Table 1.
Baseline characteristics of all randomised participants.
| UPA (N = 118) | LNG-IUS (N = 118) | Overall (N = 236) | |
|---|---|---|---|
| Agea | |||
| ≤35 years | 15 (13%) | 15 (13%) | 30 (13%) |
| >35 years | 103 (87%) | 103 (87%) | 206 (87%) |
| Mean (SD) | 42.7 (7.0) | 42.4 (6.9) | 42.5 (7.0) |
| BMIa | |||
| ≤25 kg/m2 | 28 (24%) | 28 (24%) | 56 (24%) |
| >25 kg/m2 | 90 (76%) | 90 (76%) | 180 (76%) |
| Mean (SD) | 30.7 (7.0) | 30.9 (7.1) | 30.8 (7.0) |
| Duration of symptomsa | |||
| <1 year | 16 (14%) | 12 (10%) | 28 (12%) |
| ≥1 year | 102 (86%) | 106 (90%) | 208 (88%) |
| Median [IQR] | 24 [15–64] | 48 [15–120], 1 | 36 [15–84] |
| Fibroidsa | |||
| Fibroids>2 cm | 31 (26%) | 27 (23%) | 58 (25%) |
| Fibroids≤2 cm | 12 (10%) | 11 (9%) | 23 (10%) |
| No fibroids | 75 (64%) | 80 (68%) | 155 (66%) |
| Number of fibroidsb | |||
| 1 | 22 (19%) | 21 (18%) | 43 (18%) |
| 2 | 8 (7%) | 8 (7%) | 16 (7%) |
| >2 | 12 (10%) | 9 (8%) | 21 (9%) |
| Volume of largest fibroid (ml)b | |||
| Median [IQR], n | 13.4 [2.9–41.8], 38 | 8.6 [2.1–40.6], 34 | 10.5 [2.8–41.2], 72 |
| Missing | 5 | 4 | 9 |
| Ethnicity | |||
| White | 110 (93%) | 108 (92%) | 218 (92%) |
| Mixed | 2 (2%) | 1 (1%) | 3 (1%) |
| Asian | 4 (3%) | 6 (5%) | 10 (4%) |
| Black | 2 (2%) | 3 (3%) | 5 (2%) |
| Number of times the patient has been pregnant | |||
| Median [IQR], n | 2 [1–3],118 | 2 [1–3],116 | 2 [1–3],234 |
| Missing | 0 | 2 | 2 |
| Result of pregnancyc | |||
| Live birth | 96 (81%) | 86 (73%) | 182 (77%) |
| Still birth | 3 (3%) | 1 (1%) | 4 (2%) |
| Termination | 22 (19%) | 17 (14%) | 39 (17%) |
| Miscarriage/ectopic | 30 (25%) | 20 (17%) | 52 (22%) |
| None reported | 3 | 5 | 8 |
| Route of deliveriesc | |||
| Vaginal | 73 (62%) | 65 (55%) | 138 (58%) |
| Caesarean | 29 (25%) | 28 (24%) | 57 (24%) |
| Forceps/ventouse | 13 (11%) | 14 (12%) | 27 (11%) |
| None reported | 8 | 10 | 18 |
| Previous treatments for HMB c | |||
| Mefenamic Acid/NSAIDs | 39 (33%) | 39 (33%) | 78 (33%) |
| Tranexamic Acid | 71 (60%) | 66 (56%) | 137 (58%) |
| Combined Oral Contraceptive | 29 (25%) | 28 (24%) | 57 (24%) |
| Progesterone Only Pill | 21 (18%) | 26 (22%) | 47 (20%) |
| Norethisterone | 29 (25%) | 34 (29%) | 63 (27%) |
| Depo-Provera (medroxyprogesterone acetate) | 10 (8%) | 5 (4%) | 15 (6%) |
| Implant (Nexplanon/Implanon) | 5 (4%) | 7 (6%) | 12 (5%) |
| Ulipristal Acetate | 0 (−) | 1 (1%) | 1 (<1%) |
| LNG-IUS | 17 (14%) | 16 (14%) | 33 (14%) |
| None reported | 0 | 1 | 1 |
| Previous Surgical treatments c | |||
| Surgical termination | 15 (13%) | 10 (8%) | 25 (11%) |
| Surgical management of miscarriage | 8 (7%) | 5 (4%) | 13 (6%) |
| Uterine curettage | 6 (5%) | 6 (5%) | 12 (5%) |
| None reported | 0 | 1 | 1 |
| Evidence of adenomyosis | |||
| Yes | 8 (7%) | 12 (10%) | 20 (8%) |
| No | 92 (78%) | 86 (73%) | 178 (75%) |
| Missing | 18 | 20 | 38 |
a
Minimisation variable.
b
Figures based (denominator) on those that were identified as having fibroids on ultrasound.
c
More than one option possible.