IUD Insertion During Cesarean Section

Not Applicable

Completed

• Conditions: Contraception
• Interventions: Device: IUD during CS; Device: IUD after puerperium

• Registration Number: NCT03492034
• Lead Sponsor: Ain Shams University

Brief Summary

Insertion of Intrauterine Contraceptive Device during Cesarean Section: Randomized Clinical Trial

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2018-03-24
• Study Start: 2018-04-01
• Study First Submitted QC: 2018-04-02
• Study First Posted: 2018-04-10
• Primary Completion: 2019-12-20
• Study Completion: 2019-12-20
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-26
• Last Update Posted: 2020-05-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 200

Inclusion Criteria

1. Pregnant woman aged between 18 to 40 years old.
2. Scheduled for elective cesarean section at gestational age between 37 to 42 weeks.
3. Body mass index between 19-30 kg/m2
4. Seeking contraception after delivery.

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Exclusion Criteria

1. History of menorrhagia or severe dysmenorrhea.
2. History of pelvic inflammatory disease or current pelvic infection (ex: puerperal sepsis, purulent cervicitis).
3. Patients who have bleeding disorders.
4. Anemia (Hb < 9 g %).
5. Chronic depilating diseases reducing immunity such as Diabetes.
6. Structural uterine anomaly or large uterine fibroids distorting anatomy.
7. History of previous IUD expulsion or removal for complications.
8. Unexplained uterine bleeding.
9. Copper allergy or Wilson disease.
10. Gestational trophoblastic disease with persistently elevated Beta HCG.
11. Predisposing factor to postoperative infection (e.g. rupture of membranes prior to admission or delivery of a stillborn baby at cesarean section).
12. Complications during cesarean section e.g. postpartum hemorrhage.
13. Cesarean section during placenta previa.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IUD during CS	IUD during CS	-
IUD after puerperium	IUD after puerperium	-

Primary Outcome Measures

Name	Time	Method
IUD expulsion rate	6 weeks

Secondary Outcome Measures

Name	Time	Method
Bleeding	6 weeks	number of pads changed per day
Degree of Pain	6 weeks	Visual Analogue Scale from 1 to10 (0 being no pain and 10 maximum pain tolerated)
dyspareunia	6 weeks	Visual Analogue Scale from 0 to10 (0 being no pain and 10 maximum pain tolerated)
patient satisfaction	6 weeks	Visual Analogue Scale from 0 to10 (0 being maximum dis-satisfaction and 10 maximum satisfaction)

Trial Locations

Locations (1)

Ain Shams University Maternity Hospital; 🇪🇬 Cairo, Egypt