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Complementary Therapies in Clinical Practice 43 (2021) 101366

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Complementary Therapies in Clinical Practice


journal homepage: http://www.elsevier.com/locate/ctcp

A randomized control trial to study the effect of integrated yoga on


pregnancy outcome in hypertensive disorder of pregnancy
Amrita Makhija *, 1, Neha Khatik 2, Chitra Raghunandan
Department of Obstetrics and Gynecology, Lady Hardinge Medical College, New Delhi, India

A R T I C L E I N F O A B S T R A C T

Keywords: Objective: The study aimed to evaluate the effects of integrated yoga on blood pressure and pregnancy outcome in
Integrated yoga hypertensive disorder of pregnancy.
Antenatal yoga Methods: Seventy-nine patients were randomized into study and control groups. The study group received the
Hypertensive disorder of pregnancy
intervention in the form of integrated yoga for 4 weeks. Final analysis was done on 30 patients each of study and
Labor outcome
Maternal comfort
control group.
Results: The mean systolic BP declined by 7.43 ± 5.86 mmHg in the study group as compared to 2.50 ± 5.21 mm
Hg in the control group (p value 0.002). The mean diastolic BP prior to delivery was 88.00 ± 3.71 mmHg in the
study group and 92.20 ± 5.02 mmHg in the control group (p = 0.001). The maternal comfort in labor was
significantly higher and the duration of labor significantly reduced in the study group.
Conclusion: Integrated yoga effectively reduced systolic and diastolic blood pressures and increased maternal
comfort during labor in hypertensive disorder of pregnancy.

1. Introduction morbidity and mortality in fetuses of these women. There are increased
rates of preterm deliveries and delivery of small-for-gestational-age in­
Hypertensive disorder of pregnancy (HDP) complicates around fants and intrauterine and neonatal death [8].
6–10% of all pregnancies [1]. It is defined as systolic blood pressure(BP) Anti-platelet agents like low dose aspirin and calcium supplemen­
of at least 140 mm Hg and/or diastolic BP of at least 90 mm Hg on at two tation are the only interventions shown to prevent HDP. The manage­
occasions 4 h apart, after the 20th week of gestation, in a previously ment lies on monitoring of BP and observing for any signs of progression
normotensive woman. It is considered severe if there is a sustained of disease. Anti-hypertensive drugs decrease BP and reveal improvement
elevation in systolic BP to at least 160 mm Hg and/or in diastolic BP to at of maternal and neonatal outcomes [9]. The only cure for HDP is
least 110 mm Hg. termination of pregnancy, which may endanger the life of the newborn.
HDP is associated with a substantially increased risk of adverse The aim is to minimize the maternal risk without compromising fetal
maternal outcomes and life-threatening complications, such as abruptio- maturity. Therefore, there has always been a need for an intervention
placentae, thrombocytopenia, disseminated intravascular coagulation which can prolong the pregnancy without causing any deterioration of
and pulmonary edema. Overall, 10%–15% of direct maternal deaths are the maternal condition in HDP.
associated with preeclampsia and eclampsia [2]. In a retrospective study Yoga, an ancient mind-body intervention, seems to be an effective
over the period 2000–2009 in a tertiary centre in India, HDP was the adjunctive in the treatment of HDP. It is being advocated as a form of
third leading cause of maternal death [3]. The risk of essential hyper­ treatment for hypertension in general population [10,11]. It acts
tension, cardiovascular disease, diabetes mellitus and kidney disease in through the mediation of sympathetic nervous system, decreasing the
later life is increased in these women as compared to women with peripheral vascular resistance and cardiac output.
normotensive pregnancy [4–7]. There is a significant rise in perinatal Mental stress is shown to be the causative factor for the development

Abbreviations: HDP, Hypertensive disorder of pregnancy; BP, Blood pressure.


