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Register:	ClinicalTrials.gov
Last refreshed on:	26 April 2021
Main ID:	NCT02556840
Date of registration:	13/07/2015
Prospective Registration:	Yes
Primary sponsor:	Assistance Publique - Hôpitaux de Paris
Public title:	Impact on Birth Weight of Two Therapeutic Strategies (Insulin Therapy From the Beginning of Pregnancy vs. Insulin Therapy Initiated According to Fetal Growth Evaluated by Ultrasonography Measurements) in Pregnant Women With Monogenic Diabetes MODY2
Scientific title:	Impact of Two Standardized Clinical Care Protocols on Pregnancy Outcomes in Women With Monogenic Diabetes MODY2
Date of first enrolment:	April 25, 2016
Target sample size:	46
Recruitment status:	Completed
URL:	https://clinicaltrials.gov/show/NCT02556840
Study type:	Interventional
Study design:	Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Other. Masking: None (Open Label).
Phase:	N/A

Countries of recruitment
France

Contacts

Name:	Christine Bellanné-Chantelot, PharmaD, PhD
Address:
Telephone:
Email:
Affiliation:	Assistance Publique - Hôpitaux de Paris

Key inclusion & exclusion criteria

Inclusion Criteria:

- Women diagnosed with a GCK mutation before pregnancy

- Aged = 18 years old

- Pre-gestational BMI < 30kg/m²

- Term of pregnancy < 14 WG , if delay overdue, to be validated by investigators

- Written informed consent

Exclusion Criteria:

- Twin pregnancy

- Not able to understand and sign written informed consent

- Not affiliated to the French Social Security

Age minimum: 18 Years
Age maximum: N/A
Gender: Female

Health Condition(s) or Problem(s) studied

Maturity-Onset Diabetes of the Young

Intervention(s)

Other: insulin therapy

Primary Outcome(s)

Birth weight for gestational age [Time Frame: at birth]

Secondary Outcome(s)

Mean blood glucose levels [Time Frame: before and 2 hours post prandial over one week, at weeks 36-38 of pregnancy]

Number of pregnancy induced hypertension [Time Frame: at delivery]

Fructosamine level [Time Frame: monthly during pregnancy]

Number of injections [Time Frame: at 38 weeks of pregnancy]

Number of preeclampsia [Time Frame: at delivery]

Term of insulin therapy [Time Frame: at 38 weeks of pregnancy]

HbA1c level [Time Frame: pre-gestational and monthly during pregnancy]

Mean blood glucose levels [Time Frame: before and 2 hours post prandial over one week, at weeks 25-27 of pregnancy]

Neonatal leptin level [Time Frame: at birth]

Quality of Life (SF-36 questionary) [Time Frame: at delivery]

Mean blood glucose levels [Time Frame: before and 2 hours post prandial over one week, before pregnancy]

Number of fetal and neonatal complications [Time Frame: at birth]

Number of units/kg.day of insulin [Time Frame: over one week at weeks 14/16, 25/27 and 36/38]

Anxiety score (short form of the Spielberger State - Trait Anxiety Inventory [Time Frame: at delivery]

Composite obstetrical outcome [Time Frame: at birth]

depression (Edinburgh Postnatal Depression Scale. [Time Frame: at delivery]

Mean blood glucose levels [Time Frame: before and 2 hours post prandial over one week, at weeks 14-16 of pregnancy]

Post-prandial hyperglycaemic peak (level and delay) [Time Frame: at 22 weeks of pregnancy]

Post-prandial hyperglycaemic peak (level and delay) [Time Frame: at 32 weeks of pregnancy]

Number of hyperinsulinemia [Time Frame: at birth]

Number of medical appointments [Time Frame: at delivery]

Number of women requiring insulin treatment [Time Frame: at 38 weeks of pregnancy]

Type of insulin [Time Frame: at 38 weeks of pregnancy]

Duration of hospital stay [Time Frame: at delivery]

Weight gain during pregnancy [Time Frame: at 38 weeks of pregnancy]

Number of neonatal hypoglycaemia [Time Frame: at birth]

Secondary ID(s)

2015-A00261-48

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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