Clinical trial NCT04602897: The Analgesic Efficacy of Forced Coughing During Intrauterine Device Insertion
Official title: The Analgesic Efficacy of Forced Coughing During Intrauterine Device Insertion: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Keywords: Intrauterine device, IUD, Pain, Forced coughing
Lead sponsor: Menoufia University
Sponsor class: OTHER
First posted: 2020-10-26
Enrollment: 400
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: The cough group patients were asked to cough a forced cough during different steps of IUD insertion
Primary purpose: TREATMENT

Brief 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).

Detailed description: We conducted this randomized controlled trial at the Department of Obstetrics and Gynecology at Menoufia University Hospital, Egypt, from May 2018 to March 2020. Our hospital research ethics committee approved this study. We obtained informed consent from all participants before initiating any study procedures. CONSORT guidelines were observed and completed.

We recruited non pregnant women (aged 18-45 years) requesting copper T380A IUD insertion for contraception. Eligible women had 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, they were immediately postmenstrual or 1 week after pregnancy termination and 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, and 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.

Eligibility criteria: 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

Primary outcomes:
measure: The level of pain experienced at different steps of IUD insertion measured by a visual analogue scale (VAS).
timeFrame: Up to 22 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Menoufia university hospital
Study officials:
affiliation: Assistant professor of obstetrics and gynecology, faculty of medicine menoufia university
name: Nabih Elkhouly, MD
role: PRINCIPAL_INVESTIGATOR
References: