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Randomized Controlled Trial
. 2011 Nov;20(9):1427-36.
doi: 10.1007/s11136-011-9891-x. Epub 2011 Apr 6.

Maternal health-related quality of life after induction of labor or expectant monitoring in pregnancy complicated by intrauterine growth retardation beyond 36 weeks

Affiliations
Randomized Controlled Trial

Maternal health-related quality of life after induction of labor or expectant monitoring in pregnancy complicated by intrauterine growth retardation beyond 36 weeks

Denise Bijlenga et al. Qual Life Res. 2011 Nov.

Abstract

Objective: Pregnancies complicated by intrauterine growth retardation (IUGR) beyond 36 weeks of gestation are at increased risk of neonatal morbidity and mortality. Optimal treatment in IUGR at term is highly debated. Results from the multicenter DIGITAT (Disproportionate Intrauterine Growth Intervention Trial At Term) trial show that induction of labor and expectant monitoring result in equal neonatal and maternal outcomes for comparable cesarean section rates. We report the maternal health-related quality of life (HR-QoL) that was measured alongside the trial at several points in time.

Methods: Both randomized and non-randomized women were asked to participate in the HR-QoL study. Women were asked to fill out written validated questionnaires, covering background characteristics, condition-specific issues and the Short Form (SF-36), European Quality of Life (EuroQoL 6D3L), Hospital Anxiety and Depression scale (HADS), and Symptom Check List (SCL-90) at baseline, 6 weeks postpartum and 6 months postpartum. We compared the difference scores of all summary measures between the two management strategies by ANOVA. A repeated measures multivariate mixed model was defined to assess the effect of the management strategies on the physical (PCS) and mental (MCS) components of the SF-36. Analysis was by intention to treat.

Results: We analyzed data of 361 randomized and 198 non-randomized patients. There were no clinically relevant differences between the treatments at 6 weeks or 6 months postpartum on any summary measures; e.g., on the SF-36 (PCS: P = .09; MCS: P = .48). The PCS and the MCS were below norm values at inclusion. The PCS improved over time but stayed below norm values at 6 months, while the MCS did not improve.

Conclusion: In pregnancies complicated by IUGR beyond 36 weeks, induction of labor does not affect the long-term maternal quality of life.

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Figures

Fig. 1
Fig. 1
Flowchart. HR-QoL health-related quality of life, RTC randomized controlled trial, P treatment following protocol
Fig. 2
Fig. 2
In retrospect self-reported pain at days 1, 4, and 7 after delivery between the randomized induction of labor and expectant management group
Fig. 3
Fig. 3
Error bars with 95% confidence interval (CI) of the randomized groups for induction of labor or expectant monitoring on the PCS and MCS at inclusion, at 6 weeks postpartum, and at 6 months postpartum. The horizontal lines indicate mean Dutch population norm scores (solid line) and US population norm scores for women aged 25–34

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