Fetal Movement Counting in Prolonged Pregnancies: The COMPTAMAF Prospective Randomized Trial.
Louise MoniodAgathe HovineBéatrice TrombertFlorence RanconPaul ZuffereyLaura ChauveauCéline ChauleurTiphaine Raia-BarjatPublished in: Healthcare (Basel, Switzerland) (2022)
In prolonged pregnancies, the risks of neonatal morbidity and mortality are increased. The aim of this trial was to assess the benefits of maternal information about fetal movement (FM) counting on neonatal outcomes in prolonged pregnancy. It was a prospective, single center, randomized, open-label study conducted from October 2019 to March 2022. Intention-to-treat analyses were performed on 278 patients randomized into two 1:1 groups (control group and FM counting group). The primary outcome was a composite score of neonatal morbidity (presence of two of the following items: fetal heart rate abnormality at delivery, Apgar score of <7 at 5 min, umbilical cord arterial pH of <7.20, and acute respiratory distress with mutation in neonatal intensive care unit). There was no significant difference between the two groups in the rate of neonatal morbidity (14.0% in the FM counting group versus 22.9% in the standard information group; p = 0.063; OR 0.55, 95% CI 0.29-1.0). In this study, fetal movement counting for women in prolonged pregnancy failed to demonstrate a significant reduction in adverse neonatal outcomes.
Keyphrases
- open label
- pregnancy outcomes
- heart rate
- phase iii
- preterm birth
- phase ii
- umbilical cord
- clinical trial
- end stage renal disease
- mesenchymal stem cells
- double blind
- heart rate variability
- pregnant women
- study protocol
- ejection fraction
- newly diagnosed
- chronic kidney disease
- emergency department
- gestational age
- squamous cell carcinoma
- peritoneal dialysis
- prognostic factors
- preterm infants
- type diabetes
- bone marrow
- metabolic syndrome
- insulin resistance
- birth weight
- intensive care unit
- climate change
- radiation therapy
- drug induced
- patient reported outcomes
- acute respiratory distress syndrome
- skeletal muscle
- rectal cancer
- human health