Abstract
Background
Reduced fetal movements are sometimes indicative of placental dysfunction with an increased risk of adverse perinatal outcomes. Routine assessment in term pregnancies often does not detect placental dysfunction, especially in non-small-for-gestational-age (non-SGA) fetuses. The aim of this study was to assess whether expedited birth, indicated by a low cerebroplacental ratio, or expectant management, in case of a normal cerebroplacental ratio, improved perinatal outcomes in women with reduced fetal movements at term.
Methods
We conducted a multicentre, cluster-randomised controlled trial at 22 Dutch hospitals and one Australian hospital. Women with singleton pregnancies in cephalic position presenting with perceived reduced fetal movements at term were eligible to participate if estimated fetal weight was above the 10th percentile and there were no reasons for expedited birth within 4 days. Hospitals (clusters) were randomly assigned in a 1:1 ratio to either cerebroplacental ratio-based management (revealed group) or care as usual (concealed group). Randomisation was done using a computer-generated algorithm, stratified by country and expected number of women recruited (<65 considered low vs ≥65 considered high). Women receiving care at a hospital assigned to the revealed group received cerebroplacental ratio-based management (ie, expedited birth in the case of cerebroplacental ratio <1·1 or expectant management if cerebroplacental ratio ≥1·1), whereas those receiving care at a hospital assigned to the concealed group had care as usual depending on local hospital protocol. In the concealed group, cerebroplacental ratio was not revealed to the obstetric caregivers. The primary outcome was a composite of adverse perinatal outcomes—stillbirth, neonatal mortality (<28 days), 5-min Apgar score less than 7, umbilical artery pH less than 7·10, and emergency birth for fetal distress or severe neonatal morbidity—and was analysed by intention to treat. The study was registered at the Dutch trial registry (NTR 7557/NL-OMON22934) and ISRCTN (1732969); the study is now closed.
Findings
Between July 1, 2020 and Sept 3, 2024, 1815 women participated in the trial (910 women from ten hospitals in the revealed group and 905 women from 12 hospitals in the concealed group), of whom 1684 were included in the modified intention-to-treat analysis. The primary outcome occurred in 99 (12%) of 853 women who received cerebroplacental ratio-based management versus 127 (15%) of 831 women who received care as usual (relative risk 0·76; 95% CI 0·58–0·99). No stillbirths were recorded; one neonatal death occurred in each group. 12 serious adverse events were reported in the revealed group and 14 in the concealed group, none of which was assessed to be related to the study procedure by the local principal investigator and the medical ethics board of University Medical Centre Groningen and the data safety monitoring board.
Interpretation
Our study findings show that, for women who perceived reduced fetal movements at term in non-SGA fetuses, cerebroplacental ratio-based management reduced adverse perinatal outcomes. This study supports the use of the cerebroplacental ratio for the identification of fetuses that might benefit from expedited birth or expectant management.
Funding
ZorgOnderzoek Nederland/Medische Wetenschappen (ZonMW) and Cycling for Frederik.
Introduction
Maternal perception of reduced fetal movements occurs in up to 15% of pregnancies.1 The relevance of this subjective symptom is that reduced fetal movements can be indicative of fetal compromise preceding in-utero demise due to placental dysfunction, but in the majority of cases the cause is benign. Placental dysfunction results in reduced transfer of oxygen and nutrients to the fetus2–4 and is mostly clinically recognised as fetal growth restriction and predominantly studied in small-for-gestational-age (SGA) fetuses. Regardless of the cause, reduced fetal movements are associated with a 2·4–5-fold increase in stillbirth and other adverse outcomes such as asphyxia and neurodevelopmental impairment in the offspring.
Reduced fetal movements are sometimes indicative of placental dysfunction with an increased risk of adverse perinatal outcomes. Routine assessment in term pregnancies often does not detect placental dysfunction, especially in non-small-for-gestational-age (non-SGA) fetuses. The aim of this study was to assess whether expedited birth, indicated by a low cerebroplacental ratio, or expectant management, in case of a normal cerebroplacental ratio, improved perinatal outcomes in women with reduced fetal movements at term.
Methods
We conducted a multicentre, cluster-randomised controlled trial at 22 Dutch hospitals and one Australian hospital. Women with singleton pregnancies in cephalic position presenting with perceived reduced fetal movements at term were eligible to participate if estimated fetal weight was above the 10th percentile and there were no reasons for expedited birth within 4 days. Hospitals (clusters) were randomly assigned in a 1:1 ratio to either cerebroplacental ratio-based management (revealed group) or care as usual (concealed group). Randomisation was done using a computer-generated algorithm, stratified by country and expected number of women recruited (<65 considered low vs ≥65 considered high). Women receiving care at a hospital assigned to the revealed group received cerebroplacental ratio-based management (ie, expedited birth in the case of cerebroplacental ratio <1·1 or expectant management if cerebroplacental ratio ≥1·1), whereas those receiving care at a hospital assigned to the concealed group had care as usual depending on local hospital protocol. In the concealed group, cerebroplacental ratio was not revealed to the obstetric caregivers. The primary outcome was a composite of adverse perinatal outcomes—stillbirth, neonatal mortality (<28 days), 5-min Apgar score less than 7, umbilical artery pH less than 7·10, and emergency birth for fetal distress or severe neonatal morbidity—and was analysed by intention to treat. The study was registered at the Dutch trial registry (NTR 7557/NL-OMON22934) and ISRCTN (1732969); the study is now closed.
Findings
Between July 1, 2020 and Sept 3, 2024, 1815 women participated in the trial (910 women from ten hospitals in the revealed group and 905 women from 12 hospitals in the concealed group), of whom 1684 were included in the modified intention-to-treat analysis. The primary outcome occurred in 99 (12%) of 853 women who received cerebroplacental ratio-based management versus 127 (15%) of 831 women who received care as usual (relative risk 0·76; 95% CI 0·58–0·99). No stillbirths were recorded; one neonatal death occurred in each group. 12 serious adverse events were reported in the revealed group and 14 in the concealed group, none of which was assessed to be related to the study procedure by the local principal investigator and the medical ethics board of University Medical Centre Groningen and the data safety monitoring board.
Interpretation
Our study findings show that, for women who perceived reduced fetal movements at term in non-SGA fetuses, cerebroplacental ratio-based management reduced adverse perinatal outcomes. This study supports the use of the cerebroplacental ratio for the identification of fetuses that might benefit from expedited birth or expectant management.
Funding
ZorgOnderzoek Nederland/Medische Wetenschappen (ZonMW) and Cycling for Frederik.
Introduction
Maternal perception of reduced fetal movements occurs in up to 15% of pregnancies.1 The relevance of this subjective symptom is that reduced fetal movements can be indicative of fetal compromise preceding in-utero demise due to placental dysfunction, but in the majority of cases the cause is benign. Placental dysfunction results in reduced transfer of oxygen and nutrients to the fetus2–4 and is mostly clinically recognised as fetal growth restriction and predominantly studied in small-for-gestational-age (SGA) fetuses. Regardless of the cause, reduced fetal movements are associated with a 2·4–5-fold increase in stillbirth and other adverse outcomes such as asphyxia and neurodevelopmental impairment in the offspring.
| Original language | English |
|---|---|
| Article number | 100002 |
| Number of pages | 9 |
| Journal | The Lancet Obstetrics, Gynaecology, & Women's Health |
| DOIs | |
| Publication status | E-pub ahead of print - 10-Jul-2025 |