A randomized crossover trial on the effect of compression stockings on nausea and vomiting in early pregnancy

Figures & data

Figure 1 Patient enrolment.

Notes: “First” refers to the group who wore the compression stockings during the first 2 weeks of the 4-week study. “Second” refers to the group who wore the compression stockings during the final 2 weeks of the 4-week study.

Table 1 Baseline characteristics

Characteristics	Compression first (N=29), n (%)	Compression second (N=29), n (%)	Overall (N=58), n (%)
Age, years (mean ± SD)	31.53±4.88	31.86±5.24	31.70±31.30
≤24	1 (3.4)	4 (13.8)	5 (8.6)
25–29	12 (41.4)	6 (20.7)	18 (31.0)
30–34	11 (37.9)	12 (41.4)	23 (39.7)
>35	5 (17.2)	7 (24.1)	12 (20.7)
Parity (mean ± SD)	1.90±1.37	1.62±1.35	1.76±1.36
0	3 (10.3)	2 (6.9)	5 (8.6)
1	12 (41.4)	17 (58.6)	29 (50.0)
>1	14 (48.3)	10 (34.5)	24 (41.4)
Children (mean ± SD)	0.69±0.89	0.41±0.73	0.55±0.82
0	16 (55.2)	21 (72.4)	37 (63.8)
1	7 (24.1)	4 (13.8)	11 (19.0)
>1	6 (20.7)	4 (13.8)	10 (17.2)
Week of pregnancy (mean ± SD)	9.76±1.79	9.07±1.25	9.41±1.57
8	9 (31.0)	12 (41.4)	21 (36.2)
9–10	9 (31.0)	15 (51.7)	24 (41.4)
11–12	9 (31.0)	1 (3.4)	10 (17.2)
13–14	2 (6.9)	1 (3.4)	3 (5.2)

Notes: “First” refers to the group who wore the compression stockings during the first 2 weeks of the 4-week study. “Second” refers to the group who wore the compression stockings during the final 2 weeks of the 4-week study.

Abbreviations: n, number of patients; N, total number of patients; SD, standard deviation.

Figure 2 Changes in NVPQOL score over time.

Notes: Dashed line represents a reported value for women with NVP.¹⁸ “First” refers to the group who wore the compression stockings during the first 2 weeks of the 4-week study. “Second” refers to the group who wore the compression stockings during the final 2 weeks of the 4-week study.
Abbreviations: NVP, nausea and vomiting in early pregnancy; NVPQOL, Nausea and Vomiting in Pregnancy Quality of Life questionnaire.

Table 2 Comparison between baseline scores and scores after the periods with and without compression for the NVPQOL, dizziness, and CIVIQ questionnaires

Variables	Baseline (B), mean (SD)	Without compression (NC), mean (SD), change from B (Δ)	With compression (C), mean (SD), change from B (Δ)	Comparison
				B/NC, P-value	B/C, P-value	NC/C, P-value
NVPQOL
Physical	36.65 (12.5)	29.36 (12.69), Δ: −7.29	24.29 (11.78), Δ: −12.36	<0.001	<0.001	<0.001
Fatigue	16.89 (6.45)	13.84 (6.30), Δ: −3.04	11.43 (6.20), Δ: −5.46	<0.001	<0.001	<0.001
Emotions	25.14 (10.01)	20.74 (10.03), Δ: −4.40	18.36 (10.53), Δ: −6.78	<0.001	<0.001	0.006
Limitations	39.28 (16.64)	32.33 (16.27), Δ: −5.95	27.21 (16.30), Δ: −12.16	<0.001	<0.001	0.001
Total	117.96 (43.66)	96.28 (43.26), Δ: −21.68	81.29 (43.76), Δ: −36.67	<0.001	<0.001	<0.001
Dizziness
Dizziness	12.91 (6.51)	12.47 (5.90), Δ: −0.44	9.69 (4.25), Δ: −3.22	0.55	<0.001	<0.001
CIVIQ
Pain	11.75 (17.87)	13.38 (19.06), Δ: +1.63	5.71 (9.39), Δ: −6.03	0.46	0.006	0.001
Physical	10.02 (16.60)	11.73 (17.08), Δ: +1.71	6.9 (10.84), Δ: −3.13	0.43	0.14	0.018
Social	8.91 (15.04)	7.89 (13.14), Δ: −1.02	7.04 (12.85), Δ: −1.87	0.59	0.40	0.75
Psychological	25.45 (16.03)	26.8 (15.9), Δ: +1.35	19.65 (14.42), Δ: −5.81	0.27	0.008	<0.001
Total	16.72 (14.80)	18.11 (14.49), Δ: +1.39	12.26 (9.90), Δ: −4.46	0.37	0.013	0.001

