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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03492034
Other study ID # AS1750
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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