Table 4.
Analysis of secondary outcomes for expectant management compared with clomifene citrate or unstimulated intrauterine insemination
| No (%) in expectant management group | Clomifene citrate v expectant management | Intrauterine insemination v expectant management | ||||||
|---|---|---|---|---|---|---|---|---|
| No (%) | OR (99% CI), P value | No (%) | OR (99% CI), P value | |||||
| Crude | Adjusted* | Crude | Adjusted* | |||||
| Clinical pregnancy per woman† | 33/193 (17) | 29/192 (15) | 0.86 (0.42 to 1.76), 0.69 | 0.88 (0.42 to 1.82), 0.64 | 43/191 (23) | 1.41 (0.73 to 2.74), 0.23 | 1.47 (0.75 to 2.89), 0.14 | |
| Multiple clinical pregnancy per woman‡ | 2/193 (1) | 2/192 (1) | 1.01 (0.08 to 13.39), 1.00 | — | 1/191 (1) | 0.50 (0.02 to 11.92), 1.00 | — | |
| Miscarriage¶ | 14/46 (30) | 10/38 (26) | 0.82 (0.23 to 2.87), 0.86 | — | 9/55 (16) | 0.45 (0.13 to 1.56), 0.15 | 0.35 (0.09 to 1.40), 0.05 | |
| Ectopic pregnancy¶ | 1/46 (2) | 0/38 (0) | P=1.00 | — | 2/55 (4) | 1.70 (0.07 to 41.56), 1.00 | — | |
| Preterm birth§ | 5/31 (16) | 3/26 (12) | 0.68 (0.09 to 5.12), 0.72 | — | 6/43 (14) | 0.84 (0.16 to 4.59), 1.00 | — | |
| Treatment related hospital admission | 2/160 (1) | 2/168 (1) | 0.95 (0.07 to 12.71), 1.00 | — | 0/163 (0) | P=0.25 | — | |
| Abdominal pain | 5/159 (3) | 40/169 (24) | 9.55 (2.71 to 33.67), <0.001 | 9.76 (2.75 to 34.65), <0.001 | 12/164 (7) | 2.43 (0.60 to 9.88), 0.15 | — | |
| Vaginal bleeding | 4/159 (3) | 7/165 (4) | 1.72 (0.33 to 8.86), 0.58 | 1.65 (0.32 to 8.66), 0.44 | 10/164 (6) | 2.52 (0.53 to 11.88), 0.19 | — | |
| Nausea | 4/159 (3) | 22/166 (13) | 5.92 (1.42 to 24.78), 0.001 | 6.14 (1.43 to 26.44), 0.001 | 3/164 (2) | 0.72 (0.10 to 5.28), 0.72 | — | |
| Vomiting | 0/158 (0) | 1/165 (1) | P=1.00 | — | 0/164 (0) | — | — | |
| Headache | 6/159 (4) | 33/167 (20) | 6.28 (1.92 to 20.50), <0.001 | 6.43 (1.95 to 21.25), <0.001 | 4/164 (2) | 0.64 (0.12 to 3.45), 0.54 | — | |
| Hot flushes | 4/159 (3) | 30/170 (18) | 8.30 (2.04 to 33.79), <0.001 | 8.63 (2.10 to 35.49), <0.001 | 0/164 (0) | — | — | |
| Bloating | 0/158 (0) | 33/168 (20) | P<0.001 | — | 6/164 (4) | — | — | |
| Process of treatment acceptable | 123/153 (80) | 159/170 (94) | 3.53 (1.35 to 9.20), 0.001 | 3.77 (1.42 to 9.99), <0.001 | 155/162 (96) | 5.40 (1.75 to 16.64), <0.001 | 5.55 (1.78 to 17.25), <0.001 | |
| Outcome of treatment acceptable | 82/148 (55) | 100/168 (60) | 1.18 (0.66 to 2.13), 0.53 | 1.20 (0.66 to 2.17), 0.44 | 117/159 (74) | 2.24 (1.20 to 4.21), 0.001 | 2.27 (1.19 to 4.31), 0.001 | |
| HADS subscale ≥11: | ||||||||
| Anxiety | 31/171 (18) | 34/175 (19) | 1.09 (0.54 to 2.21), 0.86 | 1.09 (0.53 to 2.25), 0.75 | 22/173 (13) | 0.66 (0.30 to 1.43), 0.22 | 0.64 (0.29 to 1.42), 0.15 | |
| Depression | 4/170 (2) | 4/174 (2) | 0.98 (0.16 to 6.17), 1.00 | — | 2/172 (1) | 0.49 (0.05 to 4.63), 0.45 | — | |
HADS=hospital anxiety and depression scale.
*Adjusted for maternal age, parity, duration of infertility, and recruitment centre.
†At least one fetal heart beat seen on ultrasound.
‡At least two fetal heart beats seen on ultrasound.
¶Denominator is biochemical pregnancy (positive pregnancy test).
§Gestation period ≤37 weeks; denominator is live births with known gestation period.