OBJECTIVE: To evaluate a policy of two stage postpartum perineal repair leaving the skin unsutured. DESIGN: A stratified randomised controlled trial using a 2 x 2 factorial design. SETTING:The maternity unit at Ipswich Hospital NHS Trust, a district general hospital, between 1992 and 1994. SAMPLE: 1780 women requiring surgical repair of episiotomy or first or second degree tear following a spontaneous or simple instrumental delivery. METHODS: A policy of two-stage perineal repair leaving skin unsutured was compared with a policy of three stage repair including skin closure with interrupted or subcuticular sutures. Both groups were assessed by a research midwife, blind to the allocation, completing questionnaires at 24 to 48 hours and 10 days postpartum, and by self-completed questionnaires at three months after birth. MAIN OUTCOME MEASURES: 1. 24 to 48 hours postpartum: perineal pain; healing; 2. 10 days postpartum: perineal pain, healing and removal of sutures; 3. three months postpartum: perineal pain, removal of sutures, resuturing, dyspareunia, and failure to resume pain-free intercourse. RESULTS: Completed questionnaires were returned for 99% of women at both 24 to 48 hours and ten days and by 93% of women three months postpartum. No differences were detected in perineal pain at 24 to 48 hours (62% vs 64%; RR 0.96, 95% CI 0.90-1.03; 2P = 0.3) and 10 days (25% vs 28%; RR 0.90, 95% CI 0.77-1.06; 2P = 0.2). Significantly fewer women allocated to two-stage repair reported tight stitches at ten days (14% vs 18%; RR 0.77, 95% CI 0.62-0.96, 2P = 0.02); similar numbers of repairs were judged to be breaking down (five compared with seven women). At three months postpartum fewer women allocated to the two-stage repair reported perineal pain and more had resumed pain-free intercourse. Amongst women who had resumed intercourse there was a significant difference in dyspareunia (15% vs 19%; RR 0.80, 95% CI 0.65-0.99; 2P = 0.04). Significantly fewer women in the two-stage repair group (7% vs 12%; RR 0.61, 95% CI 0.45-0.83; 2P = < 0.01) reported removal of suture material. Four women in the two-stage repair group had required resuturing, compared with nine allocated to the three-stage repair. CONCLUSIONS: Two-stage repair of perineal trauma leaving the skin unsutured appears to reduce pain and dyspareunia three months postpartum. There are no apparent disadvantages, in particular no evidence of an increased risk of breakdown of the repair and resuturing.
RCT Entities:
OBJECTIVE: To evaluate a policy of two stage postpartum perineal repair leaving the skin unsutured. DESIGN: A stratified randomised controlled trial using a 2 x 2 factorial design. SETTING: The maternity unit at Ipswich Hospital NHS Trust, a district general hospital, between 1992 and 1994. SAMPLE: 1780 women requiring surgical repair of episiotomy or first or second degree tear following a spontaneous or simple instrumental delivery. METHODS: A policy of two-stage perineal repair leaving skin unsutured was compared with a policy of three stage repair including skin closure with interrupted or subcuticular sutures. Both groups were assessed by a research midwife, blind to the allocation, completing questionnaires at 24 to 48 hours and 10 days postpartum, and by self-completed questionnaires at three months after birth. MAIN OUTCOME MEASURES: 1. 24 to 48 hours postpartum: perineal pain; healing; 2. 10 days postpartum: perineal pain, healing and removal of sutures; 3. three months postpartum: perineal pain, removal of sutures, resuturing, dyspareunia, and failure to resume pain-free intercourse. RESULTS: Completed questionnaires were returned for 99% of women at both 24 to 48 hours and ten days and by 93% of women three months postpartum. No differences were detected in perineal pain at 24 to 48 hours (62% vs 64%; RR 0.96, 95% CI 0.90-1.03; 2P = 0.3) and 10 days (25% vs 28%; RR 0.90, 95% CI 0.77-1.06; 2P = 0.2). Significantly fewer women allocated to two-stage repair reported tight stitches at ten days (14% vs 18%; RR 0.77, 95% CI 0.62-0.96, 2P = 0.02); similar numbers of repairs were judged to be breaking down (five compared with seven women). At three months postpartum fewer women allocated to the two-stage repair reported perineal pain and more had resumed pain-free intercourse. Amongst women who had resumed intercourse there was a significant difference in dyspareunia (15% vs 19%; RR 0.80, 95% CI 0.65-0.99; 2P = 0.04). Significantly fewer women in the two-stage repair group (7% vs 12%; RR 0.61, 95% CI 0.45-0.83; 2P = < 0.01) reported removal of suture material. Four women in the two-stage repair group had required resuturing, compared with nine allocated to the three-stage repair. CONCLUSIONS: Two-stage repair of perineal trauma leaving the skin unsutured appears to reduce pain and dyspareunia three months postpartum. There are no apparent disadvantages, in particular no evidence of an increased risk of breakdown of the repair and resuturing.
Authors: Lawrence Leeman; Anne M Fullilove; Noelle Borders; Regina Manocchio; Leah L Albers; Rebecca G Rogers Journal: Birth Date: 2009-12 Impact factor: 3.689
Authors: Patrick L Ergina; Jonathan A Cook; Jane M Blazeby; Isabelle Boutron; Pierre-Alain Clavien; Barnaby C Reeves; Christoph M Seiler; Douglas G Altman; Jeffrey K Aronson; Jeffrey S Barkun; W Bruce Campbell; Jonathan A Cook; Liane S Feldman; David R Flum; Paul Glasziou; Guy J Maddern; John C Marshall; Peter McCulloch; Jon Nicholl; Steven M Strasberg; Jonathan L Meakins; Deborah Ashby; Nick Black; John Bunker; Martin Burton; Marion Campbell; Kalipso Chalkidou; Iain Chalmers; Marc de Leval; Jon Deeks; Adrian Grant; Muir Gray; Roger Greenhalgh; Milos Jenicek; Sean Kehoe; Richard Lilford; Peter Littlejohns; Yoon Loke; Rajan Madhock; Kim McPherson; Peter Rothwell; Bill Summerskill; David Taggart; Parris Tekkis; Matthew Thompson; Tom Treasure; Ulrich Trohler; Jan Vandenbroucke Journal: Lancet Date: 2009-09-26 Impact factor: 79.321