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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04604366
Other study ID # IslamabadMDC
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date November 2, 2020
Est. completion date December 31, 2021

Study information

Verified date May 2022
Source Islamabad Medical and Dental College
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 120
Est. completion date December 31, 2021
Est. primary completion date December 15, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 20 Years to 40 Years
Eligibility 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 Design


Intervention

Drug:
misoprostol
it stimulates uterine contractions

Locations

Country Name City State
Pakistan Islamabad Medical and Dental College Islamabad Federal

Sponsors (1)

Lead Sponsor Collaborator
Islamabad Medical and Dental College

Country where clinical trial is conducted

Pakistan, 

References & 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
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