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NCT Number: NCT04604366

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.

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Key information

Conditions

Miscarriage Abortion, Spontaneous Female Urogenital Diseases and Pregnancy Complications Misoprostol Pregnancy Complications Urogenital Diseases

Age range

20 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Islamabad Medical and Dental College

Islamabad, Federal, 44000, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Misoprostol

Drug

it stimulates uterine contractions

Other names: prostaglandin E1

Primary outcomes

  1. Number of participants with complete expulsion of conceptus.

    Time frame: six months

    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 outcomes

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

    Time frame: six months

    through physical examination and detailed history

Sponsors and collaborators

Lead sponsor

Islamabad Medical and Dental College

Other

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Oct 27, 2020
Registry last updated
May 24, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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