1. Home
  2. Approved trials
  3. » فارسی

Comparison of the combined effect of Isosorbide with Misoprostol and Misoprostol alone on the cervical ripening in post-term pregnancy

View the latest revision

History
# Registration date Revision Id
2 2020-12-07, 1399/09/17 168380
1 2018-12-27, 1397/10/06 72566
Changes made to previous revision

  • Help:

    Red color represents old content. It may be empty showing addition in the new version.
    Green color represents new content. It may be empty showing deletion in the new version.

    Inline Side by side
    Added new contents, deleted old contents, contents that are not changed.
    New table contents New table contents
    Old table contents Old table contents
    Unchanged contents Unchanged contents
    Added new contents, contents that are not changed.
    Deleted old contents, contents that are not changed.
    Old table contents Old table contents
    Unchanged contents Unchanged contents
    New table contents New table contents
    Unchanged contents Unchanged contents

  • Protocol summary

    The purpose of this study was to determine the combined effect of Isosorbide with Misoprostol and Misoprostol alone on induction of labor in primigravida.
    The purpose of this study was to determine the combined effect of Isosorbide with Misoprostol and Misoprostol alone on cervical ripening in post-term pregnancy.
    هدف از این مطالعه، تعیین اثر ترکیبی ایزوسورباید با میزوپروستول و میزوپروستول به تنهایی بر القا زایمان در نخست زاها می باشد.
    هدف از این مطالعه، تعیین اثر ترکیبی ایزوسورباید با میزوپروستول و میزوپروستول به تنهایی بر آماده سازی سرویکس در حاملگی پست ترم می باشد.
    This randomized double blind clinical trial was conducted on 150 primiparous women with singleton pregnancy and Bishop score less than 6 at the Ayatollah Rouhani Hospital in Babol. Women were randomly divided into two groups.
    This randomized double-blind controlled trial phase 2 was conducted on 150 primiparous women with singleton pregnancy and Bishop score less than 6 at the Ayatollah Rouhani Hospital in Babol. Women were randomly divided into two groups.
    این کارآزمایي بالیني دو سویه کور تصادفی بر روی 150 زن حامله ترم با حاملگی تک قلو و امتیاز بیشاپ کمتر از 6 در مرکز آموزشي درماني آیت‌اله روحانی بابل انجام شد. زنان به طور تصادفي در دو گروه قرار گرفتند.
    این کارآزمایي بالیني با گروه کنترل دو سویه کور تصادفی بر روی 150 زن حامله ترم با حاملگی تک قلو و امتیاز بیشاپ کمتر از 6 در مرکز آموزشي درماني آیت‌اله روحانی بابل انجام شد. زنان به طور تصادفي در دو گروه قرار گرفتند.
    This study was conducted on all primigravida who were pregnant at 40+6 weeks of gestation who needed induction of labor and were admitted to the maternity hospital of Ayatollah Rouhani Hospital in Babol in October 2017.
    This study was conducted on all post-term pregnancy need induction of labor in the maternity hospital of Ayatollah Rouhani in Babol in October 2017.
    این مطالعه بر روی تمام خانم های باردار نخست زای 6+40 هفته بارداری که نیاز به القاء زایمان داشته و از مهر ماه 1396 در زایشگاه بیمارستان آیت اله روحانی بابل بستری شدند، انجام شد.
    این مطالعه بر روی تمام خانم های باردار نخست زای +40 هفته بارداری که نیاز به القاء زایمان داشته و از مهر ماه 1396 در زایشگاه بیمارستان آیت اله روحانی بابل بستری شدند، انجام می شد.
    Inclusion criteria: Primigravida women from 18 to 40 years old, Bishop Score 6 and less with a range score of 0 to 13, Body mass index in the first trimester of pregnancy in the normal range (19.8 - 26 kg/m2), 41 weeks pregnancy based on ultasonography of the first trimester of pregnancy, Singleton and cephalic pregnancy, Having a normal fetal heart rate or proper biophysical in 48 hours before entering the study . Exclusion criteria: Pregnant women with a history of headache, Misoprostol contraindications, Alcohol consumption, Preeclampsia and eclampsia, Uncontrolled Diabetes, Intrauterine growth restriction, Polyhydramnios and oligohydramnios, Placenta previa or any other factor that prevents the induction of labor.
    Inclusion criteria: post-term pregnancy from 18 to 40 years old, Bishop Score 6 and less with a range score of 0 to 13, Body mass index in the first trimester of pregnancy in the normal range (19.8 - 26 kg/m2), 41 weeks pregnancy based on ultasonography of the first trimester of pregnancy, Singleton and cephalic pregnancy, Having a normal fetal heart rate or proper biophysical in 48 hours before entering the study . Exclusion criteria: Pregnant women with a history of headache, Misoprostol contraindications, Alcohol consumption, Preeclampsia and eclampsia, Uncontrolled Diabetes, Intrauterine growth restriction, Polyhydramnios and oligohydramnios, Placenta previa or any other factor that prevents the induction of labor.
    Induction of labor, Delivery method, Delivery length, Congenital and Neonatal
    Time to fully cervical ripening for delivery
    القاء زایمان، روش زایمان، طول زایمان، عوارض مادرزادی، عوارض نوزادی
    فاصله زمانی تا آمادگی کامل دهانه رحم برای زایمان

