nderstanding the impact of metformin on maternal health and fetal growth in pregnancies complicated by maternal diabetes

Phase 3

Conditions: Diabetes in pregnancy
Pregnancy and Childbirth

Registration Number: ISRCTN13866189

Lead Sponsor: niversity of Manchester

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Ongoing

Sex: Female

Target Recruitment: 225

Inclusion Criteria

1. Singleton pregnancy between 6+0 and 30+0 weeks’ gestation inclusive
2. Aged 18 years or over and willing and able to give informed consent
3. Diagnosis of diabetes in pregnancy
3.1. Type 2 diabetes diagnosed before pregnancy and requiring pharmacological treatment
OR
3.2. Type 2/GDM diagnosed <24 weeks’ gestation: abnormal glucose tolerance test, abnormal HBGM and/or HbA1C =42mmol/L
OR
3.3. GDM (diagnosed 24-30 weeks): HbA1C =39mmol/L and/or abnormal glucose tolerance test
4. Abnormal HBGMb (=30 weeks)
5. Presence of at least one risk factor for placental disease
5.1. BP =130 and/or =80mmHg (clinic blood pressure)
5.2. Pulse wave velocity = 9m/s
5.3. Age =35 years
5.4. Nulliparous
5.5. Pre-eclampsia and/or small for gestational age (<10th centile) in a prior pregnancy
5.6. Mean uterine artery PI =95th centile
5.7. Placental growth factor <10th centile
6. EFW =50th centile (if =22 weeks)

Exclusion Criteria

1. Medical contraindication to metformin
2. Known diagnosis of Type 1 diabetes
3. Multifetal pregnancy
4. Prior pregnancy complicated by shoulder dystocia

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Third trimester fetal growth velocity will be assessed by change in fetal growth zscore between 20-26 weeks (average) and birth. <br>(At each scan the estimated fetal weight (EFW) will be calculated using standard 2D biometry and fractional thigh volume (TVol) measurements using a standard formula and converted to a zscore (WHO). The delta change in zscore between the average zscore of scans performed between 20-26 weeks and the birthweight zscore will be calculated. In order to verify the primary outcome, the eCRF will capture the TVol measurement and the EFW at each scan as well as recording the 2nd trimester and 3rd trimester deviation scores. The source data (scan report) will verify the 2D biometry.)

Secondary Outcome Measures