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Comparison of Vaginal Progesterone and Oral Micronized Progesterone on Pregnancy Outcomes in Women with Threatened Miscarriage

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History
# Registration date Revision Id
2 2024-10-08, 1403/07/17 317856
1 2019-05-12, 1398/02/22 89777
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  • Protocol summary

    160 pregnant women threatened with abortion from kowsar hospital which were satisfied to participate in the study were selected and randomly allocated in one of the groups A and B. For the A group micronized progesterone was prescribed and for the group B progesterone suppository was prescribed.
    170 pregnant women threatened with abortion from kowsar hospital which were satisfied to participate in the study were selected and randomly allocated in one of the groups A and B. For the A group micronized progesterone was prescribed and for the group B progesterone suppository was prescribed.
    تعداد 160 خانم باردار دچار تهدید به سقط از بیمارستان کوثر که رضایت به شرکت در مطالعه دارند انتخاب شده و به صورت تصادفی در یکی از دو گروه A و B قرار میگیرند. برای گروه A پروژسترون میکرونیزه وبرای گروه B شیاف پروژسترون تجویز می شود.
    تعداد 170 خانم باردار دچار تهدید به سقط از بیمارستان کوثر که رضایت به شرکت در مطالعه دارند انتخاب شده و به صورت تصادفی در یکی از دو گروه A و B قرار میگیرند. برای گروه A پروژسترون میکرونیزه وبرای گروه B شیاف پروژسترون تجویز می شود.
    6 to 13 weeks Gestational age , Appearance of fetal heart rate, uterine bleeding, Closed uterine orifice ;Having embryonic or uterine anomalies in ultrasound, not appearancing of fetal heart rate, multi fetal, Hydatidiform mole, A known underlying disease in mother, patients who have been treated by a specific medication to treat abortion
    Pregnant women with a gestational age of more than 6 weeks and less than or equal to 13 weeks, presenting with a closed cervix on vaginal examination and exhibiting symptoms of threatened miscarriage, such as bloody discharge or uterine bleeding with or without pain, were considered eligible for inclusion in the study.Exclusion criteria included absence of fetal heartbeat, confirmation of fetal or uterine abnormalities, multiple pregnancy or hydatidiform pregnancy.
    سن بارداری 6 تا 13 هفته. رویت ضربان قلب جنین. خونریزی از رحم. دهانه بسته رحم .؛ آنومالی جنینی یا رحمی، عدم رویت ضربان قلب جنین، چند قلویی، مول هیداتی فورم، بیماری زمینه ای شناخته شده در مادر
    زنان باردار با سن حاملگی بیش از 6 هفته و کمتر یا مساوی 13 هفته که با دهانه رحم بسته در معاینه واژینال مراجعه می کردند و علائم تهدید به سقط جنین مانند ترشحات خونی یا خونریزی رحم با یا بدون درد را نشان می دادند، واجد شرایط در نظر گرفته شدند. برای گنجاندن در مطالعه معیارهای خروج شامل فقدان ضربان قلب جنین، تایید ناهنجاری های جنینی یا رحمی، حاملگی چندقلویی یا هیداتی فرم بود.

  • General information

    empty
    170
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    2022-02-01, 1400/11/12
    empty
    2022-11-06, 1401/08/15
    empty
    2023-09-05, 1402/06/14
    empty
    Due to the coincidence of the sampling with the corona pandemic, the sampling has started with a delay.In addition, during the research, changes were made in the way it was done, and we are required to record these changes and approve them.
    empty
    به دلیل همزمانی نمونه گیری با پاندمی کرونا، بیمارگیری با تاخیر شروع شده است. علاوه بر ان در حین انجام پژوهش تغییراتی در نحوه انجام ان ایجاد شد که ملزم به ثبت این تغییرات و تایید ان می باشیم.
    Comparison of the Micronized Progesteron and Progesteron supository on pregnancy residues in mothers who are at risk of abortion
    Comparison of Vaginal Progesterone and Oral Micronized Progesterone on Pregnancy Outcomes in Women with Threatened Miscarriage
    مقایسه پروژسترون میکرونیزه و شیاف پروژسترون بر پیامد بارداری در مادران باردار تهدید به سقط
    مقایسه پروژسترون واژینال و پروژسترون میکرونیزه خوراکی بر پیامدهای بارداری در زنان با تهدید سقط جنین
    Having embryonic or uterine anomalies in ultrasound
    Multi fetal
    Hydatidiform mole
    A known underlying disease in mother
    Patients who have been treated by a specific medication to treat abortion
    Having embryonic or uterine anomalies in ultrasound
    Multi fetal
    Hydatidiform mole
    A known underlying disease in mother
    Patients who have been treated by a specific medication to treat abortion
    the absence of fetal heartbeat,
    malignancy
    presence of anorectal disorders
    genital tract infections
    endocrine disorders
    cardiovascular disorders
    progesterone hypersensitivity
    refusal to participate
    داشتن آنومالی رحمی یا جنینی در سونو گرافی
    چند قلویی
    مول هیداتیفورم
    بیماری زمینه ای شناخته شده در مادر
    بیمارانی که تحت درمان با داروی خاصی جهت درمان تهدید به سقط بوده اند
    داشتن آنومالی رحمی یا جنینی در سونو گرافی
    چند قلویی
    مول هیداتیفورم
    بیماری زمینه ای شناخته شده در مادر
    بیمارانی که تحت درمان با داروی خاصی جهت درمان تهدید به سقط بوده اند
    عدم ضربان قلب جنین
    بدخیمی
    وجود اختلالات آنورکتال
    عفونت های دستگاه تناسلی
    اختلالات غدد درون ریز
    اختلالات قلبی عروقی
    حساسیت بیش از حد به پروژسترون
    امتناع از شرکت در مطالعه

  • Primary outcomes

    #1
    From the start of the intervention to the 20th week of pregnancy
    From the start of the intervention up to end of pregnancy
    از شروع مداخله تا هفته 20 بارداری
    از شروع مداخله تا پایان بارداری
    Weekly visit
    Weekly visit until the end of bleeding
    ویزیت هفتگی
    ویزیت هفتگی تا قطع خونریزی

  • Recruitment centers

    #1
    Name of recruitment center - English: Kowsar hospital
    Name of recruitment center - Persian: بیمارستان کوثر
    Full name of responsible person - English: Hamide pakniat
    Full name of responsible person - Persian: دکتر حمیده پاک نیت
    Street address - English: Taleghani Blvd, Valiasr
    Street address - Persian: ولیعصر، بلوار طالقانی
    City - English: Qazvin
    City - Persian: قزوین
    Province: Qazvin
    Country: Iran (Islamic Republic of)
    Postal code: 3415613176
    Phone: +98 28 3223 6374
    Fax:
    Email: pakniat110@yahoo.com
    Web page address:
    Name of recruitment center - English: Kowsar hospital
    Name of recruitment center - Persian: بیمارستان کوثر
    Full name of responsible person - English: Hamide Pakniat
    Full name of responsible person - Persian: دکتر حمیده پاک نیت
    Street address - English: Taleghani Blvd, Valiasr
    Street address - Persian: ولیعصر، بلوار طالقانی
    City - English: Qazvin
    City - Persian: قزوین
    Province: Qazvin
    Country: Iran (Islamic Republic of)
    Postal code: 3415613176
    Phone: +98 28 3223 6374
    Fax:
    Email: pakniat110@yahoo.com
    Web page address:

  • Person responsible for scientific inquiries


    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Dr Hamideh Pakniat
    Full name of responsible person - Persian: دکتر حمیده پاک نیت
    Position - English: Asistant Professor, Department of Obstetrics and Gynecology
    Position - Persian: استادیار گروه زنان و زایمان
    Latest degree: specialist
    Area of specialty/work: 49
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Kowsar Hospital, Taleghani St, Qazvin, Iran
    Street address - Persian: ایران، قزوین، خیابان طالقانی، بیمارستان کوثر
    City - English: Qazvin
    City - Persian: قزوین
    Province: Qazvin
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 3415613176
    Phone: +98 28 3223 6374
    Mobile: +98 912 182 2448
    Fax:
    Email: pakniat110@yahoo.com
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Dr Hamideh Pakniat
    Full name of responsible person - Persian: دکتر حمیده پاک نیت
    Position - English: Associated Professor, Department of Obstetrics and Gynecology
    Position - Persian: دانشیار گروه زنان و زایمان
    Latest degree: specialist
    Area of specialty/work: 49
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Kowsar Hospital, Taleghani St, Qazvin, Iran
    Street address - Persian: ایران، قزوین، خیابان طالقانی، بیمارستان کوثر
    City - English: Qazvin
    City - Persian: قزوین
    Province: Qazvin
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 3415613176
    Phone: +98 28 3223 6374
    Mobile: +98 912 182 2448
    Fax:
    Email: pakniat110@yahoo.com
    Web page address:

Protocol summary

Study aim
the effect of micronized progesterone and progesterone suppository on pregnancy survival compars in pregnant women threatened with abortion.
Design
Two parallel groups randomized trial, not blinded, single center
Settings and conduct
170 pregnant women threatened with abortion from kowsar hospital which were satisfied to participate in the study were selected and randomly allocated in one of the groups A and B. For the A group micronized progesterone was prescribed and for the group B progesterone suppository was prescribed.
Participants/Inclusion and exclusion criteria
Pregnant women with a gestational age of more than 6 weeks and less than or equal to 13 weeks, presenting with a closed cervix on vaginal examination and exhibiting symptoms of threatened miscarriage, such as bloody discharge or uterine bleeding with or without pain, were considered eligible for inclusion in the study.Exclusion criteria included absence of fetal heartbeat, confirmation of fetal or uterine abnormalities, multiple pregnancy or hydatidiform pregnancy.
Intervention groups
to one group progesterone suppository is given 400 milligrams per day and to the other group 100 milligrams of progesterone capsule is given per day.
Main outcome variables
Pregnancy residues ;pre term delivery ; complications of post consumption of medicines.

General information

Reason for update
Due to the coincidence of the sampling with the corona pandemic, the sampling has started with a delay.In addition, during the research, changes were made in the way it was done, and we are required to record these changes and approve them.
Acronym
IRCT registration information
IRCT registration number: IRCT20120104008611N9
Registration date: 2019-05-12, 1398/02/22
Registration timing: prospective

Last update: 2024-10-19, 1403/07/28
Update count: 1
Registration date
2019-05-12, 1398/02/22
Registrant information
Name
Hamideh Pakniat
Name of organization / entity
Qazvin University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 282242452
Email address
hpakniat@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-04-21, 1397/02/01
Expected recruitment end date
2019-01-20, 1397/10/30
Actual recruitment start date
2022-02-01, 1400/11/12
Actual recruitment end date
2022-11-06, 1401/08/15
Trial completion date
2023-09-05, 1402/06/14
Scientific title
Comparison of Vaginal Progesterone and Oral Micronized Progesterone on Pregnancy Outcomes in Women with Threatened Miscarriage
Public title
Comparison of the effect of two progesteron drugs in protection of abortion
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Gestational age 6 to 13 weeks Apearance of fetal heart rate Uterine bleeding Closed uterine orifice
Exclusion criteria:
Having embryonic or uterine anomalies in ultrasound Multi fetal Hydatidiform mole A known underlying disease in mother Patients who have been treated by a specific medication to treat abortion the absence of fetal heartbeat, malignancy presence of anorectal disorders genital tract infections endocrine disorders cardiovascular disorders progesterone hypersensitivity refusal to participate
Age
No age limit
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 160
Actual sample size reached: 170
Randomization (investigator's opinion)
Randomized
Randomization description
Medications are encoded in separate envelopes and delivered to the participants.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Qazvin University of Medical Sciences
Street address
Bahonar Blvd, Qazvin, Iran
City
Qazvin
Province
Qazvin
Postal code
3419759811
Approval date
2018-03-12, 1396/12/21
Ethics committee reference number
IR.QUMS.REC.1396.498

Health conditions studied

1

Description of health condition studied
Abortion
ICD-10 code
-
ICD-10 code description
-

Primary outcomes

1

Description
Abortion
Timepoint
From the start of the intervention up to end of pregnancy
Method of measurement
Weekly visit until the end of bleeding

Secondary outcomes

1

Description
Preeclampsia
Timepoint
Up to 28 weeks monthly until 36 weeks every two weeks and thereafter weekly until delivery
Method of measurement
Mercury pressure gauge

2

Description
Gestational Diabetes
Timepoint
Up to 28 weeks monthly until 36 weeks every two weeks and thereafter weekly until delivery
Method of measurement
Glucose tolerance test

Intervention groups

1

Description
Intervention group: Progesterone suppository 400 milligrams per day
Category
Treatment - Drugs

2

Description
Intervention group: Progesterone capsule 100 mg per day
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Kowsar hospital
Full name of responsible person
Hamide Pakniat
Street address
Taleghani Blvd, Valiasr
City
Qazvin
Province
Qazvin
Postal code
3415613176
Phone
+98 28 3223 6374
Email
pakniat110@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Dr. Amir Peymani
Street address
Bahonar Blvd, Qazvin, Iran
City
Qazvin
Province
Qazvin
Postal code
3415613176
Phone
+98 28 3333 6001
Email
pakniat110@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Qazvin 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
Qazvin University of Medical Sciences
Full name of responsible person
Dr Hamideh Pakniat
Position
Asistant Professor, Department of Obstetrics and Gynecology Qazvin University of Medical Sciences
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Kowsar Hospital, Taleghani St, Qazvin, Iran
City
Qazvin
Province
Qazvin
Postal code
3415613176
Phone
+98 28 3223 6374
Email
pakniat110@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Dr Hamideh Pakniat
Position
Associated Professor, Department of Obstetrics and Gynecology
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Kowsar Hospital, Taleghani St, Qazvin, Iran
City
Qazvin
Province
Qazvin
Postal code
3415613176
Phone
+98 28 3223 6374
Email
pakniat110@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Dr Hamideh Pakniat
Position
Asistant Professor, Department of Obstetrics and Gynecology Qazvin University of Medical Sciences
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Kowsar Hospital, Taleghani St, Qazvin, Iran
City
Qazvin
Province
Qazvin
Postal code
3415613176
Phone
+98 28 3223 6374
Email
hpakniat@qums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Information is the most commonly used questionnaire, which is a statistical analysis
When the data will become available and for how long
Starting 1 years after publication .
To whom data/document is available
Only available for people working in academic institutions
Under which criteria data/document could be used
Path analysis
From where data/document is obtainable
Dr Hamideh Pakniat executor of plan
What processes are involved for a request to access data/document
The email will be submitted to the project promoter at the discretion of the information.
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