Comparative Study Between Combined Vaginal Misoprostol

Missed Abortion Clinical Trial

— comparative  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04981457
• Other study ID #: MS-196-2021
• Status: Active, not recruiting
• Phase: Phase 1
• 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
• 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

Related Conditions & MeSH terms

• Abortion, Missed
• Missed Abortion

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