IUCD Insertion in Patients Delivered by Cesarean Section

NCT06864078 | Completed DMC

• 1 other identifier: Safaa Bashandy
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

Brief Summary

Long-acting reversible contraceptive (LARC) methods, including intrauterine devices (IUDs), are highly effective and safe options for preventing unintended pregnancies. IUDs have failure rates below one percent, making them one of the most reliable forms of contraception available. They are suitable for females of all ages, including adolescents and nulliparous women, and offer long-term protection without requiring daily adherence, unlike oral contraceptives. Increasing the utilization of IUDs can provide a safe, long-acting, highly effective, and reversible method of contraception, reducing the incidence of unintended pregnancies and associated complications.

Conditions

IUD

Outcome Measures

Primary Outcomes (1)

• Pain Management

  Assessing the efficacy of the pain strategy resulted from IUD insertion By using VAS scale and improving patient comfort and increasing the acceptance of this highly effective contraceptive method

  2 hours

Study Arms (2)

Group I (Study Group)

ACTIVE COMPARATOR

About 64 women who received lidocaine gel and diclofenac potassium tablets,to be administered 1 hour before planned intrauterine device insertion (Cu T380A) insertion, according to the assigned group. A syringe consists of six millimeters of two percent lidocaine gel (Xylocaine Jelly, AstraZeneca, Australia) for the active management group

Device: IUD Insertion during Cesarean Section; Drug: lidocaine gel and diclofenac potassium tablets

Control Group

PLACEBO COMPARATOR

About 64 women who received placebo tablets and placebo gel,2 placebo tablets to be administered 1 hour before planned intrauterine devices insertion (Cu T380A) insertion,six millimeter of placebo gel (K-Y jelly, Johnson \& USA, Johnson).

Device: IUD Insertion during Cesarean Section; Drug: Placebo

Interventions

IUD Insertion during Cesarean Section DEVICE

to evaluate the analgesic effect of diclofenac potassium and lidocaine gel applied to the posterior vaginal fornix before IUD insertion in women who had previously undergone cesarean section. By assessing the efficacy of this pain management strategy, this study seeks to contribute to the optimization of IUD insertion protocols, improving patient comfort and increasing the acceptance of this highly effective contraceptive method.

Control Group; Group I (Study Group)

lidocaine gel and diclofenac potassium tablets DRUG

lidocaine gel and diclofenac potassium tablets

Group I (Study Group)

Placebo DRUG

Placebo

Control Group

Eligibility Criteria

• Age: 18 Years - 39 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Women at term pregnancy willing to give birth at the hospital, either via c-section or vaginal delivery.- - - Singleton pregnancy with viable fetus.
• Women who are willing and able to provide informed consent to participate in the study.
• Women who are able to communicate in the language of the study, either verbally or through a translator

You may not qualify if:

• Women who have a medical condition that would prevent them from participating in the study, such as severe mental illness.
• Women with medical disorder during pregnancy as pre-eclampsia.
• Having a history of dystocia or instrumental delivery, stillbirth, giving birth to a child with a weight of less than 2500 grams, having a history of general medical conditions, disabilities, depression, drug intake, major psychological problems, or having stress-inducing experiences such as the loss of a family member, divorce, or family problems.
• Individuals with medical conditions such as low back pain, chronic constipation, urination problems, or breast problems before pregnancy.
• Women who have had multiple c-sections in the past.
• Women who were not able to give a birth vaginally due to medical reasons such as placenta previa, cord prolapse, or fetal distress.
• Women who are not willing or able to provide informed consent to participate in the study.

Sponsors & Collaborators

• Al-Azhar University: lead

Study Sites (1)

Al-Azhar University Hospitals

Asyut, Egypt

Location

MeSH Terms

Interventions

Diclofenac

Intervention Hierarchy (Ancestors)

Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Yousry Omar Salim El Maraghy, Professor

  Obstetrics and Gynecology, Faculty of medicine Al-Azhar University Assuit.

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident of Obstetrics & Gynecology

Study Record Dates

• First Submitted: March 4, 2025
• First Posted: March 7, 2025
• Study Start: September 10, 2023
• Primary Completion: August 5, 2024
• Study Completion: August 10, 2024
• Last Updated: March 7, 2025

Record last verified: 2023-09

Locations

EG (1)