From: Perineal Assessment and Repair Longitudinal Study (PEARLS): a matched-pair cluster randomized trial
Post-natal women-reported outcomes | Phase 1a | Phase 2b | Phase 3c | ||||
---|---|---|---|---|---|---|---|
A | B | A | B | A | B | ||
10-12 days | Primary outcome: pain on walking or sitting in previous 24 hours, % (n) | 74.5% (140) | 75.6% (201) | 76.7% (217) | 74.1% (363) | 78.5% (277) | 78.2% (358) |
Total walking and sitting pain scores over previous 24 hours, mean (SD) | 1.9 (1.6) | 1.7 (1.4) | 1.7 (1.5) | 1.8 (1.5) | 1.9 (1.5) | 1.8 (1.5) | |
Required removal of sutures, % (n) | 2.1% (4) | 2.2% (6) | 0% (0) | 3.7% (18) | 1.4% (5) | 2.8% (13) | |
Took pain relief in previous 24 hours, % (n) | 29.6% (56) | 25.7% (69) | 22.9% (66) | 31.7% (156) | 29.8% (106) | 25.0% (116) | |
Still breastfeeding, % (n) | 65.8% (125) | 66.1% (181) | 63.9% (186) | 67.5% (332) | 68.6% (243) | 69.2% (324) | |
Had perineal wound infection requiring antibiotics, % (n) | 6.9% (13) | 5.5% (15) | 2.8% (8) | 6.1% (30) | 5.0% (18) | 3.9% (18) | |
3 months | Edinburgh Postnatal Depression Score ≥13, % (n) | 6.7% (10) | 7.6% (16) | 11.2% (26) | 10.1% (35) | 11.8% (36) | 10.6% (47) |
Resumed intercourse after 9 weeks or more, % (n) | 41.9% (62) | 48.6% (101) | 53.3% (120) | 56.1% (193) | 56.0% (163) | 50.7% (219) | |
Poor or fairly poor perineal healing, % (n) | 9.3% (14) | 4.7% (10) | 7.5% (17) | 6.7% (23) | 7.5% (23) | 7.1% (31) | |
Still breastfeeding, % (n) | 48.3% (71) | 50.0% (106) | 44.8% (103) | 47.6% (165) | 45.2% (140) | 47.4% (210) |