PostPlacental IUD Insertion

NCT ID: NCT02679820

Last Updated: 2019-01-09

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

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-31

Study Completion Date

2018-12-31

Brief Summary

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The immediate post cesarean section IUD insertion is a further step towards spreading more compliance to females in developing countries, with rapid increase in population size

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

PREVENTION

Blinding Strategy

NONE

Study Groups

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PostPlacental IUD insertion

Copper T intrauterine device will be inserted immediately following delivery of the placenta in cases of cesarean section deliveries.

Group Type EXPERIMENTAL

Copper T intrauterine device

Intervention Type DEVICE

Control

IUD will be offered as a method of contraception after puerperium

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Copper T intrauterine device

Intervention Type DEVICE

Other Intervention Names

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copper T IUD

Eligibility Criteria

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Inclusion Criteria

* Females desiring contraception by using intrauterine device following their vaginal delivery or cesarean section

Exclusion Criteria

* refusal to participate in the study
* desiring other methods of contraception
* will not use any method of contraception
* has a contraindication for the use of IUD as bicornuate or septate uterus, sub mucous myomas, etc.
Minimum Eligible Age

20 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Woman's Health University Hospital, Egypt

OTHER

Sponsor Role lead

Responsible Party

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Dina Mohamed Refaat Dakhly

Lecturer of Obstetrics and Gynecology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dina MR Dakhly, MD

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Locations

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Kasr el aini hospital

Cairo, , Egypt

Site Status

Countries

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Egypt

References

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Bayoumi YA, Dakhly DMR, Bassiouny YA, Gouda HM, Hassan MA, Hassan AA. Post-placental intrauterine device insertion vs puerperal insertion in women undergoing caesarean delivery in Egypt: a 1 year randomised controlled trial. Eur J Contracept Reprod Health Care. 2020 Dec;25(6):439-444. doi: 10.1080/13625187.2020.1823366. Epub 2020 Oct 2.

Reference Type DERIVED
PMID: 33006501 (View on PubMed)

Other Identifiers

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LA010516

Identifier Type: -

Identifier Source: org_study_id

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