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Optimizing Postpartum Contraception in Women With Preterm Births

NCT ID: NCT01864629

Last Updated: 2017-10-26

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

134 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

Study Completion Date

2016-01-31

Brief Summary

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The purpose of this study is to examine the effectiveness of focused family planning counseling on the uptake and continuation of highly effective contraceptive methods (defined as the intrauterine device, implant, and both male and female sterilization methods including vasectomy, tubal ligation and Essure) during the postpartum period in women who have recently experienced a preterm delivery.

The investigators hypothesize that women with a recent preterm birth (PTB) will be more likely to initiate and continue using a highly effective method of contraception when provided with focused family planning counseling.

Detailed Description

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Conditions

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Method of Contraception Preterm Birth Recurrence

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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Contraception after preterm birth

Intervention name: Focused contraception counseling This intervention will be provided to those randomized to the intervention group only. This counseling will follow a pre-written, structured script describing all contraceptive methods in rank order starting with most effective to least effective in preventing unplanned pregnancy.

Group Type OTHER

Focused contraception counseling

Intervention Type BEHAVIORAL

This intervention will be provided to those randomized to the intervention group only. This counseling will follow a pre-written, structured script describing all contraceptive methods in rank order starting with most effective to least effective in preventing unplanned pregnancy.

Control Group

Participants will receive the standard postpartum contraception counseling that is received by all patients who deliver at our institution.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Focused contraception counseling

This intervention will be provided to those randomized to the intervention group only. This counseling will follow a pre-written, structured script describing all contraceptive methods in rank order starting with most effective to least effective in preventing unplanned pregnancy.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Women who deliver a premature infant that is between the gestational ages of 24 weeks 0 days and 36 weeks 6 days at our institution.

Exclusion Criteria

* Women who have delivered via cesarean section and have also had a sterilization procedure at the time of the cesarean section.
Minimum Eligible Age

14 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Utah

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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David K Turok, MD

Role: PRINCIPAL_INVESTIGATOR

University of Utah

Locations

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University of Utah Hospital

Salt Lake City, Utah, United States

Site Status

Countries

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United States

Other Identifiers

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IRB_00061119

Identifier Type: -

Identifier Source: org_study_id