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    i

    JOURNAL READING

    Disusun oleh :Dian Muflikhy PutriNIM 112011101076

    Dokter Pembimbing:dr. Gogot Suharyanto Sp.OG

    SMF ILMU OBSTETRI DAN GINEKOLOGI

    RSD DR. SOEBANDI JEMBER

    FAKULTAS KEDOKTERAN

    UNIVERSITAS JEMBER

    2015

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    ii

    JOURNAL READING

    Disusun oleh :Dian Muflikhy PutriNIM 112011101076

    Dokter Pembimbing:dr. Gogot Suharyanto Sp.OG

    Disusun untuk melaksanakan tugas Kepaniteraan Klinik MadyaSMF Ilmu Obstetri dan Ginekologi di RSD dr. Soebandi

    SMF ILMU OBSTETRI DAN GINEKOLOGIRSD DR. SOEBANDI JEMBER

    FAKULTAS KEDOKTERAN

    UNIVERSITAS JEMBER

    2015

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    Gynecology & ObstetricsRegmi et al., Gynecol Obstet 2012, 2:4

    http://dx.doi.org/10.4172/2161-0932.1000125

    Research Article Open Access

    Volume 2 • Issue 4 • 1000125Gynecol ObstetISSN:2161-0932 Gynecology an open access journal

    Progesterone for Prevention of Recurrent Preterm Labor after ArrestedPreterm Labor- A Randomized Controlled TrialMohan C. Regmi*, Pappu Rijal, Ajay Agrawal and Dhruba Uprety

    Department of Obstetrics and Gynecology, BPKIHS, Dharan, Nepal

    Abstract

    Background: Preterm birth is the major cause of neonatal mortality and morbidity. In developing countries, it’s amajor health hazard. But there are very few evidence based interventions to prevent it. This study focus on preventionof preterm birth.

    Methods: A randomized controlled trial was undertaken in BP Koirala Institute of Health Sciences, where 60patients were randomized into group 1 (n=29, weekly intramuscular Progesterone) and group 2 (n=31,no treatment)after the arrest of preterm labor with tocolysis. Their latency period till delivery and recurrence of preterm labor andneonatal outcomes were compared.

    Results: There was signi cant reduction in recurrence of preterm labor and increase in latency period inprogesterone group. However neonatal outcomes were similar.

    Conclusion: Progesterone is useful in reducing the recurrence of preterm labor in a patient who had pretermlabor.

    *Corresponding author: Mohan C. Regmi, Associate Professor, Department ofObstetrics and Gynecology, BPKIHS, Dharan, Nepal, Tel: 9852049414; E-mail:[email protected]

    Received June 17, 2012; Accepted July 11, 2012; Published July 17, 2012

    Citation: Regmi MC, Rijal P, Agrawal A, Uprety D (2012) Progesterone forPrevention of Recurrent Preterm Labor after Arrested Preterm Labor- A RandomizedControlled Trial. Gynecol Obstet 2:125. doi: 10.4172/2161-0932.1000125

    Copyright: © 2012 Regmi MC, et al. This is an open-access article distributedunder the terms of the Creative Commons Attribution License, which permitsunrestricted use, distribution, and reproduction in any medium, provided theoriginal author and source are credited.

    Keywords: Progesterone; Preterm labor; ocolysis

    IntroductionPreterm birth is the major cause o neonatal mortality and

    morbidity [1]. In addition, prematurity is strongly associated withlong-term developmental disabilities, accounting or 1 in 5 childrenwith mental retardation, 1 in 3 children with vision impairment, andalmost hal o children with cerebral palsy. Importantly, low-birth-weight in ants who are spared signicant neonatal morbidity are athigher risk or cardiovascular disease (myocardial in arction, stroke,and hypertension) and diabetes as adults [2]. Te incidence o pretermbirth in developing countries is higher than in developed countries. So,prevention o preterm birth is a public health priority. Pharmacologicaltherapy with a variety o drugs o different categories has been theprimary method o treating acute preterm labour [3]. Patients witharrested preterm labor are at increased risk or recurrence, but tothis point, continued tocolytic treatment with any agent afer arresto acute preterm labor is o questionable value in extending gestationor improving outcome [3,4]. Te efficacy o maintenance tocolytictherapy afer success ul arrest o preterm labor remains controversial.Tis question is not limited to the use o a specic drug as the dataare similar or terbutaline, magnesium sulphate, and calcium channelblockers [3].