  • General information

    1
    1
    1
    empty
    150
    empty
    2018-04-06, 1397/01/17
    empty
    2019-05-05, 1398/02/15
    empty
    2019-08-06, 1398/05/15
    empty
    Data sharing, revising title, clarifying the inclusion and exclusion criteria, and adding some secondary outcomes, a better description of randomization
    empty
    به اشتراک گذاری اطلاعات، اصلاح عنوان، واضح کردن برخی موارد ورود و خروج و اضافه کردن پیامدهای ثانویه بیشتر و توضیح بهتر تصادفی سازی
    Effect of Isosorbide with Misoprostol and Misoprostol alone on induction of labor
    Effect of Isosorbide with Misoprostol on the cervical ripening
    اثر ایزوسورباید با میزوپروستول و میزوپروستول به تنهایی بر القا زایمان
    اثر ایزوسورباید با میزوپروستول بر باز شدن دهانه رحم
    Comparison of the combined effect of Isosorbide with Misoprostol and Misoprostol alone on induction of labor in primigravida
    Comparison of the combined effect of Isosorbide with Misoprostol and Misoprostol alone on the cervical ripening in post-term pregnancy
    مقایسه اثر ترکیبی ایزوسورباید با میزوپروستول و میزوپروستول به تنهایی بر القا زایمان در نخست‌زاها
    مقایسه اثر ترکیبی ایزوسورباید با میزوپروستول و میزوپروستول به تنهایی بر باز شدن دهانه رحم در حاملگی پست ترم
    Pregnant women with a history of headache
    Misoprostol contraindications
    Alcohol consumption
    Preeclampsia and eclampsia
    Uncontrolled diabetes
    Intrauterine growth restriction
    Polyhydramnios and oligohydramnios
    Placenta previa or any other factor that prevents the induction of labor
    Pregnant women with a history of headache
    Misoprostol contraindications
    Alcohol consumption
    Preeclampsia and eclampsia
    Uncontrolled diabetes
    Intrauterine growth restriction
    Polyhydramnios and oligohydramnios
    Placenta previa or any other factor that prevents the induction of labor
    Interaction medicine with Isosorbide
    خانم‌های باردار با سابقه سردرد
    موارد منع مصرف میزوپروستول
    مصرف الکل
    پره اکلامپسی و اکلامپسی
    دیابت کنترل نشده
    محدودیت رشد داخل رحمی
    پلی‌هیدرآمنیوس و اولگیوآمنیوس‌
    جفت سرراهی و یا هر عاملی که منع القاء زایمان داشته باشد.
    خانم‌های باردار با سابقه سردرد
    موارد منع مصرف میزوپروستول
    مصرف الکل
    پره اکلامپسی و اکلامپسی
    دیابت کنترل نشده
    محدودیت رشد داخل رحمی
    پلی‌هیدرآمنیوس و اولگیوآمنیوس‌
    جفت سرراهی و یا هر عاملی که منع القاء زایمان داشته باشد.
    داروهایی که با ایزوسورباید تداخل دارند
    Simple randomization is done using a random number table.
    Randomization is done using the randomization.com website. The size of blocks will be 8
    تصادفی سازی ساده با استفاده از جدول اعداد تصادفی انجام می شود.
    تصادفی سازی با استفاده از سایت randomization.com انجام می شود با بلوک ها با سایز 8.
    The Isosorbide and placebo tablets, which are very similar in appearance, are located in two containers A and B, and the senior resident of gynecology and people eligible for inclusion are not aware of the used drug, and the drug was given to patients based on a randomized number table. Only one person who was in charge of the maternity was aware of the drug doses of both containers.
    The Isosorbide and placebo tablets, which are very similar in appearance, are located in two containers A and B. The resident of obstetrics that aware of the allocation will be given to patients (not aware) based on a randomized block size number. Staff is aware of the drug doses of both containers. The resident will transfer the data checklist to the outcome assessor that is not aware of allocation.
    داروی ایزوسورباید و پلاسبو که از نظر شکل کاملا شبیه هم می باشند در دو ظرف آ و ب، قرار گرفته و رزیدنت ارشد زنان و افراد واجد شرایط ورود به مطالعه از نوع داروی استفاده شده اطلاعی نداشته و دارو را بر اساس جدولی که بر اساس جدول اعدادتصادفی تهیه شده به بیماران داده شد.از محتوای داروی هر دو ظرف تنها یک نفر که مسئول زایشگاه بودند اطلاع داشتند.
    داروی ایزوسورباید و پلاسبو که از نظر شکل کاملا شبیه هم می باشند در دو ظرف آ و ب، قرار گرفته و افراد واجد شرایط ورود به مطالعه از نوع داروی استفاده شده اطلاعی نداشته و دارو بر اساس لیست بلوک سازی توسط رزیدنت زنان به بیماران داده می شود.از محتوای داروی هر دو ظرف پرسنل اتاق زایمان اطلاع داشتند. رزیدنت چک لیست اطلاعات بیماران در انتها به ارزیابی کننده پیامد انتقال داده می شودکه از تخصیص تصادفی اطلاع ندارد.

  • Primary outcomes

    #1
    Necessity of induction
    the time interval between administration of the first dose of Isosorbide until the cervix is fully ripened and dilated (hours)
    نیاز به القا
    فاصله زمانی بین تجویز اولین دوز ایزوسوربید تا رسیدن کامل دهانه رحم و گشاد شدن آن
    During the intervention
    the time interval between administration of the first dose of Isosorbide until the cervix is fully ripened and dilated (hours)
    در طول مداخله
    زمان اولین دوز ایزوسوربید تا رسیدن کامل دهانه رحم و گشاد شدن آن
    Observation and Examination
    ٍVaginal examinatin by Hours
    مشاهده و معاینه
    معاینه واژینال به ساعت

  • Secondary outcomes

    #1
    Method of delivery
    The time interval between administration of the first dose of Isosorbide until delivery of the neonate
    روش زایمان
    فاصله زمانی بین تجویز اولین دوز ایزوسوربید تا زمان زایمان نوزاد
    During the intervention
    ّFrom administration of the first dose of Isosorbide until delivery of the neonate
    در طی مداخله
    از زمان تجویز اولین دوز ایزوسوربید تا زمان زایمان نوزاد
    Observation and Examination
    Hours
    مشاهده و معاینه
    ساعت
    #2
    Duration the first stage of labor
    the effect of Isosorbide on the Bishop score 24 hours after administration of Isosorbide
    طول مدت مرحله‎ی اول زایمان
    اثر ایزوسوربید بر نمره بیشاپ 24 ساعت پس از تجویز ایزوسورباید تا زمان زایمان
    Active stage of labor
    24 hours after administration of Isosorbide To delivery
    فاز فعال زایمان
    24 ساعت بعد از تجویز ایزوسوربابد تا زمان زایمان
    Hour
    Bishop Score Scale
    ساعت
    رتبه بندی بیشاب
    #3
    Maternal complications (Over stimulation of the uterus, headaches, tachycardia, hypotension, nausea, vomiting, and dizziness)
    The effect of Isosorbide on the number of Misoprostol used during labor
    عوارض مادری(هایپراستیمولاسیون رحم، سردرد، تاکی کاردی، افت فشار خون، تهوع، استفراغ، و سرگیجه)
    اثر ایزوسوربید بر تعداد میزوپروستول استفاده شده درطی درد زایمان
    During the intervention
    24 hours after intervention to delivery
    در طی مداخله
    24 ساعت بعد از مداخله تا زایمان
    Observation and Examination
    Number Of misoprostol suppository
    مشاهده و معاینه
    شمارش تعداد شیاف میزوپروستول
    #4
    Neonatal outcomes (Apgar score at first and fifth minutes, birth weight, hospitalization of neonate in the Neonatal Intensive Care Unit)
    empty
    پیامدهای نوزادی (امتیاز آپگار دقیقه اول و پنجم، وزن نوزاد، بستری نوزاد در بخش مراقبت های ویژه نوزادان)
    empty
    During the intervention
    empty
    در طی مداخله
    empty
    Observation and Examination
    empty
    مشاهده و معاینه
    empty

  • Intervention groups

    #1
    Treatment - Drugs
    Placebo

  • Sharing plan

    no
    yes
    no
    undecided
    no
    yes
    no
    undecided
    no
    undecided
    no
    undecided
    no
    undecided
    .
    empty
    .
    empty
    empty
    Primary outcome and some secondary outcomes are available to be shared.
    empty
    پیامد اولیه و برخی پیامد های ثانویه برای اشتراک گذاری در دسترس هستند.
    empty
    sharting 6 months after publication
    empty
    شروع دوره دسترسی 6 ماه پس از چاپ نتایج
    empty
    available for people working in academic institutions and can also apply to receive it.
    empty
    داده ها فقط برای محققین شاغل در موسسات دانشگاهی و علمی در دسترس خواهد بود و می توانند برای دریافت آنها اقدام کنند.
    empty
    Use in systematic review and meta-analysis studies is permitted
    empty
    استفاده در مطالعات مرور سیستماتیک و متاآنالیز مجاز است
    empty
    The data mentioned by the request will be available through my academic email.sh.barat@mubabol.ac.ir
    empty
    دیتاهای ذکر شده توسط تقاضا از طریق ایمیل دانشگاهی اینجانب در دسترس خواهد بود. sh.barat@mubabol.ac.ir
    empty
    6 months after the results are published, the data mentioned will be available by my email.
    empty
    6 ماه بعد از چاپ نتایج، دیتاهای ذکر شده توسط ایمیل اینجانب در دسترس خواهد بود.