* Corresponding author. Himalayan Institute of Medical Sciences, Jollygrant, Dehradun, India.
E-mail address: amritamakhija@gmail.com (A. Makhija).
1
Present address: Department of Obstetrics and Gynecology, Himalayan Institute of Medical Sciences, Dehradun, India.
2
Present address: Department of Obstetrics and Gynecology, S. S. Medical College, Rewa, India.

https://doi.org/10.1016/j.ctcp.2021.101366
Received 29 September 2020; Received in revised form 1 January 2021; Accepted 13 March 2021
Available online 19 March 2021
1744-3881/© 2021 Elsevier Ltd. All rights reserved.
A. Makhija et al. Complementary Therapies in Clinical Practice 43 (2021) 101366

of gestational hypertension [12]. Yoga is known to reduce stress in decline in salivary cortisol and salivary α-amylase levels [16,17]. Be­
medical students [13]. Yogic practice improves the adaptive autonomic sides, Yoga has also been shown to decrease the stress associated with
response to stress and reduces perceived stress in healthy pregnant complications in high-risk pregnancy [18].
women [14,15]. Immediate stress reduction has been demonstrated by a Women who participate in daily yoga practice have decreased rates

Fig. 1. Participant flow diagram.

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A. Makhija et al. Complementary Therapies in Clinical Practice 43 (2021) 101366

of preterm delivery and fetal growth retardation [19]. Yoga is known to Muladhara chakra suddi (perineal muscle contractions).
increase flexibility and muscle strength, enhances breathing and pre­ Swadhisthan chakra suddi (perineal muscle contractions).
pares the patient for labor and delivery. The breathing techniques used
in yoga can help reduce the shortness of breath that may accompany (II) Asana (Postures) for 10 min. It comprised of the following,
labor. tailored as per the capability of the patient:
Thus, the present study was undertaken to find the effect of inte­
grated yoga on the blood pressure in patients with mild HDP. Although Shavasana.
studies have been done in high-risk pregnancy, studies in women with Sukhasana.
HDP are scarce. The effect of yoga on labor, maternal comfort during Ardhapadmasana.
labor and the maternal and perinatal outcome was also studied. Gomukhasana.

2. Materials and methods (III) Pranayam for 10 min

The present study, an open label randomized controlled trial, was Nadishodhanpranayam (anulom-vilom).
conducted in the department of Obstetrics and Gynecology of Lady
Hardinge Medical College, New Delhi, from November 2011 to March (IV) Dhyana (Meditation) - Om meditation for 10 min.
2013, in collaboration with the department of Physiology. Approval was
obtained from the institutional review board. Blood pressure was measured biweekly till the end of the study.
Inclusion criteria: Primigravida in the third trimester of pregnancy Routine hospital protocols were followed regarding the termination of
with mild hypertensive disorder of pregnancy and known to be pregnancy and management of labor.
normotensive before conception and before 20 weeks of gestation. The labor duration and the perinatal outcome were recorded. A Vi­
Exclusion criteria: known cases of hypertension, diabetes mellitus sual Analog Scale (VAS) for Total Comfort was used at 3–4 cm dilatation
or other systemic diseases, major fetal congenital anomalies, multifetal (Time 1), 2 h post-delivery (Time 2) and 4 h post-delivery (Time 3). The
pregnancy and patients who did not consent. VAS is a 10 cm long scale with markings from 0 (colour-coded as red) to
The patients were randomised by using randomization table into 10 (colour-coded as green). The score of 10 meant maximum comfort
study group and control group. The study group was subjected to the and 0 meant least comfort. The patients were asked to place a mark
intervention of yoga practice besides routine physical activities and bed corresponding to their level of comfort at that particular point of time.
rest. The recording of results and outcomes and all the assessments were done
A total of 79 cases were recruited for the study after satisfying the by a blinded assessor in a separate file, while the care provider was a
inclusion criteria. Twelve women were excluded from the study (1 had different person.
severe anaemia, 1 had fetal congenital anomaly, 2 were twin gestation Statistical analysis was done on the latest version of SPSS software.
and rest patients did not consent). The 67 patients included in the study The results were expressed as mean ± standard deviation. Student t-test
were randomized into study group comprising 35 patients and the and Fishers exact test were used to find the difference between the
control group comprising 32 patients. Simple randomization was done measures of two central tendencies.
using the minimized randomization program version 2.019. Random
allocation sequence was implemented by creating random allocation 4. Observations and results
cards which were folded and kept inside opaque envelopes. The enve­
lopes were kept with the obstetric ward nurse. Assignment of partici­ The demographic characteristics of the study and control group are
pants to interventions was done by the help of obstetrics ward nurse. presented in Table 1. The baseline characteristics in both the groups
Three patients of the study group were lost to follow-up and 2 dis­ were comparable. Most of the patients in both the groups belonged to
continued the yoga practice. Two patients of the control group were lost 18–25 years age group. In the study group, 25 women (83.33%) were
to follow-up. Final analysis was done on 30 patients of the study and 30 booked at our hospital. In the control group, 24 (80%) women were
of control group (Fig. 1). It was a single-blinded study, where the booked.
assessor (statistician) was blinded.

3. Methodology Table 1
Demographic characteristics of the study and control groups.
After an informed consent, the cases in the study group received the Demographic characteristics Study group (n Control group p value
intervention in the form of integrated yoga. The session lasted for 40 min = 30) (n = 30)
and was practiced at least thrice per week till delivery and for at least 4 No. Percent No. Percent
weeks. The initial few sessions were conducted in a separate room in the
Maternal age (years)
antenatal ward, under the guidance of a trained yoga teacher. The yoga 18-25 19 63.33 17 56.67 0.598
sessions were administered from Mondays to Saturdays in the morning 26-35 11 36.67 13 43.33
hours (between 8 and 9 AM) after a light breakfast. The patients were Registration of Pregnancy
mandatorily asked to participate on alternate days. However, they were Booked 25 83.33 24 80 0.739
Unbooked 5 16.67 6 20
encouraged to participate more frequently including daily participation.
Education level
After initial few sessions, the patients continued the same at their homes. ≤Grade 12 23 76.67 25 83.33 0.519
Compliance was ensured by maintenance of an activity diary and >Grade 12 7 23.33 5 16.67
frequent telephone calls. Integrated yoga comprised of: Anti-hypertensive use (n¼30)
On drugs 10 33.33 12 40.00 0.592
Not on drugs 20 66.67 18 60.00
(I) SukshamaVyayama (Micro Exercises)for 2 min each (total 10 Mean age±SD 24.97 ± 3.02 25.87 ± 4.86 0.396
min) comprising of: Mean weight±SD 68.97 ± 7.51 66.23 ± 6.80 0.149
Mean Systolic BP±SD (mmHg) 148.57 ± 5.96 149.90 ± 7.14 0.440
Breathing exercises. Mean Diatolic BP±SD (mmHg) 91.63 ± 2.14 93.97 ± 6.61 0.076
Mean POG±SD (days) 237.40 ± 12.91 242.80 ± 19.73 0.220
Grivashaktivikasaka (neck movements).
Vakshsthalashaktivikasaka (body extension). POG: period of gestation.

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The education level, mean age and mean weight of subjects in the Table 3
study and control group was comparable. The mean blood pressure (BP) Labor events.
at the start of study was 148.57/91.63 mmHg and 149.90/93.97 mmHg Mean duration Study group Control group p
in study and control groups, respectively. The mean period of gestation of labor value
N Mean SD n Mean SD
at the time of enrollment in the study was 237.40 days (34 weeks) in the (minutes)
study group and 242.80 days (34 weeks 5 days) in the control group. The 1st stage 23 671.01 137.66 21 767.38 125.40 0.022
numbers of patients on drugs at the start of study were 10 (33.3%) in the 2nd stage 22 44.09 14.61 19 46.32 17.94 0.654
study group and 12 (40%) in the control group. Total time 22 702.04 129.56 19 817.37 142.06 0.011

