Comparison Between Intrauterine Contraceptive Device Insertion During Cesarean Section Vs Conventional Application

NCT02674139 | Unknown Phase 4 DMC

• 1 other identifier: GO-MD-IUD
• Study Type: interventional
• Target: 8
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Contraception

Keywords

post placental-caesarean-IUD

Outcome Measures

Primary Outcomes (1)

• Expulsion: Complete IUD expulsion will be verified clinically and by transvaginal ultrasound

  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)

  6 months

Secondary Outcomes (6)

• Uterine perforation (assessed by pelvic ultrasonography or X-ray)

  6 months

• Pelvic pain (using the 0-10 Numeric Pain Rating Scale)

  6 months

• Strings not visible (assessed by speculum examination)

  6 months

• Pelvic infection: number of participants with Pelvic infection

  6 months

• Psychological (satisfied or not) using questionnaire

  6 months

Study Arms (2)

IUD insertion 6 Weeks after delivery

ACTIVE COMPARATOR

Subjects randomized to interval placement will have their Copper T 380A IUD placed in the office at six weeks postpartum or later

Device: Copper T 380A IUD

Immediate Post-placental insertion

EXPERIMENTAL

Subjects randomized to receive the Copper T 380A IUD within 10 minutes of delivery of the placenta during caesarean section.

Device: Copper T 380A IUD

Interventions

Copper T 380A IUD DEVICE

intrauterine contraceptive device T-shaped loaded with cupper

Also known as: Pregna

IUD insertion 6 Weeks after delivery; Immediate Post-placental insertion

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• sara AbdAllah: lead
• Beni-Suef University: collaborator

Study Officials

• sara AA mohamed, master

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant lecturer of Obstetrics and Gynecology Faculty of Medicine- Beni-sueif University

Study Record Dates

• First Submitted: January 30, 2016
• First Posted: February 4, 2016
• Study Start: February 1, 2016
• Primary Completion: March 1, 2017
• Study Completion: June 1, 2017
• Last Updated: September 27, 2016

Record last verified: 2016-09