The Impact of Oral Intake of

Dydrogesterone on Fetal Heart

Development During
Early Pregnancy
Zaqout M, Aslem E, Abuqamar M, et al.
Pediatr Cardiol 2015; DOI 10.1007/s00246-015-1190-9

O CH3 Dydrogesterone: A steroidal progestin, used to prevent early

CH3 miscarriage and preterm labour during pregnancy
CH3 H Structure of dydrogesterone reproduced from www.chemspider.com (Royal Society of Chemistry)

H H
O

Study objective To determine whether oral intake of dydrogesterone during

early phase of pregnancy affects fetal heart development  
Study design A case-controlled, retrospective study 

Data collection Statistical

Study subjects – Place: Gaza Strip,
Children born Palestine
analysis
Cases Analysis using
with CHD (case) 202 Duration: June to
SPSS - (a) Bivariate
and those born children December 2013
Chi-square test to
without CHD with CHD Questionnaire:
identify significant
(control) pregnancy and
associations,
Inclusion criteria: family history, use
(b) Univariate
gross structural of medication
Controls analysis of each
abnormalities during pregnancy
200 risk factor
of the heart or Risk factors
children (c) Multivariate
intrathoracic great identified: maternal
without analysis of the
vessels. Mean age of age, family history of
CHD risk factors in
children included in CHD, consanguinity,
comparison to the
the study was exposure to
control group
13 months dydrogesterone
(d) Calculation of
during early
OR and 95% CI
pregnancy
CHD- Congenital heart disease; CI- Confidence intervals; OR- Odds Ratio; SPSS- Statistical Package for the Social Sciences
Statistical software version: IBM—SPSS Statistics v20.0, Inc. Chicago, IL
Adapted from Mahmoud Zaqout et al. Pediatr Cardiol 2015
The Impact of Oral Intake of Dydrogesterone on Fetal Heart
Development During Early Pregnancy
Key Results
Frequency and univariate analysis of risk factors associated with CHD
Adapted from Mahmoud Zaqout et al. Pediatr Cardiol 2015

100 Case (n=202)

93.5 94
90.1 Control (n=200)
90 87.1
Percentage of risk factors associated with

82
80

70 64 62.9
occurence of CHD

59.4
60

50

40 37.1

30 26.7 28

20 18
13.9
10.4
10 8 6
2.5 2.0 4.5 4 5.5
0.5
0
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ye

ye

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No

Family history of CHD Consanguinity Maternal age Dydrogesterone exposure

P=0.069 P=0.153 P=0.094 P=0.001*
Risk factors

Significantly more mothers with Multivariate analysis of risk factors associated

CHD-affected children were exposed to with CHD (adjusted OR*)
dydrogesterone during the first trimester of Adapted from Mahmoud Zaqout et al. Pediatr Cardiol 2015

pregnancy compared with controls (37% vs 18% Progesterone

P=0.001*
respectively; P= 0.001) exposure

First degree family

By bivariate analysis, only dydrogesterone had been history of CHD
P=0.747
found to be a significant risk factor for congenital
Second degree
heart disease (P = 0.001). There was a trend of a family history P=0.024*
positive family history of CHD and the occurrence of CHD

CHD, but it did not reach statistical significance Gravida P=0.411

(P=0.069)
Maternal age
After controlling for other risk factors (family P=0.149
(20–35 years)
history of CHD, consanguinity, numbers of gravida
First degree
and maternal age) in the second logistic model, consanguinity
P=0.060
dydrogesterone exposure was significantly linked to
the occurrence of CHD (OR* 2.71, CI 1.64–4.24) Second degree
P=0.776
consanguinity
0.00 3.00 6.00
Second-degree family history of CHD also remained
CHD- Congenital heart disease; CI- Confidence intervals; OR- Odds Ratio
significant (OR 2.42, CI 1.04–5.59). According to Adjusted OR: Separately, each variable was adjusted for family history, consanguinity,
the odds ratio, dydrogesterone had the strongest mother’s age and dydrogesterone treatment.
Adjusted OR*: All variables were entered in one model with adjustment for family
correlation to the occurrence CHD followed by history, consanguinity, mother’s age and dydrogesterone treatment
second-degree family history of CHD Adapted from Zaqout M, et al. Pediatr Cardiol 2015.

Conclusion “The main finding of this study is the increased incidence of

dydrogesterone usage during first trimester of pregnancy in
the group affected by CHD”