Managing Reduced Fetal Movements After 36 Weeks Gestation
Managing Reduced Fetal Movements After 36 Weeks Gestation
One hundred and thirty seven women were approached to participate in the study between December 2011 and August 2012 (Figure 1). One hundred and twenty (87.5%) agreed and 60 were randomised to each arm. Women who chose not to participate in the study had similar demographic characteristics to participants except for a higher proportion of women of Black African ethnicity in non-participants (Table 1). However, women participating in this study had similar demographic characteristics to the whole unit population. This was also the case in a previous cohort study carried out in the same institution. Two patients (1.7%) withdrew from the study, both of whom were in the standard treatment arm; these women cited pressure from partners not to participate as motivating their decision to withdraw from the study.
(Enlarge Image)
Figure 1.
Flow diagram of the trial process.
There was no difference in the anxiety score before investigations between women assigned to the control or intensive management groups (Figure 2A). Women in both groups experienced a reduction in state anxiety after investigations (Figure 2B); this reduction in state anxiety was greater in women in the control group (Figure 2C). This may either be a chance finding or could be attributed to the increased detection of abnormalities requiring intervention in the intensive management group. Eighty-three participants (69%) responded to the end of study questionnaire given after the birth of their child; 44 (53%) of respondents received standard care and 39 (47%) of respondents received intensive management. All participants felt that the time at which they were approached to participate was acceptable (Table 2); 99% and 98% of participants felt they had sufficient information and time to make a decision to participate respectively. All patients understood the patient information and consent form. The majority of participants did not mind which group they were assigned to, although 6 (7%) expressed a clear preference to enter the intervention arm. Eighty-one (98%) participants felt that the number of tests to establish fetal wellbeing was satisfactory; the remaining two participants would have liked more tests, these participants were both in the standard management group. Seventy-seven (93%) of respondents felt the results were given in a timely manner. Overall, 98% of participants would recommend the study to a friend whose baby was moving less.
(Enlarge Image)
Figure 2.
State-trait anxiety scores for participants (n = 120). A) There was no difference in the trait score between participants randomised to the control or intensive management protocol. B) Maternal state anxiety was significantly reduced in both control and intensive management groups after completion of the investigations (** p < 0.01). C) The reduction in state anxiety was greatest in the women in the control group (* p < 0.05).
All patients in the intensive management arm had an ultrasound assessment of fetal growth, liquor volume and umbilical artery Doppler as compared to 97% in the control group. All women in the intensive group had hPL measured in maternal serum compared to no patients in the control group (Table 3). Ultrasound scans showed reduced fetal growth, oligohydramnios or abnormal umbilical artery Doppler in 14% of cases, 20% of the intensive group and 8% of the control group; as randomisation occurred before the ultrasound scan was performed this discrepancy must be due to chance. hPL was <0.8 MoM in 30% of women in the intensive management group. Overall, the frequency of induction of labour (IOL) was no different between groups (Table 3); 59% in control compared to 62% in intensive management group. However, the proportion of women being induced for RFM was higher in the intensive management group 50% vs. 26%. In the control group the majority of IOL were for prolonged rupture of membranes or prolonged pregnancy. There was no difference in gestational age at presentation or at delivery. There was no increase in instrumental or Caesarean birth rates. Perinatal outcomes are shown in Table 4. Overall, 20% of women had a poor perinatal outcome, with the most frequent outcome being birthweight <10 centile; there were no stillbirths in either group. Although the study was not powered to detect differences in outcomes, and no formal hypothesis tests were planned; there were fewer poor perinatal outcomes in the intensive management group. It is interesting that the increased number of abnormalities on the ultrasound scan observed in the intensive group did not translate into increased poor pregnancy outcomes.
Eight consultant obstetricians and seven experienced midwives from the maternity day unit, maternity triage and delivery unit responded to the staff questionnaire (Table 5). Fourteen staff (93%) were confident in which investigations to use and 87% confident when to expedite delivery when caring for women with RFM. However, only 33% felt that care of women with RFM is currently based on grade 1/2 evidence. All staff were aware that the study had taken place, 87% were aware that women in their care had participated in the study and 73% were aware of the recommended management plan. Ten (67%) of professionals felt that results were given in a timely manner, 60% felt that the results of the investigations for patients in the intensive group altered their management with 27% perceiving an increase in labour interventions. Twenty percent of professionals felt that the study increased workload to the antenatal service, but the majority (47%) disagreed with this statement. All professionals would offer participation in this trial to a woman presenting with RFM.