Abbreviations: CIVIQ, Chronic Venous Disease Quality of Life questionnaire; NVPQOL, Nausea and Vomiting in Pregnancy Quality of Life questionnaire; SD, standard deviation.

Table 3 Mean value of PUQE scores over the last 7 days of each period

Variables	N	PUQE scores without compression, mean (SD)	PUQE scores with compression, mean (SD)	P-value
Nausea	58	2.48 (1.06)	2.13 (1.16)	0.018
Vomiting	58	1.31 (0.59)	1.32 (0.69)	0.78
Retching	58	1.75 (0.94)	1.5 (0.84)	0.036
Circulatory disturbance	58	2.05 (0.93)	1.73 (0.79)	0.010
PUQE total score	58	5.52 (2.18)	4.94 (2.33)	0.042

Abbreviations: N, total number of patients; PUQE, Pregnancy-Unique Quantification of Emesis and Nausea; SD, standard deviation.

Table 4 PUQE total scores without and with compression according to severity of PUQE total score without compression

Group score at baseline	PUQE total score		P-value
	Without compression, mean (SD)	With compression, mean (SD)
PUQE score ≤6, n=36	4.11 (0.80)	4.15 (1.36)	0.885
PUQE score >6, n=21	7.81 (1.72)	6.24 (2.98)	0.014

Abbreviations: n, number of patients; PUQE, Pregnancy-Unique Quantification of Emesis and Nausea; SD, standard deviation.

Figure S1 Mean scores for dizziness at baseline and after each study period.

Notes: “First” refers to the group who wore the compression stockings during the first 2 weeks of the 4-week study. “Second” refers to the group who wore the compression stockings during the final 2 weeks of the 4-week study.

Figure S2 PUQE scores over time.

Notes: The black dashed line represents a reported value for women with NVP.³ “First” refers to the group who wore the compression stockings during the first 2 weeks of the 4-week study. “Second” refers to the group who wore the compression stockings during the final 2 weeks of the 4-week study.

Abbreviations: NVP, nausea and vomiting in early pregnancy; PUQE, Pregnancy-Unique Quantification of Emesis and Nausea.

Table S1 Validated NVPQOL questionnaire

Factor/domain	Items for inclusion
Physical symptoms/aggravating factors	Nausea Sick to your stomach Vomiting Dry heaves Poor appetite Symptoms worse in evening Not eaten for longer than you would like Worse when exposed to certain smells Worse when exposed to certain foods
Fatigue	Fatigue Worn out, lack of energy Exhausted Tired
Emotions	Emotional Less interested in sex Downhearted, blue, sad, unhappy, depressed, gloomy Frustrated Fed up with being sick Reassured that your symptoms are part of normal pregnancy Can’t enjoy your pregnancy
Limitations	Everything is an effort Accomplished less than you would like Took longer to get things done than usual Difficult or took extra effort to perform, and/or limited in types of work/other activities Difficulty maintaining your normal social activities with family, friends, neighbors, or social groups Rely on your partner to do things that you would normally do for family Difficulty looking after home Difficulty shopping for food Difficulty preparing or cooking meals Cut down on amount of time you spent at work/other activities

Notes: Respondents rate the occurrence of each item using a Likert 7-point scale ranging from 1 (none of the time) to 7 (all of the time). (The item “Reassured that your symptoms are part of normal pregnancy” is reversed.) The total score is the sum of the 30 items and is between 30 and 210. Lower scores correspond to better QoL. Reprinted from J Obstet Gynecol, 186(5 Suppl Understanding), Magee LA, Chandra K, Mazzotta P, Stewart D, Koren G, Guyatt GH, Development of a health-related quality of life instrument for nausea and vomiting of pregnancy, S232–8, 2002, with permission from Elsevier. Copyright © 2002 Published by Mosby, Inc.¹

Abbreviations: NVPQOL, Nausea and Vomiting in Pregnancy quality of Life; QOL, Quality of life.

