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Comparison of Vaginal Versus Sublingual Misoprostol in the Treatment of First Trimester Missed Miscarriage

Primary Purpose

Miscarriage, Misoprostol

Status
Completed
Phase
Phase 2
Locations
Pakistan
Study Type
Interventional
Intervention
misoprostol
Sponsored by
Islamabad Medical and Dental College
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Miscarriage focused on measuring mesoprostol, vaginal, sublingual

Eligibility Criteria

20 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Confirmed diagnosis of missed miscarriage on pelvic ultrasound
  • Gestational age ≤ 13 weeks

Exclusion Criteria:

  • Patients who opted for surgical or expectant management.
  • Patients with co-morbidity

Sites / Locations

  • Islamabad Medical and Dental College

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

vaginal mesoprostol

sublingual mesoprostol

Arm Description

Vaginal dose---800 microgram 3 hourly two doses

Sub lingual 600 microgram 3 hourly two doses

Outcomes

Primary Outcome Measures

Number of participants with complete expulsion of conceptus.
primary outcome measure is to record the number of patients in each group who achieved complete expulsion of products of conception.complete expulsion will be confirmed by pelvic USG

Secondary Outcome Measures

Number of patients having side effects of misoprostol like shivering, fever diarrhea and oral ulcers and others
through physical examination and detailed history

Full Information

First Posted
October 6, 2020
Last Updated
May 23, 2022
Sponsor
Islamabad Medical and Dental College
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1. Study Identification

Unique Protocol Identification Number
NCT04604366
Brief Title
Comparison of Vaginal Versus Sublingual Misoprostol in the Treatment of First Trimester Missed Miscarriage
Official Title
Comparison of Vaginal Versus Sublingual Misoprostol in the Treatment of First Trimester Missed Miscarriage
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
November 2, 2020 (Actual)
Primary Completion Date
December 15, 2021 (Actual)
Study Completion Date
December 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Islamabad Medical and Dental College

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
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The miscarriage is one of the adverse outcomes of pregnancy and is responsible for stress and anxiety of the couple. there are different types of miscarriages.missed miscarriage also known as early fetal demise is one of the type of miscarriage in which patient is mostly asymptomatic but Ultrasound shows absent fetal cardiac activity.Traditionally surgical evacuation of uterus was the treatment of choice for miscarriage.The treatment of miscarriage has evolved significantly in recent years.medical management using misoprostol is the newest treatment option.Misoprostol is a synthetic prostaglandin E(1) analogue that is commonly used for medical miscarriage It can be given orally, vaginally and sublingually.
Detailed Description
This study will be conducted in gynae and obstetric department of Akbar Niazi teaching hospital.Patients coming to gynaecology Outpatient department having confirmed diagnosis of missed miscarriage on pelvic ultrasound in first trimester will be enrolled after taking written consent for medical treatment.Patients will be randomly selected for oral or vaginal route of misoprostol,dosage according to international federation of gynaecology and obstetrics protocol. Vaginal dose---800 microgram 3 hourly two doses Sub lingual 600 microgram 3 hourly two doses Patients will be observed for vaginal bleeding and expulsion for 24 hours if no expulsion or vaginal bleeding occurred then dose will be repeated .maximum of two cycles will be given. Failure of treatment confirmed by Ultrasonography will be dealt with surgical evacuation In case of heavy vaginal bleeding or expulsion pelvic USG will be done to confirm.After admission baseline investigation and coagulation studies will be performed . demographic details will be recorded... Patients will be assessed for time taken in complete expulsion of conceptus. No of doses required Need for surgical evacuation Haemorrhage Fall in Hb level Need of blod transfusion Patient satisfaction Side effects of misoprostol like shivering,fever diarrhea and oral ulcers and others EXCLUSION CRITERIA patients who opted for surgical management or expectant management. Gestational age >13 weeks Patients with co-morbidity Sample size: A total of 120 women will be selected for the study, divided into two equal groups of 60 women in each group. The sample size was calculated by WHO sample size calculator with of help of 5% level of significance, 90% power of test, 48% vs. 20% overall complication rate in sub inguinal and vaginal misoprostol groups (???). Statistical analysis: All the collected data will be entered into SPSS v. 21 for analysis. Quantitative data will be presented in the form of mean ± standard deviation. Independent sample t-test will be applied to compare the quantitative variables (like age and gestational age) between both groups. Frequency with percentages will be calculated for qualitative data and chi-square test will be used to compare the qualitative variables (like abortion and complications) between both groups. P-value ≤ 0.05 will be taken as significant.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Miscarriage, Misoprostol
Keywords
mesoprostol, vaginal, sublingual

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
lottery method will be used .one hundred and twenty slips will be made .60 will be marked as group A and 60 will be as Group B. these will be put in basket .and will be picked by the team member
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
vaginal mesoprostol
Arm Type
Active Comparator
Arm Description
Vaginal dose---800 microgram 3 hourly two doses
Arm Title
sublingual mesoprostol
Arm Type
Experimental
Arm Description
Sub lingual 600 microgram 3 hourly two doses
Intervention Type
Drug
Intervention Name(s)
misoprostol
Other Intervention Name(s)
prostaglandin E1
Intervention Description
it stimulates uterine contractions
Primary Outcome Measure Information:
Title
Number of participants with complete expulsion of conceptus.
Description
primary outcome measure is to record the number of patients in each group who achieved complete expulsion of products of conception.complete expulsion will be confirmed by pelvic USG
Time Frame
six months
Secondary Outcome Measure Information:
Title
Number of patients having side effects of misoprostol like shivering, fever diarrhea and oral ulcers and others
Description
through physical examination and detailed history
Time Frame
six months

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Confirmed diagnosis of missed miscarriage on pelvic ultrasound Gestational age ≤ 13 weeks Exclusion Criteria: Patients who opted for surgical or expectant management. Patients with co-morbidity
Facility Information:
Facility Name
Islamabad Medical and Dental College
City
Islamabad
State/Province
Federal
ZIP/Postal Code
44000
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
27698600
Citation
Dehbashi Z, Moosazadeh M, Afshari M. COMPARISON BETWEEN SUBLINGUAL AND VAGINAL ROUTE OF MISOPROSTOL IN MANAGEMENT OF FIRST TRIMESTER MISCARRIAGE MISSING. Mater Sociomed. 2016 Jul 24;28(4):271-273. doi: 10.5455/msm.2016.28.271-273.
Results Reference
background

Learn more about this trial

Comparison of Vaginal Versus Sublingual Misoprostol in the Treatment of First Trimester Missed Miscarriage

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