IUD Insertion During Cesarean Section

• Sponsor: Ain Shams University (Other)
• Overall Status: Completed
• CT.gov ID: NCT03492034
• Collaborator: (none)
• Enrollment: 200
• Location: 1
• Arms: 2
• Actual Duration (Months): 20.6
• Patients Per Site Per Month: 9.7

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Contraception	Device: IUD during CS; Device: IUD after puerperium	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 200 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Insertion of Intrauterine Contraceptive Device During Cesarean Section: Randomized Clinical Trial
• Actual Study Start Date: Apr 1, 2018
• Actual Primary Completion Date: Dec 20, 2019
• Actual Study Completion Date: Dec 20, 2019

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: IUD during CS	Device: IUD during CS; IUD insertion during CS
Active Comparator: IUD after puerperium	Device: IUD after puerperium; IUD after puerperium

Outcome Measures

Primary Outcome Measures

1. IUD expulsion rate [6 weeks]

Secondary Outcome Measures

1. Bleeding [6 weeks]

   number of pads changed per day

2. Degree of Pain [6 weeks]

   Visual Analogue Scale from 1 to10 (0 being no pain and 10 maximum pain tolerated)

3. dyspareunia [6 weeks]

   Visual Analogue Scale from 0 to10 (0 being no pain and 10 maximum pain tolerated)

4. patient satisfaction [6 weeks]

   Visual Analogue Scale from 0 to10 (0 being maximum dis-satisfaction and 10 maximum satisfaction)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 40 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ain Shams University Maternity Hospital	Cairo		Egypt

Sponsors and Collaborators

• Ain Shams University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Mohamed S Sweed, MD, Principal Investigator, Ain Shams University
• ClinicalTrials.gov Identifier: NCT03492034
• Other Study ID Numbers: AS1750
• First Posted: Apr 10, 2018
• Last Update Posted: May 27, 2020
• Last Verified: May 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of May 27, 2020