Comparative Study of Intrauterine Contraceptive Device Insertion During Caesarean Section Versus Conventional Application
Trial Snapshot
- Phase
- Phase 4
- Sponsor
- Enrollment
- 8
- Primary Endpoint
- Expulsion: Complete IUD expulsion will be verified clinically and by transvaginal ultrasound
Study Overview
Brief Summary
The study aims to compare immediate post-placental (within 10 minutes of placenta delivery) intrauterine contraceptive device (Copper T 380A) insertion versus conventional placement at 6 weeks (often referred to as delayed or interval insertion) regarding the clinical outcomes (safety, efficacy, expulsion and continuation rates) for women undergoing caesarean section.
Detailed Description
• Study Design: A controlled randomized clinical trial (CRCT)
• Study Site: The study will be carried out in the Department of Obstetrics and Gynecology at Beni-suef University Hospital
• Study Population: The study population will include pregnant women between 36-40 weeks gestational ages who attend antenatal care and are eligible for insertion of IUCD during delivery through elective caesarean section.
• Study Sample: The study will consist of 200 women which will be chosen randomly to whom elective lower segment caesarean section will be done at the Obstetrics and Gynecology department, willing to have an intrauterine device (IUD) inserted for postpartum contraception and willing to comply with the study protocol.
After informed consent is obtained, eligible study participants will be randomized into 2 groups:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Age: 18 - 45 years.
- •GA 36-40 weeks based upon the date of last normal menstruation, confirmed by ultrasonographic scan.
- •Desire to have intrauterine contraceptive device (Cu T) after counseling about different contraceptive options and consented to the study.
Exclusion Criteria
- •Allergy to copper.
- •Ante- or intra-partum hemorrhage.
- •Hemorrhagic disorders.
- •Current or past history of pelvic inflammatory disease.
- •Women known to have pelvic TB.
- •Known to have ruptured membranes for more than 24 h prior to delivery.
- •History of chorioamnionitis.
- •Known uterine abnormalities e.g., Bicornuate/septate Uterus, uterine myoma.
- •Patients presented with febrile morbidity prior to the operation defined as temperature above 38'c.
- •Multiple pregnancies.
- •Placenta previa.
- •History of ectopic pregnancy.
- •Anemia (hemoglobin <10 g/dl).
- •Cervical cancer or carcinoma in situ.
- •Diagnosis of active cervical infection for standard insertion.
Arms & Interventions
IUD insertion 6 Weeks after delivery
Subjects randomized to interval placement will have their Copper T 380A IUD placed in the office at six weeks postpartum or later
Intervention: Copper T 380A IUD (Device)
Immediate Post-placental insertion
Subjects randomized to receive the Copper T 380A IUD within 10 minutes of delivery of the placenta during caesarean section.
Intervention: Copper T 380A IUD (Device)
Outcomes
Primary Outcomes
Expulsion: Complete IUD expulsion will be verified clinically and by transvaginal ultrasound
Time Frame: 6 months
Complete IUD expulsion will be verified clinically and by transvaginal ultrasound. An IUD will be considered to be partially expelled if a distance greater than 10 mm is measured between the vertical arm of the IUD and the junction between the endometrium and the uterine cavity)
Secondary Outcomes
- Psychological (satisfied or not) using questionnaire(6 months)
- Strings not visible (assessed by speculum examination)(6 months)
- Uterine perforation (assessed by pelvic ultrasonography or X-ray)(6 months)
- Pelvic pain (using the 0-10 Numeric Pain Rating Scale)(6 months)
- Pregnancy (assessed by serum pregnancy test and pelvic ultrasound)(6 months)
- Pelvic infection: number of participants with Pelvic infection(6 months)
Investigators
sara AbdAllah
Assistant lecturer of Obstetrics and Gynecology Faculty of Medicine- Beni-sueif University
Beni-Suef University