Early Versus Late Interval Postpartum Copper Intrauterine... | NCT03106805

Studies
Early Versus Late Interval Postpartum Copper Intrauterine Device Insertion

NCT03106805

Sponsor

Assiut University

Status

Withdrawn

Last Update Posted

May 11, 2022Actual

Enrollment

0Actual

Phase

Not Applicable

Conditions

Contraception Behavior

Interventions

early insertion
late insertion

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 2022

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

no participants

Expanded Access Info

Start Date

Jul 1, 2017Actual

Primary Completion Date

Nov 2021Estimated

Completion Date

Mar 2022Estimated

First Submitted Date

Apr 4, 2017

First Submission Date that Met QC Criteria

Apr 4, 2017

First Posted Date

Apr 10, 2017Actual

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 6, 2022

Last Update Posted Date

May 11, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

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

Description Module

Brief Summary

The optimal interval between pregnancies is debated, but a duration greater than 11-18 months has been suggested as reducing complications in the subsequent pregnancy. Improved birth spacing can be a key benefit use of long-acting reversible contraception, but delay to initiation can still be problematic.So women who have recently given birth can be cost-effectively targeted for family planning education and engagement because often they are already connected with health professionals

Detailed Description

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

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
insertion by the end of the 4th week postpartum	Experimental		Procedure: early insertion
insertion by the end of the 6th week postpartum	Active Comparator		Procedure: late insertion

Interventions

Name	Type	Description	Arm Group Labels	Other Names
early insertion	Procedure	insertion at 4th postpartum week	insertion by the end of the 4th week postpartum

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The number of participants use the device	number of women place the intrauterine device within 6 weeks	6 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Delivered (vaginal or Cesarean) a singleton living baby ≥28weeks gestation. Women desire birth spacing for one year or more. Women who will accept to participate in the study and follow up.

Exclusion Criteria:

Known uterine anomalies.
Women with previous ectopic pregnancy.
Presence of postpartum pyrexia.
Women with history of postpartum hemorrhage in the last delivery either primary or secondary.
Retained products of conception.
History of previous uterine perforation.
Anticipation of difficulty of subsequent follow-up with the women.
Women with uncontrolled diabetes and hypertension.
Women who wish to use other contraceptive methods.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ahmed Abbas, MD	Assiut University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Assiut Faculty of Medicine		Asyut			Egypt

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
27405702	Background	Shachar BZ, Mayo JA, Lyell DJ, Baer RJ, Jeliffe-Pawlowski LL, Stevenson DK, Shaw GM. Interpregnancy interval after live birth or pregnancy termination and estimated risk of preterm birth: a retrospective cohort study. BJOG. 2016 Nov;123(12):2009-2017. doi: 10.1111/1471-0528.14165. Epub 2016 Jul 13.

ID	Term
D043762	Reproductive Behavior
D001519	Behavior