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

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.

Study Overview

• Status: Completed
• Conditions: Miscarriage; Misoprostol
• Intervention / Treatment: Drug: misoprostol

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.

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Phase 2

Contacts and Locations

Study Locations

• Pakistan
  • Federal
    • Islamabad, Federal, Pakistan, 44000
      • Islamabad Medical and Dental College

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: vaginal mesoprostol; Vaginal dose---800 microgram 3 hourly two doses	Drug: misoprostol; it stimulates uterine contractions; Other Names: prostaglandin E1
Experimental: sublingual mesoprostol; Sub lingual 600 microgram 3 hourly two doses	Drug: misoprostol; it stimulates uterine contractions; Other Names: prostaglandin E1

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients having side effects of misoprostol like shivering, fever diarrhea and oral ulcers and others	through physical examination and detailed history	six months

Collaborators and Investigators

• Sponsor: Islamabad Medical and Dental College

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 2, 2020
• Primary Completion (Actual): December 15, 2021
• Study Completion (Actual): December 31, 2021

Study Registration Dates

• First Submitted: October 6, 2020
• First Submitted That Met QC Criteria: October 24, 2020
• First Posted (Actual): October 27, 2020

Study Record Updates

• Last Update Posted (Actual): May 24, 2022
• Last Update Submitted That Met QC Criteria: May 23, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: sublingual; vaginal; mesoprostol
• Additional Relevant MeSH Terms: Pregnancy Complications; Abortion, Spontaneous; Abortion, Missed; Physiological Effects of Drugs; Vasodilator Agents; Urological Agents; Platelet Aggregation Inhibitors; Gastrointestinal Agents; Reproductive Control Agents; Anti-Ulcer Agents; Abortifacient Agents, Nonsteroidal; Abortifacient Agents; Oxytocics; Misoprostol; Alprostadil
• Other Study ID Numbers: IslamabadMDC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• 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