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Although remote monitoring (RM) has proven its added value in various health care domains, little is known about the remote follow-up of pregnant women diagnosed with a gestational hypertensive disorders (GHD).
The aim of this study was to evaluate the added value of a remote follow-up program for pregnant women diagnosed with GHD.
A 1-year retrospective study was performed in the outpatient clinic of a 2nd level prenatal center where pregnant women with GHD received RM or conventional care (CC). Primary study endpoints include number of prenatal visits and admissions to the prenatal observation ward. Secondary outcomes include gestational outcome, mode of delivery, neonatal outcome, and admission to neonatal intensive care (NIC). Differences in continuous and categorical variables in maternal demographics and characteristics were tested using Unpaired Student’s two sampled
Of the 166 patients diagnosed with GHD, 53 received RM and 113 CC. After excluding 5 patients in the RM group and 15 in the CC group because of the missing data, 48 patients in RM group and 98 in CC group were taken into final analysis. The RM group had more women diagnosed with gestational hypertension, but less with preeclampsia when compared with CC (81.25% vs 42.86% and 14.58% vs 43.87%). Compared with CC, univariate analysis in RM showed less induction, more spontaneous labors, and less maternal and neonatal hospitalizations (48.98% vs 25.00%; 31.63% vs 60.42%; 74.49% vs 56.25%; and 27.55% vs 10.42%). This was also true in multivariate analysis, except for hospitalizations.
An RM follow-up of women with GHD is a promising tool in the prenatal care. It opens the perspectives to reverse the current evolution of antenatal interventions leading to more interventions and as such to ever increasing medicalized antenatal care.
Gestational hypertensive disorders (GHD) remain one of the most significant and intriguing unsolved problems in obstetrics [
As part of the Hasselt University and the Limburg Clinical Research Program (LCRP), Ziekenhuis Oost-Limburg (Genk, Belgium) initiated in January 2015 a remote monitoring (RM) program for women with or at risk for GHD. RM is an alternative approach in medical management (dating back to the early 1990s) facilitating patients’ management at home [
In this paper, we report our first clinical results of RM in GHD, obtained retrospectively during the year of technical installation of remote communication between hospital doctors or midwives and pregnant women at home.
RM has already shown benefits in Cardiology and Pneumology [
All women diagnosed with GHD who delivered at the outpatient prenatal clinic of Ziekenhuis Oost-Limburg (Genk, Belgium) during 2015 were included. Women received RM on demand of the responsible obstetrician before admission or after discharge from the prenatal observation ward. The criteria to initiate RM were GHD at gestational age ≥20 weeks where an intensive follow-up until delivery was desirable. Women without a mobile phone, a gestational age less than 20 weeks, a fetus with congenital malformations, and women who refused informed consent were excluded and received conventional care (CC).
Between January 1, 2015 and December 31, 2015, there were 2058 women who had prenatal care and delivery at Ziekenhuis Oost-Limburg. It was found that 166 women were diagnosed with GHD, 53 of them received CC added with RM. The remaining 113 pregnant women with GHD did not receive RM but only CC.
Women consenting for RM received obstetric surveillance by a Withings Wireless Blood Pressure Monitor, Withings Smart Body Analyzer, and a Withings Pulse O² (Withings, Issy-les-Moulineux, France). Pregnant women participating in the prenatal remote follow-up program were asked to perform one blood pressure measurement in the morning and one in the evening, one weight measurement a day, and wear an activity tracker day and night until delivery or hospital admission (see
The data from the monitor devices were transmitted to a Web-based dashboard developed by the Mobile Health Unit of the University of Hasselt. Predetermined alarm signals were set; one midwife performed remote follow-up of all transformed data at the dashboard. She had to discriminate normal and alarm signals of systolic blood pressure >140 mmHg, diastolic blood pressure >90 mmHg, or weight gain >1 kg/day. Alarm events were communicated with the obstetrician in charge to discuss management options before contacting and instructing patients at home. Type of interventions were (1) expectant management, (2) ambulatory blood sampling and 24-h urine collection at home, (3) adjustment of the antihypertensive therapy or physical activity, (4) admission to the antenatal ward, and (5) induction of labor. Therapeutic interventions were according to local management.
The hospital’s Medical Ethics Committee approved the study.
The equipment used in the remote monitoring group.
Maternal demographics and characteristics of the patients in the RM group were collected at study entry. In the CC group, these data were obtained by manual search through the electronic medical records.
Total numbers of prenatal consultations were collected from 10 weeks of gestation onwards: ultrasound scans, cardiotocographics (CTG), admission to the prenatal ward, total days of hospitalization, and the number of admissions until delivery. These data were retrospectively collected from the electronic medical records after the delivery of the women in both the RM and CC group. These data were checked with the hospital administration and billing records.
Maternal parameters collected at birth were gestational age at delivery and mode of delivery. Neonatal outcomes collected were birth weight, birth weight percent, length, Apgar at 1′ and 5′, and number of admissions to NIC.
