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

Phase 4

Completed

• Conditions: IUCD Complication
• Interventions: Drug: Placebo Comparator; Drug: INH

• Registration Number: NCT04499989
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2020-08-02
• Study First Submitted QC: 2020-08-02
• Study First Posted: 2020-08-05
• Study Start: 2020-09-01
• Primary Completion: 2021-06-30
• Status Verified: 2021-08
• Study Completion: 2021-08-01
• Last Update Submitted: 2021-08-06
• Last Update Posted: 2021-08-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 220

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo Comparator	Placebo Comparator	3 vaginal tablet of Placebo Comparator self-inserted by the patient 12 hours before IUD insertion.
INH	INH	3 vaginal tablet of isonicotinic acid hydrazide self-inserted by the patient 12 hours before IUD insertion.

Primary Outcome Measures

Name	Time	Method
the difference in the pain intensity scores between the study groups	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

Name	Time	Method
Provider ease of insertion	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	10 minutes	IUD insertion time from speculum in to speculum out

Trial Locations

Locations (1)

Aswan University Hospital; 🇪🇬 Aswan, Egypt