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

NCT04604366 | Completed Phase 2 DMC

• 1 other identifier: IslamabadMDC
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Miscarriage; Misoprostol

Keywords

mesoprostol; vaginal; sublingual

Outcome Measures

Primary Outcomes (1)

• 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

  six months

Secondary Outcomes (1)

• Number of patients having side effects of misoprostol like shivering, fever diarrhea and oral ulcers and others

  six months

Study Arms (2)

vaginal mesoprostol

ACTIVE COMPARATOR

Vaginal dose---800 microgram 3 hourly two doses

Drug: misoprostol

sublingual mesoprostol

EXPERIMENTAL

Sub lingual 600 microgram 3 hourly two doses

Drug: misoprostol

Interventions

misoprostol DRUG

it stimulates uterine contractions

Also known as: prostaglandin E1

sublingual mesoprostol; vaginal mesoprostol

Eligibility Criteria

• Age: 20 Years - 40 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Islamabad Medical and Dental College: lead

Study Sites (1)

Islamabad Medical and Dental College

Islamabad, Federal, 44000, Pakistan

Location

Related Publications (1)

• 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.

  PMID: 27698600 BACKGROUND

MeSH Terms

Conditions

Abortion, Spontaneous

Interventions

Misoprostol; Alprostadil

Condition Hierarchy (Ancestors)

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; Prostaglandins E; Fatty Acids, Monounsaturated

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: October 6, 2020
• First Posted: October 27, 2020
• Study Start: November 2, 2020
• Primary Completion: December 15, 2021
• Study Completion: December 31, 2021
• Last Updated: May 24, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)