Additional work package 4.2 tables

Christine MacArthur; Debra Bick; Victoria Salmon; Ellie Jones; Jean Hay-Smith; Jon Bishop; Eleni Gkini; Karla Hemming; Sara Webb; Mark Pearson; Tim Coleman; Rohini Terry; Libby Edwards; Helena Frawley; Eivor Oborn; Sarah Dean

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MacArthur C, Bick D, Salmon V, et al. Midwifery-led antenatal pelvic floor muscle exercise intervention to reduce postnatal urinary incontinence: APPEAL research programme including a feasibility and pilot cluster RCT. Southampton (UK): National Institute for Health and Care Research; 2024 Nov. (Programme Grants for Applied Research, No. 12.09.)

Appendix 4Additional work package 4.2 tables

TABLE 9

General information on sending/receiving women’s questionnaire

Number of women in the database	1304
Number of women in the database who received maternity care from one of the midwifery teams randomised to APPEAL	1005
Number of out of area women in the database	269
Number of new team’s^a women in the database	4
Number of women in the database for whom no midwifery team recorded	26
Number of women to whom the questionnaire was sent	1294 ^b
Number of women to whom the questionnaire was sent, who received maternity care from one of the midwifery teams randomised to APPEAL	998
Number of out of area women to whom the questionnaire was sent	266
Number of new team’s^a women to whom the questionnaire was sent	4
Number of women to whom the questionnaire was sent but no midwifery team recorded	26
Number of women who returned the questionnaire	231
Number of women who returned the questionnaire, who received maternity care from one of the midwifery teams randomised to APPEAL	175
Number of out of area women who returned the questionnaire	56
Number of new team’s^a women who returned the questionnaire	0
Number of women to whom the short, translated version of the questionnaire was sent	111
Number of women to whom the short, translated version of the questionnaire was sent, who received maternity care from one of the midwifery teams randomised to APPEAL	90
Number of out of area women to whom the short, translated version of the questionnaire was sent	17
Number of new team’s^a women to whom the short, translated version of the questionnaire was sent	3
Number of women to whom the short, translated version of the questionnaire was sent but no midwifery team recorded	1
Number of women who returned the short, translated version of the questionnaire	10
Number of women who returned the short, translated version of the questionnaire and who received maternity care from one of the midwifery teams randomised to APPEAL	8
Number of out of area women who returned the short, translated version of the questionnaire	2
Number of new team’s^a women who returned the short, translated version of the questionnaire	0
Number of women to whom the standard questionnaire was sent	1179
Number of women to whom the standard questionnaire was sent, who received maternity care from one of the midwifery teams randomised to APPEAL	905
Number of out of area women to whom the standard questionnaire was sent	248
Number of new team’s^a women to whom the standard questionnaire was sent	1
Number of women to whom the standard questionnaire was sent but no midwifery team recorded	25
Number of women who returned the standard questionnaire	221
Number of women who returned the standard questionnaire and who received maternity care from one of the midwifery teams randomised to APPEAL	167
Number of out of area women who returned the standard questionnaire	54
Number of new team’s^a women who returned the standard questionnaire	0

a: A new continuity of care team was created in the last month of the trial.
b: 296 women have been excluded from the analysis because either they did not receive maternity care from any of the midwifery teams randomised to APPEAL or the midwifery team name was not reported.

TABLE 10

Information on sending/receiving women’s questionnaire by group

	Intervention (N = 531)	Control (N = 467)	Overall (N = 998)
Number of women to whom the questionnaire was sent	531	467	998
Number of women to whom the short, translated version of the questionnaire was sent	52	38	90
Number of women to whom the standard questionnaire was sent	479	426	905
Number of women to whom the questionnaire was sent one time	98	76	174
Number of women to whom the questionnaire was sent one time, who returned the questionnaire	62	48	110
Number of women to whom the questionnaire was sent two times	433	391	824
Number of women to whom the questionnaire was sent two times, who returned the questionnaire	26	39	65
Total number of questionnaires returned	88	87	175
Number of women who returned the short questionnaire	5	3	8
Number of women who returned the standard questionnaire	83	84	167
Number of women recorded on the database and the questionnaire was not sent to them^a:	6	1	7

a: The questionnaire was not sent to these women due to serious health issues; see Table 11.

