Have ongoing individual lifestyle education (diet and exercise) with a clinic dietitian at a 20 minute clinic appointment every 4 weeks, written dietary advice and examples of meal plans will be provided.

Medication, as required, will be prescibed by a clinic physician in order to maintain blood glucose levels within the usual targets for pregnancy. This group will attend clinic appointments approximately once per month throughout pregnancy.

Adherence to treatment will be monitored through participant blood glucose diaries, downloading data from glucometers, recording patient weight at clinic appointments, dietary and exercise questionnaire at trial entry, 36 weeks' gestation and at three months postpartum.

Group B will not perform an OGTT in pregnancy.
Intervention code [1] 292410 0
Treatment: Other
Intervention code [2] 292518 0
Lifestyle
Comparator / control treatment
Group A – Care as per the New Zealand Ministry of Health Gestational Diabetes (GDM) guideline.
Follow-up with their usual lead maternity carer (community midwife or obstetrician) as per routine care.

Attend one 1-hr group lifestyle education session (dietary, weight-gain and exercise advice) at or before 14 weeks gestation with our clinic dietitian. Written dietary advice and examples of meal plans will be provided.

Perform an oral glucose tolerance test (75g, with bloods taken at 0-hour, 1-hour, and 2-hour time points) to screen for GDM at 24-28 weeks’ gestation and refer to a diabetes in pregnancy service if this test is positive.

Adherence to lifestyle intervention will be monitored by recording patient weight-gain in pregnancy at 36 weeks gestation by the lead maternity carer and a dietary and exercise questionnaire at trial entry, 36 weeks' gestation and at three months postpartum.
Control group
Active

Outcomes
Primary outcome [1] 295652 0
Maternal Primary outcome: Preeclampsia
Diagnosis confirmed by Obstetrician as per SOMANZ (Society of Obstetric Medicine Australia and New Zealand) diagnostic guidelines.
Timepoint [1] 295652 0
at delivery
Primary outcome [2] 295653 0
Neonatal primary outcome: composite of preterm delivery, small for gestational age (SGA), and perinatal death. Assessed by review of hospital records.
Timepoint [2] 295653 0
up to 1 month postpartum
Secondary outcome [1] 316112 0
Neonatal: birth weight and customised birth weight centile. Assessed from hospital records.
Timepoint [1] 316112 0
At delivery
Secondary outcome [2] 316113 0
Health-care costs - Resources used and their unit prices will be determined from the time of randomisation until 28 days postpartum for the mother and baby. Costs considered will include medications, outpatient visits and hospital admissions, tests of maternal and fetal wellbeing, and neonatal care. Assessed by review of hospital records.
Timepoint [2] 316113 0
28 days postpartum
Secondary outcome [3] 316491 0
Maternal: weight gain in pregnancy. Assessed from participants maternity records.
Timepoint [3] 316491 0
At 36 weeks gestation and / or at delivery if earlier
Secondary outcome [4] 316492 0
Maternal: gestational hypertension as assessed by an obstetrician and according to SOMANZ diagnostic guidelines
Timepoint [4] 316492 0
At delivery
Secondary outcome [5] 316493 0
Maternal: change in HbA1c level (indicating glycaemic control). Assessed by blood test at 36 weeks' gestation.
Timepoint [5] 316493 0
36 weeks' gestation
Secondary outcome [6] 316494 0
Maternal: induction of labour. Assessed from hospital records.
Timepoint [6] 316494 0
at delivery
Secondary outcome [7] 316495 0
Maternal: mode of delivery. Assessed from hospital records.
Timepoint [7] 316495 0
At delivery
Secondary outcome [8] 316496 0
Maternal: trauma at delivery (third or fourth degree tear). Assessed from hospital records.
Timepoint [8] 316496 0
At delivery
Secondary outcome [9] 316497 0
Maternal: psychological outcomes (wellbeing). Assessed by maternal questionnaire at trial entry and at 36 weeks' gestation.

Questionnaire modified from the WHO (Five) Well-Being Index designed by the Psychiatric Research UNIT, WHO Collaborating Center for Mental Health, for the DAWN study: www.dawnstudy.com.
Timepoint [9] 316497 0
At trial entry and at 36 weeks' gestation.
Secondary outcome [10] 316498 0
Maternal: change in dietary intake.

Assessed by maternal questionnaire at trial entry and at 36 weeks' gestation. Questionnaire modified from the questionnaire designed for the MiG study: N Engl J Med 2008;358:2003-15
Timepoint [10] 316498 0
At 36 weeks' gestation.
Secondary outcome [11] 316499 0
Neonatal: composite of admission to the neonatal intensive care unit for >4 hours, respiratory support for >4 hours, hypoglycaemia <2.3mmol/L, need for i.v dextrose, jaundice requiring phototherapy. Assessed from hospital records.
Timepoint [11] 316499 0
At 72 hours post delivery.
Secondary outcome [12] 316500 0
Neonatal: composite of neonatal trauma (shoulder dystocia requiring obstetric manoeuvre, erb’s palsy or fracture). Assessed from hospital records.
Timepoint [12] 316500 0
At delivery.
Secondary outcome [13] 316613 0
Maternal: change in exercise frequency / level.
Assessed by maternal questionnaire at trial entry and at 36 weeks' gestation.
Questionnaire modified from the WHO Global Physical Activity Questionnaire (GPAQ): http://www.who.int/chp/steps/GPAQ/en/
Timepoint [13] 316613 0
At 36 weeks' gestation.