Results
Participant Recruitment and Retention
One hundred and thirty seven women were approached to participate in the study between December 2011 and August 2012 (Figure 1). One hundred and twenty (87.5%) agreed and 60 were randomised to each arm. Women who chose not to participate in the study had similar demographic characteristics to participants except for a higher proportion of women of Black African ethnicity in non-participants (Table 1). However, women participating in this study had similar demographic characteristics to the whole unit population. This was also the case in a previous cohort study carried out in the same institution. Two patients (1.7%) withdrew from the study, both of whom were in the standard treatment arm; these women cited pressure from partners not to participate as motivating their decision to withdraw from the study.
(Enlarge Image)
Figure 1.
Flow diagram of the trial process.
Participant Acceptability
There was no difference in the anxiety score before investigations between women assigned to the control or intensive management groups (Figure 2A). Women in both groups experienced a reduction in state anxiety after investigations (Figure 2B); this reduction in state anxiety was greater in women in the control group (Figure 2C). This may either be a chance finding or could be attributed to the increased detection of abnormalities requiring intervention in the intensive management group. Eighty-three participants (69%) responded to the end of study questionnaire given after the birth of their child; 44 (53%) of respondents received standard care and 39 (47%) of respondents received intensive management. All participants felt that the time at which they were approached to participate was acceptable (Table 2); 99% and 98% of participants felt they had sufficient information and time to make a decision to participate respectively. All patients understood the patient information and consent form. The majority of participants did not mind which group they were assigned to, although 6 (7%) expressed a clear preference to enter the intervention arm. Eighty-one (98%) participants felt that the number of tests to establish fetal wellbeing was satisfactory; the remaining two participants would have liked more tests, these participants were both in the standard management group. Seventy-seven (93%) of respondents felt the results were given in a timely manner. Overall, 98% of participants would recommend the study to a friend whose baby was moving less.
(Enlarge Image)
Figure 2.
State-trait anxiety scores for participants (n = 120). A) There was no difference in the trait score between participants randomised to the control or intensive management protocol. B) Maternal state anxiety was significantly reduced in both control and intensive management groups after completion of the investigations (** p < 0.01). C) The reduction in state anxiety was greatest in the women in the control group (* p < 0.05).
Protocol Adherence and Professionals' Views
All patients in the intensive management arm had an ultrasound assessment of fetal growth, liquor volume and umbilical artery Doppler as compared to 97% in the control group. All women in the intensive group had hPL measured in maternal serum compared to no patients in the control group (Table 3). Ultrasound scans showed reduced fetal growth, oligohydramnios or abnormal umbilical artery Doppler in 14% of cases, 20% of the intensive group and 8% of the control group; as randomisation occurred before the ultrasound scan was performed this discrepancy must be due to chance. hPL was <0.8 MoM in 30% of women in the intensive management group. Overall, the frequency of induction of labour (IOL) was no different between groups (Table 3); 59% in control compared to 62% in intensive management group. However, the proportion of women being induced for RFM was higher in the intensive management group 50% vs. 26%. In the control group the majority of IOL were for prolonged rupture of membranes or prolonged pregnancy. There was no difference in gestational age at presentation or at delivery. There was no increase in instrumental or Caesarean birth rates. Perinatal outcomes are shown in Table 4. Overall, 20% of women had a poor perinatal outcome, with the most frequent outcome being birthweight <10 centile; there were no stillbirths in either group. Although the study was not powered to detect differences in outcomes, and no formal hypothesis tests were planned; there were fewer poor perinatal outcomes in the intensive management group. It is interesting that the increased number of abnormalities on the ultrasound scan observed in the intensive group did not translate into increased poor pregnancy outcomes.
Eight consultant obstetricians and seven experienced midwives from the maternity day unit, maternity triage and delivery unit responded to the staff questionnaire (Table 5). Fourteen staff (93%) were confident in which investigations to use and 87% confident when to expedite delivery when caring for women with RFM. However, only 33% felt that care of women with RFM is currently based on grade 1/2 evidence. All staff were aware that the study had taken place, 87% were aware that women in their care had participated in the study and 73% were aware of the recommended management plan. Ten (67%) of professionals felt that results were given in a timely manner, 60% felt that the results of the investigations for patients in the intensive group altered their management with 27% perceiving an increase in labour interventions. Twenty percent of professionals felt that the study increased workload to the antenatal service, but the majority (47%) disagreed with this statement. All professionals would offer participation in this trial to a woman presenting with RFM.