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Vaginal Isonicotinic Acid Hydrazide (INH) Administration Prior to T380A Intrauterine Device Insertion

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ClinicalTrials.gov Identifier: NCT04499989
Recruitment Status : Recruiting
First Posted : August 5, 2020
Last Update Posted : September 21, 2020
Sponsor:
Information provided by (Responsible Party):
hany farouk, Aswan University Hospital

Study Description
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Brief Summary:
To investigate whether vaginal isonicotinic acid hydrazide administered before intrauterine device (IUD) insertion reduces failed insertions, insertion-related complications and pain in in Women Delivered Only by Cesarean Delivery.

Condition or disease Intervention/treatment Phase
IUCD Complication Drug: INH Drug: Placebo Comparator Phase 4

Detailed Description:
Women may experience pain and technical difficulties may be encountered when insertion of an intrauterine device is attempted through a narrow cervical canal. intrauterine device insertion- related complications and side effects are more common among women who had never delivered vaginally.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 220 participants
Allocation: Randomized
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
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine

Drug Information available for: Isoniazid

Arms and Interventions
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Arm Intervention/treatment
Experimental: INH
3 vaginal tablet of isonicotinic acid hydrazide self-inserted by the patient 12 hours before IUD insertion.
 Drug: INH
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


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.

  2. insertion time [ Time Frame: 10 minutes ]
    IUD insertion time from speculum in to speculum out


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Women Delivered Only by Elective Cesarean Section
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Non-pregnant women
  • Women that did not receive any analgesics or Dinoprostone in the 24 hours prior to insertion
  • Women who delivered only by cesarean section

Exclusion Criteria:

  • Women with any uterine abnormalities as congenital anomalies, endometrial lesions, adenomyosis, fibroids.
  • Those with a Category 3 or 4 conditions for intrauterine device insertion according to the WHO Medical Eligibility Criteria for contraceptive use
  • Allergy to isonicotinic acid hydrazide .
  • Women refuse to participate in the study
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: hany wf Sallam, md +20102435461 ext 002 hany.farouk@aswu.edu.eg
Contact: nahla w Shady, md +201022336052 ext 002 hanygyne@yahoo.com

Locations
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Egypt
Aswan University Hospital Recruiting
Aswan, Egypt, 81528
Contact: Hany F Sallam, MD    0122336052 ext 002    hany.farouk@aswu.edu.eg   
Contact: Nahla W Shady, MD    01092440504 ext 002    nahla.elsayed@aswu.edu.eg   
Sponsors and Collaborators
Aswan University Hospital
Investigators
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Study Chair: nahla w Shady, md Aswan universirty
More Information
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Responsible Party: hany farouk, A Professor, Aswan University Hospital
ClinicalTrials.gov Identifier: NCT04499989    
Other Study ID Numbers: aswu/353/4/19
First Posted: August 5, 2020    Key Record Dates
Last Update Posted: September 21, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Isoniazid
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents
Fatty Acid Synthesis Inhibitors
 Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents