Early Versus Late Interval Postpartum Copper Intrauterine Device Insertion

NCT ID: NCT03106805

Last Updated: 2022-05-11

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

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-01

Study Completion Date

2022-03-31

Brief Summary

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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

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Conditions

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Contraception Behavior

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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insertion by the end of the 4th week postpartum

Group Type EXPERIMENTAL

early insertion

Intervention Type PROCEDURE

insertion at 4th postpartum week

insertion by the end of the 6th week postpartum

Group Type ACTIVE_COMPARATOR

late insertion

Intervention Type PROCEDURE

insertion at 6th postpartum week

Interventions

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early insertion

insertion at 4th postpartum week

Intervention Type PROCEDURE

late insertion

insertion at 6th postpartum week

Intervention Type PROCEDURE

Eligibility Criteria

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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

1. Known uterine anomalies.
2. Women with previous ectopic pregnancy.
3. Presence of postpartum pyrexia.
4. Women with history of postpartum hemorrhage in the last delivery either primary or secondary.
5. Retained products of conception.
6. History of previous uterine perforation.
7. Anticipation of difficulty of subsequent follow-up with the women.
8. Women with uncontrolled diabetes and hypertension.
9. Women who wish to use other contraceptive methods.
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Ahmed Mohamed Abbas

Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ahmed Abbas, MD

Role: PRINCIPAL_INVESTIGATOR

Assiut University

Locations

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Assiut Faculty of Medicine

Asyut, , Egypt

Site Status

Countries

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Egypt

References

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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.

Reference Type BACKGROUND
PMID: 27405702 (View on PubMed)

Other Identifiers

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EAIUD

Identifier Type: -

Identifier Source: org_study_id

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