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Sublingual Versus Vaginal Misoprostol In Medical Treatment of First Trimestric Missed Miscarriage

Primary Purpose

Missed Abortion

Status
Completed
Phase
Phase 3
Locations
Egypt
Study Type
Interventional
Intervention
sublingual misoprostol
vaginal misoprostol
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Missed Abortion

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • All women above 18 years of age
  • Less than 12 weeks of gestation.
  • Pregnancy is confirmed by pregnancy test or ultrasound scan.
  • missed abortion
  • Normal general and gynecological examination.
  • The size of the uterus on pelvic examination was compatible with the estimated duration of pregnancy

Exclusion Criteria:

  • Hemodynamically unstable.
  • Suspected sepsis with temperature 38 °C.
  • Concurrent medical illness e.g. hematological, cardiovascular, thromboembolism, respiratory illnesses, recent liver disease or pruritus of pregnancy.
  • Presence of intrauterine contraceptive device (IUCD).
  • Suspect or proven ectopic pregnancy.
  • Failed medical or surgical evacuation before presentation.
  • Known allergy to misoprostol.

Sites / Locations

  • Ain shams university maternity hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

sublingual misoprostol

vaginal misoprostol

Arm Description

Group A (100 patients): will be treated with sublingual misoprostol

Group B (100 patients): will be treated with vaginal misoprostol

Outcomes

Primary Outcome Measures

Completeness of abortion: expulsion of Products of conception (POC)x by visual inspection

Secondary Outcome Measures

Successful medical abortion: cervical os is closed with endometrial thickness of less than 15 mm
Failure: endometrial thickness of more than 15 mm on day seven (from third dose of misoprostol) or developing of complications before day seven needing early surgical evacuation.
Bleeding pattern following treatment
This will be assessed by hemoglobin(g/dl) and haematocrit level after the treatment , if the patients required blood transfusion and number of units transfused and number of days of bleeding
Pain resulting from the procedure
this will be assessed by the doses of paracetamol given in mg
Additional uterotonic used
additional misoprostol doses in mcg

Full Information

First Posted
January 27, 2016
Last Updated
August 13, 2017
Sponsor
Ain Shams University
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1. Study Identification

Unique Protocol Identification Number
NCT02686840
Brief Title
Sublingual Versus Vaginal Misoprostol In Medical Treatment of First Trimestric Missed Miscarriage
Official Title
Sublingual Versus Vaginal Misoprostol In Medical Treatment of First Trimestric Missed Miscarriage: A Randomized Controlled Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
January 2016 (Actual)
Primary Completion Date
January 2017 (Actual)
Study Completion Date
March 2017 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The aim of this work is to compare the effectiveness of vaginal versus sub-lingual misoprostol for medical treatment of first trimester missed miscarriage.
Detailed Description
In women with first trimetric-missed miscarriage, sublingual misoprostol may be as vaginal misoprostol in achievement of successful miscarriage so our aim was to compare the effectiveness of vaginal versus sub-lingual misoprostol for medical treatment of first trimester missed miscarriage.

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 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
sublingual misoprostol
Arm Type
Experimental
Arm Description
Group A (100 patients): will be treated with sublingual misoprostol
Arm Title
vaginal misoprostol
Arm Type
Active Comparator
Arm Description
Group B (100 patients): will be treated with vaginal misoprostol
Intervention Type
Drug
Intervention Name(s)
sublingual misoprostol
Other Intervention Name(s)
Misotac
Intervention Description
All patients will receive three doses of sublingual misoprostol every four hours The first dose of misoprostol 800 mcg will be administrated at the hospital. Then the patient will be observed for 1 hour for any immediate adverse reaction Clear instructions about the method and timing of second dose will be given upon sending home. Two doses of misoprostol 800 mcg each (four tablets of 200 mcg per dose). Paracetamol, eight hourly, will be provided as analgesic or antipyretic. A specimen bottle to collect the POC if passed out. Two pairs of disposable gloves. Pre-filled histopathological examination form to be sent to the laboratory together with the products of conception
Intervention Type
Drug
Intervention Name(s)
vaginal misoprostol
Other Intervention Name(s)
Misotac
Intervention Description
All patients will receive three doses of vaginal misoprostol every four hours The first dose of misoprostol 800 mcg will be administrated at the hospital. Then the patient will be observed for 1 hour for any immediate adverse reaction Clear instructions about the method and timing of second dose will be given upon sending home. Paracetamol, eight hourly, will be provided as analgesic or antipyretic
Primary Outcome Measure Information:
Title
Completeness of abortion: expulsion of Products of conception (POC)x by visual inspection
Time Frame
7 days
Secondary Outcome Measure Information:
Title
Successful medical abortion: cervical os is closed with endometrial thickness of less than 15 mm
Time Frame
7 days
Title
Failure: endometrial thickness of more than 15 mm on day seven (from third dose of misoprostol) or developing of complications before day seven needing early surgical evacuation.
Time Frame
7 days
Title
Bleeding pattern following treatment
Description
This will be assessed by hemoglobin(g/dl) and haematocrit level after the treatment , if the patients required blood transfusion and number of units transfused and number of days of bleeding
Time Frame
7 days
Title
Pain resulting from the procedure
Description
this will be assessed by the doses of paracetamol given in mg
Time Frame
7 days
Title
Additional uterotonic used
Description
additional misoprostol doses in mcg
Time Frame
7 days

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: All women above 18 years of age Less than 12 weeks of gestation. Pregnancy is confirmed by pregnancy test or ultrasound scan. missed abortion Normal general and gynecological examination. The size of the uterus on pelvic examination was compatible with the estimated duration of pregnancy Exclusion Criteria: Hemodynamically unstable. Suspected sepsis with temperature 38 °C. Concurrent medical illness e.g. hematological, cardiovascular, thromboembolism, respiratory illnesses, recent liver disease or pruritus of pregnancy. Presence of intrauterine contraceptive device (IUCD). Suspect or proven ectopic pregnancy. Failed medical or surgical evacuation before presentation. Known allergy to misoprostol.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hassan A Bayoumy, MD
Organizational Affiliation
Ain Shams University
Official's Role
Study Chair
Facility Information:
Facility Name
Ain shams university maternity hospital
City
Cairo
ZIP/Postal Code
25187
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
30747547
Citation
Abdelshafy A, Awwad H, Abo-Gamra A, Alanwar A, Elkotb AM, Shahin M, Abd El-Razek M, Abbas AM. Sublingual vs vaginal misoprostol for completion of first trimester missed abortion: a randomised controlled trial. Eur J Contracept Reprod Health Care. 2019 Apr;24(2):134-139. doi: 10.1080/13625187.2019.1569224. Epub 2019 Feb 12.
Results Reference
derived

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Sublingual Versus Vaginal Misoprostol In Medical Treatment of First Trimestric Missed Miscarriage

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