Comparison of Vaginal Versus Sublingual Misoprostol in the Treatment of First Trimester Missed Miscarriage
Condition: Miscarriage; Misoprostol
MeSH terms: Abortion, Spontaneous; Abortion, Missed
Study type: Interventional
Phase: Phase 2

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.
    

Intervention name(s): misoprostol
Intervention type(s): Drug
Intervention description(s): it stimulates uterine contractions
Other intervention name(s): prostaglandin E1
Intervention MeSH terms: Alprostadil; Misoprostol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: mesoprostol; vaginal; sublingual