Trials / Completed
CompletedNCT04499989
Vaginal Isonicotinic Acid Hydrazide (INH) Administration Prior to T380A Intrauterine Device Insertion
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
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 220 (actual)
- Sponsor
- Aswan University Hospital · Academic / Other
- Sex
- Female
- Age
- 18 Years – 45 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | INH | 3 vaginal tablet of isonicotinic acid hydrazide self inserted 12 hours before IUD insertion. |
| DRUG | Placebo Comparator | 3 vaginal tablet of Placebo Comparator self inserted 12 hours before IUD insertion |
Timeline
- Start date
- 2020-09-01
- Primary completion
- 2021-06-30
- Completion
- 2021-08-01
- First posted
- 2020-08-05
- Last updated
- 2021-08-09
Locations
1 site across 1 country: Egypt
Source: ClinicalTrials.gov record NCT04499989. Inclusion in this directory is not an endorsement.