Protocol summary

Study aim
The purpose of this study was to determine the combined effect of Isosorbide with Misoprostol and Misoprostol alone on cervical ripening in post-term pregnancy.
Design
This randomized double-blind controlled trial phase 2 was conducted on 150 primiparous women with singleton pregnancy and Bishop score less than 6 at the Ayatollah Rouhani Hospital in Babol. Women were randomly divided into two groups.
Settings and conduct
This study was conducted on all post-term pregnancy need induction of labor in the maternity hospital of Ayatollah Rouhani in Babol in October 2017.
Participants/Inclusion and exclusion criteria
Inclusion criteria: post-term pregnancy from 18 to 40 years old, Bishop Score 6 and less with a range score of 0 to 13, Body mass index in the first trimester of pregnancy in the normal range (19.8 - 26 kg/m2), 41 weeks pregnancy based on ultasonography of the first trimester of pregnancy, Singleton and cephalic pregnancy, Having a normal fetal heart rate or proper biophysical in 48 hours before entering the study . Exclusion criteria: Pregnant women with a history of headache, Misoprostol contraindications, Alcohol consumption, Preeclampsia and eclampsia, Uncontrolled Diabetes, Intrauterine growth restriction, Polyhydramnios and oligohydramnios, Placenta previa or any other factor that prevents the induction of labor.
Intervention groups
In the intervention group, isosorbide tablet (Isocor Tablets, 40 mg, Aria Pharmacy) and in the control group, placebo placed vaginally in the posterior fornix, vagina by the senior gynecology resident. Then 24 hours later in both groups, after re-establishing a Bishop: 25 micrograms vaginal misoprostol (mcg, P.I.C, High Wycombe, England) are placed in the posterior fornix, vagina.
Main outcome variables
Time to fully cervical ripening for delivery

General information

Reason for update
Data sharing, revising title, clarifying the inclusion and exclusion criteria, and adding some secondary outcomes, a better description of randomization
Acronym
IRCT registration information
IRCT registration number: IRCT20180922041083N1
Registration date: 2018-12-27, 1397/10/06
Registration timing: registered_while_recruiting

Last update: 2021-01-24, 1399/11/05
Update count: 1
Registration date
2018-12-27, 1397/10/06
Registrant information
Name
Shahnaz Barat
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3222 7667
Email address
sh.barat@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-09-23, 1396/07/01
Expected recruitment end date
2018-09-23, 1397/07/01
Actual recruitment start date
2018-04-06, 1397/01/17
Actual recruitment end date
2019-05-05, 1398/02/15
Trial completion date
2019-08-06, 1398/05/15
Scientific title
Comparison of the combined effect of Isosorbide with Misoprostol and Misoprostol alone on the cervical ripening in post-term pregnancy
Public title
Effect of Isosorbide with Misoprostol on the cervical ripening
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Pregnant mothers from 18 to 40 years old Bishop Score 6 and less with a range score of 0 to 13 Body mass in the first trimester of pregnancy in the normal range (26 - 19.8 kg . m2) 41 weeks pregnancy based on ultrasonography of the first trimester of pregnancy Singleton and cephalic pregnancy Having a normal fetal heart rate or proper biophysical in 48 hours before entering the study
Exclusion criteria:
Pregnant women with a history of headache Misoprostol contraindications Alcohol consumption Preeclampsia and eclampsia Uncontrolled diabetes Intrauterine growth restriction Polyhydramnios and oligohydramnios Placenta previa or any other factor that prevents the induction of labor Interaction medicine with Isosorbide
Age
From 18 years old to 40 years old
Gender
Female
Phase
2-3
Groups that have been masked
  • Participant
  • Outcome assessor
Sample size
Target sample size: 150
Actual sample size reached: 150
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization is done using the randomization.com website. The size of blocks will be 8
Blinding (investigator's opinion)
Double blinded
Blinding description
The Isosorbide and placebo tablets, which are very similar in appearance, are located in two containers A and B. The resident of obstetrics that aware of the allocation will be given to patients (not aware) based on a randomized block size number. Staff is aware of the drug doses of both containers. The resident will transfer the data checklist to the outcome assessor that is not aware of allocation.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Babol University of Medical Sciences
Street address
Babol University of Medical Sciences, Ganj Afrouz Avenue
City
Babol
Province
Mazandaran
Postal code
4716681451
Approval date
2018-08-20, 1397/05/29
Ethics committee reference number
IR.MUBABOL.HRI.REC.1397.122

