Optimizing Postpartum Contraception in Women With Preterm Births

Not Applicable

Completed

• Conditions: Method of Contraception; Preterm Birth Recurrence
• Interventions: Behavioral: Focused contraception counseling

• Registration Number: NCT01864629
• Lead Sponsor: University of Utah

Brief Summary

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

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2013-04
• Study First Submitted: 2013-05-11
• Study First Submitted QC: 2013-05-24
• Study First Posted: 2013-05-29
• Primary Completion: 2014-10
• Study Completion: 2016-01
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-24
• Last Update Posted: 2017-10-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 134

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.

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Exclusion Criteria

• Women who have delivered via cesarean section and have also had a sterilization procedure at the time of the cesarean section.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Contraception after preterm birth	Focused contraception counseling	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.

Primary Outcome Measures

Name	Time	Method
Use of highly effective method	Three months

Secondary Outcome Measures

Name	Time	Method
Pregnancy outcomes	12 months, 18 months, 24 months, 36 months
Use of highly effective method	12 months, 24 months, 36 months

Trial Locations

Locations (1)

University of Utah Hospital; 🇺🇸 Salt Lake City, Utah, United States