MAVRIC: A Multicentre Randomised Controlled Trial of Transabdominal Versus Transvaginal Cervical Cerclage

TY - JOUR

T1 - MAVRIC

T2 - A Multicentre Randomised Controlled Trial of Transabdominal Versus Transvaginal Cervical Cerclage

AU - Shennan, Andrew

AU - Chandiramani, Manju

AU - Bennett, Phillip

AU - David, Anna L

AU - Girling, Joanna

AU - Ridout, Alexandra

AU - Seed, Paul T

AU - Simpson, Nigel

AU - Thornton, Steven

AU - Tydeman, Graham

AU - Quenby, Siobhan

AU - Carter, Jenny

N1 - Copyright © 2019. Published by Elsevier Inc.

PY - 2020/3/1

Y1 - 2020/3/1

N2 - BACKGROUND: Vaginal cerclage (a suture around the cervix) is commonly placed in women with recurrent pregnancy loss. These women may experience late miscarriage or extreme preterm delivery, despite being managed with cerclage. Transabdominal cerclage has been advocated following failed cerclage, although its efficacy is unproven by randomised controlled trial.OBJECTIVE: The objective of this study was to compare transabdominal cerclage or high vaginal cerclage to low vaginal cerclage in women with a history of failed cerclage. Our primary outcome was delivery before 32 completed weeks of pregnancy.STUDY DESIGN: This was a multicentre randomised controlled trial. Women were randomly assigned (1:1:1) to receive transabdominal cerclage, high vaginal cerclage or low vaginal cerclage, either prior to conception or before 14 weeks' gestation.RESULTS: 111/139 women recruited who conceived were analysed: 39 to transabdominal cerclage, 39 to high vaginal cerclage and 33 to low vaginal cerclage. Rates of preterm birth <32 weeks were significantly lower in women who received transabdominal cerclage compared to low vaginal cerclage [8% (3/39) v 38% (15/39), RR 0.23 (95% CI 0.07 to 0.76), p=0.0078]. Number needed to treat to prevent one preterm birth was 3.9 (95% CI 2.2 to 13.3). There was no difference in preterm birth rates between high and low vaginal cerclage [38% (15/39) vs 33% (11/33), RR 1.15 (95% CI 0.62 to 2.16), p=0.81]. No neonatal deaths occurred. In an exploratory analysis, women with transabdominal cerclage had fewer fetal losses compared to low vaginal cerclage [3% (1/39) vs 21% (7/33), RR 0.12 (95% CI 0.016 to 0.93), p=0.02]. Number needed to treat to prevent one fetal loss was 5.3 (95% CI 2.9 to 26).CONCLUSIONS: Transabdominal cerclage is the treatment of choice for women with failed vaginal cerclage. It is superior to low vaginal cerclage in reducing risk of early preterm birth and fetal loss in women with previous failed vaginal cerclage. High vaginal cerclage does not confer this benefit. Numbers needed to treat are sufficiently low to justify transabdominal surgery and caesarean delivery required in this select cohort.

AB - BACKGROUND: Vaginal cerclage (a suture around the cervix) is commonly placed in women with recurrent pregnancy loss. These women may experience late miscarriage or extreme preterm delivery, despite being managed with cerclage. Transabdominal cerclage has been advocated following failed cerclage, although its efficacy is unproven by randomised controlled trial.OBJECTIVE: The objective of this study was to compare transabdominal cerclage or high vaginal cerclage to low vaginal cerclage in women with a history of failed cerclage. Our primary outcome was delivery before 32 completed weeks of pregnancy.STUDY DESIGN: This was a multicentre randomised controlled trial. Women were randomly assigned (1:1:1) to receive transabdominal cerclage, high vaginal cerclage or low vaginal cerclage, either prior to conception or before 14 weeks' gestation.RESULTS: 111/139 women recruited who conceived were analysed: 39 to transabdominal cerclage, 39 to high vaginal cerclage and 33 to low vaginal cerclage. Rates of preterm birth <32 weeks were significantly lower in women who received transabdominal cerclage compared to low vaginal cerclage [8% (3/39) v 38% (15/39), RR 0.23 (95% CI 0.07 to 0.76), p=0.0078]. Number needed to treat to prevent one preterm birth was 3.9 (95% CI 2.2 to 13.3). There was no difference in preterm birth rates between high and low vaginal cerclage [38% (15/39) vs 33% (11/33), RR 1.15 (95% CI 0.62 to 2.16), p=0.81]. No neonatal deaths occurred. In an exploratory analysis, women with transabdominal cerclage had fewer fetal losses compared to low vaginal cerclage [3% (1/39) vs 21% (7/33), RR 0.12 (95% CI 0.016 to 0.93), p=0.02]. Number needed to treat to prevent one fetal loss was 5.3 (95% CI 2.9 to 26).CONCLUSIONS: Transabdominal cerclage is the treatment of choice for women with failed vaginal cerclage. It is superior to low vaginal cerclage in reducing risk of early preterm birth and fetal loss in women with previous failed vaginal cerclage. High vaginal cerclage does not confer this benefit. Numbers needed to treat are sufficiently low to justify transabdominal surgery and caesarean delivery required in this select cohort.

U2 - 10.1016/j.ajog.2019.09.040

DO - 10.1016/j.ajog.2019.09.040

M3 - Article

C2 - 31585096

SN - 0002-9378

VL - 222

SP - 261.e1-261.e9

JO - American Journal of Obstetrics and Gynecology

JF - American Journal of Obstetrics and Gynecology

IS - 3

ER -