    Spontaneous preterm birth, that is preterm birth afer laboror rupture o the membranes, represents approximately 75% o allpreterm births [5]. O all treatments evaluated or the preventiono spontaneous preterm birth to date, progestational agents havedemonstrated the greatest promise. Te exact mechanism oprogesterone in the prevention o preterm birth is not known,although progesterone has been shown to prevent the ormation o gap junctions, to have an inhibitory effect on myometrial contractions, andto prevent spontaneous abortion in women in early pregnancy aferexcision o the corpus luteum [6-8]. Progesterone has also been shownto delay parturition in animals [9]. In the last 40 years, progestins havebeen administered to pregnant women or several reasons, includingthreatening miscarriage, recurrent miscarriage, prevention o pretermlabor and luteal support during in vitro ertilization treatment [10-12].

    Progesterone is use ul in allowing pregnancy to reach its physiologicterm because at sufficient levels in the myometrium, it blocks theoxytocin effect o prostaglandin F2α and α-adrenergic stimulation and

    there ore, increases the α-adrenergic tocolytic response [13]. Naturalprogesterone is ree o any disturbing teratogenic, metabolic, orhemodynamic effects. Tis is not true or certain articial progestagensand -mimetics [14].

    In 2003, two widely published double-blind trials, one odaily vaginal progesterone suppositories and the other o weeklyintramuscular injections o 17alpha-hydroxyprogesterone, claimedthat the treatments effectively reduce the incidence o preterm birth inwomen at risk o spontaneous preterm labour [15,16].

    In study published in 2007, vaginal progesterone treatmentreduced the rate o preterm birth among women who were at highrisk or preterm birth because o a short cervix [17]. Progesterone haslong been considered important agents in the maintenance o uterinequiescence and has been used extensively in primary and secondaryprevention o preterm labor [15,18].

    We there ore, chose this pharmacological agent as the active drugor our study. Tis randomized trial was designed to assess the use

    o progesterone therapy in women who presented with symptomso preterm labor in preventing the recurrence o preterm labor andincrease the latency period afer success ul tocolysis.

    Methods

    Tis randomized controlled trial was per ormed in the Departmento Obstetrics and Gynecology at B.P. Koirala Institute o HealthSciences over the duration o 1.5 years rom 2009 January to June 2010.Te Institutional Ethical Review Board approved this.

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    Citation: Regmi MC, Rijal P, Agrawal A, Uprety D (2012) Progesterone for Prevention of Recurrent Preterm Labor after Arrested Preterm Labor- ARandomized Controlled Trial. Gynecol Obstet 2:125. doi: 10.4172/2161-0932.1000125

    Page 2 of 3

    Volume 2 • Issue 4 • 1000125Gynecol ObstetISSN:2161-0932 Gynecology an open access journal

    Women o 28-34 weeks period o gestation who were admittedto the Obstetrics ward with preterm labor were involved in the studyafer their labor was success ully arrested with tocolytics. Pretermlabor was dened as the simultaneous presence o contractions (> sixcontractions in 30 min) and cervical changes, either shortening and/orsofening or dilation, by manual examination.

    Recurrence o preterm labor was dened as recurrence ocontractions within 48 h afer discontinuation o tocolysis and arrest ocontractions. Arrested preterm labor was dened as a 12-h contraction-

    ree period afer tocolytic therapy had been discontinued.

    Inclusion criteria were singleton pregnancy, intact membranes,no cerclage, cervical dilation o < 2 cm, and the dating o pregnancyconrmed through rst trimester ultrasound scanning or lastmenstrual period. Te cervical dilatation o 2 cm was taken accordingto observation in the institute that > 2cm dilatation was associated withpoor response with tocolysis.

    Exclusion criteria included clinical evidence o intra-amnioticin ection or pyelonephritis, medical complications contraindicatingtocolysis, evidence o etal growth retardation, and sonographicevidence o congenital anomalies inconsistent with li e.

