IUD Insertion During Cesarean Section

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03492034

Enrollment

200

Registered

2018-04-10

Start date

2018-04-01

Completion date

2019-12-20

Last updated

2020-05-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Contraception

Brief summary

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

Interventions

DEVICEIUD during CS

IUD insertion during CS

DEVICEIUD after puerperium

IUD after puerperium

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 40 Years

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.

Design outcomes

Primary

Measure	Time frame
IUD expulsion rate	6 weeks

Secondary

Measure	Time frame	Description
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)

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026