Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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
Sponsor:
Information provided by (Responsible Party):
hany farouk, Aswan University Hospital

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.

Layout table for study information
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

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




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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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

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
Layout table for location contacts
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
Layout table for location information
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
Layout table for investigator information
Study Chair: nahla w Shady, md Aswan universirty
Layout table for additonal information
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

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