Sie sind auf Seite 1von 12

JOURNAL READING

Disusun oleh :
Dian Muflikhy Putri
NIM 112011101076

Dokter Pembimbing:
dr. Gogot Suharyanto Sp.OG

SMF ILMU OBSTETRI DAN GINEKOLOGI


RSD DR. SOEBANDI JEMBER FAKULTAS
KEDOKTERAN UNIVERSITAS JEMBER
2015

i
JOURNAL READING

Disusun oleh :
Dian Muflikhy Putri
NIM 112011101076

Dokter Pembimbing:
dr. Gogot Suharyanto Sp.OG

Disusun untuk melaksanakan tugas Kepaniteraan Klinik Madya


SMF Ilmu Obstetri dan Ginekologi di RSD dr. Soebandi

SMF ILMU OBSTETRI DAN GINEKOLOGI RSD DR.


SOEBANDI JEMBER FAKULTAS KEDOKTERAN
UNIVERSITAS JEMBER 2015

ii
Regmi et al., Gynecol Obstet 2012, 2:4

Gynecology & Obstetrics http://dx.doi.org/10.4172/2161-0932.1000125

Research Article Open Access

Progesterone for Prevention of Recurrent Preterm Labor after Arrested


Preterm Labor- A Randomized Controlled Trial
Mohan 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 a
major health hazard. But there are very few evidence based interventions to prevent it. This study focus on
prevention of preterm birth.
Methods: A randomized controlled trial was undertaken in BP Koirala Institute of Health Sciences, where 60
patients 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 and
neonatal outcomes were compared.
Results: There was significant reduction in recurrence of preterm labor and increase in latency period in
progesterone group. However neonatal outcomes were similar.
Conclusion: Progesterone is useful in reducing the recurrence of preterm labor in a patient who had preterm
labor.

Keywords: Progesterone; Preterm labor; Tocolysis therefore, increases the α-adrenergic tocolytic response [13]. Natural
progesterone is free of any disturbing teratogenic, metabolic, or
Introduction hemodynamic effects. This is not true for certain artificial
Preterm birth is the major cause of neonatal mortality and progestagens and -mimetics [14].
morbidity [1]. In addition, prematurity is strongly associated with In 2003, two widely published double-blind trials, one of daily
long-term developmental disabilities, accounting for 1 in 5 children vaginal progesterone suppositories and the other of weekly
with mental retardation, 1 in 3 children with vision impairment, and intramuscular injections of 17alpha-hydroxyprogesterone, claimed
almost half of children with cerebral palsy. Importantly, low-birth- that the treatments effectively reduce the incidence of preterm birth in
weight infants who are spared significant neonatal morbidity are at women at risk of spontaneous preterm labour [15,16].
higher risk for cardiovascular disease (myocardial infarction, stroke,
and hypertension) and diabetes as adults [2]. The incidence of preterm In study published in 2007, vaginal progesterone treatment
birth in developing countries is higher than in developed countries. reduced the rate of preterm birth among women who were at high risk
So, prevention of preterm birth is a public health priority. for preterm birth because of a short cervix [17]. Progesterone has long
Pharmacological therapy with a variety of drugs of different been considered important agents in the maintenance of uterine
categories has been the primary method of treating acute preterm quiescence and has been used extensively in primary and secondary
labour [3]. Patients with arrested preterm labor are at increased risk prevention of preterm labor [15,18].
for recurrence, but to this point, continued tocolytic treatment with
We therefore, chose this pharmacological agent as the active drug
any agent after arrest of acute preterm labor is of questionable value
in extending gestation or improving outcome [3,4]. The efficacy of for our study. This randomized trial was designed to assess the use of
maintenance tocolytic therapy after successful arrest of preterm labor progesterone therapy in women who presented with symptoms of
remains controversial. This question is not limited to the use of a preterm labor in preventing the recurrence of preterm labor and
specific drug as the data are similar for terbutaline, magnesium increase the latency period after successful tocolysis.
sulphate, and calcium channel blockers [3]. Methods
Spontaneous preterm birth, that is preterm birth after labor or rupture
of the membranes, represents approximately 75% of all preterm births [5]. This randomized controlled trial was performed in the Department
Of all treatments evaluated for the prevention of spontaneous preterm of Obstetrics and Gynecology at B.P. Koirala Institute of Health
birth to date, progestational agents have demonstrated the greatest Sciences over the duration of 1.5 years from 2009 January to June
promise. The exact mechanism of progesterone in the prevention of 2010. The Institutional Ethical Review Board approved this.
preterm birth is not known, although progesterone has been shown to
prevent the formation of gap junctions, to have an inhibitory effect on
myometrial contractions, and to prevent spontaneous abortion in women *Corresponding author: Mohan C. Regmi, Associate Professor, Department of
in early pregnancy after excision of the corpus luteum [6-8]. Progesterone Obstetrics and Gynecology, BPKIHS, Dharan, Nepal, Tel: 9852049414; E-mail:
mohanchallo@yahoo.com
has also been shown to delay parturition in animals [9]. In the last 40
years, progestins have been administered to pregnant women for several Received June 17, 2012; Accepted July 11, 2012; Published July 17, 2012
reasons, including threatening miscarriage, recurrent miscarriage, Citation: Regmi MC, Rijal P, Agrawal A, Uprety D (2012) Progesterone for Prevention of
prevention of preterm labor and luteal support during in vitro fertilization Recurrent Preterm Labor after Arrested Preterm Labor- A Randomized Controlled Trial.
treatment [10-12]. Gynecol Obstet 2:125. doi:10.4172/2161-0932.1000125

Progesterone is useful in allowing pregnancy to reach its physiologic Copyright: © 2012 Regmi MC, et al. This is an open-access article distributed
under the terms of the Creative Commons Attribution License, which permits
term because at sufficient levels in the myometrium, it blocks the
unrestricted use, distribution, and reproduction in any medium, provided the
oxytocin effect of prostaglandin F2α and α-adrenergic stimulation and original author and source are credited.

Gynecol Obstet Volume 2 • Issue 4 • 1000125

ISSN:2161-0932 Gynecology an open access journal


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

Page 2 of 3

Women of 28-34 weeks period of gestation who were admitted to There was significant increase in latency period in intervention
the Obstetrics ward with preterm labor were involved in the study arm with decrease in incidence of recurrent preterm labor (Table 2).
after their labor was successfully arrested with tocolytics. Preterm
There was no difference in neonatal outcome in both groups. The
labor was defined as the simultaneous presence of contractions (> six
birth weight, incidence of respiratory distress syndrome, need of
contractions in 30 min) and cervical changes, either shortening and/or
neonatal intensive care unit admission was similar in both groups
softening or dilation, by manual examination.
(Table 3).
Recurrence of preterm labor was defined as recurrence of
contractions within 48 h after discontinuation of tocolysis and arrest Discussion
of contractions. Arrested preterm labor was defined as a 12-h The study showed significant reduction in recurrent preterm labor
contraction-free period after tocolytic therapy had been discontinued. with the use of progesterone (38% vs. 64%). However neonatal outcomes
Inclusion criteria were singleton pregnancy, intact membranes, no were comparable. In 2005, Roberta Mackenzie et al. [19] conducted a
cerclage, cervical dilation of < 2 cm, and the dating of pregnancy meta-analysis evaluating the use of progesterone for women with high risk
confirmed through first trimester ultrasound scanning or last of preterm birth. Three trials were eligible for inclusion. There was a
menstrual period. The cervical dilatation of 2 cm was taken according significant reduction in risk of delivery less than 37 weeks with
to observation in the institute that > 2cm dilatation was associated progestational agents. There was no significant effect on perinatal
with poor response with tocolysis. mortality or serious neonatal morbidity. The finding was similar to our
Exclusion criteria included clinical evidence of intra-amniotic study. In 2006, a meta-analysis by Aravinthan Coomarasamy et al. [20]
infection or pyelonephritis, medical complications contraindicating evaluated the use of progesterone in prevention of preterm delivery in
tocolysis, evidence of fetal growth retardation, and sonographic high risk patients. A total of nine randomized control trials were evaluated
evidence of congenital anomalies inconsistent with life. comprising of about 500 patients. Meta-analyses showed reductions in
delivery rates before 37 weeks as well as in respiratory
At admission, all patients had a haemogram, urine microscopy and
culture sensitivity and a high vaginal swab for culture and sensitivity. All
patients were given oral tocolytic, with an initial bolus of 30 mg
Nifedipine followed by 10 mg 8 hourly. All patients received antibiotic Patients with arrested
