Systemic sclerosis & Raynaud's

Fetal and maternal outcome in the pregnancies of patients with systemic sclerosis and very early diagnosis of systemic sclerosis in France: a prospective study

Lancet RheumatolPublished Prospective cohort study

Authors' conclusion

Despite 53 (91.4%) of 58 livebirths, systemic sclerosis pregnancies were associated with higher rates of adverse pregnancy outcomes and severe postpartum haemorrhage.

Study context

Population
Pregnant women with SSc or VEDOSS in the GR2 French prospective study, 2014–202058 pregnancies in 52 women
Participants
58 vs 530
Exposure
SSc or VEDOSS pregnancies vs age-matched controls from the French perinatal survey (ENP) 2016
  • SSc/VEDOSSn = 58
  • ENP 2016n = 530reference
Outcome
Frequency of composite adverse pregnancy outcomes (preterm birth ≤34 weeks, placental insufficiency complications, small for gestational age, or fetal or neonatal death) and maternal disease course
Methodological detailsmulticentre, comparison with age-matched controls from ENP 2016
  • Multicentre
  • Comparison with age-matched controls from ENP 2016

Main finding

As reported in the abstract

Co-primary: composite adverse pregnancy outcome (preterm birth ≤34 weeks, placental insufficiency complications, small for gestational age, or fetal or neonatal death) and maternal disease course

Composite adverse pregnancy outcome: 14 of 53 ongoing pregnancies beyond 22 weeks

26.4%

SSc or VEDOSS worsened, mainly postpartum: 23 of 58 pregnancies

39.7%

Observational data: associations, not effects.

Secondary outcomes

Livebirths: 53 of 58 pregnancies

Livebirths: 53 of 58 pregnancies
91.4%

Components of composite adverse pregnancy outcome (of 53 ongoing pregnancies)

Preterm deliveries at ≤34 weeks: 2 of 53
3.8%
Placental insufficiency complications (pre-eclampsia or fetal growth restriction): 12 of 53
22.6%
Small for gestational age: 6 of 53
11.3%

Severe postpartum haemorrhage: 6 of 53 pregnancies

Severe postpartum haemorrhage: 6 of 53 pregnancies
11.3%

Outcomes vs age-matched controls from the 2016 ENP survey (general population)

Pre-eclampsia: 7 [13.2%] of 53 vs 16 [3.0%] of 530
P = 0.0010
Preterm birth before 37 weeks: 7 [13.2%] of 53 vs 31 [5.8%] of 530
P = 0.047
Birthweight <2500 g: 11 [21.1%] of 52 vs 23 [4.3%] of 530
P < 0.0001
Severe postpartum haemorrhage: 6 [11.3%] of 53 vs 7 [1.4%] of 516
P = 0.0001
  • More frequent than in the general population

Predictors of composite adverse pregnancy outcome (univariate)

No factors significantly associated with the composite adverse pregnancy outcome

Predictors of maternal disease progression (univariate)

dcSSc, OR
3.7 (95% CI 1.1-12.4)
Previous cutaneous vascular involvement, OR
3.7 (95% CI 1.2-11.5)
Anticentromere antibodies, inversely associated with stable disease, OR
0.2 (95% CI 0.1-0.8)

Safety

Severe postpartum haemorrhage vs general population

P = 0.0001

  • Severe postpartum haemorrhage vs general population: ENP denominator 516

Original publication

Fetal and maternal outcome in the pregnancies of patients with systemic sclerosis and very early diagnosis of systemic sclerosis in France: a prospective study. Lancet Rheumatol. Published 28 October 2025. doi:10.1016/s2665-9913(25)00185-7

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