A total of 46 patients were studied in this study including 20 patients in the intervention group and 26 patients in the control group. No patient was excluded in the two groups. Two patients in control group and three in intervention group underwent cesarean section for different reasons. There was no significant difference in mean age (p = 0.79), height (p = 0.94), and weight (p = 0.2) between the intervention and control groups. Comparison of mean cervical dilatation and effacement between the two groups showed no significant difference in mean dilatation (p = 0.89) and effacement (p = 0.87). The comparison of demographic characteristics between the two groups is shown in (Table 1).
Table 1
Comparison of demographic characteristics between the two groups
|
groups
|
N
|
Minimum
|
Maximum
|
Mean
|
Std. Deviation
|
p-value
|
Age(year)
|
intervention
|
20
|
22
|
38
|
27.9000
|
4.51
|
0.79
|
control
|
26
|
18
|
36
|
26.5385
|
4.76
|
Height (cm)
|
intervention
|
20
|
157
|
170
|
162.7500
|
4.35
|
0.94
|
control
|
26
|
147
|
173
|
162.6154
|
7.40
|
Weight(kg)
|
intervention
|
20
|
59
|
88
|
77.0000
|
13.79
|
0.2
|
control
|
26
|
51
|
98
|
72.1154
|
11.77
|
Dilatation)cm)
|
intervention
|
20
|
4
|
8
|
5.42
|
5.42
|
0.89
|
control
|
26
|
4
|
7
|
5.38
|
5.38
|
Effacement (%)
|
intervention
|
20
|
30
|
90
|
53.15
|
53.15
|
0.87
|
control
|
26
|
30
|
80
|
53.84
|
53.84
|
Results showed a significant difference in mean duration of first stage of labor between intervention and control groups (p = 0.002). There was no significant difference in the mean duration of second (p = 0.95) and third (p = 0.47) stages of delivery between groups (Table 2).
Table 2
comparing mean duration of labor stages (minutes) between the two groups
|
groups
|
N
|
Minimum
|
Maximum
|
Mean
|
Std. Deviation
|
p-value
|
Stage I
|
intervention
|
17
|
10
|
300
|
81.23
|
75.83
|
0.002
|
control
|
24
|
33
|
402
|
192.75
|
120.76
|
Stage II
|
intervention
|
17
|
10
|
90
|
42.47
|
27.58
|
0.95
|
control
|
24
|
10
|
93
|
41.95
|
23.87
|
Stage III
|
intervention
|
17
|
4
|
10
|
5.94
|
1.71
|
0.47
|
control
|
24
|
4
|
50
|
7.58
|
9.16
|
Two patients (8.33%) in intervention and no patients in control group needed assisted delivery device and no significant difference was noted between groups (p = 0.22). Need of oxytocin in control and intervention groups was 10 out of 26 patients (38.46%) and 8 out of 20 patients (40%), respectively. There was no significant difference in the frequency of patients who were in need for oxytocin administration between the two groups (p = 0.91).
Furthermore, there was no significant difference in FHR1 between groups (p = 0.98). Mean FHR1 was 132.55 ± 9.11 in the intervention group and 132.50 ± 9.88 in the control group. The mean FHR1, FHR2 and FHR3 in the intervention group were 132.55 ± 9.11 and 134.38 ± 8.40 and 133.44 ± 8.02, respectively. There was no significant difference in mean of FHR1 and FHR2 (p = 0.31), mean of FHR1 and FHR3 (p = 0.42) and mean of FHR2 and FHR3 (p = 0.51) in intervention group. Mean FHR1 and FHR3 in the control group were 132.50 ± 9.88 and 135.08 ± 8.84, respectively. There was no significant difference in the mean of FHR1 and FHR3 in the control group (p = 0.51).
Mean baseline DBP in the intervention and control groups were 81.88 ± 6.39 and 81.00 ± 8.82, respectively. There was no significant difference in mean baseline DBP between the two groups (p = 0.72), indicating the homogeneity of samples before the study.
The mean of first, second, third and fourth DBP in the intervention group were 81.88 ± 6.39, 79.11 ± 12.8, 77.50 ± 10.47 and 73.0 ± 8.01, respectively (Fig. 1).
There was no significant difference in the mean of first and second DBP (p = 0.16). But there was a significant difference between the mean of first and third DBP (p = 0.039) and the mean of first and fourth DBP (p = 0.023). There was no significant difference in the mean of second and third DBP (p = 0.31), second and fourth DBP (p = 0.11) and mean third and fourth DBP (p = 0.09) (Fig. 1).
The mean of first, third and fourth DBP in the control group was 81.00 ± 8.82, 83.22 ± 6.07 and 80.81 ± 6.27, respectively. There was no significant difference between the mean of first to third DBP in the control group (p > 0.05) (Fig. 2).
Mean baseline SBP in the intervention group was 134.70 ± 10.68 and in the control group 132.88 ± 10.77. There was no significant difference in mean baseline SBP between the two groups (p = 0.34), indicating that the samples were homogeneous before drug intervention.
