Skip to main content
OpenTrials
Completed

NCT Number: NCT04499989

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

IUCD Complication

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Aswan University Hospital

Aswān, 81528, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

INH

Drug

3 vaginal tablet of isonicotinic acid hydrazide self inserted 12 hours before IUD insertion.

Other names: isonicotinic acid hydrazide

placebo comparator

Drug

3 vaginal tablet of Placebo Comparator self inserted 12 hours before IUD insertion

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Aswan University Hospital

Other

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Aug 5, 2020
Registry last updated
Aug 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.