prophylaxis consisting of Tablet Azithromycin 500 mg once a day for 5 preterm labor (n=60)
days along with a five day course of oral Metronidazole. They were given
single course of Betamethasone, consisting of two 12 mg injections
during the first 24 h after admission. After arrested preterm labor was
Group 1 (17-OHP) Group 2 (no Therapy )
diagnosed, the patient was counseled about the study and offered an
institutional review board-approved informed consent document. Patients n=29, followed till n=31 followed till
included in the study were randomized within 24 h of arrest of labor. The delivery delivery
random list was prepared with a computer generated number list. Odds
(progesterone, Group 1) and pairs (control, Group 2) defined treatment Figure 1: A randomized controlled trial with tocolysis in two different groups.
allocation (Figure 1). Patients who were enrolled as cases received
Hydroxy progesterone Caproate 250 mg intramuscular weekly till 37 Variables 17-OHP (n=29) No therapy(n=31) P value*
completed weeks or earlier if they delivered. The remaining patients were Age in years(mean) 23.24 ± 3.47 22.81 ± 3.73 0.642
included as control subjects and received no drugs. They were discharged Period of gestation at 32.62 ± 1.72 32.90 ± 1.94 0.552
for observation in the obstetric clinic weekly. They were followed up admission(weeks)
either at clinic or by telephone if they do not follow at clinic. The primary Parity 1.48 1.29
outcomes measure were the time until delivery (latency period) and Bishop Score <3 <3
Nulliparity 0 0
recurrence of preterm labor within 48 h after discontinuation of tocolytic
treatment and arrest of contraction. Secondary outcome measures were *P value<0.05 was considered significant
incidence of low birth weight, and perinatal morbidity (respiratory Table 1: General character of both groups.
distress syndrome, intraventricular hemorrhage, necrotizing enterocolitis,
and proven sepsis) assessed at the admission to Neonatal Intensive Care Variables 17-OHP (n=29) No therapy (n=31) P value*
Unit (NICU). Period of gestation at 36.59 ± 1.94 34.30 ± 1.47 0.004
delivery(weeks)
Categorical data were tested for significance with the χ2 and Fisher Recurrent preterm labor 11 20 0.039
exact tests. Continuous data were evaluated for normal distribution and Latency period (in days) 25.48 ± 14.64 16.42 ± 9.82 0.003
tested for significance with the Student’s t-test. Statistical significance
*P value<0.05 was considered significant
was defined as P < 0.05. All patients were included in the analysis.
Table 2: Outcome of patients after intervention.
Results
Variables 17-OHP(n=29) No therapy(n=31) P value*
There were total 60 patients at the study duration that fulfilled the
Birth weight(in kg) 2.903 ± 0.596 2.781 ± 0.444 0.372
inclusion criteria and were randomized to receive either progesterone or Respiratory Distress Syndrome 3 2 0.938
no treatment at all. Most of the patients admitted were from vicinity of the Need of admission in NICU 3 3 1
institute in both groups. Only few of them were (n=8) were illiterate. Presence of sepsis 2 2 1
None of the patient had history of infertility. No patients had history of Low birth weight 6 5 0.856
previous preterm birth. None of the patients were nullipara *P value<0.05 was considered significant
.There was no history of polyhydramnios. All the patients had Bishop
Table 3: Neonatal outcomes.
Score < 3.Both groups were comparable to each other (Table 1).

