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The aim of this study is to determine whether dinoprostone administered 10 hours before office hysteroscopy can relieve pain more effectively compared with dinoprostone administered 3 hours before office hysteroscopy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| long interval dinoprostone | Experimental | A small envelope including two labeled plastic bags (A & B) (each bag containing either 1 dinoprostone tablet(3mg) or 1 identically appearing placebo tablet) will be packaged in sequentially numbered sealed envelopes. In long interval dinoprostone group, bag (A) contains dinoprostone tablet and bag (B) contains placebo tablet. After signing the informed consent, the sequentially numbered sealed envelopes will be opened (according to the sequence of attendance of the patient) by the study nurse. Tablets in bag (A) will be inserted 12 hours before office hysteroscopy and tablets in bag (B) will be inserted 3 hours before office hysteroscopy. |
|
| short interval dinoprostone | Active Comparator | A small envelope including two labeled plastic bags (A& B) (each bag containing either 1 dinoprostone tablets(3 mg) or 1 identically appearing placebo tablet) will be packaged in sequentially numbered sealed envelopes. In short interval dinoprostone group, bag (A) contains placebo tablet and bag (B) contains dinoprostone tablet. After signing the informed consent, the sequentially numbered sealed envelopes will be opened (according to the sequence of attendance of the patient) by the study nurse. Tablets in bag (A) will be inserted 12 hours before office hysteroscopy and tablets in bag (B) will be inserted 3 hours before office hysteroscopy. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| long interval dinoprostone | Drug | A small envelope including two labeled plastic bags (A & B) (each bag containing either 1 dinoprostone tablet(3mg) or 1 identically appearing placebo tablet) will be packaged in sequentially numbered sealed envelopes. In long interval dinoprostone group, bag (A) contains dinoprostone tablet and bag (B) contains placebo tablet. After signing the informed consent, the sequentially numbered sealed envelopes will be opened (according to the sequence of attendance of the patient) by the study nurse. Tablets in bag (A) will be inserted 12 hours before office hysteroscopy and tablets in bag (B) will be inserted 3 hours before office hysteroscopy. |
| Measure | Description | Time Frame |
|---|---|---|
| Intensity of pain | Intensity of pain by visual analog scale from 0(no pain) to 100 mm(worst pain imaginable) | intraoperative |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| AHMED SAMY | Cairo University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| faculty of medicine Cairo university | Giza | 11231 | Egypt | |||
| Tertiary referral hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34217851 | Derived | Rund NMA, El Shenoufy H, Islam BA, El Husseiny T, Nassar SA, Mohsen RA, Alaa D, Gad Allah SH, Bakry A, Refaat R, Gehad MA, Kotb MMM, Osman OM, Ashour ASA, Ali AS, Taher A, Kholaif K, Hashem AT, Elsallamy AAH, Nour DA, Dahab S, Talaat B, Almohammady M. Determining the Optimal Time Interval between Vaginal Dinoprostone Administration and Diagnostic Office Hysteroscopy in Nulliparous Women: A Randomized, Double-blind Trial. J Minim Invasive Gynecol. 2022 Jan;29(1):85-93. doi: 10.1016/j.jmig.2021.06.021. Epub 2021 Jul 1. |
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| short interval dinoprostone | Drug | A small envelope including two labeled plastic bags (A& B) (each bag containing either 1 dinoprostone tablet(3 mg) or 1 identically appearing placebo tablet) will be packaged in sequentially numbered sealed envelopes. In short interval dinoprostone group, bag (A) contains placebo tablet and bag (B) contains dinoprostone tablet. After signing the informed consent, the sequentially numbered sealed envelopes will be opened (according to the sequence of attendance of the patient) by the study nurse. Tablets in bag (A) will be inserted 12 hours before office hysteroscopy and tablets in bag (B) will be inserted 3 hours before office hysteroscopy. |
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| Giza |
| Egypt |