Protocol summary
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Study aim
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the effect of micronized progesterone and progesterone suppository on pregnancy survival compars in pregnant women threatened with abortion.
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Design
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Two parallel groups randomized trial, not blinded, single center
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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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.
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Intervention groups
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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.
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Main outcome variables
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Pregnancy residues ;pre term delivery ; complications of post consumption of medicines.
General information
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Reason for update
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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.
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Acronym
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IRCT registration information
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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
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Registration date
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2019-05-12, 1398/02/22
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2018-04-21, 1397/02/01
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Expected recruitment end date
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2019-01-20, 1397/10/30
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Actual recruitment start date
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2022-02-01, 1400/11/12
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Actual recruitment end date
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2022-11-06, 1401/08/15
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Trial completion date
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2023-09-05, 1402/06/14
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Scientific title
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Comparison of Vaginal Progesterone and Oral Micronized Progesterone on Pregnancy Outcomes in Women with Threatened Miscarriage
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Public title
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Comparison of the effect of two progesteron drugs in protection of abortion
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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
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Age
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No age limit
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Gender
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Female
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Phase
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3
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Groups that have been masked
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No information
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Sample size
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Target sample size:
160
Actual sample size reached:
170
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Medications are encoded in separate envelopes and delivered to the participants.
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2018-03-12, 1396/12/21
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Ethics committee reference number
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IR.QUMS.REC.1396.498
Health conditions studied
1
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Description of health condition studied
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Abortion
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ICD-10 code
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ICD-10 code description
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Primary outcomes
1
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Description
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Abortion
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Timepoint
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From the start of the intervention up to end of pregnancy
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Method of measurement
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Weekly visit until the end of bleeding
Secondary outcomes
1
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Description
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Preeclampsia
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Timepoint
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Up to 28 weeks monthly until 36 weeks every two weeks and thereafter weekly until delivery
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Method of measurement
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Mercury pressure gauge
2
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Description
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Gestational Diabetes
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Timepoint
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Up to 28 weeks monthly until 36 weeks every two weeks and thereafter weekly until delivery
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Method of measurement
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Glucose tolerance test
Intervention groups
1
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Description
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Intervention group: Progesterone suppository 400 milligrams per day
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Category
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Treatment - Drugs
2
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Description
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Intervention group: Progesterone capsule 100 mg per day
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Qazvin University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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No - There is not a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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No - There is not a plan to make this available
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Data Dictionary
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No - There is not a plan to make this available
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Title and more details about the data/document
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Information is the most commonly used questionnaire, which is a statistical analysis
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When the data will become available and for how long
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Starting 1 years after publication .
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To whom data/document is available
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Only available for people working in academic institutions
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Under which criteria data/document could be used
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Path analysis
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From where data/document is obtainable
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Dr Hamideh Pakniat executor of plan
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What processes are involved for a request to access data/document
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The email will be submitted to the project promoter at the discretion of the information.
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Comments
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