Termination Of Anembryonic Pregnancy
Paraules clau
Resum
Dates
Darrera verificació: | 09/30/2015 |
Primer enviat: | 10/07/2015 |
Inscripció estimada enviada: | 10/07/2015 |
Publicat per primera vegada: | 10/08/2015 |
Última actualització enviada: | 10/07/2015 |
Publicació de l'última actualització: | 10/08/2015 |
Data d'inici de l'estudi real: | 05/31/2015 |
Data estimada de finalització primària: | 09/30/2015 |
Condició o malaltia
Intervenció / tractament
Drug: Misoprostol
Drug: Misoprostol plus isosorbide mononitrate
Other: Misoprostol plus placebo
Fase
Grups de braços
Braç | Intervenció / tractament |
---|---|
Active Comparator: Misoprostol plus isosorbide mononitrate this group will receive 800 µg of misoprostol (Misotac 200 µg Sigma for Pharmaceutical Industries) plus 40 mg isosorbide mononitrate (Effox 40 mg Minipharma Company) will be inserted into the posterior vaginal fornix | Drug: Misoprostol plus isosorbide mononitrate 40 mg isosorbide mononitrate (Effox 40 mg Minipharma Company) |
Active Comparator: Misoprostol plus placebo This group will receive misoprostol 800 µg plus placebo in the same site. | Other: Misoprostol plus placebo |
Criteris d'elegibilitat
Edats elegibles per estudiar | 20 Years Per a 20 Years |
Sexes elegibles per estudiar | Female |
Accepta voluntaris saludables | Sí |
Criteris | Inclusion Criteria: - Maternal age ≥20years old. - No vaginal bleeding. - No dilation of internal os. - Gestational age: from 8-11weeks. - Gestational sac with a mean gestational sac diameter (MGD) greater than 25 mm and no yolk sac, or an MGD >25 mm with no embryo. Exclusion Criteria: - Patients with excessive vaginal bleeding (soaking more than a pad per day). - Patients with dilated cervix. - Patients with allergy either to misoprostol or isosorbide mononitrate. - Those who will be insisted on D and C will be excluded from the study. - Women will be excluded from the study if they are anemic (hemoglobin less than 11 g/dl). - Hemo-dynamically unstable with signs of pelvic infection and/or sepsis. - Suffering from a clotting disorder or using anticoagulants. - Women with uterine pathology such as myomas or malformation. - Women had previous caesarian section. - Asthmatic patients. |
Resultat
Mesures de resultats primaris
1. The measurement of endometrial thickness by ultrasound in mm [6 months]
Mesures de resultats secundaris
1. Induction - abortion interval in hours [6 months]
2. Induction dilatation interval in hours [6 month]
3. The occurrence of sever uncontrolled lower abdominal pain by visual analogue scale [6 months]