TABLE 11

Details on women’s exclusion

	Site 1	Site 2
Stillbirth	0	0
Neonatal death	0	5
Infant death	0	1
Fetal abnormality	1	0
Women whose infants were taken into care due to safeguarding concerns	1	0
Women who have severe mental health problems	8	0
Restricted address	1	0
Twin pregnancy – one twin intrauterine death	0	1

TABLE 12

Minimisation variables used in the randomisation by group and overall

Minimisation variables		Women who returned questionnaire			Women who did not return questionnaire
Minimisation variables		Intervention (N = 88), n (%)	Control (N = 87), n (%)	Overall (N = 175), n (%)	Overall (N = 823), n (%)
Midwifery team size	Small	35 (39.8)	25 (28.7)	60 (34.3)	276 (33.5)
	Large	53 (60.2)	62 (71.3)	115 (65.7)	547 (66.5)
Trust	Site 1	46 (52.3)	23 (26.4)	69 (39.4)	300 (36.5)
	Site 2	42 (47.7)	64 (73.6)	106 (60.6)	523 (63.5)

TABLE 13

Other baseline characteristics by group and overall

		Women who returned questionnaire			Women who did not return questionnaire
		Intervention (N = 88)	Control (N = 87)	Overall (N = 175)	Overall (N = 1063)
*Women’s demographics and other baseline characteristics*
Maternal
Age, years	n	78	77	155	1063
	Mean (SD)	31.6 (4.9)	31.9 (5.5)	31.8 (5.2)	29.6 (N/A^a)
	Minimum, maximum	22, 45	19, 48	19, 48	15, 46
	Median (IQR)	32 (28–35)	32 (29–35)	32 (28–35)	Ν/Α^a
	Missing	10	10	20	0
Ethnicity	n	88	87	175	1063
	British	40 (52.0%)	37 (48.1%)	77 (50.0%)	371 (34.9%)
	Irish	1 (1.3%)	0 (0%)	1 (0.7%)	5 (0.5%)
	White other	5 (6.5%)	1 (1.3%)	6 (3.9%)	46 (4.3%)
	White and Black Caribbean	0 (0%)	0 (0%)	0 (0%)	11 (1.0%)
	White and Black African	0 (0%)	0 (0%)	0 (0%)	4 (0.4%)
	White and Asian	0 (0%)	0 (0%)	0 (0%)	5 (0.5%)
	Mixed other	0 (0%)	0 (0%)	0 (0%)	8 (0.8%)
	Indian	0 (0%)	3 (3.9%)	3 (2.0%)	33 (3.1%)
	Pakistani	3 (3.9%)	7 (9.1%)	10 (6.5%)	205 (19.3%)
	Bangladeshi	2 (2.6%)	0 (0%)	2 (1.3%)	16 (1.5%)
	Asian other	6 (7.8%)	7 (9.1%)	13 (8.4%)	29 (2.7%)
	Black Caribbean	0 (0%)	1 (1.3%)	1 (0.7%)	10 (0.9%)
	Black African	1 (1.3%)	1 (1.3%)	2 (1.3%)	37 (3.5%)
	Black other	3 (3.9%)	1 (1.3%)	4 (2.6%)	16 (1.5%)
	Chinese	0 (0%)	0 (0%)	0 (0%)	6 (0.6%)
	Any other ethnic group	6 (7.8%)	1 (1.3%)	7 (4.6%)	56 (5.3%)
	Not stated	6 (7.8%)	4 (5.2%)	10 (6.5%)	193 (18.2%)
	Declined to answer	0 (0%)	0 (0%)	0 (0%)	0 (0%)
	Not known	4 (5.2%)	14 (18.2%)	18 (11.7%)	12 (1.1%)
	Missing	11	10	21	0
Parity	n	88	87	175	1063
	0	34 (45.3%)	28 (36.8%)	62 (41.0%)	367 (34.5%)
	1	28 (37.3%)	33 (43.4%)	61 (40.4%)	317 (29.8%)
	2	9 (12.0%)	7 (9.2%)	16 (10.6%)	181 (17.0%)
	3	4 (5.4%)	5 (6.6%)	9 (6.0%)	91 (8.6%)
	4	0 (0%)	1 (1.4%)	1 (0.7%)	35 (3.3%)
	5 or more	0 (0%)	2 (2.6%)	2 (1.3%)	72 (6.8%)
	Missing	13	11	24	0
*Obstetric*
Onset of labour	n	88	87	175	1063