Eligibility
Key inclusion criteria
Inclusion criteria: Women with an HbA1c level of 41-46mmol/mol and who are <14 weeks’ gestation with an ongoing pregnancy.
Minimum age
16 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria: Women with HbA1c levels greater than or equal to 47mmol/mol. Women with known diabetes. Women carrying a fetus with a known lethal congenital anomaly and / or an abnormal karyotype / chromosomal abnormality. Women planning to terminate the pregnancy. Women taking metformin to manage pre-diabetes or polycystic ovarian syndrome will be excluded from the study and referred to the local antenatal diabetes clinic, or be advised to have an early 75g oral glucose tolerance test (OGTT) depending on local policy.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/12/2015
Actual
3/11/2015
Date of last participant enrolment
Anticipated
Actual
1/07/2016
Date of last data collection
Anticipated
Actual
6/11/2016
Sample size
Target
150
Accrual to date
Final
47
Recruitment outside Australia
Country [1] 7050 0
New Zealand
State/province [1] 7050 0
Canterbury and Auckland

Funding & Sponsors
Funding source category [1] 291711 0
Government body
Name [1] 291711 0
Health Research Council of New Zealand
Country [1] 291711 0
New Zealand
Primary sponsor type
Individual
Name
Ruth Hughes
Address
Department of Obstetrics and Gynaecology
University of Otago
Christchurch Women's Hospital
Private Bag 4711
Christchurch 8140
Country
New Zealand
Secondary sponsor category [1] 290386 0
Individual
Name [1] 290386 0
Janet Rowan
Address [1] 290386 0
Department of Obstetrics
National Women's Health
Private Bag 92-024
Auckland City Hospital
Grafton
Auckland 1010
Country [1] 290386 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293233 0
New Zealand Health and Disability Ethics Committees
Ethics committee address [1] 293233 0
Ministry of Health
Ethics Department
Freyberg Building
Reception – Ground Floor
20 Aitken Street
Wellington 6011
Ethics committee country [1] 293233 0
New Zealand
Date submitted for ethics approval [1] 293233 0
24/07/2015
Approval date [1] 293233 0
19/08/2015
Ethics approval number [1] 293233 0
15/NTA/98

Summary
Brief summary
We hypothesise that in women with HbA1c levels in the pre-diabetes range, that early intervention, including blood glucose monitoring and optimisation of blood glucose levels through dietary measures and medication as required, will reduce preeclampsia, preterm birth, neonatal morbidity and mortality without causing harm, compared with lifestyle advice and screening for gestational diabetes at 24-28 weeks’ gestation. This study is important to enable clinicians to decide how to manage women with early pregnancy HbA1c levels in the pre-diabetes range, which is especially relevant now that national and international groups and societies are endorsing the use of HbA1c as a screening test in early pregnancy. This is a feasibility study for the main randomised control trial.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 57994 0
Dr Ruth Hughes
Address 57994 0
Department of Obstetrics and Gynaecology
University of Otago
Christchurch Women's Hospital
Private Bag 4711
Christchurch 8140
Country 57994 0
New Zealand
Phone 57994 0
+64 3 3644031
Fax 57994 0
Email 57994 0
[email protected]
Contact person for public queries
Name 57995 0
Dr Ruth Hughes
Address 57995 0
Department of Obstetrics and Gynaecology
University of Otago
Christchurch Women's Hospital
Private Bag 4711
Christchurch 8140
Country 57995 0
New Zealand
Phone 57995 0
+64 3 3644031
Fax 57995 0
Email 57995 0
[email protected]
Contact person for scientific queries
Name 57996 0
Dr Ruth Hughes
Address 57996 0
Department of Obstetrics and Gynaecology
University of Otago
Christchurch Women's Hospital
Private Bag 4711
Christchurch 8140
Country 57996 0
New Zealand
Phone 57996 0
+64 3 3644031
Fax 57996 0
Email 57996 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseResearch gaps in gestational diabetes mellitus: Executive summary of a national institute of diabetes and digestive and kidney diseases workshop.2018https://dx.doi.org/10.1097/AOG.0000000000002726
EmbasePrediabetes in pregnancy, can early intervention improve outcomes? A feasibility study for a parallel randomised clinical trial.2018https://dx.doi.org/10.1136/bmjopen-2017-018493
N.B. These documents automatically identified may not have been verified by the study sponsor.