Table 2 shows the changes in the BP from the start of the study to the Study group (n¼30) Control group (n¼30)
time of delivery. Prior to delivery mean systolic BP declined by 7.43 ± No. Percent No. Percent
5.86 mmHg in the study group as compared to 2.50 ± 5.21 mm Hg in the Induction of labor
control group (p value 0.002). The mean diastolic BP prior to delivery None 15 50.00 13 43.33 0.604
was 88.00 ± 3.71 mmHg in the study group and 92.20 ± 5.02 mmHg in Required 15 50.00 17 56.67
Mode of delivery
the control group (p = 0.001). However, the absolute value of decline Vaginal delivery 22 73.33 18 60.00 0.392
was not statistically significant. Emergency LSCS 8 26.67 11 36.67
The progression of disease can be seen from Table 2. Patients that Instrumental 0 0.00 1 3.33
needed anti-hypertensive drugs or increase in the dosages of the drugs delivery
were comparable in both the groups. The number of patients progressing
to pre-eclampsia were 1 (3.3%) in the study group as compared to 5
(16.7%) in the control group. No patient in either group developed Table 4
eclampsia. Comparison of maternal comfort during labor.
The labor outcomes can be seen from Table 3. The mean duration of VAS score to total Study group Control group p value
first stage of labor in the study group was 671.01 ± 137.66 min as comfort
n Mean SD N Mean SD
compared to 767.38 ± 124.40 min in the control group (p value 0.022).
Time 1 24 50.33 4.68 25 45.36 3.92
There was reduction in the total duration of labor in the group practicing <0.001
Time 2 22 63.82 6.12 19 60.84 5.52 0.115
yoga (p value 0.011). Time 3 22 66.72 3.74 19 65.26 3.52 0.210
The patients needing induction of labor were comparable in the two
groups. In the study group, 22 (73.3%) patients had vaginal delivery as n = no. of patients out of 30 who were analyzed.
compared to 18 (60%) in the control group. One patient (3.3%) of
control group needed instrumental vaginal delivery.
Table 5
Table 4 talks about the maternal comfort during labor. The mean Comparison of neonatal outcomes.
visual analogue scale (VAS) score for maternal comfort Time 1 was
Study group Control group p value
50.33 ± 4.68 in the study group and 45.36 ± 3.92 in the control group (p
(n = 30) (n = 30)
value < 0.001). There is a definite improvement in the VAS scores over
Time 1 to Time 3 in both the groups and the comfort level was com­ No. % No. %

parable in both the groups after delivery (Time 2 and Time 3). Mean birth weight±SD 2845 ± 2655 ± 0.244
The neonatal outcome is presented in Table 5. The mean birth weight 533.91 694.23
Low Birth Weight (<2500 g) 6 20.00 9 30.00 0.371
in the study group was 2845 ± 533.91 g as compared 2655 ± 694.23 g in
Mean gestational age at delivery±SD 271.03 ± 267.93 ± 0.415
the control group. The mean gestational age at delivery was 271.03 ± 14.51 14.52
14.51 days (38 weeks 5 days) in the study group as compared to 267.93 Gestational age<34 weeks 2 6.67 2 6.67 1
± 14.52 days (38 weeks 2 days) in the control group. Preterm births (<37 weeks) 3 10.00 4 13.33 0.688
The number of low-birth-weight babies (<2500 g) in the study group Fetal Growth Restriction 3 10.00 5 16.67 0.448
Meconium-Stained Liquor 1 3.33 4 13.33 0.161
were 6 (20%) as compared to 9 (30%) in the control group. The number Fetal Distress 2 6.67 5 16.67 0.228
Apgar score at first minute
≤7 2 6.67 3 10.00 0.840
Table 2 8–10 28 93.33 27 90.00
Apgar score at 5 min
Comparison of mean BP and progression of disease in the study and control
≤7 2 6.67 3 10.00 0.840
groups.
8–10 28 93.33 27 90.00
Study group (n = Control group (n = p
30) (mmHg) 30) (mmHg) value

