search
Back to results

Comparative Study Between Combined Vaginal Misoprostol (comparative)

Primary Purpose

Missed Abortion

Status
Unknown status
Phase
Phase 1
Locations
Egypt
Study Type
Interventional
Intervention
Misoprostol and iso sorbide mononitrates
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Missed Abortion

Eligibility Criteria

18 Years - 35 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Cairo U

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

patients who recieve misoprostol alone

patients who recieve misoprostol and iso sorbide mononitrate

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
July 12, 2021
Last Updated
July 28, 2021
Sponsor
Cairo University
search

1. Study Identification

Unique Protocol Identification Number
NCT04981457
Brief Title
Comparative Study Between Combined Vaginal Misoprostol
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
March 2, 2021 (Actual)
Primary Completion Date
September 2021 (Anticipated)
Study Completion Date
October 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No

5. Study Description

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"

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Missed Abortion

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Model Description
A Randomized Clinical Trial
Masking
Participant
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
patients who recieve misoprostol alone
Arm Type
Active Comparator
Arm Description
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.
Arm Title
patients who recieve misoprostol and iso sorbide mononitrate
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Misoprostol and iso sorbide mononitrates
Other Intervention Name(s)
misotac and effox
Intervention Description
drug
Primary Outcome Measure Information:
Title
Induction to abortion interval
Description
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.
Time Frame
6 months
Title
Number of the doses
Description
the Number of the doses of misoprostol needed to complete expulsion (spontaneous or surgical)
Time Frame
6 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
mohamed shalaby, MD
Organizational Affiliation
Cairo u
Official's Role
Study Chair
Facility Information:
Facility Name
Cairo U
City
Cairo
State/Province
Married
ZIP/Postal Code
12345
Country
Egypt

12. IPD Sharing Statement

Citations:
PubMed Identifier
16305563
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.
Results Reference
background
PubMed Identifier
30253769
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.
Results Reference
background
PubMed Identifier
28138973
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.
Results Reference
background

Learn more about this trial

Comparative Study Between Combined Vaginal Misoprostol

We'll reach out to this number within 24 hrs