IUD Insertion During Cesarean Section

Ain Shams University

Status: Completed

Conditions: Contraception

Treatments: Device: IUD after puerperium; Device: IUD during CS

Study type: Interventional

Funder types: Other

Identifiers

NCT03492034

AS1750

Details and patient eligibility

About

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

Enrollment: 200 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

IUD during CS

Active Comparator group

Treatment:

Device: IUD during CS

IUD after puerperium

Active Comparator group

Treatment:

Device: IUD after puerperium