Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1
60 participants
INTERVENTIONAL
2021-03-02
2021-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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patients who recieve misoprostol alone
Group A (n =30 ) will receive only vaginal Misoprostol 800mcg (4 tablets Cytotec 200mcg ) ) every 3 hours to a maximum of two doses or until reaching cervical ripening or uterine contractions or bleeding assessed by the same doctor who made evaluation at the beginning.
Misoprostol and iso sorbide mononitrates
drug
patients who recieve misoprostol and iso sorbide mononitrate
Group B (n =30 ) will receive combined vaginal Misoprostol 800mcg (4 tablets Cytotec ) ) every 3 hours to a maximum of two doses or until reaching cervical ripening or start of uterine contractions or bleeding. with Isosorbide-5-mononitrate (20 mg). Effox 20 mg )once at the beginning with misoprostol until reaching cervical ripening or start of and uterine contractions assessed by the same doctor who made the evaluation at the beginning.
Misoprostol and iso sorbide mononitrates
drug
Interventions
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Misoprostol and iso sorbide mononitrates
drug
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Gestational age first trimester of pregnancy (between 5-13 weeks).
* Missed abortion confirmed by ultrasound.
* Singleton pregnancy.
* Normal uterus and cervix on clinical examination.
* Cervix is not dilated.
* No vaginal bleeding.
Exclusion Criteria
* Multi-fetal pregnancy.
* Suspicion of septic abortion.
* History of Previous cervical surgery or manipulation. Ex: cervical tear , cervical cauterization .
* Uterine anomaly.
* Presence of IUD( intrauterine device) in situ
* Underlying medical diseases.Ex:diabetes mellitus,hypertension
* History of allergy or adverse effects to vaginally administered medication e.g. isosorbide -5- mononitrate
* Those unwilling to participate in the trial
* Higher order cesarean section(more than three
18 Years
35 Years
FEMALE
Yes
Sponsors
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Cairo University
OTHER
Responsible Party
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Kholod Mohamed Mahmoud Mousa Elkholy
resident of obstetrics and gynacology
Principal Investigators
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mohamed shalaby, MD
Role: STUDY_CHAIR
Cairo u
Locations
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Cairo U
Cairo, Married, Egypt
Countries
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References
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Arteaga-Troncoso G, Villegas-Alvarado A, Belmont-Gomez A, Martinez-Herrera FJ, Villagrana-Zesati R, Guerra-Infante F. Intracervical application of the nitric oxide donor isosorbide dinitrate for induction of cervical ripening: a randomised controlled trial to determine clinical efficacy and safety prior to first trimester surgical evacuation of retained products of conception. BJOG. 2005 Dec;112(12):1615-9. doi: 10.1111/j.1471-0528.2005.00760.x.
Carlsson I, Breding K, Larsson PG. Complications related to induced abortion: a combined retrospective and longitudinal follow-up study. BMC Womens Health. 2018 Sep 25;18(1):158. doi: 10.1186/s12905-018-0645-6.
Kim C, Barnard S, Neilson JP, Hickey M, Vazquez JC, Dou L. Medical treatments for incomplete miscarriage. Cochrane Database Syst Rev. 2017 Jan 31;1(1):CD007223. doi: 10.1002/14651858.CD007223.pub4.
Provided Documents
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Document Type: Study Protocol
Other Identifiers
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MS-196-2021
Identifier Type: -
Identifier Source: org_study_id
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