Health conditions studied

1

Description of health condition studied
Vaginal Delivery
ICD-10 code
O80.0
ICD-10 code description
Spontaneous Vertex Delivery

Primary outcomes

1

Description
the time interval between administration of the first dose of Isosorbide until the cervix is fully ripened and dilated (hours)
Timepoint
the time interval between administration of the first dose of Isosorbide until the cervix is fully ripened and dilated (hours)
Method of measurement
ٍVaginal examinatin by Hours

Secondary outcomes

1

Description
The time interval between administration of the first dose of Isosorbide until delivery of the neonate
Timepoint
ّFrom administration of the first dose of Isosorbide until delivery of the neonate
Method of measurement
Hours

2

Description
the effect of Isosorbide on the Bishop score 24 hours after administration of Isosorbide
Timepoint
24 hours after administration of Isosorbide To delivery
Method of measurement
Bishop Score Scale

3

Description
The effect of Isosorbide on the number of Misoprostol used during labor
Timepoint
24 hours after intervention to delivery
Method of measurement
Number Of misoprostol suppository

Intervention groups

1

Description
In the Intervention group, Isosorbide tablets (Isocor Tablet, 40 m, Aria Pharmacy) are used vaginally. Then 24 hours later, after re-establishing a bishop: 25 microgram vaginal misoprostol (P.I.C, High Wycombe, England) is placed in the posterior fornix of the vagina.
Category
Treatment - Drugs

2

Description
In the control group, the placebo is placed by the senior resident of gynecology in the posterior fornix of the vagina, and 24 hours later, after re-establishing a bishop, 25 microgram vaginal misoprostol (P.I.C, High Wycombe, England) are placed in the posterior fornix of the vagina.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Ayatollah Rouhani Hospital Babol
Full name of responsible person
Dr. Shanaz Barat
Street address
Ayatollah Rouhani Hospital in Babol, Ganj Afrooz Avenue,
City
Babol
Province
Mazandaran
Postal code
4716681451
Phone
+98 11 3222 7667
Email
shahnaz-barat200@yahoo.com
Web page address
http://www.mubabol.ac.ir/

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Dr. reza Ghadimi
Street address
Babol University of Medical Sciences, Ganj Afrouz Avenue
City
Babol
Province
Mazandaran
Postal code
4716681451
Phone
+98 11 3222 7667
Email
rezaghadimi@yahoo.com
Web page address
http://www.mubabol.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Babol University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Dr. Shahnaz Barat
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Babol University of Medical Sciences, Ganj Afrouz Avenue
City
Babol
Province
Mazandaran
Postal code
4716681451
Phone
+98 11 3222 7667
Email
shahnaz-barat200@yahoo.com
Web page address
http://www.mubabol.ac.ir/

Person responsible for scientific inquiries

Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Dr. Mobina Baes
Position
Resident of Obstetrics and Gynecology
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Babol University of Medical Sciences, Ganj Afrouz Avenue
City
Babol
Province
Mazandaran
Postal code
4716681451
Phone
+98 11 3222 7667
Email
neda_amani60@yahoo.com
Web page address
http://www.mubabol.ac.ir/

Person responsible for updating data

Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Dr. Shahnaz Barat
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Babol University of Medical Sciences, Ganj Afrouz Avenue
City
Babol
Province
Mazandaran
Postal code
4716681451
Phone
+98 11 3222 7667
Email
shahnaz-barat200@yahoo.com
Web page address
http://www.mubabol.ac.ir/

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Primary outcome and some secondary outcomes are available to be shared.
When the data will become available and for how long
sharting 6 months after publication
To whom data/document is available
available for people working in academic institutions and can also apply to receive it.
Under which criteria data/document could be used
Use in systematic review and meta-analysis studies is permitted
From where data/document is obtainable
The data mentioned by the request will be available through my academic email.sh.barat@mubabol.ac.ir
What processes are involved for a request to access data/document
6 months after the results are published, the data mentioned will be available by my email.
Comments
Loading...