Mean baseline, second, third and fourth SBP in the intervention group were 134.70 ± 10.68 and 128.0 ± 16.32 and 126.05 ± 10.66 and 121.44 ± 9.90 mmHg, respectively. Significant differences were observed in mean of first and second SBP (p = 0.034), mean of first and third SBP (p = 0.028) and mean of first and fourth SBP (p = 0.019). There was no significant difference in the mean of the second and third SBP (p = 0.42), but there was a significant difference in the mean of the second and fourth SBP (p = 0.043) and mean third and fourth SBP (p = 0.047) (Fig. 1).
The mean of first, third and fourth SBP in control group were 132.88 ± 10.77, 135.00 ± 7.63 and 132.68 ± 7.42, respectively. There was no significant difference between the mean of first and third SBP (p > 0.05) (Fig. 2).
Mean baseline PR in the intervention group was 98.05 ± 20.12 minutes and in the control group was 92.53 ± 17.41 minutes. There was no significant difference in mean baseline PR between the two groups (p = 0.32), indicating that the samples were homogeneous before drug use.
Mean first, second, third and fourth PR in the intervention group were 98.05 ± 20.12 and 93.44 ± 19.43, 92.66 ± 16.74 and 93.11 ± 13.86, respectively. There was no significant difference in mean PR during the different stages. Mean first, third and fourth PR in control group were 92.53 ± 17.41, 93.33 ± 12.82 and 92.70 ± 12.16, respectively. There was no significant difference in mean PR at different stages (p > 0.05).
No patient in both groups needed treatment with atropine or ephedrine.
Mean baseline RR was 14.55 ± 1.23 in the intervention group and 14.34 ± 1.29 in the control group. There was no significant difference in mean baseline RR between the two groups (p = 0.59), indicating that the samples were homogeneous prior to drug intervention.
Mean baseline, second, third, and fourth RRs in the intervention group were 14.55 ± 1.23 and 13.88 ± 1.18, and 13.44 ± 1.09 and 13.27 ± 0.89, respectively. Although Mean first, third and fourth RR in control group were 14.34 ± 1.29, 13.75 ± 0 3.02 and 13.58 ± 3.02, respectively. There was no significant difference between the mean of first to third RR (p > 0.05). Also, no patient in the two groups had percent of saturated hemoglobin less than 94.
Mean baseline VAS score was 9.25 ± 1.37 in the intervention group and 9.46 ± 1.14 in the control group. There was no significant difference in the mean baseline VAS score between the two groups (p = 0.57), indicating that the samples were homogeneous before drug intervention.
Mean baseline, second, third, and fourth VAS scores in the intervention group were 9.25 ± 1.37, 4.61 ± 1.75, 3.88 ± 1.45, and 1.88 ± 0.47, respectively. Significant differences in mean of first and second VAS (p < 0.01), mean of first and third VAS (p < 0.01), mean of first and fourth VAS (p < 0.001) and mean of second and fourth VAS (p < 0.05) and the mean of the third and fourth VAS scores (p < 0.05), but the mean of the second and third VAS scores were not significant (p = 0.38) (Fig. 3).
Mean first and third VAS scores in control group were 9.46 ± 1.14 and 9.45 ± 1.17, respectively. But the fourth VAS score was 3.12 ± 2.25 significantly lower than the first and third VAS score (p < 0.001).
Mean baseline RSS score was 1.0 0 ± 0.00 in intervention group and 1.11 ± 0.32 in control group. There was no significant difference in the mean baseline RSS score between the two groups (p = 0.12), indicating that the samples were homogeneous before drug intervention.
Mean baseline, second, third and fourth RSS scores in the intervention group were 1.0 ± 0.00, 2.05 ± 0.63 and 2.22 ± 0.54, and 2.05 ± 0.23, respectively. There was a significant difference between the mean of the first and second RSS scores (p < 0.001), the mean of the first and third RSS scores (p < 0.001), and the mean of the first and fourth RSS scores (p < 0.001), but there was no significant difference in the mean scores of second and third RSS and mean second and fourth RSS and mean third and fourth RSS scores (p > 0.05).
The mean of first, third and fourth RSS scores in the control group were 1.11 ± 0.32 and 1.12 ± 0.33, and 1.12 ± 0.33, respectively. There was no significant difference in the mean of the first, third and fourth RSS scores (p > 0.05).
Comparing the mean Apgar scores of 1 and 5 minutes in the two groups showed no significant difference in the mean Apgar scores of 1 minute (p = 0.09) and 5 (p = 0.34) between the intervention and control groups. Mean Apgar scores at 1 and 5 minutes in the intervention group were 9.06 ± 0.25 and 9.87 ± 0.34, respectively. Mean Apgar scores at 1 and 5 minutes in the control group were 8.84 ± 0.47 and 9.32 ± 0.68, respectively.
The mean score of midwifery satisfaction of the patients in the intervention group was 4 ± 0.91 based on the five-point Likert scale.