The Analgesic Efficacy of Forced Coughing During Intrauterine Device Insertion (NCT04602897) | Clinical Trial Compass
CompletedNot Applicable
The Analgesic Efficacy of Forced Coughing During Intrauterine Device Insertion
Egypt400 participantsStarted 2018-05-01
Plain-language summary
This was a randomized controlled trial of 400 women who attended the outpatient clinic of Menoufia University Hospital for copper IUD insertion. The women were randomly assigned to cough and control groups.The primary outcome measure was the level of pain experienced at different steps of IUD insertion measured by a visual analogue scale (VAS).
Who can participate
Age range18 Years – 45 Years
SexFEMALE
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Inclusion Criteria:
* Non pregnant women (aged 18-45 years) requesting copper T380A IUD insertion for contraception.
* No prior vaginal delivery or pregnancy termination beyond 12 weeks gestation (as patulous cervical os may affect VAS score).
* Any previous deliveries had been by cesarean section.
* Immediately postmenstrual or 1 week after pregnancy termination.
* They were willing to complete the study questionnaires.
* All women had to be alert, oriented, and cooperative to respond easily to VAS.
Exclusion criteria were:
* Current pregnancy.
* Prior vaginal delivery.
* History of cervical stenosis.
* Current pelvic inflammatory disease.
* Uterine anomalies.
* Undiagnosed abnormal uterine bleeding.
* Fibroids distorting the uterine cavity.
* Patients using chronic NSAIDs or on chronic pain medication. We randomized participants in a 1:1 ratio to cough and control groups. A statistician not directly involved in the study prepared a computer generated randomization list and placed the allocation information in sequentially numbered sealed envelopes that were opened according to the attendance of the subjects after signing the informed consent
What they're measuring
1
The level of pain experienced at different steps of IUD insertion measured by a visual analogue scale (VAS).