    At admission, all patients had a haemogram, urine microscopy andculture sensitivity and a high vaginal swab or culture and sensitivity.All patients were given oral tocolytic, with an initial bolus o 30 mgNi edipine ollowed by 10 mg 8 hourly. All patients received antibioticprophylaxis consisting o ablet Azithromycin 500 mg once a day or 5days along with a ve day course o oral Metronidazole. Tey were givensingle course o Betamethasone, consisting o two 12 mg injectionsduring the rst 24 h afer admission. Afer arrested preterm labor wasdiagnosed, the patient was counseled about the study and offered aninstitutional review board-approved in ormed consent document.Patients included in the study were randomized within 24 h o arresto labor. Te random list was prepared with a computer generatednumber list. Odds (progesterone, Group 1) and pairs (control, Group 2)dened treatment allocation (Figure 1). Patients who were enrolled ascases received Hydroxy progesterone Caproate 250 mg intramuscularweekly till 37 completed weeks or earlier i they delivered. Teremaining patients were included as control subjects and receivedno drugs. Tey were discharged or observation in the obstetric clinicweekly. Tey were ollowed up either at clinic or by telephone i they donot ollow at clinic. Te primary outcomes measure were the time untildelivery (latency period) and recurrence o preterm labor within 48 hafer discontinuation o tocolytic treatment and arrest o contraction.Secondary outcome measures were incidence o low birth weight, andperinatal morbidity (respiratory distress syndrome, intraventricularhemorrhage, necrotizing enterocolitis, and proven sepsis) assessed atthe admission to Neonatal Intensive Care Unit (NICU).

    Categorical data were tested or signicance with the χ2 and Fisherexact tests. Continuous data were evaluated or normal distribution andtested or signicance with the Student’s t -test. Statistical signicancewas dened as P < 0.05. All patients were included in the analysis.

    ResultsTere were total 60 patients at the study duration that ullled the

    inclusion criteria and were randomized to receive either progesteroneor no treatment at all. Most o the patients admitted were rom vicinityo the institute in both groups. Only ew o them were (n=8) wereilliterate. None o the patient had history o in ertility. No patients had

    history o previous preterm birth. None o the patients were nullipara.Tere was no history o polyhydramnios. All the patients had BishopScore < 3.Both groups were comparable to each other ( able 1).

    Tere was signicant increase in latency period in intervention armwith decrease in incidence o recurrent preterm labor ( able 2).

    Tere was no difference in neonatal outcome in both groups.

    Te birth weight, incidence o respiratory distress syndrome, needo neonatal intensive care unit admission was similar in both groups( able 3).

    DiscussionTe study showed signicant reduction in recurrent preterm labor

    with the use o progesterone (38% vs. 64%). However neonatal outcomeswere comparable. In 2005, Roberta Mackenzie et al. [19] conducted ameta-analysis evaluating the use o progesterone or women with highrisk o preterm birth. Tree trials were eligible or inclusion. Terewas a signicant reduction in risk o delivery less than 37 weeks withprogestational agents. Tere was no signicant effect on perinatalmortality or serious neonatal morbidity. Te nding was similar to ourstudy. In 2006, a meta-analysis by Aravinthan Coomarasamy et al. [20]evaluated the use o progesterone in prevention o preterm deliveryin high risk patients. A total o nine randomized control trials wereevaluated comprising o about 500 patients. Meta-analyses showedreductions in delivery rates be ore 37 weeks as well as in respiratory

    Pa t ents with arrestedpreterm labor (n=60)

    Group 1 (17-OHP)n=29, followed t ll

    delivery

    Group 2 (no Therapy )n=31 followed t ll

    delivery

    Figure 1: A randomized controlled trial with tocolysis in two different groups.