Differences in continuous and categorical variables in maternal demographics and characteristics were tested using Unpaired Student’s two sampled
Of the 2058 deliveries in Ziekenhuis Oost-Limburg in 2015, 18.06% (166/2058) were diagnosed with GHD and had both prenatal care and birth in the same hospital. A total of 31.92% (53/166) (31.92%) of the GHD pregnancies had RM. Of these, 3.01% (5/53) were excluded from analysis because of missing data (n=4) and fetal loss (n=1). In total, 28.92% (48/166) RM women were eligible for analysis. The other 68.08% (133/166) GHD pregnancies had CC. Of these, 9.04% (15/133) women were excluded because of missing data, leaving 59.04% (98/166) eligible for analysis.
Maternal demographics and characteristics.
Variable | RMa group |
CCb group |
Statistical significance |
|
Maternal age in years, mean (SD) | 31.69 (4.25) | 31.94 (4.77) | .73 | |
Pre pregnancy weight (kg), mean (SD) | 72.00 (17.99) | 76.80 (19.74) | .11 | |
Height (cm), mean (SD) | 166.00 (6.94) | 167.08 (6.86) | .38 | |
BMI (kg/m²), mean (SD) | 25.54 (5.58) | 27.08 (6.92) | .32 | |
Primigravidity, n (%) | 20 (41.66) | 65 (66.32) | .005 | |
Cardiovascular disorders | 0 (0) | 1 (1.02) | .48 | |
Blood coagulation disorder | 1 (2.08) | 1 (1.02) | .61 | |
Endocrine disorders | 2 (4.16) | 5 (5.10) | .81 | |
Immunological disorders | 1 (2.08) | 2 (2.04) | .99 | |
Smoking, n (%) | 0 (0) | 10 (10.20) | .02 | |
GAc first visit in weeks, mean (SD) | 10.10 ( 5.36) | 11.21 ( 7.60) | .66 |
aRM: remote monitoring.
bCC: conventional care.
cGA: gestational age.
The study population.
Data on prenatal follow-up balance are shown in
Prenatal follow-up.
Variable | Univariate analysis | Multivariate analysis | |||||
RMa group |
CCb group |
RM versus no RM |
95% CIc for beta | ||||
Total number of prenatal visits, mean (SD) | 8.77 |
8.86 |
.90 | −.56 | −1.74 to 9.14 | .54 | |
CTG’s, mean (SD) | 2.23 |
1.89 |
.46 | −.08 | −1.12 to 0.53 | .48 | |
Echo’s, mean (SD) | 3.95 |
3.67 |
.08 | .07 | −0.56 to 1.19 | .48 | |
Prenatal admission, n (%) | 27 (56.25) | 73 (74.49) | .03 | .46 | 0.18-1.45 | .09 | |
Days hospitalized, mean (SD) | 5.74 |
4.73 |
.57 | .10 | −1.62 to 4.81 | .32 | |
Prenatal admission until delivery, n (%) | 13 (27.08) | 61 (62.24) | <.001 | .38 | 0.12-1.22 | .11 | |
Essential hypertension | 1 (2.08) | 9 (9.18) | .11 | ||||
Gestational hypertension | 39 (81.25) | 42 (42.86) | <.001 | 6.62 | 2.40-18.27 | <.001 | |
Preeclampsia | 7 (14.58) | 43 (43.87) | <.001 | 0.24 | 0.08-0.71 | .01 | |
HELLPc | 1 (2.08) | 4 (4.08) | .53 |
aRM: remote monitoring.
bCC: conventional care.
cHELLP: hemolysis elevated liver enzymes and low platelets.
In order to investigate the influence of the maternal demographics and characteristics on the prenatal follow-up, a multiple linear regression analysis and a multivariate logistic regression analysis is performed. A detailed overview of these data is proved in
Delivery outcomes are shown in
Delivery outcomes.
Variable | Univariate analysis | Multivariate analysis | |||||
RMa group |
CCb group |
RM versus no RM |
95% CI |
||||
GAc delivery in weeks, mean (SD) | 37.49 |
37.20 |
.94 | −.21 | −1.29 to 0.06 | .85 | |
Spontaneous | 29 (60.42) | 31 (31.63) | .001 | 3.25 | 1.36 to 7.78 | .001 | |
Induction | 12 (25.00) | 48 (48.98) | .006 | .36 | 0.14 to 0.89 | .03 | |
Primary cesarean section | 7 (14.54) | 19 (19.39) | .48 | .67 | 0.21 to 2.18 | .51 | |
Vaginal | 32 (66.67) | 58 (59.18) | .38 | 1.06 | 0.44 to 2.54 | .90 | |
Instrumental | 4 (8.33) | 8 (8.16) | .97 | 2.34 | 0.47 to 11.64 | .30 | |
Primary cesarean section | 7 (14.54) | 19 (19.39) | .48 | .67 | 0.21 to 2.18 | .51 | |
Secondary cesarean section | 5 (10.42) | 13 (13.27) | .63 | .49 | 0.11 to 2.10 | .33 | |
Birth weight in g, mean (SD) | 3058.54 |
2953.09 |
.36 | .11 | −162.71 to 535.33 | .29 | |
Length in cm | 49.53 |
48.33 |
.07 | .23 | 0.02 to 3.45 | .05 | |
Apgar 1′, mean (SD) | 8.11 |
7.91 |
.86 | .08 | −0.38 to 0.88 | .43 | |
Apgar 5′, mean (SD) | 9.13 |
9.03 |
>.99 | .06 | −0.37 to 0.65 | .59 | |
Admission NICd, n (%) | 5 (10.42) | 27 (27.55) | .02 | .34 | 0.10 to 1.14 | .08 |
aRM: remote monitoring.
bCC: conventional care.
cGA: gestational age.
dNIC: neonatal intensive care.
