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Vaginal Misoprostol In Medical Treatment of First Trimester Missed Miscarriage

Not Applicable
Conditions
Miscarriage
Interventions
Registration Number
NCT05094375
Lead Sponsor
hany farouk
Brief Summary

Efficacy of vaginal misoprostol 600 Mg versus 800 Mg in termination of the first trimester missed abortion were assist

Detailed Description

In women with first trimetric-missed miscarriage, vaginal misoprostol in the achievement of successful miscarriage so our aim was to compare the effectiveness of vaginal misoprostol 600 Mg versus 800 Mg for medical treatment of the first trimester missed miscarriage.

Recruitment & Eligibility

Status
UNKNOWN
Sex
Female
Target Recruitment
200
Inclusion Criteria
  • All women above 18 years of age
  • Less than 12 weeks of gestation.
  • Pregnancy is confirmed by pregnancy test or ultrasound scan.
  • missed abortion
  • Normal general and gynecological examination.
Exclusion Criteria
  • Hemodynamically unstable.
  • Suspected sepsis with temperature 38 °C.
  • Concurrent medical illness e.g. hematological, cardiovascular, thromboembolism,
  • respiratory , recent liver disease, or pruritus of pregnancy.
  • Presence of intrauterine contraceptive device (IUCD).
  • Suspect or proven ectopic pregnancy.
  • Failed medical or surgical evacuation before the presentation.
  • Known allergy to misoprostol.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Vaginal Misoprostol 600 mcgVaginal Misoprostol 600 mcgAll patients will receive three doses of vaginal misoprostol every four hours. The first dose of misoprostol 600 mcg will be administrated at the hospital. Then the patient will be observed for 1 hour for any immediate adverse reaction Clear instructions about the method and timing of the second dose will be given upon sending home. * Two doses of misoprostol 600 mcg each (3 tablets of 200 mcg per dose). * Paracetamol, eight hourlies, will be provided as analgesic or antipyretic. * A specimen bottle to collect the POC if passed out. * Two pairs of disposable gloves. * Pre-filled histopathological examination form to be sent to the laboratory together with the products of conception
Vaginal Misoprostol 800 mcgVaginal Misoprostol 800 mcgAll patients will receive three doses of vaginal misoprostol every four hours. The first dose of misoprostol 800 mcg will be administrated at the hospital. Then the patient will be observed for 1 hour for any immediate adverse reaction Clear instructions about the method and timing of the second dose will be given upon sending home. * Two doses of misoprostol 800 mcg each (four tablets of 200 mcg per dose). * Paracetamol, eight hourlies, will be provided as analgesic or antipyretic. * A specimen bottle to collect the POC if passed out. * Two pairs of disposable gloves. * Pre-filled histopathological examination form to be sent to the laboratory together with the products of conception
Primary Outcome Measures
NameTimeMethod
Completeness of abortion7 days

expulsion of Products of conception by visual inspection

Secondary Outcome Measures
NameTimeMethod
Pain resulting from the procedure7 days

this will be assessed by the doses of paracetamol given in mg

Bleeding pattern following treatment7 days

This will be assessed by hemoglobin(g/dl) and haematocrit level after the treatment , if the patients required blood transfusion and number of units transfused and number of days of bleeding

Additional uterotonic used14 days

additional misoprostol doses in mcg

Successful medical abortion14 days

cervical os is closed with endometrial thickness of less than 15 mm

Trial Locations

Locations (1)

Aswan University Hospital

🇪🇬

Aswan, Egypt

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