Miscarriage
Conditions
Brief summary
Miscarriage is defined as the spontaneous loss of a pregnancy before 24 weeks gestation, that is, before fetal viability. The clinical signs of miscarriage are usually vaginal bleeding associated with abdominal pain and cramping. The miscarriage is named 'complete' or 'incomplete' according to whether or not tissues are retained in the uterus. If a woman has minimal bleeding but her cervix is closed, this is known as a 'threatened miscarriage. However; if the pregnancy is still inside the uterus but the cervix is open, this is described as an 'inevitable miscarriage', which it will not usually be possible to save the fetus.
Detailed description
the aim of the study is to evaluate 2 doses with misoprostol in Women With Incomplete First-trimester Miscarriage After Misoprostol Treatment
Interventions
DRUGmisoprostol 800 µg
received misoprostol 800 µg (Misotac 200 µg tablets, SIGMA pharmaceutical) once dose sublingually
DRUGmisoprostol 400 µg
received misoprostol 400 µg (Misotac 200 µg tablets, SIGMA pharmaceutical) once dose sublingually
Sponsors
Aswan University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
a double-blind placebo-controlled randomized trial
Intervention model description
a double-blind placebo-controlled randomized trial
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
* Women with confirmed incomplete induced miscarriage, less than 12 weeks' gestation. * No known allergy to misoprostol. * Women who will be hemodynamically stable. * Good access to emergency facilities
Exclusion criteria
* Women with signs of severe infection ( fever \> 38°) * Women with severe vaginal bleeding * Women are known to have allergies to prostaglandins * Severe abdominal pain requiring immediate intervention
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The number of patients with complete miscarriage at 1 week | 7 days | The number of patients with complete miscarriage at 1 week |
Countries
Egypt
Outcome results
None listed