In order to investigate the influence of the maternal demographics and characteristics on the delivery outcomes, a multiple linear regression analysis and multivariate logistic regression analysis is performed. A detailed overview of these data is proved in
We sought to determine whether RM was an added value to facilitate the prenatal follow-up and to improve the delivery outcomes in patients diagnosed with GHD. To our knowledge, this is the first publication about a prenatal follow-up program for pregnant women with GHD.
The findings show us a reduced appearance of preeclampsia, but an increased appearance of gestational hypertension in the group of women who received a prenatal RM program when compared with women who received CC. Women in the RM group, when compared with CC group, had a lower number of prenatal hospitalizations, prenatal hospitalizations until delivery, and their neonates were less likely to be admitted to the NIC department in univariate but not in multivariate analysis. In both analysis, spontaneous deliveries were more likely and inductions less likely to occur in the RM group when compared with CC group.
Despite the potential benefits, the use of RM in obstetrical care is still very limited and is not integrated into healthcare systems. The Commission of the European Communities has, in 2012, written an eHealth Action Plan [
Our study has three main limitations. First, the data collection was done retrospectively so selection bias cannot be excluded. Second, in CC group, there were more primigravida and women who smoked during their pregnancy when compared with RM group. Although, our multivariate analysis did not show any influence of these parameters on our principal findings, nulliparous women are known to have a higher risk for the development of preeclampsia superimposed on chronic hypertension [
To our knowledge, this is the first publication about a prenatal follow-up program for pregnant women with GHD to date. There are a few publications about a RM program during prenatal follow-up in the management for pregnant women at risk for preterm labor or with the diagnosis of gestational diabetes mellitus. When looking at their maternal outcomes, the results of these studies are not in line with our findings. Compared with the usual care, these studies report no significant difference in prenatal hospitalizations [
A possible hypothesis of the differences in admission to the prenatal observational ward, admission to the NIC and the gestational outcomes is the hypothesis that preeclampsia is possibly a result of gestational hypertension or essential hypertension [
When women are diagnosed with preeclampsia, an induction of labor is often necessary for the prevent of further complications [
Additionally, our study shows that there are no differences in prenatal consults between RM and CC. These findings are in contradiction with the statement that medicalization of childbirth has gone too far, which arises from different angles [
Although women in the RM group were invited for an extra prenatal consult to evaluate fetal and maternal wellbeing when events occurred, no statistical significant difference is present in prenatal consultations (total number of consultations, total number of CTG’s, and total number of echo’s) in the RM group versus the CC group. This indicates that RM does not cause extra prenatal consultations but, when further implemented, can ensure a reduction in this number when obstetricians and gynecologists are more familiar with this system. A study to evaluate the cost-effectiveness of a RM follow-up program needs to be performed later. Additionally, early detection of GHD in the monitoring group demonstrated the value of objective measurements of increase in blood pressure by a remote blood pressure monitoring device. The patients not receiving these devices relied on standard prenatal care, where a GHD mostly will be discovered by chance or when the patient comes to the hospital with self-reported complaints, for example, headache or blurred vision. In these cases, the degree of the GHD is often severe and an active management is necessary [
Prenatal RM follow-up is linked with an increased prevalence of a spontaneous start of the birth process, when compared with CC. This may relate to a trend for less maternal and neonatal hospitalizations in RM group compared with the CC group. This study illustrates that RM opens perspectives to timely initiate and monitor antihypertensive treatments for gestational hypertension, and early identifications of alarm events without increasing ambulatory or in-hospital interventions. To our knowledge, this is the first publication about a prenatal follow-up program for pregnant women with GHD to date. Further examinations about the effect of a prenatal RM follow-up program for women at risk for the development of GHD needs to be done in a randomized controlled trial to confirm these results.
Multivariable model for the prediction of prenatal follow-up using maternal demographics and characteristics.
Untitled.Supplementary file 2: Multivariable model for the prediction of gestational outcomes using maternal demographics and characteristics.
This study is part of the Limburg Clinical Research Program (LCRP) UHasselt-ZOL-Jessa, supported by the foundation Limburg SterkMerk (LSM), Hasselt University, Ziekenhuis Oost-Limburg, and Jessa Hospital. We like to thank NeleGeusens, Wilco Waaijer, and Thomas Reyskens for their participation in this project. No specific funding was provided for publication of this pilot study.
None declared.