Missed Abortion
Conditions
Brief summary
Comparative study between Combined Vaginal Misoprostol with Isosorbide-5-Mononitrate
Detailed description
Comparative study between Combined Vaginal Misoprostol with Isosorbide-5-Mononitrate versus Misoprostol Alone For Induction Of The first trimester Missed Abortion A Randomized Clinical Trial
Interventions
DRUGMisoprostol and iso sorbide mononitrates
drug
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Intervention model description
A Randomized Clinical Trial
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 35 Years
Healthy volunteers
Yes
Inclusion criteria
* \- Maternal Age 18 - 35 years. * Gestational age first trimester of pregnancy (between 5-13 weeks). * Missed abortion confirmed by ultrasound. * Singleton pregnancy. * Normal uterus and cervix on clinical examination. * Cervix is not dilated. * No vaginal bleeding.
Exclusion criteria
- Evidences suggesting start of spontaneous abortion and previous trial to induce abortion. * Presence of uterine contraction or bleeding, * Multi-fetal pregnancy. * Suspicion of septic abortion. * History of Previous cervical surgery or manipulation. Ex: cervical tear , cervical cauterization . * Uterine anomaly. * Presence of IUD( intrauterine device) in situ * Underlying medical diseases.Ex:diabetes mellitus,hypertension * History of allergy or adverse effects to vaginally administered medication e.g. isosorbide -5- mononitrate * Those unwilling to participate in the trial * Higher order cesarean section(more than three
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Induction to abortion interval | 6 months | Induction to abortion interval: the Duration interval between the beginning of the induction and beginning of cervical ripening assessed by cervical examination(cervix become soft and start to dilate) and uterine contractions leading to complete expulsion of the abortus spontaneous and if cervical ripening isn't occur by maximum doses the investigators will make surgical evacuation. |
| Number of the doses | 6 months | the Number of the doses of misoprostol needed to complete expulsion (spontaneous or surgical) |
Countries
Egypt
Outcome results
None listed