Mean SD Mean SD
of preterm deliveries, babies with fetal growth restriction, meconium-
stained liquor and fetal distress were not significantly different be­
Start of study (Systolic) 148.57 5.96 149.90 7.14 0.440
tween the two groups. Babies born in the two groups had similar Apgar
At the onset of labor 141.13 8.17 147.40 8.81 0.008
(Systolic) scores.
Mean change (Systolic) − 7.43 5.86 − 2.50 5.21 0.002
Start of study (Diastolic) 91.63 2.14 93.97 6.61 0.076
5. Discussion
At the onset of labor 88.00 3.71 92.20 5.02 0.001
(Diastolic)
Mean change(Diastolic) − 3.63 3.49 − 1.77 4.53 0.567 In the present study, the mean age was 24.93 ± 3.02 years in the
study group and 25.87 ± 4.86 years in the control group, similar to other
No. Percent No. Percent p
value studies from India [19,20]. The mean period of gestation at the start of
this study was 34 weeks in the study group and 34 weeks 5 days in the
Patients needing drugs or 8 26.7 10 33.3 0.573
increase in dosage control group. Other studies enrolled patients variously at 18–20 weeks
Initially on drugs, requiring 2 6.7 5 16.7 0.228 of pregnancy [19] and at around 26–28 weeks [21,22]. In another study,
additional drugs the patients received yoga sessions from 32 weeks onwards [23]. The
Pre-eclampsia 1 3.3 5 16.7 0.085 gestational age in the present study was higher as compared to other
Eclampsia 0 0 0 0 1
studies. This is because this study was done in women diagnosed with