Table S2 Validated and modified PUQE questionnaire

Pregnancy-Unique Quantification of Emesis and Nausea Index
Circle the answer that best suits your situation for the last 12 hours
1. In the last 12 hours, for how long have you felt nauseated or sick to your stomach?
Not at all	≤1 hr	2–3 hr	4–6 hr	>6 hr
(1)	(2)	(3)	(4)	(5)
2. In the last 12 hours, have you vomited or thrown up?
≥7 times	5–6 times	3–4 times	1–2 times	I did not throw up
(5)	(4)	(3)	(2)	(1)
3. In the last 12 hours, how many times have you had retching or dry heaves without bringing anything up?
None	1–2 times	3–4 times	5–6 times	≥7 times
(1)	(2)	(3)	(4)	(5)

Notes: Total score (sum of replies to 1, 2, and 3): mild NVP, ≤6; moderate NVP, 7–12; severe NVP, ≥13. Reprinted from Am J Obstet Gynecol, 186, Koren G, Boskovich R, Hard M, Maltepe C, Navioz Y, Einarson A, Motherisk-PUQE (pregnancy-unique quantification of emesis and nausea) scoring system for nausea and vomiting of pregnancy, S228–31, 2002, with permission from Elsevier. Copyright © 2002 Published by Mosby, Inc.²

Abbreviation: NVP, nausea and vomiting in early pregnancy.

Table S3 Questions to be answered at study end

Did the compression stockings help against nausea and vomiting?

Did the compression stockings help against heavy legs?

Would you go on wearing the compression stockings during your pregnancy?

Would you recommend wearing compression during pregnancy?

Note: Participants answered the above questions and graded their answers using a 7-point Likert scale, where 1 was “not at all” and 7 was “always”.

Table S4 Power analysis

Measurement	Reduction with stockings (n=17)	Effect size dz, (mean/SD)	n needed
			Power =0.8	Power =0.9
NVPQOL	10.18±19.41	0.52	31	41
CIVIQ	3.24±6.07	0.53	30	39
Dizziness	3.47±4.64	0.75	17	21
PUQE	0.33±1.05	0.33	91	112

Notes: Power analysis with G*Power version 3.1.7 based on an unpublished crossover pilot study. For NVPQOL and CIVIQ the numbers needed were 31 and 30 patients, respectively, with a power of 80%, and 41 and 39 patients with a power of 90%. As estimations were based on a small sample, the number of enrolled subjects was increased to 60.

Abbreviations: CIVIQ, Chronic Venous Disease Quality of Life questionnaire; d_z, Cohen’s d_z (effect size indicator for paired Student’s t-tests); n, number of patients; NVPQOL, Nausea and Vomiting in Pregnancy Quality of Life questionnaire; PUQE, Pregnancy-Unique Quantification of Emesis and Nausea; SD, standard deviation.

MageeLAChandraKMazzottaPStewartDKorenGGuyattGHDevelopment of a health-related quality of life instrument for nausea and vomiting of pregnancyAm J Obstet Gynecol2002186Suppl 5S232S23812011892

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LacasseABerardAValidation of the nausea and vomiting of pregnancy specific health related quality of life questionnaireHealth Qual Life Outcomes200863218471301

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MageeLAChandraKMazzottaPStewartDKorenGGuyattGHDevelopment of a health-related quality of life instrument for nausea and vomiting of pregnancyAm J Obstet Gynecol2002186Suppl 5S232S23812011892

 PubMed Web of Science ®Google Scholar

KorenGBoskovicRHardMMaltepeCNaviozYEinarsonAMotherisk-PUQE (pregnancy-unique quantification of emesis and nausea) scoring system for nausea and vomiting of pregnancyAm J Obstet Gynecol2002186Suppl 5S228S23112011891

 PubMed Web of Science ®Google Scholar