Clinical trial NCT04981457: Comparative Study Between Combined Vaginal Misoprostol
Official title: 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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Missed Abortion
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2021-07-29
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A Randomized Clinical Trial
Primary purpose: TREATMENT

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"

Eligibility criteria: 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

Primary outcomes:
measure: Induction to abortion interval
timeFrame: 6 months
measure: Number of the doses
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo U
state: Married
Study officials:
affiliation: Cairo u
name: mohamed shalaby, MD
role: STUDY_CHAIR
References:
citation: 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.
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.
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(1):CD007223. doi: 10.1002/14651858.CD007223.pub4.