Comparative Study Between Combined Vaginal Misoprostol

NCT04981457 | Unknown Phase 1

• 1 other identifier: MS-196-2021
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Missed Abortion

Outcome Measures

Primary Outcomes (2)

• 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

• Number of the doses

  the Number of the doses of misoprostol needed to complete expulsion (spontaneous or surgical)

  6 months

Study Arms (2)

patients who recieve misoprostol alone

ACTIVE COMPARATOR

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.

Drug: Misoprostol and iso sorbide mononitrates

patients who recieve misoprostol and iso sorbide mononitrate

ACTIVE COMPARATOR

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.

Drug: Misoprostol and iso sorbide mononitrates

Interventions

Misoprostol and iso sorbide mononitrates DRUG

drug

Also known as: misotac and effox

patients who recieve misoprostol alone; patients who recieve misoprostol and iso sorbide mononitrate

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• \- 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo U

Cairo, Married, 12345, Egypt

Location

Related 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. doi: 10.1111/j.1471-0528.2005.00760.x.

  PMID: 16305563 BACKGROUND

• 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.

  PMID: 30253769 BACKGROUND

• 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.

  PMID: 28138973 BACKGROUND

MeSH Terms

Conditions

Abortion, Missed

Interventions

Misoprostol

Condition Hierarchy (Ancestors)

Abortion, Spontaneous; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Prostaglandins E, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors

Study Officials

• mohamed shalaby, MD

  Cairo u

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: resident of obstetrics and gynacology

Model Details: A Randomized Clinical Trial

Study Record Dates

• First Submitted: July 12, 2021
• First Posted: July 29, 2021
• Study Start: March 2, 2021
• Primary Completion: September 1, 2021
• Study Completion: October 1, 2021
• Last Updated: July 29, 2021

Record last verified: 2021-07

Locations

EG (1)