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HDP, which usually develops and is diagnosed around this gestation. labor, and birth outcomes including comfort and duration of labor and
Previous studies show yoga postures to be safe in pregnancy and no labor pain [32]. Maharana S et al. report lesser need of epidural anal­
adverse effects on the maternal or fetal physiology have been observed gesia in the yoga group [27].
[24,25]. In previous studies, yoga programs have been offered variously. A review article highlights the significantly lower average birth
In one study, sessions lasted for 1 h and were practiced 6–7 times per weight for gestational age and increased pre-term deliveries in babies of
week [19,21]. In another study, yoga sessions lasting 1 h were done stressed or anxious mothers [33]. Yogic exercises aim at reducing
thrice a week [22]. However, in the present study, the session lasted for maternal stress and thus, help in preventing these unwanted outcomes.
40 min and was done at least thrice weekly. The yoga program consisted Maharana et al. noted significantly higher birth weight in the yoga
of integrated yoga, which consisted of micro-exercises, asana (postures), group [27]. However, in the present study, the mean gestational age at
pranayam (anulom-vilom) and meditation. T. delivery and the mean birth weight was comparable in both the groups.
In the present study, a decline of 7.43 ± 5.86 mmHg was noted in the Similar results have been observed by certain other authors [19,21,23].
mean systolic BP in the study group prior to delivery, as compared to In this study, the numbers of pre-term births were comparable in
2.50 ± 5.21 mm Hg in the control group (p value 0.002). The mean both the groups, similar to a previous study [29]. In contrast, other
diastolic BP declined by 3.63 ± 3.49 mmHg in the study group as studies have shown a significant reduction in pre-term deliveries in yoga
compared to 1.77 ± 4.53 mm Hg in the control group (p value 0.567). group [19,20,27,30]. Juhl et al. reported the risk of preterm birth to be
Lesser number of patients progressed to severe pre-eclampsia in the reduced with physical activity in pregnancy, including yoga [34].
group practicing yoga. Thus, the present trial finds beneficial effect of The number of low-birth-weight babies born in the study and control
yoga on blood pressure and in the progression of disease in women with groups did not show any statistically significant difference in this study,
HDP. Similar results have been observed in another randomized similar to the observations of Rakshani et al. [20]. However, other
controlled trial which noted the incidence of pre-eclampsia/eclampsia studies report a significant reduction in low-birth-weight babies in yoga
to be significantly less in the yoga group [20]. Studies have shown group [19,29].
that the chances of developing HDP are 3–4 times less in the yoga group The rate of fetal growth restriction (FGR) was comparable in the two
[20,26,27]. An absolute risk reduction by 21% has been noted in the groups, in this study. In contrast, previous studies found a significant
yoga group by Jayashree et al. [26]. They noted the platelet count and reduction in the rate of FGR alone or FGR associated with PIH [19,20].
uric acid levels in women doing yoga in pregnancy and concluded that Improvement in the utero-fetal-placental circulation and thus, intra­
antenatal integrated yoga from early gestation promotes healthy he­ uterine fetal growth and colour doppler parameters was observed in the
modilution and physiological adaptation [26]. In contrast, a systematic women practicing yoga [35,36]. In women having abnormal doppler
review found no effect on the development of pre-eclampsia, use of indices, higher birth weight was observed in the yoga group [37].
anti-hypertensive medication and neonatal outcomes from the in­ In the present study, Apgar scores were comparable in the two
terventions evaluated, which included yoga and relaxation therapies groups. This is similar to the findings of other studies [21,23,29].
[28]. However, higher Apgar scores have been observed with yoga by others
This study found yoga to have no significant effect on the rates of [20,27].
induction of labor, similar to the findings of previous study by Kim et al.
[23]. However, a positive effect was noted on shortening the duration of 6. Conclusion
labor. In the present study, the duration of first stage of labor was
671.01 ± 137.66 min in the study group and 767.38 ± 125.40 min in the The practice of integrated yoga appears to be safe and acceptable to
control group (p = 0.022). The second stage of labor was also reduced in pregnant women. Integrated yoga for 40 min, thrice weekly for 4 weeks
the yoga group but the difference was not significant. Statistically sig­ effectively reduced systolic and diastolic blood pressures in mild hy­
nificant difference in the total duration of labor was also observed be­ pertensive disorder of pregnancy. Yoga, with no adverse effects, can
tween the groups (p = 0.011). Similar results have been observed in an effectively prevent the disease or its progression even at advanced
Indian study [29]. Other studies report the duration of all the stages and gestation when other therapeutic options are lacking. Ante-natal yoga
total duration of labor to be significantly reduced in the yoga group [21, was found capable of increasing the maternal comfort during labor and
27]. Kim et al. noted reduction in the duration of labor in women un­ shortening the duration of labor. The study encourages us to integrate
dergoing spontaneous as well as induced labor, but the difference was yoga as an alternative medical intervention in the care of pregnant
not statistically significant [23]. women.
In this study, we observed increased number of vaginal deliveries in
women practicing yoga (73.3% as compared to 60% in the control 7. Limitations and recommendations
group). Higher vaginal delivery rate in yoga group was also noted in
previous studies (27, 28). Rakshani et al. and Narendran et al. noted The study was done in only mild HDP cases. Details of the yoga
lesser number of emergency caesarean sections in the yoga group [19, practice at home were self-reported by the patients. The sample size was
20]. A meta-analysis reports improved vaginal delivery with yoga [30]. small. A larger cohort with yoga interventions started early, co-related
The maternal comfort was measured by the visual analogue scale with predictors of HDP and inclusive of mild and severe cases needs to
(VAS) during and after labor. We observed that at all the times, maternal be studied to consolidate the beneficial effects of yoga in HDP. It is
comfort was higher in the study group. The score was significantly suggested that yoga centers be setup alongside ante-natal clinics to reach
higher in the study group (p value < 0.001) at 3–4 cm dilatation. In a to a larger population.
similar study, the yoga group was found to have higher levels of
maternal comfort during labor and 2-hours post-labor [21]. However, in Funding
the present study, post-delivery scores were not significantly different
between the two groups. This research did not receive any specific grant from funding
Better pain tolerance and higher postpartum maternal comfort was agencies in the public, commercial, or not-for-profit sectors.
observed in the yoga group by Bolanthakodi et al. [29]. Sun et al. re­
ported significantly fewer pregnancy discomforts and better outcome Author statement
during active labor and second stage of labor, in patients practicing
pre-natal yoga [22]. Significantly less labor pain and discomfort after Amrita Makhija: Writing- Original draft, Investigation, Formal
delivery were observed in women participating in yoga by other authors analysis, Visualization.
[31]. A systematic review found yoga to improve a variety of pregnancy, Neha Khatik: Software, Validation, Data Curation.

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