Home-Based Extended Low Dose Buccal Misoprostol Versus Hospital-Based Standard Vaginal Dose In Management Of First Trimester Missed Abortion.
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Assiut University
- Enrollment
- 140
- Locations
- 1
- Primary Endpoint
- Percentage of patients with complete abortion (success rate).
Study Overview
Brief Summary
The world health organization defined abortion or miscarriage as : the expulsion or extraction from its mother of a fetus or an embryo weighting 500 grams or less ,or any other wise product of gestation of any weight irrespective of gestational age and weather or not there is evidence of life and weather or not the abortion was spontaneous or induced Miscarriage is the most common complication of pregnancy occurring in 10-20% of clinically recognized pregnancies (Bag. It is estimated that around 40% of early pregnancies result in miscarriage. A large majority of those are lost before the menstrual period is missed. More than 80%of abortions occur in first 12 weeks of pregnancy, and the rate decrease there after For clinical purposes: abortion is subdivided into: threatened abortion, inevitable abortion, incomplete abortion ,missed abortion ,septic abortion ,and recurrent abortion
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to 40 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •single dead fetus up-to 12 weeks.
- •no low lying placenta
- •no scarred uterus
- •no or mild bleeding
- •no evidence of infection
- •accepting to participate in the study.
Exclusion Criteria
- •Advanced hepatic diseases .
- •Suspected molar pregnancy
- •Ectopic pregnancy or pregnancy of unknown location
- •Haemodynamically unstable with significant anaemia ie Hb<10
- •Uncontrolled severe asthma
- •Chronic adrenal failure
- •Known or suspected heart disease
- •Haemoglobinopathies
- •Haemorrhagic disorders and anti-coagulation therapy (aspirin accepted)
- •Adrenal suppression and long term glucocorticoid therapy (may require corticosteroid)
- •Patient living in remote areas with difficulty in accessing hospital
Arms & Interventions
hospital- based vaginal misoprostol
hospital- based vaginal misoprostol
Intervention: vaginal misoprostol (Drug)
extended low dose oral misoprostol
extended low dose oral misoprostol
Intervention: buccal/sublingual misoprostol (Drug)
Outcomes
Primary Outcomes
Percentage of patients with complete abortion (success rate).
Time Frame: 1 week
Secondary Outcomes
- Number of misoprostol doses(1 week)
- induction-abortion time(1 week)
Investigators
Mohammed Khairy Ali
Lecturer of obstetrics and gynecology
Assiut University