The Analgesic Efficacy of Forced Coughing During Intrauterine Device Insertion

NCT04602897 | Completed

• 1 other identifier: 12-2019OBSGN38
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

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).

Conditions

Pain

Keywords

Intrauterine device, IUD, Pain, Forced coughing

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

cough group

EXPERIMENTAL

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

Other: forced coughing

control

NO INTERVENTION

the control group received no pain management at all during different steps of IUD insertion

Interventions

forced coughing OTHER

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

cough group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Menoufia University: lead

Study Sites (1)

Menoufia university hospital

Cairo, Egypt

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

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

Study Officials

• Nabih Elkhouly, MD

  Assistant professor of obstetrics and gynecology, faculty of medicine menoufia university

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asssistant professor of obstetrics and gynecology

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

Study Record Dates

• First Submitted: October 16, 2020
• First Posted: October 26, 2020
• Study Start: May 1, 2018
• Primary Completion: March 12, 2020
• Study Completion: March 25, 2020
• Last Updated: October 26, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)