Vaginal Progesterone
to Prevent
Preterm Birth
in High-Risk Women
Abstract Preterm birth is a significant problem in the United States, contributing to neonatal morbidity and mortality.
Progesterone is a hormone naturally produced by the corpus luteum and the placenta in early pregnancy and is essential for
maintaining pregnancy. Clinicians and researchers have used this hormone in later gestation to try to prevent preterm birth.
However, mechanisms of action, indications for use, dosing and administration have varied and are not fully understood.
Th is article revisits two recent randomized controlled trials in which researchers investigated the eff ectiveness of vaginal
progesterone suppositories and gel in the prevention of preterm birth among women who were at high risk for delivering
prematurely.
In this column, we will take a second look
at two recent randomized controlled trials in
which researchers investigated the eff ectiveness
of vaginal progesterone in the prevention of
preterm birth among women who were at high
risk for delivering prematurely. In the fi rst study,
Hassan et al. (2011) identifi ed women who had
a sonographic diagnosis of short cervix and
randomized the women to receive either vaginal
progesterone gel or placebo. In the second
study, Cetingoz et al. (2011) identifi ed women
who were at high risk for preterm birth based
upon history of previous preterm birth, current
twin gestation or existing uterine malformation.
Th ese researchers randomized the women to receive
either vaginal progesterone suppositories
or placebo. Both of these studies provide Level I
evidence
First Study
Previous researchers have established that a
short cervix during pregnancy (diagnosed
by vaginal ultrasound) is predictive of preterm
birth among women who are asymptomatic
( Crane & Hutchens, 2008; Vasibuch et al.,
2010), though management of these asymptomatic
women was unclear. Th e authors of the fi rst
study of vaginal progesterone gel, Hassan et al.
(2011), investigated the effi cacy of vaginal progesterone
gel in reducing the rate of preterm
birth prior to 33 weeks among women with sonographic
evidence of a short cervix but were
otherwise asymptomatic
Design, Sample and Data Analysis
Th ese researchers used a prospective, doubleblind,
placebo-controlled, randomized design
to conduct this international, multicenter study.
Women who were between 19 and 23 weeks gestational
age (GA) were eligible to be screened
for inclusion in the study. Inclusion criteria were
as follows: singleton pregnancy, GA between 19
and 23 weeks, no current signs or symptoms of
preterm labor and a shortened cervical length
(diagnosed by transvaginal ultrasound) of 10
to 20 mm. Once enrolled in the study, the participants
were randomized 1:1 to receive either
90 mg of daily vaginal progesterone (treatment
group) or placebo (control group). Participants
self-administered the progesterone or placebo
each morning and were seen every 2 weeks by
study staff to review medication adherence and
ช่องคลอดโปรเจสเตอโรเพื่อป้องกันไม่ให้คลอดก่อนกำหนดในผู้หญิงอิกนามธรรมคลอดก่อนกำหนดเป็นปัญหาสำคัญในสหรัฐอเมริกา ให้เกิด morbidity ทารกแรกเกิดและการตายโปรเจสเตอโรเป็นฮอร์โมนธรรมชาติผลิต โดย luteum คอร์พัสคริและเข้าสู่รกในครรภ์แรก และเป็นสิ่งจำเป็นสำหรับรักษาการตั้งครรภ์ Clinicians และนักวิจัยได้ใช้ฮอร์โมนนี้ในครรภ์ในภายหลังเพื่อป้องกันการคลอดก่อนกำหนดอย่างไรก็ตาม กลไกของการดำเนินการ บ่งชี้ การใช้ กระบวนการจัดการได้แตกต่างกัน และจะไม่เข้าใจทั้งหมดTh เป็นบทความ revisits สองล่า randomized ควบคุมการทดลองที่นักวิจัยตรวจสอบ ectiveness eff ของช่องคลอดโปรเจสเตอโรยาเหน็บและเจลในการป้องกันการคลอดก่อนกำหนดในหมู่ผู้หญิงที่มีความเสี่ยงสูงสำหรับการส่งมอบก่อนกำหนดในคอลัมน์นี้ เราจะใช้แบบที่สองที่สองล่าสุด randomized ควบคุมการทดลองในนักวิจัยที่สอบสวน eff ectivenessเอกสารช่องคลอดในการป้องกันการคลอดในผู้หญิงสูงความเสี่ยงสำหรับการส่งมอบก่อนกำหนด ในการศึกษาบริษัทอาร์เอสทีเน็ตไร้สายIdentifi Hassan et al. (2011) นักเรียนหญิงที่มีการวินิจฉัย sonographic ของปากมดลูกสั้น และrandomized ผู้หญิงจะได้รับช่องคลอดโปรเจสเตอโรเจลหรือยาหลอก ในที่สองศึกษา identifi Cetingoz et al. (2011) นักเรียนหญิงที่มีความเสี่ยงสูงสำหรับคลอดตามตามประวัติศาสตร์ก่อนคลอด ปัจจุบันครรภ์แฝดหรือ malformation มดลูกอยู่Th ese researchers randomized the women to receiveeither vaginal progesterone suppositoriesor placebo. Both of these studies provide Level IevidenceFirst StudyPrevious researchers have established that ashort cervix during pregnancy (diagnosedby vaginal ultrasound) is predictive of pretermbirth among women who are asymptomatic( Crane & Hutchens, 2008; Vasibuch et al.,2010), though management of these asymptomaticwomen was unclear. Th e authors of the fi rststudy of vaginal progesterone gel, Hassan et al.