    Variables 17-OHP (n=29) No therapy(n=31) P value*

    Age in years(mean) 23.24 ± 3.47 22.81 ± 3.73 0.642

    Period of gestation atadmission(weeks) 32.62 ± 1.72 32.90 ± 1.94 0.552

    Parity 1.48 1.29

    Bishop Score

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    Citation: Regmi MC, Rijal P, Agrawal A, Uprety D (2012) Progesterone for Prevention of Recurrent Preterm Labor after Arrested Preterm Labor- ARandomized Controlled Trial. Gynecol Obstet 2:125. doi: 10.4172/2161-0932.1000125

    Page 3 of 3

    Volume 2 • Issue 4 • 1000125Gynecol ObstetISSN:2161-0932 Gynecology an open access journal

    distress syndrome with progestational agents. Most o the patients hadsome o one or more risk actors or preterm birth prior to pregnancy.Our study had homogenous comparable population prior to onset opreterm labor. A similar study was carried out by Sedigheh BORNAand Noshin SAHABI [21] in ehran in 2004, where progesterone wasgiven to women afer threatened preterm labor in one arm where asanother arm o patients received no treatment. Tere was signicantincrease in mean latency until delivery, decrease in respiratorydistress syndrome, and decrease in low birth weight in progesteronearm group. No signicant differences were ound between recurrentpreterm labor, admission to intensive care unit and neonatal sepsis

    or the progesterone and control groups, respectively. Our study hadsignicantly decreased in incidence o recurrent preterm labor inprogesterone arm group.

    All the study discussed above except that one by SedighehBORNA and Noshin SAHABI, the comparison was difficult becausein other study it was to prevent the preterm labor with progesterone

    with patients already having risk o preterm labor. Our study hadprogesterone started afer the arrest o preterm labor. Te risk presentin our patient was episode o preterm labor arrested by tocolysis. Terewas difference in type o progesterone use and the gestational age atwhich they were recruited. In our study it was bit late (32 weeks).

    Te limitation o our study was small sample size and was notcompared with placebo. Tere was no blinding. So selection bias couldnot be reduced.

    ConclusionProgesterone are promising agent to reduce the incidence o

    recurrent preterm birth afer arrest o preterm labor. Studies withlarger sample size with double blinding as well as earlier recruitment o

    patient (at 28-32 weeks) would probably give more convincing results.Acknowledgement

    We would extend my sincere thanks to National Health Research Council forsupporting this research. We would like to extend sincere thanks to our instituteand all the participants of the study.

    Con ict of Interest

    The authors have no potential con ict of interest.

    References

    1. National Center for Health Statistics, NVSR (2001) Deaths and percentage oftotal deaths for the 10 leading causes of neonatal and postneonatal deaths:United States, 2001.

    2. Gluckman PD, Hanson MA (2004) Living with the past: evolution, developmentand patterns of disease. Science 305: 1733-1736.

    3. Sanchez-Ramos L, Kaunitz AM, Gaudier FL, Delke I (1999) Ef cacy ofmaintenance therapy after acute tocolysis: a meta-analysis. Am J ObstetGynecol 181: 484-490.

    4. Thornton JG (2005) Maintenance tocolysis. BJOG 112 : 118-121.

    5. Meis PJ, Goldenberg RL, Mercer BM, Iams JD, Moawad AH, et al. (1998) Thepreterm prediction study: risk factors for indicated preterm births. Maternal-Fetal Medicine Units Network of the National Institute of Child Health andHuman Development. Am J Obstet Gynecol 178: 562-567.

    6. Gar eld RE, Kannan MS, Daniel EE (1980) Gap junction formation inmyometrium: control by estrogens, progesterone, and prostaglandins. Am JPhysiol 238: C81-C89.

    7. Allen WM, Reynolds SRM (1935) Physiology of the corpus luteum: thecomparative actions of crystalline progestin and crude progestin on uterinemotility in unanesthetized rabbits. Am J Obstet Gynecol 30: 309-318.

    8. Csapo AI, Pulkkinen MO, Wiest WG (1973) Effects of luteectomy andprogesterone replacement therapy in early pregnant patients. Am J ObstetGynecol 115: 759-765.

    9. Whitely JL, Hartmann PE, Willcox DL, Bryant-Greenwood GD, GreenwoodFC (1990) Initiation of parturition and lactation in the sow: effects of delayingparturition with medroxyprogesterone acetate. J Endocrinol 124: 475-484.

    10. Daya S, Gunby J (2004) Luteal phase support in assisted reproduction cycles.

    Cochrane Database Syst Rev CD004830.11. Oates-Whitehead RM, Haas DM, Carrier JA (2003) Progestogen for preventing

    miscarriage. Cochrane Database Syst Rev CD003511.

