Vaginal Isonicotinic Acid Hydrazide (INH) Administration Prior to T380A Intrauterine Device Insertion
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04499989|
Recruitment Status : Recruiting
First Posted : August 5, 2020
Last Update Posted : September 21, 2020
|Condition or disease||Intervention/treatment||Phase|
|IUCD Complication||Drug: INH Drug: Placebo Comparator||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||220 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||double blind randomized trial|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Masking Description:||double blind randomized trial|
|Official Title:||Clinical Outcomes of Vaginal Isonicotinic Acid Hydrazide (INH) Administration Prior to T380A Intrauterine Device Insertion in Women Delivered Only by Cesarean Delivery: a Randomized Double Blinded Clinical Trial|
|Actual Study Start Date :||September 1, 2020|
|Estimated Primary Completion Date :||June 30, 2021|
|Estimated Study Completion Date :||July 30, 2021|
3 vaginal tablet of isonicotinic acid hydrazide self-inserted by the patient 12 hours before IUD insertion.
3 vaginal tablet of isonicotinic acid hydrazide self inserted 12 hours before IUD insertion.
Other Name: isonicotinic acid hydrazide
Placebo Comparator: Placebo Comparator
3 vaginal tablet of Placebo Comparator self-inserted by the patient 12 hours before IUD insertion.
Drug: Placebo Comparator
3 vaginal tablet of Placebo Comparator self inserted 12 hours before IUD insertion
- the difference in the pain intensity scores between the study groups [ Time Frame: 10 minutes ]the difference in the pain intensity scores between the study groups at IUD insertion BY10 cm visual analog scale score where 0 denotes no pain and 10 denotes the most imaginable pain
- Provider ease of insertion [ Time Frame: 10 minutes ]Provider ease of insertion was evaluated using a visual analog scale from 0 to 10 cm where 0 denotes very easy insertion and 10 denotes a very difficult insertion.
- insertion time [ Time Frame: 10 minutes ]IUD insertion time from speculum in to speculum out
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04499989
|Contact: hany wf Sallam, md||+20102435461 ext firstname.lastname@example.org|
|Contact: nahla w Shady, md||+201022336052 ext email@example.com|
|Study Chair:||nahla w Shady, md||Aswan universirty|