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

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04499989

Enrollment

220

Registered

2020-08-05

Start date

2020-09-01

Completion date

2021-08-01

Last updated

2021-08-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

IUCD Complication

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.

Interventions

DRUGINH

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

DRUGPlacebo Comparator

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Masking description

double blind randomized trial

Intervention model description

double blind randomized trial

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 45 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026