    12. Friedler S, Raziel A, Schachter M, Strassburger D, Bukovsky I, et al. (1999)Luteal support with micronized progesterone following in-vitro fertilization usinga down-regulation protocol with gonadotrophin releasing hormone agonist: Acomparative study between vaginal and oral administration. Hum Reprod 14:1944-1948.

    13. Fuchs AR, Fuchs F (1984) Endocrinology of human parturition: a review. Br JObstet Gynaecol 91: 948-967.

    14. Keelan JA, Myatt L, Mitchell MD (1997) Endocrinology and paracrinology ofparturition. In: Elder MG, Lamont RF, Romero R, (Eds) Preterm labor. ChurchillLivingstone, Philadelphia pp: 457-491.

    15. da Fonseca EB, Bittar RE, Carvalho MH, Zugaib M (2003) Prophylacticadministration of progesterone by vaginal suppository to reduce the incidenceof spontaneous preterm birth in women at increased risk: A randomizedplacebo-controlled double-blind study. Am J Obstet Gynecol 188: 419-424.

    16. Meis PJ, Klebanoff M, Thom E, Dombrowski MP, Sibai B, et al. (2003)Prevention of recurrent preterm delivery by 17 alpha-hydroxyprogesteronecaproate. N Engl J Med 348: 2379-2385.

    17. Fonseca EB, Celik E, Parra M, Singh M, Nicolaides KH, et al. (2007)Progesterone and the risk of preterm birth among women with a short cervix. NEngl J Med 357: 462-469.

    18. Noblot G, Audra P, Dargent D, Faguer B, Mellier G (1991) The use of micronizedprogesterone in the treatment of menace of preterm delivery. Euro J ObstetGynecol Reprod Biol 40: 203-209.

    19. Mackenzie R, Walker M, Armson A, Hannah ME (2006) Progesterone for theprevention of preterm birth among women at increased risk: A systematicreview and meta-analysis of randomized controlled trials. Am J Obstet Gynecol

    194: 1234-1242.20. Coomarasamy A, Thangaratinam S, Gee H, Khan KS (2006) Progesterone for

    the prevention of preterm birth: A critical evaluation of evidence. Eur J ObstetGynecol Reprod Biol 129: 111-118.

    21. Borna S, Sahabi N (2008) Progesterone for maintenance tocolytic therapy afterthreatened preterm labour: A randomised controlled trial. Aust N Z J ObstetGynaecol 48: 58-63.

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    Abstrak

    Latar belakang : kelahiran preterm merupakan penyebab utama mortalitas dan

    morbiditas dari neonatal. Masalah ini menjadi sorotan di negara berkembang.

    Tetapi, hanya ada sedikit tindakan medis yang efektif untuk mencegahnya.

    Penelitian ini bertujuan pada pencegahan dari kelahiran preterm.

    Metode : sebuah kontrol aacak dilakukan di institut ilmu kesehatan BP koirla,

    dimana terdapat 60 pasien dimasukkan ke dalam 2 kelompok secara acak ( grup 1,

    diberikan progesterone mingguan; grup 2, tidak diberikan perlakuan). Waktu

    hingga persalinan terjadi dan kejadian rekurensi dari persalinan preterm dan

    keadaan neonatal akan dibandingkan.

    Hasil : terdapat hasill signifikan dalam pengurangan kejadian persalinan preterm

    dan peningkatan periode latensi dari persalinan dalam kelompok yang diberi

    progesteron, namun, kondisi neonatal hampir sama.

    Kesimpulan. Progesteron memberikan hasil dalam mengurangi persalinan preterm

    pada pasien yag telah mengalami persalinan preterm sebelumnya.

    PendahuluanPersalinan preterm adalah penyebab utaama dari mortalitas dan

    morbiditas neonatal. Prematuritas berhubugan erat degan disabilitas

    perkembangan anak, seperti retardasi mental, gangguan penglihatan, dan cerebral

    palsy. Lebih jauh lagi, bayi lahir dengan berat badan rendar lebih beresiko terkena

    penyakit kardiovaskuler dan diabetes melitus pada masa dewasa. Insiden

    kelahiran preterm pada negara berkembang lebih tinggi dari negara maju. Oleh

    karena itu, pencegahan persalinan preterm menjadi masalah kesehatan yang

    penting. Terapi farmakologis menjadi metode utama dalam mengobati persalinan

    preterm. Pasien dengan persalinan preterm memiiliki tingkat rekurensi yang

    tinggi.

    Pasien ynag pernah mengalami persalinan prematur memiliki

    kesempatan tinggi untuk kekambuhan. Khasiat pemeliharaan tokolitik masih

    kontroversial. Begitu juga dengan penggunaan obat terbutalin , magnesium sulfat ,

    dan calcium channelblockers

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    Kelahiran prematur spontan , yang lahir setelah pecahnya membran,

    mewakili sekitar 75 % dari semuakelahiran prematur. Dari semua perawatan

    dievaluasi untuk pencegahan kelahiran prematur spontan sampai saat ini , agen

    progestasional memiliki potensi besar. Mekanisme yang tepat dari progesteron

    dalam pencegahan kelahiran prematur tidak diketahui, meskipun progesteron telah

    terbukti mencegah pembentukan gap persimpangan , memiliki efek penghambatan

    pada kontraksi miometrium , dan untuk mencegah aborsi spontan pada wanita di

    awal kehamilan setelah eksisi korpus luteum. Progesteron juga telah ditunjukkan

    untuk menunda proses kelahiran pada hewan. Dalam 40 tahun terakhir , progestin

    telah diberikan kepada wanita hamil karena beberapa alasan, abortus iminens,

    abortus inibitus, pencegahan persalinan preterm.

    Progesteron berguna dalam memungkinkan kehamilan mencapai aterm

    pada kadar yang cukup dalam miometrium, bekerja denagn memblok efek

    oksitosin prostaglandin F2α dan stimulasi α - adrenergik dan oleh karena itu,

    meningkatkan respon tokolitik α - adrenergik. Alam progesteron bebas dari

    mengganggu teratogenik , metabolisme , atau efek hemodinamik . Hal ini tidak

    berlaku untuk progestagens buatan tertentu dan – mimetics.

    Pada tahun 2003 , dua dipublikasikan secara luas percobaan double-

    blind, salah satu harian supositoria progesteron vaginal dan lain mingguan

    suntikan intramuskular 17alpha - hidroksiprogesteron , mengaku bahwa

    perawatan efektif mengurangi kejadian kelahiran prematur di wanita yang berisiko

    persalinan prematur spontan.

    Dalam studi yang dipublikasikan pada tahun 2007 , pengobatan

    progesteron vaginal mengurangi tingkat kelahiran prematur pada wanita yang

    berada di tinggi risiko kelahiran prematur karena leher rahim pendek. Progesteron

    memiliki lama dianggap agen penting dalam pemeliharaan uterus ketenangan dan

    telah digunakan secara luas di primer dan sekunder pencegahan persalinan

    prematur.

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    Oleh karena itu kita , memilih agen farmakologis ini sebagai obat aktif

    untuk penelitian kami . Uji coba secara acak ini dirancang untuk menilai

    penggunaanterapi progesteron pada wanita yang disajikan dengan gejalapersalinan

    prematur dalam mencegah kekambuhan persalinan prematur dan meningkatkan

    masa laten setelah sukses tokolisis.

    Metode

    Uji coba terkontrol secara acak ini dilakukan di Departemen Obstetri

    dan Ginekologi di B.P. Koirala Institut Kesehatan Ilmu selama durasi 1,5 tahun

    dari Januari 2009 hingga Juni 2010 . The Institutional Ethical Review Boarddisetujui ini .

    Wanita periode 28-34 minggu kehamilan yang dirawat ke bangsal

    Obstetri dengan persalinan prematur yang terlibat dalam penelitian ini setelah

    kerja mereka berhasil ditangkap dengan tokolitik . prematurtenaga kerja

    didefinisikan sebagai keberadaan simultan kontraksi ( > enam kontraksi dalam 30

    menit ) dan perubahan serviks , baik shortening dan / atau pelunakan atau

    pelebaran , dengan pemeriksaan manual.Kekambuhan persalinan prematur didefinisikan sebagai kambuhnya

    kontraksi dalam waktu 48 jam setelah penghentian tokolisis dan penangkapan

    kontraksi. Persalinan prematur ditangkap didefinisikan sebagai 12 - h

    contractionfree periode setelah terapi tokolitik telah dihentikan.

    Kriteria inklusi adalah kehamilan tunggal , membran utuh, ada cerclage ,

    dilatasi serviks dari < 2 cm , dan kencan kehamilan dikonfirmasi melalui trimester

    pertama ultrasound scanning atau terakhir periode menstruasi. Dilatasi serviks

    dari 2 cm diambil sesuai pengamatan di lembaga yang > 2 cm dilatasi dikaitkan

    dengan

    Tanggapan miskin dengan tokolisis .

    Kriteria eksklusi meliputi bukti klinis intra – amnion infeksi atau

    pielonefritis, komplikasi medis kontraindikasi tokolisis , bukti retardasi

    pertumbuhan janin , dan sonografi bukti anomali kongenital tidak konsisten

    dengan kehidupan .

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    Saat masuk, semua pasien memiliki haemogram, mikroskop urin dan

    sensitivitas budaya dan swab vagina tinggi untuk kultur dan sensitivitas. Semua

    pasien diberi tokolitik lisan, dengan bolus awal 30 mg Nifedipine diikuti oleh 10

    mg 8 jam. Semua pasien menerima antibiotikprofilaksis terdiri dari Tablet

    Azitromisin 500 mg sekali sehari selama 5 hari bersama dengan kursus lima hari

    oral Metronidazole. Mereka diberi Tentu saja satu Betametason, yang terdiri dari

    dua 12 mg suntikan selama 24 jam pertama setelah masuk. Setelah persalinan

    prematur ditangkap adalah didiagnosis, pasien konseling tentang penelitian dan

    menawarkan Ulasan kelembagaan dewan disetujui dokumen informed consent.

    Pasien dimasukkan dalam penelitian ini diacak dalam waktu 24 jam dari

    penangkapan tenaga kerja. Daftar acak disiapkan dengan komputer yang

    dihasilkan

    daftar nomor. Odds (progesteron, Kelompok 1) dan pasang (kontrol, Kelompok 2)

    alokasi pengobatan didefinisikan (Gambar 1). Pasien yang terdaftar sebagai kasus

    yang diterima Hydroxy progesteron kaproat 250 mg intramuskular mingguan

    sampai 37 minggu selesai atau sebelumnya jika mereka disampaikan. Itu pasien

    yang tersisa dimasukkan sebagai subyek kontrol dan menerima tidak ada obat.

    Mereka dipulangkan untuk observasi di klinik kebidanan mingguan. Mereka

    ditindaklanjuti baik di klinik atau melalui telepon jika mereka lakukan tidak

    mengikuti di klinik. Ukuran hasil utama adalah waktu sampai pengiriman (masa

    laten) dan kekambuhan persalinan prematur dalam waktu 48 jam setelah

    penghentian pengobatan tokolitik dan penangkapan kontraksi. Ukuran hasil

    sekunder adalah kejadian berat badan lahir rendah, dan morbiditas perinatal

    (sindrom gangguan pernapasan, intraventrikular perdarahan, necrotizing

    enterocolitis, dan terbukti sepsis) dinilai pada yang masuk ke Neonatal Intensive

    Care Unit (NICU).

    Data kategorikal diuji si gnifikansi dengan χ2 dan Fisher tes yang tepat .

    Data kontinyu dievaluasi untuk distribusi normal dan diuji signifikansi dengan t -

    test pelajar . signifikansi statistik didefinisikan sebagai P < 0,05 . Semua pasien

    dimasukkan dalam analisis .

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    Ada Total 60 pasien pada durasi studi yang memenuhi kriteria inklusi

    dan diacak untuk menerima baik progesteron atau tanpa pengobatan sama sekali .

    Sebagian besar pasien mengaku berasal dari sekitarnya dari lembaga pada kedua

    kelompok . Hanya sedikit dari mereka yang ( n = 8 ) yang buta huruf . Tak satu

    pun dari pasien memiliki riwayat infertilitas . Tidak ada pasiensejarah kelahiran

    prematur sebelumnya . Tidak ada pasien yang nulipara. Ada Ada riwayat

    polihidramnion . Semua pasien memiliki Bishop Skor < kelompok 3. Baik

    sebanding dengan satu sama lain ( Tabel 1).