Gynecol Obstet Volume 2 • Issue 4 • 1000125

ISSN:2161-0932 Gynecology an open access journal


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

Page 3 of 3

distress syndrome with progestational agents. Most of the patients had 9. Whitely JL, Hartmann PE, Willcox DL, Bryant-Greenwood GD, Greenwood FC
some of one or more risk factors for preterm birth prior to pregnancy. (1990) Initiation of parturition and lactation in the sow: effects of delaying
parturition with medroxyprogesterone acetate. J Endocrinol 124: 475-484.
Our study had homogenous comparable population prior to onset of
preterm labor. A similar study was carried out by Sedigheh BORNA 10. Daya S, Gunby J (2004) Luteal phase support in assisted reproduction cycles.
Cochrane Database Syst Rev CD004830.
and Noshin SAHABI [21] in Tehran in 2004, where progesterone was
given to women after threatened preterm labor in one arm where as 11. Oates-Whitehead RM, Haas DM, Carrier JA (2003) Progestogen for
another arm of patients received no treatment. There was significant preventing miscarriage. Cochrane Database Syst Rev CD003511.
increase in mean latency until delivery, decrease in respiratory 12. Friedler S, Raziel A, Schachter M, Strassburger D, Bukovsky I, et al. (1999)
distress syndrome, and decrease in low birth weight in progesterone Luteal support with micronized progesterone following in-vitro fertilization
using a down-regulation protocol with gonadotrophin releasing hormone
arm group. No significant differences were found between recurrent agonist: A comparative study between vaginal and oral administration. Hum
preterm labor, admission to intensive care unit and neonatal sepsis for Reprod 14: 1944-1948.
the progesterone and control groups, respectively. Our study had 13. Fuchs AR, Fuchs F (1984) Endocrinology of human parturition: a review. Br J
significantly decreased in incidence of recurrent preterm labor in Obstet Gynaecol 91: 948-967.
progesterone arm group.
14. Keelan JA, Myatt L, Mitchell MD (1997) Endocrinology and paracrinology of
All the study discussed above except that one by Sedigheh BORNA parturition. In: Elder MG, Lamont RF, Romero R, (Eds) Preterm labor.
and Noshin SAHABI, the comparison was difficult because in other study Churchill Livingstone, Philadelphia pp: 457-491.
it was to prevent the preterm labor with progesterone with patients 15. da Fonseca EB, Bittar RE, Carvalho MH, Zugaib M (2003) Prophylactic
already having risk of preterm labor. Our study had progesterone started administration of progesterone by vaginal suppository to reduce the incidence
of spontaneous preterm birth in women at increased risk: A randomized
after the arrest of preterm labor. The risk present in our patient was placebo-controlled double-blind study. Am J Obstet Gynecol 188: 419-424.
episode of preterm labor arrested by tocolysis. There was difference in
16. Meis PJ, Klebanoff M, Thom E, Dombrowski MP, Sibai B, et al. (2003)
type of progesterone use and the gestational age at which they were Prevention of recurrent preterm delivery by 17 alpha-hydroxyprogesterone
recruited. In our study it was bit late (32 weeks). caproate. N Engl J Med 348: 2379-2385.
The limitation of our study was small sample size and was not 17. Fonseca EB, Celik E, Parra M, Singh M, Nicolaides KH, et al. (2007)
compared with placebo. There was no blinding. So selection bias Progesterone and the risk of preterm birth among women with a short cervix.
N Engl J Med 357: 462-469.
could not be reduced.
18. Noblot G, Audra P, Dargent D, Faguer B, Mellier G (1991) The use of
Conclusion micronized progesterone in the treatment of menace of preterm delivery. Euro
J Obstet Gynecol Reprod Biol 40: 203-209.
Progesterone are promising agent to reduce the incidence of recurrent
19. Mackenzie R, Walker M, Armson A, Hannah ME (2006) Progesterone for the
preterm birth after arrest of preterm labor. Studies with larger sample size prevention of preterm birth among women at increased risk: A systematic
with double blinding as well as earlier recruitment of patient (at 28-32 review and meta-analysis of randomized controlled trials. Am J Obstet
weeks) would probably give more convincing results. Gynecol 194: 1234-1242.
20. Coomarasamy A, Thangaratinam S, Gee H, Khan KS (2006) Progesterone for
Acknowledgement
the prevention of preterm birth: A critical evaluation of evidence. Eur J Obstet
We would extend my sincere thanks to National Health Research Council for Gynecol Reprod Biol 129: 111-118.
supporting this research. We would like to extend sincere thanks to our institute 21. Borna S, Sahabi N (2008) Progesterone for maintenance tocolytic therapy
and all the participants of the study. after threatened preterm labour: A randomised controlled trial. Aust N Z J
Conflict of Interest Obstet Gynaecol 48: 58-63.

