IUD Insertion During Cesarean Section | NCT03492034

Studies
IUD Insertion During Cesarean Section

NCT03492034

Sponsor

Ain Shams University

Status

Completed

Last Update Posted

May 27, 2020Actual

Enrollment

200Actual

Phase

Not Applicable

Conditions

Contraception

Interventions

IUD during CS
IUD after puerperium

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 1, 2018Actual

Primary Completion Date

Dec 20, 2019Actual

Completion Date

Dec 20, 2019Actual

First Submitted Date

Mar 24, 2018

First Submission Date that Met QC Criteria

Apr 2, 2018

First Posted Date

Apr 10, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 26, 2020

Last Update Posted Date

May 27, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

200Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
IUD during CS	Active Comparator		Device: IUD during CS
IUD after puerperium	Active Comparator		Device: IUD after puerperium

Interventions

Name	Type	Description	Arm Group Labels	Other Names
IUD during CS	Device	IUD insertion during CS	IUD during CS
IUD after puerperium

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
IUD expulsion rate		6 weeks

Secondary Outcomes

Measure	Description	Time Frame
Bleeding	number of pads changed per day	6 weeks
Degree of Pain	Visual Analogue Scale from 1 to10 (0 being no pain and 10 maximum pain tolerated)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Pregnant woman aged between 18 to 40 years old.
Scheduled for elective cesarean section at gestational age between 37 to 42 weeks.
Body mass index between 19-30 kg/m2
Seeking contraception after delivery.

Exclusion Criteria:

History of menorrhagia or severe dysmenorrhea.
History of pelvic inflammatory disease or current pelvic infection (ex: puerperal sepsis, purulent cervicitis).
Patients who have bleeding disorders.
Anemia (Hb < 9 g %).
Chronic depilating diseases reducing immunity such as Diabetes.
Structural uterine anomaly or large uterine fibroids distorting anatomy.
History of previous IUD expulsion or removal for complications.
Unexplained uterine bleeding.
Copper allergy or Wilson disease.
Gestational trophoblastic disease with persistently elevated Beta HCG.
Predisposing factor to postoperative infection (e.g. rupture of membranes prior to admission or delivery of a stillborn baby at cesarean section).
Complications during cesarean section e.g. postpartum hemorrhage.
Cesarean section during placenta previa.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
36302159	Derived	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.