    Gambar 1. Kelompok kontrol acak dengan tokolisis

    Variabel 17-OHP (n=29) Tanpaterapi(n=31) Nilai P

    Usia (rata-rata) 23.24 ± 3.47 22.81±3.73 0.642

    Usia fgestasi 32.62±1.72 32.90±1.94 0.552

    Paritas 1.48 1.29

    bishop score

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    Tidak ada perbedaan dalam hasil neonatal pada kedua kelompok. Berat

    lahir, kejadian sindrom gangguan pernapasan , perlu neonatal unit perawatan

    intensif tiket masuk adalah serupa pada kedua kelompok ( Tabel 3 ) .

    Diskusi

    Hasil penelitian menunjukkan penurunan yang signifikan dalam

    persalinan prematur berulang dengan penggunaan progesteron ( 38 % vs 64 % ) .

    Namun hasil neonatal sebanding . Pada tahun 2005 , Roberta Mackenzie et al .

    melakukan meta - analisis mengevaluasi penggunaan progesteron untuk wanita

    dengan tinggi risiko kelahiran prematur . Tiga uji coba yang memenuhi syaratuntuk dimasukkan . di sana adalah penurunan yang signifikan dalam risiko

    kelahiran kurang dari 37 minggu dengan agen progestasional . Tidak ada efek

    yang signifikan pada perinatal mortalitas atau morbiditas neonatal serius . Temuan

    ini mirip dengan kami studi . Pada tahun 2006 , sebuah meta - analisis oleh

    Aravinthan Coomarasamy et al.mengevaluasi penggunaan progesteron dalam

    pencegahan kelahiran prematur pada pasien berisiko tinggi . Sebanyak sembilan

    percobaan terkontrol secara acak yang dievaluasi terdiri dari sekitar 500 pasien .Meta - analisis menunjukkan penurunan tarif pengiriman sebelum 37 minggu serta

    pernapasansindrom gangguan dengan agen progestasional . Sebagian besar pasien

    memiliki beberapa dari satu atau lebih faktor risiko kelahiran prematur sebelum

    kehamilan .

    Penelitian kami memiliki populasi sebanding homogen sebelum onset persalinan

    prematur . Sebuah studi serupa dilakukan oleh Sedigheh BORNA dan Noshin

    Sahabi [ 21 ] di Teheran pada tahun 2004 , di mana progesteron adalah diberikan

    kepada wanita setelah persalinan prematur mengancam di satu tangan dimana

    lengan lain dari pasien tidak menerima pengobatan . Ada signifikanpeningkatan

    rata-rata latency sampai melahirkan , penurunan pernapasan distress syndrome ,

    dan penurunan berat badan lahir rendah di progesteron kelompok lengan . Tidak

    ada perbedaan signifikan yang ditemukan antara berulang persalinan prematur ,

    masuk ke unit perawatan intensif dan sepsis neonatal untuk progesteron dan

    kelompok kontrol , masing-masing. Penelitian kami memiliki secara signifikan

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    menurun pada kejadian persalinan prematur berulang di progesteron lengan

    kelompok .

    Semua penelitian yang dibahas di atas kecuali bahwa satu per Sedigheh

    BORNA dan Noshin sahabi , perbandingan itu sulit karena dalam penelitian lain

    adalah untuk mencegah persalinan prematur dengan progesteron dengan pasien

    yang sudah memiliki risiko persalinan prematur . Penelitian kami memiliki

    progesteron mulai setelah penangkapan persalinan prematur . Saat ini risiko pada

    pasien kami adalah episode persalinan prematur ditangkap oleh tokolisis . di sana

    perbedaan dalam jenis penggunaan progesteron dan usia kehamilan di yang

    mereka direkrut . Dalam penelitian kami itu agak terlambat ( 32 minggu ).

    Keterbatasan dari studi kami adalah ukuran sampel yang kecil dan tidak

    dibandingkan dengan plasebo . Tidak ada menyilaukan . Jadi bias seleksi bisa

    tidak dikurangi .