(2011), investigated the effi cacy of vaginal progesteronegel in reducing the rate of pretermbirth prior to 33 weeks among women with sonographicevidence of a short cervix but wereotherwise asymptomaticDesign, Sample and Data AnalysisTh ese researchers used a prospective, doubleblind,placebo-controlled, randomized designto conduct this international, multicenter study.Women who were between 19 and 23 weeks gestationalage (GA) were eligible to be screenedfor inclusion in the study. Inclusion criteria wereas follows: singleton pregnancy, GA between 19and 23 weeks, no current signs or symptoms ofpreterm labor and a shortened cervical length(diagnosed by transvaginal ultrasound) of 10to 20 mm. Once enrolled in the study, the participantswere randomized 1:1 to receive either90 mg of daily vaginal progesterone (treatmentgroup) or placebo (control group). Participantsself-administered the progesterone or placeboทุกเช้า และได้เห็นทุก 2 สัปดาห์โดยเรียนเพื่อทบทวนการใช้ยาต่าง ๆ และ
การแปล กรุณารอสักครู่..
Vaginal Progesterone
to Prevent
Preterm Birth
in High-Risk Women
Abstract Preterm birth is a significant problem in the United States, contributing to neonatal morbidity and mortality.
Progesterone is a hormone naturally produced by the corpus luteum and the placenta in early pregnancy and is essential for
maintaining pregnancy. Clinicians and researchers have used this hormone in later gestation to try to prevent preterm birth.
However, mechanisms of action, indications for use, dosing and administration have varied and are not fully understood.
Th is article revisits two recent randomized controlled trials in which researchers investigated the eff ectiveness of vaginal
progesterone suppositories and gel in the prevention of preterm birth among women who were at high risk for delivering
prematurely.
In this column, we will take a second look
at two recent randomized controlled trials in
which researchers investigated the eff ectiveness
of vaginal progesterone in the prevention of
preterm birth among women who were at high
risk for delivering prematurely. In the fi rst study,
Hassan et al. (2011) identifi ed women who had
a sonographic diagnosis of short cervix and
randomized the women to receive either vaginal
progesterone gel or placebo. In the second
study, Cetingoz et al. (2011) identifi ed women
who were at high risk for preterm birth based
upon history of previous preterm birth, current
twin gestation or existing uterine malformation.
Th ese researchers randomized the women to receive
either vaginal progesterone suppositories
or placebo. Both of these studies provide Level I
evidence
First Study
Previous researchers have established that a
short cervix during pregnancy (diagnosed
by vaginal ultrasound) is predictive of preterm
birth among women who are asymptomatic
( Crane & Hutchens, 2008; Vasibuch et al.,
2010), though management of these asymptomatic
women was unclear. Th e authors of the fi rst
study of vaginal progesterone gel, Hassan et al.
(2011), investigated the effi cacy of vaginal progesterone
gel in reducing the rate of preterm
birth prior to 33 weeks among women with sonographic
evidence of a short cervix but were
otherwise asymptomatic
Design, Sample and Data Analysis
Th ese researchers used a prospective, doubleblind,
placebo-controlled, randomized design
to conduct this international, multicenter study.
Women who were between 19 and 23 weeks gestational
age (GA) were eligible to be screened
for inclusion in the study. Inclusion criteria were
as follows: singleton pregnancy, GA between 19
and 23 weeks, no current signs or symptoms of
preterm labor and a shortened cervical length
(diagnosed by transvaginal ultrasound) of 10
to 20 mm. Once enrolled in the study, the participants
were randomized 1:1 to receive either
90 mg of daily vaginal progesterone (treatment
group) or placebo (control group). Participants
self-administered the progesterone or placebo
each morning and were seen every 2 weeks by
study staff to review medication adherence and
การแปล กรุณารอสักครู่..