IUD Insertion During Cesarean Section

Contraception Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03492034
• Other study ID #: AS1750
• Status: Completed
• Phase: N/A
• Start date: April 1, 2018
• Est. completion date: December 20, 2019

Study information

• Verified date: May 2020
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: December 20, 2019
• Est. primary completion date: December 20, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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.

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.

Related Conditions & MeSH terms

• Contraception

Intervention

Device:
• IUD during CS
IUD insertion during CS
• IUD after puerperium
IUD after puerperium

Locations

Country	Name	City	State
Egypt	Ain Shams University Maternity Hospital	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	IUD expulsion rate		6 weeks
Secondary	Bleeding	number of pads changed per day	6 weeks
Secondary	Degree of Pain	Visual Analogue Scale from 1 to10 (0 being no pain and 10 maximum pain tolerated)	6 weeks
Secondary	dyspareunia	Visual Analogue Scale from 0 to10 (0 being no pain and 10 maximum pain tolerated)	6 weeks
Secondary	patient satisfaction	Visual Analogue Scale from 0 to10 (0 being maximum dis-satisfaction and 10 maximum satisfaction)	6 weeks