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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04981457
Other study ID # MS-196-2021
Secondary ID
Status Active, not recruiting
Phase Phase 1
First received
Last updated
Start date March 2, 2021
Est. completion date October 2021

Study information

Verified date July 2021
Source Cairo University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

"Comparative study between Combined Vaginal Misoprostol with Isosorbide-5-Mononitrate


Description:

"Comparative study between Combined Vaginal Misoprostol with Isosorbide-5-Mononitrate versus Misoprostol Alone For Induction Of The first trimester Missed Abortion A Randomized Clinical Trial"


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 60
Est. completion date October 2021
Est. primary completion date September 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 35 Years
Eligibility Inclusion Criteria: - - Maternal Age 18 - 35 years. - 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:- Evidences suggesting start of spontaneous abortion and previous trial to induce abortion. - Presence of uterine contraction or bleeding, - 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Misoprostol and iso sorbide mononitrates
drug

Locations

Country Name City State
Egypt Cairo U Cairo Married

Sponsors (1)

Lead Sponsor Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

References & Publications (3)

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. — View Citation

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. — View Citation

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:CD007223. doi: 10.1002/14651858.CD007223.pub4. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Induction to abortion interval Induction to abortion interval: the Duration interval between the beginning of the induction and beginning of cervical ripening assessed by cervical examination(cervix become soft and start to dilate) and uterine contractions leading to complete expulsion of the abortus spontaneous and if cervical ripening isn't occur by maximum doses the investigators will make surgical evacuation. 6 months
Primary Number of the doses the Number of the doses of misoprostol needed to complete expulsion (spontaneous or surgical) 6 months
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Recruiting NCT04705324 - Dilation and Curettage Versus Operative Hysteroscopy for Missed Abortion N/A
Completed NCT02686840 - Sublingual Versus Vaginal Misoprostol In Medical Treatment of First Trimestric Missed Miscarriage Phase 3
Terminated NCT02342002 - Mifepristone and Misoprostol Versus Misoprostol Alone for Missed Abortion: A Randomized-controlled Trial Phase 4
Recruiting NCT01775917 - The Role of Uterine Artery Doppler Parameters in the Management of Retained Products of Conception. N/A
Active, not recruiting NCT04593108 - Misoprostol With or Without Letrozole in Treatment of Missed Miscarriage