	Spontaneous	42 (55.3%)	39 (50.0%)	81 (52.6%)	429 (41.7%)
	Induced	12 (15.8%)	23 (29.5%)	35 (22.7%)	307 (29.8%)
	N/A – elective caesarean section (including failed induction)	22 (28.9%)	16 (20.5%)	38 (24.7%)	293 (28.5%)
	Missing	12	9	21	34
Mode of birth	n	88	87	175	1063
	Ventouse	10 (13.3%)	11 (14.1%)	21 (13.7%)	61 (5.7%)
	Forceps	4 (5.3%)	4 (5.1%)	8 (5.2%)	49 (4.6%)
	Caesarean section	26 (34.7%)	24 (30.8%)	50 (32.7%)	405 (38.1%)
	Spontaneous vaginal birth	35 (46.7%)	39 (50.0%)	74 (48.4%)	547 (51.5%)
	Missing	13	9	22	1
Anaesthetic^b	n	88	87	175	1063
	Spinal	23 (79.3%)	23 (76.7%)	46 (78.0%)	345 (69.4%)
	Epidural	5 (17.2%)	7 (23.3%)	12 (20.3%)	122 (24.5%)
	General	1 (3.5%)	0 (0%)	1 (1.7%)	30 (6.0%)
	Missing	59	57	116	566
Analgesia^c	n	88	87	175	1063
	Yes	39 (72.2%)	50 (80.7%)	89 (76.7%)	524 (49.3%)
	No	15 (27.8%)	12 (19.3%)	27 (23.3%)	539 (50.7%)
	Missing	34	25	59	0
Perineal trauma	n	88	87	175	1063
	First degree	6 (8.3%)	7 (9.1%)	13 (8.7%)	86 (15.2%)
	Second degree	21 (29.2%)	27 (35.1%)	48 (32.2%)	223 (39.5%)
	3a	1 (1.4%)	1 (1.3%)	2 (1.3%)	5 (0.9%)
	3b	1 (1.4%)	0 (0%)	1 (0.7%)	2 (0.4%)
	3c	1 (1.4%)	0 (0%)	1 (0.7%)	0 (0%)
	Fourth degree	0 (0%)	0 (0%)	0 (0%)	1 (0.2%)
	Labial lacerations	0 (0%)	0 (0%)	0 (0%)	0 (0%)
	None	42 (58.3%)	42 (54.5%)	84 (56.4%)	248 (43.9%)
	Missing	16	10	26	498
Episiotomy	n	88	87	175	1063
	Yes	17 (23.3%)	16 (21.1%)	33 (22.2%)	143 (24.0%)
	No	56 (76.7%)	60 (78.9%)	116 (77.8%)	453 (76.0%)
	Missing	15	11	26	467
Duration of second stage (minutes)	n	26	37	63	809
	Minimum, maximum	0, 1260	0, 1860	0, 1860	0, 300
	Median (IQR)	35 (2–143)	36 (10–77)	36 (8–94)	Ν/Α^a
	Missing	62	50	112	254
*Infants*
Gestation at birth (weeks)	n	78	78	156	1063
	Mean (SD)	39.6 (1.6)	39.3 (2.2)	39.4 (1.9)	36.0 (N/A^a)
	Minimum, maximum	34.6, 42.1	24.1, 41.9	24.1, 42.1	23.0, 42.0
	Missing	10	9	19	0
Birthweight (g)	n	78	78	156	1063
	Mean (SD)	3356 (435)	3325 (499)	3340 (467)	3171 (N/A^a)
	Minimum, maximum	2170, 4550	700, 4150	700, 4550	550, 4850
	Missing	10	9	19	0
Head circumference (cm)	n	73	74	147	1015
	Mean (SD)	34.5 (1.3)	34.2 (1.2)	34.4 (1.2)	33.3 (N/A^a)
	Minimum, maximum	32.0, 38.0	30.5, 36.5	30.5, 38.0	21.0, 52.0
	Missing	15	13	28	48

a: The two sites were unable to provide this number.
b: Women can have a combination of anaesthetic methods or none. The specific types of each method have not been reported.
c: Types of analgesia used: APPEAL intervention: aromatherapy, combined spinal and epidural, paracetamol, pethidine, paracetamol codeine, codeine, diamorphine, Entonox^®, TENS, birthing pool, gas and air. Standard care: epidural, combined spinal and epidural, pethidine, paracetamol, codeine, Entonox, TENS, birthing pool.

