Objective: To evaluate the effect of adjunctive use of vaginal progesterone afterMcDonald cerclage on the rate of second-trimester abortion in singleton pregnancy.
Methods:A randomized controlled trial at Woman's Health Hospital, Assiut University, Egypt, between April 2017 and March 2019 enrolled women eligible for McDonald cerclage. After cerclage, participants were randomly assigned to receive progesterone (400 mg pessary) once daily until 37 weeks or no progesterone. The primary outcome was rate of abortion before 28 weeks. Secondary outcomes included gestational age at delivery, preterm delivery, mean birthweight, Apgar score, and admission to the neonatal intensive care unit (NICU).
Results:The rate of spontaneous abortion was higher in the no-progesterone group (P=0.016). Mean gestational age and mean birthweight was higher in the progesterone group (P<0.001 and P=0.002, respectively). The frequency of preterm neonates, neonates with Apgar score less than 7, and admission to NICU was higher in the progesterone group than in the no-progesterone group (P=0.005, P=0.008, and P=0.044, respectively).
Conclusion: Adjunctive use of vaginal progesterone after McDonald cerclage was foundto decrease the frequency of second-trimester abortion and to improve perinatal outcomes in singleton pregnancy.
Clinicaltrials.gov: NCT02846909.
K E Y W O R D S
Cerclage; Perinatal outcome; Progesterone; Spontaneous abortion
| INTRODUCTIONSpontaneous abortion in the second trimester is defined as pregnancy loss between 12 and 24 gestational weeks. 1 Less than 0.5% of pregnancies that reach 20 gestational weeks will end in fetal demise. 2 However, congenital and acquired uterine abnormalities are associated with higher rates of second-trimester abortion, preterm labor, and abnormal fetal presentation. 3Cervical incompetence means that the cervix is weak and unable to remain closed during pregnancy. 4 Cervical cerclage is a commonly performed procedure during pregnancy: it provides mechanical support to the cervix and maintains the endo-cervical mucus plug as a barrier to ascending infection. 5,6 Nevertheless, the rate of abortion before 28 weeks is approximately 30% for women after vaginal cerclage. 7 Therefore, many post-cerclage therapies have been proposed to increase the effectiveness of this procedure. At present, however, there remains controversy regarding these therapies because well-designed randomized studies are lacking and/or have yielded conflicting results. 8Progesterone is known to have an inhibitory action on uterine contractility and is thought to play a key role in maintaining a pregnancy