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

IUCD Complication Clinical 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04499989
• Other study ID #: aswu/353/4/19
• Status: Completed
• Phase: Phase 4
• Start date: September 1, 2020
• Est. completion date: August 1, 2021

Study information

• Verified date: August 2021
• Source: Aswan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 220
• Est. completion date: August 1, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• IUCD Complication

Intervention

Drug:
• INH
3 vaginal tablet of isonicotinic acid hydrazide self inserted 12 hours before IUD insertion.
• Placebo Comparator
3 vaginal tablet of Placebo Comparator self inserted 12 hours before IUD insertion

Locations

Country	Name	City	State
Egypt	Aswan University Hospital	Aswan

Sponsors (1)

Lead Sponsor	Collaborator
Aswan University Hospital

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the difference in the pain intensity scores between the study groups	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	10 minutes
Secondary	Provider ease of insertion	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.	10 minutes
Secondary	insertion time	IUD insertion time from speculum in to speculum out	10 minutes