The Analgesic Efficacy of Forced Coughing During Intrauterine Device Insertion

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).

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Key information

Conditions

Pain Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Menoufia university hospital

Cairo, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

forced coughing

Other

The cough group patients were asked to cough a forced cough during different steps of IUD insertion

Primary outcomes

The level of pain experienced at different steps of IUD insertion measured by a visual analogue scale (VAS).

Time frame: Up to 22 months

The primary outcome measure was the level of pain experienced at different steps of IUD insertion measured by a visual analogue scale (VAS).

Sponsors and collaborators

Lead sponsor

Menoufia University

Other

Registry information

Official study title

The Analgesic Efficacy of Forced Coughing During Intrauterine Device Insertion: A Randomized Clinical Trial

Important dates

Study start: 2018
Primary completion: 2020
Study completion: 2020
First posted: Oct 26, 2020
Registry last updated: Oct 26, 2020

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.

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