The Analgesic Efficacy of Forced Coughing During Intrauterine Device Insertion

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

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).

Study Overview

• Status: Completed
• Conditions: Pain
• Intervention / Treatment: Other: forced coughing

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.

• Study Type: Interventional
• Enrollment (Actual): 400
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Menoufia University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 41 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: cough group; The cough group patients were asked to cough a forced cough during different steps of IUD insertion	Other: forced coughing; The cough group patients were asked to cough a forced cough during different steps of IUD insertion
No Intervention: control; the control group received no pain management at all during different steps of IUD insertion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The level of pain experienced at different steps of IUD insertion measured by a visual analogue scale (VAS).	The primary outcome measure was the level of pain experienced at different steps of IUD insertion measured by a visual analogue scale (VAS).	Up to 22 months

Collaborators and Investigators

• Sponsor: Menoufia University
• Investigators: Principal Investigator: Nabih Elkhouly, MD, Assistant professor of obstetrics and gynecology, faculty of medicine menoufia university

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2018
• Primary Completion (Actual): March 12, 2020
• Study Completion (Actual): March 25, 2020

Study Registration Dates

• First Submitted: October 16, 2020
• First Submitted That Met QC Criteria: October 20, 2020
• First Posted (Actual): October 26, 2020

Study Record Updates

• Last Update Posted (Actual): October 26, 2020
• Last Update Submitted That Met QC Criteria: October 20, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: Intrauterine device, IUD, Pain, Forced coughing
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Cough
• Other Study ID Numbers: 12-2019OBSGN38

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No