TABLE 14

Prevalence of UI at 10–12 weeks using ICIQ-UI SF⁴⁰, EARS ⁴³ and PFMESES ⁴²

Prevalence of UI using the ICIQ-UI SF		Intervention (n = 88)	Control (n = 87)
Total ICIQ-UI SF score^a	N	87	86
	Mean (SD)	3.3 (4.5)	4.2 (4.3)
	Missing	1	1
	95% CI	2.1 to 4.5^b	2.9 to 5.6^c
How often do you leak urine?	Never	49 (55.7%)	40 (46.0%)
	About once a week or less	22 (25.0%)	21 (24.1%)
	Two or three times a week	8 (9.0%)	15 (17.2%)
	About once a day	5 (5.7%)	4 (4.6%)
	Several times a day	2 (2.3%)	7 (8.1%)
	All of the time	2 (2.3%)	0 (0%)
	Missing	0	0
How much urine do you usually leak (whether you wear protection or not)?	None	49 (53.3%)	36 (41.8%)
	A small amount	35 (40.2%)	44 (51.2%)
	A moderate amount	3 (23.5%)	6 (7.0%)
	A large amount	0 (0%)	0 (0%)
	Missing	1	1
Overall, how much does leaking urine interfere with your everyday life? Please tick a number between 0 (not at all) and 10 (a great deal)	0	53 (60.2%)	39 (45.3%)
	1	6 (6.8%)	10 (11.6%)
	2	5 (5.7%)	9 (10.5%)
	3	8 (9.1%)	10 (11.6%)
	4	3 (3.4%)	4 (4.7%)
	5	6 (6.8%)	6 (7.0%)
	6	0 (0%)	4 (4.7%)
	7	2 (2.3%)	2 (2.3%)
	8	3 (3.4%)	0 (0%)
	9	0 (0%)	0 (0%)
	10	2 (2.3%)	2 (2.3%)
	Missing	0	1
When does urine leak?^d	Never – urine does not leak	47 (53.4%)	36 (41.4%)
	Leaks before you can get to the toilet	16 (18.2%)	25 (28.7%)
	Leaks when you sneeze	25 (28.4%)	34 (39.1%)
	Leaks when you are asleep	1 (1.1%)	4 (4.6%)
	Leaks when you are physically active/exercising	20 (22.7%)	21 (24.1%)
	Leaks when you have finished urinating and are getting dressed	7 (8.0%)	11 (12.6%)
	Leaks for no obvious reason	5 (5.7%)	3 (3.5%)
	Leaks all of the time	1 (1.1%)	2 (2.3%)
	Missing	0	1
Prevalence of UI^e	Yes	39 (44.3%)	47 (54.0%)
	No	49 (55.7%)	40 (46.0%)
	Missing	0	0
	95% CI	32.0% to 56.1%^f	42.2% to 65.8%^g
Women’s EARS score	N	82	82
	Mean (SD)	10.8 (5.6)	9.4 (5.4)
	Missing	6	5
	95% CI	9.1 to 12.4^f	5.3 to 15.0^g
Total score of self-efficacy (PFMESES): women’s confidence in their practice of performing PFME^h	N	19	22
	Mean (SD)	65.7 (9.1)	65.6 (8.1)
	Missing	69	65
	95% CI	58.0 to 73.2^e	61.0 to 70.3^f
Subscore of self-efficacy (PFMESES): women’s belief in PFME execution and its benefitsⁱ	N	79	76
	Mean (SD)	41.6 (7.5)	41.6 (6.8)
	Missing	9	11
	95% CI	38.9 to 44.2^e	37.9 to 45.4^f
Subscore sum of self-efficacy (PFMESES) in performing PFME as scheduled and despite barriers^j	N	19	24
	Mean (SD)	22.4 (4.5)	23.2 (4.0)
	Missing	69	63
	95% CI	17.9 to 27.0^e	21.3 to 25.1^f

a: The total UI score was calculated using the ICIQ-UI SF, and a higher score indicates a greater impairment from incontinence, with a possible total from 0 to 21.
b: 95% CI around the mean was estimated using a t-distribution with 7 degrees of freedom.
c: 95% CI around the mean was estimated using a t-distribution with 6 degrees of freedom.
d: Responses were not mutually exclusive.
e: UI prevalence was determined by the question ‘How often do you leak urine?’ and defined as ‘no’ if the answer was ‘never’ and ‘yes’ if it was any other response.
f: 95% CI around the proportion who responded ‘yes’ was estimated using a t-distribution with 7 degrees of freedom.
g: 95% CI around the proportion who responded ‘yes’ was estimated using a t-distribution with 6 degrees of freedom.
h: The total score of women’s confidence in their practice of PFME was calculated using the self-efficacy (PFMESES) questionnaire. Higher scores indicate greater confidence of women’s practice of PFME (score can range from 17 to 85).
i: The subscore of belief in PFME execution and its benefits was calculated using 11 of the 17 questions of the self-efficacy (PFMESES) questionnaire. Higher scores indicate a greater belief in PFME execution and its benefits (score can range from 11 to 55).
j: The subscore sum of belief in performing PFME as scheduled and despite barriers was calculated using 6 of the 17 questions of the self-efficacy (PFMESES) questionnaire. Higher scores indicate greater belief in performing PFME as scheduled and despite barriers (score can range from 6 to 30).
: Note
: All 95% CIs are estimated using cluster-level analyses, weighted by the cluster size, after natural log transformations of the data.

TABLE 15

Prevalence of FI at 10–12 weeks using RFIS

		Intervention (n = 88)	Control (n = 87)
*Prevalence of FI at 10–12 weeks using the RFIS* ⁴¹
Total RFI score^a	N	82	82
	Mean (SD)	1.2 (3.1)	0.7 (2.2)
	Missing	6	5
	Total score < 4	72 (87.8%)	78 (95.1%)
	4 ≤ Total score ≤ 6	4 (4.9%)	2 (2.5%)
	7 ≤ Total score ≤ 12	4 (4.9%)	1 (1.2%)
	Total score ≥ 13	2 (2.4%)	1 (1.2%)
	95% CI	0.2 to 2.0^b	0.2 to 0.9^c
Prevalence of FI^d	Yes	15 (18.1%)	11 (13.3%)
	No	68 (81.9)	72 (86.7%)
	Missing	5	4
	95% CI	6.6% to 28.9%^e	4.8% to 21.2%^f
*Prevalence of flatus incontinence*
Prevalence of flatus incontinence^g	Yes	34 (41.0%)	30 (35.7%)
	No	49 (59.0%)	54 (64.3%)
	Missing	5	3
	95% CI	17.9% to 64.6%^e	25.5% to 45.8%^f

a: Total RFI score was calculated using the RFIS, and a higher score indicates greater impairment from incontinence, with a possible total score from 0 to 20.
b: 95% CI around the mean was estimated using a t-distribution with 7 degrees of freedom.
c: 95% CI around the mean was estimated using a t-distribution with 6 degrees of freedom.
d: Prevalence of FI was determined by the following two questions: ‘Do you leak, have accidents or lose control with solid stool?’ and ‘Do you leak, have accidents or lose control with liquid stool?’ and was defined as ‘no’ if the answer to the above question was ‘never’ and ‘yes’ if it was any of the other options.
e: 95% CI around the proportion who responded ‘yes’ was estimated using a t-distribution with 7 degrees of freedom.
f: 95% CI around the proportion who responded ‘yes’ was estimated using a t-distribution with 6 degrees of freedom.
g: Prevalence of flatus incontinence was determined by the question: ‘Do you leak, have accidents or lose control with gas (flatus or wind)?’and defined as ‘no’ if the answer to the above question was ‘never’ and ‘yes’ if it was not.
: Note
: All 95% CIs are estimated using cluster-level analyses, weighted by the cluster size, after natural log transformations of the data.

This work was produced by MacArthur et al. under the terms of a commissioning contract issued by the Secretary of State for Health and Social Care. This is an Open Access publication distributed under the terms of the Creative Commons Attribution CC BY 4.0 licence, which permits unrestricted use, distribution, reproduction and adaptation in any medium and for any purpose provided that it is properly attributed. See: https://creativecommons.org/licenses/by/4.0/. For attribution the title, original author(s), the publication source – NIHR Journals Library, and the DOI of the publication must be cited.

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