The authors have no potential conflict of interest.

References
1. National Center for Health Statistics, NVSR (2001) Deaths and percentage of
total 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, development
and patterns of disease. Science 305: 1733-1736.

3. Sanchez-Ramos L, Kaunitz AM, Gaudier FL, Delke I (1999) Efficacy of


maintenance therapy after acute tocolysis: a meta-analysis. Am J Obstet
Gynecol 181: 484-490.
Submit your next manuscript and get advantages of OMICS
4. Thornton JG (2005) Maintenance tocolysis. BJOG 112 : 118-121. Group submissions
Unique features:
5. Meis PJ, Goldenberg RL, Mercer BM, Iams JD, Moawad AH, et al. (1998) The
preterm prediction study: risk factors for indicated preterm births. Maternal- • User friendly/feasible website-translation of your paper to 50 world’s leading
Fetal Medicine Units Network of the National Institute of Child Health and languages
Human Development. Am J Obstet Gynecol 178: 562-567. • Audio Version of published paper
• Digital articles to share and explore
6. Garfield RE, Kannan MS, Daniel EE (1980) Gap junction formation in
Special features:
myometrium: control by estrogens, progesterone, and prostaglandins. Am J
Physiol 238: C81-C89. • 200 Open Access Journals
• 15,000 editorial team
7. Allen WM, Reynolds SRM (1935) Physiology of the corpus luteum: the
• 21 days rapid review process
comparative actions of crystalline progestin and crude progestin on uterine
• Quality and quick editorial, review and publication processing
motility in unanesthetized rabbits. Am J Obstet Gynecol 30: 309-318.
• Indexing at PubMed (partial), Scopus, DOAJ, EBSCO, Index Copernicus and
8. Csapo AI, Pulkkinen MO, Wiest WG (1973) Effects of luteectomy and Google Scholar etc
progesterone replacement therapy in early pregnant patients. Am J Obstet • Sharing Option: Social Networking Enabled
Gynecol 115: 759-765. • Authors, Reviewers and Editors rewarded with online Scientific Credits
• Better discount for your subsequent articles
Submit your manuscript at: http://www.omicsonline.org/submission/

Gynecol Obstet Volume 2 • Issue 4 • 1000125

ISSN:2161-0932 Gynecology an open access journal


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.

Pendahuluan
Persalinan 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
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.
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 Board
disetujui 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 .
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 signifikansi 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 .
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 <3 <3

Nulliparitas 0 0

Gambar 1. Karakter umum dari kedua grup


Hasil

Ada peningkatan yang signifikan dalam periode laten di lengan

intervensi dengan penurunan kejadian persalinan prematur berulang ( Tabel 2 ) .


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 syarat
untuk 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
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 .

Das könnte Ihnen auch gefallen