Misoprostol Allergy Clinical Trial
Official title:
Randomized Control Trial Comparing Patient Acceptability and Tolerance to Pain Using Oral Versus Vaginal Misoprostol for Cervical Priming Before Office Hysteroscopy.
The objective of the present study is to evaluate the appropriate route of administration of misoprostol, either oral or vaginal, for cervical priming to facilitate the procedure of office hysteroscopy and reduce patient discomfort to minimum
Sample size calculation was done using the comparison of pain sensation represented through
VAS between oral and vaginal misoprostol for cervical ripening before office hysteroscopy. As
reported in previous publication (Sordia-Herna'ndez et al., 2011), the mean ±SD of VAS in
oral misoprostol group was approximately 6.04 ± 1.5, while in vaginal misoprostol group was
approximately 2.8 ± 1.2. Accordingly, we calculated that the minimum proper sample size was
23 women in each arm to be able to detect a real difference of 1 unit with 80% power at α =
0.05 level using Student's t test for independent samples. Sample size calculation was done
using Stats Direct statistical software version 2.7.2 for MS Windows, StatsDirect Ltd.,
Cheshire, UK
However, the study population consists of 100 patients in reproductive age that requires
diagnostic hysteroscopy for investigation of infertility or AUB.
The patients will be recruited from Office hysteroscopy clinic of the Obstetrics and
Gynecology Department, Faculty of Medicine, Cairo University from October 2017 to march 2018.
The Patients will be allocated equally into 2 groups ( each group contain 50 patients)
Groups will be as follows:
1. Group A: 50 patients receive 200 mg oral misoprostol (Misotac; Sigma Pharm) 3h before
the procedure.
2. Group B: 50 patients receive 200 mg misoprostol (Misotac; Sigma Pharm) 3h before the
procedure moistened with saline solution will be inserted in posterior fornix of vagina.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT05806307 -
Methods Decreasing Bleeding in Open Myomectomy
|
Phase 4 | |
| Recruiting |
NCT05928871 -
Pre Versus Post-operative Misoprostol in Reducing Blood Loss After Cesarean Section
|
Phase 4 |