Comparative Study Between Combined Vaginal Misoprostol

Phase 1

• Conditions: Missed Abortion
• Interventions: Drug: Misoprostol and iso sorbide mononitrates

• Registration Number: NCT04981457
• Lead Sponsor: Cairo University

Brief Summary

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

Detailed 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"

Study Timeline

• Study Start: 2021-03-02
• Status Verified: 2021-07
• Study First Submitted: 2021-07-12
• Study First Submitted QC: 2021-07-28
• Last Update Submitted: 2021-07-28
• Study First Posted: 2021-07-29
• Last Update Posted: 2021-07-29
• Primary Completion: 2021-09
• Study Completion: 2021-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 60

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
patients who recieve misoprostol alone	Misoprostol and iso sorbide mononitrates	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.
patients who recieve misoprostol and iso sorbide mononitrate	Misoprostol and iso sorbide mononitrates	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.

Primary Outcome Measures

Name	Time	Method
Induction to abortion interval	6 months	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.
Number of the doses	6 months	the Number of the doses of misoprostol needed to complete expulsion (spontaneous or surgical)

Trial Locations

Locations (1)

Cairo U; 🇪🇬 Cairo, Married, Egypt