TY - JOUR
T1 - Sexual intercourse association with asymptomatic bacterial vaginosis and Trichomonas vaginalis treatment in relationship to preterm birth
AU - Berghella, Vincenzo
AU - Klebanoff, Mark
AU - McPherson, Cora
AU - Carey, J. Christopher
AU - Hauth, John C.
AU - Ernest, J. M.
AU - Heine, R. Phillip
AU - Wapner, Ronald J.
AU - Trout, Wayne
AU - Moawad, Atef
AU - Leveno, Kenneth J.
AU - Miodovnik, Menachem
AU - Sibai, Baha M.
AU - Van Dorsten, J. Peter
AU - Dombrowski, Mitchell P.
AU - O'Sullivan, Mary J.
AU - Varner, Michael
AU - Langer, Oded
N1 - Funding Information:
Supported by National Institute of Child Health and Human Development grants No. U10 HD21410, U10 HD21414, U10 HD27860, U10 HD27861, U10 HD27869, U10 HD27883, U10 HD27889, U10 HD27905, U10 HD27915, U10 HD27917, U10 HD34116, U10 HD34122, U10 HD34136, U10 HD34208, U10 HD34210, and U10 HD36801 and by National Institute of Allergy and Infectious Diseases grant No. AI 38514.
PY - 2002/11/1
Y1 - 2002/11/1
N2 - OBJECTIVE: The purpose of this study was to determine whether sexual intercourse was associated with the treatment efficacy or the incidence of preterm birth in two large randomized trials in which metronidazole treatment of bacterial vaginosis or Trichomonas vaginalis did not reduce preterm birth. STUDY DESIGN: Secondary analysis of two multicenter, double-blind, placebo-controlled trials in which women with asymptomatic bacterial vaginosis on Gram stain or asymptomatic T vaginalis on culture were randomized at 16 to 23 weeks of gestation to metronidazole or placebo. In both studies, women took 2 g of metronidazole or placebo in the presence of a nurse (first dose) and were given a second dose to take 48 hours later. This regimen was repeated (third and fourth doses) at 24 to 29 weeks. At the time of the third dose, bacterial vaginosis and T vaginalis specimens were collected again. Patients who were randomly selected to receive metronidazole were analyzed for bacterial vaginosis and T vaginalis at 24 to 29 weeks and for preterm birth of <37 weeks of gestation, according to intercourse between first and second doses and between the second and third doses. Continuous variables were compared with the use of the Wilcoxon ranksum test; categoric variables were compared with the use of the χ2 test, Fisher exact test, or the Mantel-Haenzel test of trend. RESULTS: Sexual intercourse between the first and second doses or between the second and third doses did not influence the incidence of bacterial vaginosis (18% vs 24%; relative risk, 0.7; 95% Cl, 0.5-1.1; and 23% vs 20%; relative risk, 1.2; 95% Cl, 0.9-1.6, respectively) or T vaginalis (4% vs 8%; relative risk, 0.5; 95% Cl, 0.1-3.6; and 5% vs 10%; relative risk, 0.5; 95% Cl, 0.2-1.1; respectively) at 24 to 29 weeks of gestation compared with no intercourse. In the T vaginalis trial, sexual intercourse between the first and second doses or between the second and third doses did not influence the incidence of preterm birth (13% vs 17%; relative risk, 0.8; 95% Cl, 0.3-2.1; and 16% vs 17%; relative risk, 1.0; 95% Cl, 0.6-1.6; respectively) compared with no intercourse. In the bacterial vaginosis trial, although sexual intercourse between the first and second doses did not influence the incidence of preterm birth (11% vs 12%; relative risk, 0.9; 95% Cl, 0.6-1.5), sexual intercourse between the second and third doses was associated with a reduction in the incidence of preterm birth (10% vs 16%; relative risk, 0.6; 95% Cl, 0.4-0.9) compared with no intercourse. CONCLUSION: Sexual intercourse was associated with neither the efficacy of metronidazole treatment of bacterial vaginosis or T vaginalis nor with the incidence of preterm birth. In the bacterial vaginosis study, intercourse between the second and third doses had a negative association with preterm birth.
AB - OBJECTIVE: The purpose of this study was to determine whether sexual intercourse was associated with the treatment efficacy or the incidence of preterm birth in two large randomized trials in which metronidazole treatment of bacterial vaginosis or Trichomonas vaginalis did not reduce preterm birth. STUDY DESIGN: Secondary analysis of two multicenter, double-blind, placebo-controlled trials in which women with asymptomatic bacterial vaginosis on Gram stain or asymptomatic T vaginalis on culture were randomized at 16 to 23 weeks of gestation to metronidazole or placebo. In both studies, women took 2 g of metronidazole or placebo in the presence of a nurse (first dose) and were given a second dose to take 48 hours later. This regimen was repeated (third and fourth doses) at 24 to 29 weeks. At the time of the third dose, bacterial vaginosis and T vaginalis specimens were collected again. Patients who were randomly selected to receive metronidazole were analyzed for bacterial vaginosis and T vaginalis at 24 to 29 weeks and for preterm birth of <37 weeks of gestation, according to intercourse between first and second doses and between the second and third doses. Continuous variables were compared with the use of the Wilcoxon ranksum test; categoric variables were compared with the use of the χ2 test, Fisher exact test, or the Mantel-Haenzel test of trend. RESULTS: Sexual intercourse between the first and second doses or between the second and third doses did not influence the incidence of bacterial vaginosis (18% vs 24%; relative risk, 0.7; 95% Cl, 0.5-1.1; and 23% vs 20%; relative risk, 1.2; 95% Cl, 0.9-1.6, respectively) or T vaginalis (4% vs 8%; relative risk, 0.5; 95% Cl, 0.1-3.6; and 5% vs 10%; relative risk, 0.5; 95% Cl, 0.2-1.1; respectively) at 24 to 29 weeks of gestation compared with no intercourse. In the T vaginalis trial, sexual intercourse between the first and second doses or between the second and third doses did not influence the incidence of preterm birth (13% vs 17%; relative risk, 0.8; 95% Cl, 0.3-2.1; and 16% vs 17%; relative risk, 1.0; 95% Cl, 0.6-1.6; respectively) compared with no intercourse. In the bacterial vaginosis trial, although sexual intercourse between the first and second doses did not influence the incidence of preterm birth (11% vs 12%; relative risk, 0.9; 95% Cl, 0.6-1.5), sexual intercourse between the second and third doses was associated with a reduction in the incidence of preterm birth (10% vs 16%; relative risk, 0.6; 95% Cl, 0.4-0.9) compared with no intercourse. CONCLUSION: Sexual intercourse was associated with neither the efficacy of metronidazole treatment of bacterial vaginosis or T vaginalis nor with the incidence of preterm birth. In the bacterial vaginosis study, intercourse between the second and third doses had a negative association with preterm birth.
KW - Bacterial vaginosis
KW - Preterm birth
KW - Sex
KW - Trichomonas vaginalis
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U2 - 10.1067/mob.2002.127134
DO - 10.1067/mob.2002.127134
M3 - Article
C2 - 12439520
AN - SCOPUS:0036856112
SN - 0002-9378
VL - 187
SP - 1277
EP - 1282
JO - American journal of obstetrics and gynecology
JF - American journal of obstetrics and gynecology
IS - 5
ER -