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Table 1 Design characteristics of observational studies of glycated haemoglobin and pregnancy outcomes.

From: Poor glycated haemoglobin control and adverse pregnancy outcomes in type 1 and type 2 diabetes mellitus: Systematic review of observational studies

Author

Country

Study Design

Time Period

Sample size (n)

Glycaemic Control Groupings (n) (HbA 1c unless stated)

Timing of Glycaemic Control Measurement

Outcomes (n)

Vaarasmaki et al, 2000 [26]

Finland

Cohort

1986–1995

84

Optimal < 8.0% (n = 48)

Poor > 8.0% (n = 36)

First antenatal visit 20 and 28th week Before delivery

Malformations (n = 4)

Caesarean section (n = 34)

Stillbirth (n = 1)

NICU (n = 39)

Neonatal hypoglycaemia(n = 11)

RDS (n = 5)

Greene et al, 1989 [23]

US

Cohort

Dec.5th 1983–Dec.31st 1987

303

Optimal ≤ 9.3% (n = 113)

Poor ≥ 9.4% (n = 190)

(Data based on HbA1)

1st trimester

Malformations (n = 20)

Spontaneous abortion (n = 52)

Evers et al, 2004 [16]

Netherlands

Cohort

April 1st 1999 – April 1st 2000

261

Optimal ≤ 7.0% (n = 212)

Poor ≥ 7.0% (n = 71)

1st trimester

Malformations (n = 29)

Key et al, 1987 [19].

US

Cohort

Jan.1st 1979 – Dec.31st 1984

83

Optimal <7.5% (n = 8)

Poor ≥ 7.5% (n = 75)

1st trimester

Malformations (n = 9)

Spontaneous abortion (n = 22)

Temple et al, 2002 [7]

UK

Cohort

Jan. 1991–Dec. 2000

158

Optimal < 7.5% (n = 110)

Poor ≥ 7.5% (n = 48)

1st trimester booking

Malformations (n = 5)

Stillbirth (n = 2)

Spontaneous abortion (n = 11)

Neonatal death (n = 2)

Kitzmiller et al, 1991 [22]

USA

Cohort

1982–1988

194

Optimal ≤ 7.6% (n = 53)

Poor > 7.6% (n = 141)

1st trimester booking visit

Malformations (n = 13)

Ylinen et al, 1984 [21]

Finland

Cohort

April 1978–Dec. 1982

142

Optimal ≤ 7.9% (n = 63)

Poor >7.9% (n = 79)

Before 16 weeks gestation

Malformations (n = 17)

CEMACH, 2005 [25]

England, Wales & Northern Ireland

Descriptive Cohort

March 1st 2002–Feb 28th 2003

2459

Optimal < 7% (n = 962)

Poor ≥ 7% (n = 1497)

1st trimester

Malformations (n = 101)

Stillbirths or neonatal deaths (n = 67)

Hiilesmaa et al, 2000 [17]

Finland

Case-Control

1988 – 1997

587

Optimal ≤ 6.8% (n = 195)

Poor > 6.8% (n = 392)

Early pregnancy

Pre-eclampsia (n = 77)

PIH (n = 65)

Hanson et al, 1990 [24]

Sweden

Case-Control

1982–1985

532

Optimal < 10.1% (n = 490)

Poor ≥ 10.1% (n = 42)

1st trimester

Spontaneous abortion (n = 41)

Malformation (n = 21)

Diabetes and Pregnancy Group, France 2003 [15]

France

Cross-sectional

Jan. 2000 – Dec. 2001

435

Optimal < 8.0% (n = 315)

Poor > 8.0% (n = 120)

1st trimester

Malformations (n = 18)

Perinatal mortality (n = 19)

Preterm delivery (n = 147)

Miller et al, 1981 [18]

US

Case-series

April 1977 – April 1980

116

Optimal ≤ 8.5% (n = 58)

Poor ≥ 8.6% (n = 58)

Initial value

Malformations (n = 15)

Wender-Ozegowska et al, 2005 [20]

Poland

Case-Series

1st Jan. 1994–31st Jan. 1999

126

Optimal ≤ 5.6% (n = 43)

Poor > 5.6% (n = 83)

1st trimester

Malformations (n = 14)