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To assess the effect of vaginal estradiol pretreatment before vaginal misoprostol on labor induction.
A prospective double blind randomized clinical trial. Conducted at Ain Shams University Maternity Hospital. Patients fulfilling inclusion and exclusion criteria will be divided into two groups. Group (A):
100 patient will receive single dose vaginal estradiol 50mcg tablet (Ethinyl Estradiol manufactured by KAHIRA Pharmaceutical company) and vaginal misoprostol 25mcg tablet (Vagiprost manufactured by ADWIA Pharmaceutical company), misoprostol alone will repeated every 6hours up to five doses.
Group (B):
100 patients will receive placebo vaginally and misoprostol 25 mcg which will be repeated every 6 hours up to five doses.
Primary Outcome
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Estradiol + Misoprostol | Experimental | 100 patient will receive single dose vaginal estradiol 50mcg tablet (Ethinyl Estradiol manufactured by KAHIRA Pharmaceutical company) and vaginal misoprostol 25mcg tablet (Vagiprost manufactured by ADWIA Pharmaceutical company), misoprostol alone will repeated every 6hours up to five doses. |
|
| Placebo + Misoprostol | Placebo Comparator | 100 patients will receive placebo vaginally and misoprostol 25 mcg which will be repeated every 6 hours up to five doses. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Estradiol | Drug |
|
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Time to cervical ripening. | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Time to active labor | 30 hours | |
| Number of misoprostol doses | 24 hours | |
| Induction delivery time |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Osama El-Kady, MD | AinShams University | Principal Investigator |
| AbdEl-Latif El-Kholy, MD | AinShams University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ain Shams University | Cairo | Egypt |
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| ID | Term |
|---|---|
| D004958 | Estradiol |
| D004997 | Ethinyl Estradiol |
| D016595 | Misoprostol |
| ID | Term |
|---|---|
| D004963 | Estrenes |
| D004962 | Estranes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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| Drug |
|
| Misoprostol | Drug |
|
|
| 48 hours |
| D011083 |
| Polycyclic Compounds |
| D045166 | Estradiol Congeners |
| D012739 | Gonadal Steroid Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D009651 | Norpregnatrienes |
| D009650 | Norpregnanes |
| D009654 | Norsteroids |
| D042782 | Estrogenic Steroids, Alkylated |
| D011459 | Prostaglandins E, Synthetic |
| D011465 | Prostaglandins, Synthetic |
| D011453 | Prostaglandins |
| D015777 | Eicosanoids |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |