IUD Insertion During Cesarean Section

NCT ID: NCT03492034

Last Updated: 2020-05-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-01

Study Completion Date

2019-12-20

Brief Summary

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

Detailed Description

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Conditions

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Contraception

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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IUD during CS

Group Type ACTIVE_COMPARATOR

IUD during CS

Intervention Type DEVICE

IUD insertion during CS

IUD after puerperium

Group Type ACTIVE_COMPARATOR

IUD after puerperium

Intervention Type DEVICE

IUD after puerperium

Interventions

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IUD during CS

IUD insertion during CS

Intervention Type DEVICE

IUD after puerperium

IUD after puerperium

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

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Mohamed S Sweed, MD

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ain Shams University Maternity Hospital

Cairo, , Egypt

Site Status

Countries

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Egypt

References

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Sothornwit J, Kaewrudee S, Lumbiganon P, Pattanittum P, Averbach SH. Immediate versus delayed postpartum insertion of contraceptive implant and IUD for contraception. Cochrane Database Syst Rev. 2022 Oct 27;10(10):CD011913. doi: 10.1002/14651858.CD011913.pub3.

Reference Type DERIVED
PMID: 36302159 (View on PubMed)

Other Identifiers

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AS1750

Identifier Type: -

Identifier Source: org_study_id

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