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Optimizing Postpartum Contraception in Women With Preterm Births

Primary Purpose

Method of Contraception, Preterm Birth Recurrence

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Focused contraception counseling
Sponsored by
University of Utah
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Method of Contraception

Eligibility Criteria

14 Years - 50 Years (Child, Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • University of Utah Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

No Intervention

Arm Label

Contraception after preterm birth

Control Group

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Use of highly effective method

Secondary Outcome Measures

Pregnancy outcomes
Use of highly effective method

Full Information

First Posted
May 11, 2013
Last Updated
October 24, 2017
Sponsor
University of Utah
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1. Study Identification

Unique Protocol Identification Number
NCT01864629
Brief Title
Optimizing Postpartum Contraception in Women With Preterm Births
Official Title
Optimizing Postpartum Contraception in Women With Preterm Births
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
April 2013 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
January 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Utah

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Method of Contraception, Preterm Birth Recurrence

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
134 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Contraception after preterm birth
Arm Type
Other
Arm Description
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.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Participants will receive the standard postpartum contraception counseling that is received by all patients who deliver at our institution.
Intervention Type
Behavioral
Intervention Name(s)
Focused contraception counseling
Intervention Description
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 Measure Information:
Title
Use of highly effective method
Time Frame
Three months
Secondary Outcome Measure Information:
Title
Pregnancy outcomes
Time Frame
12 months, 18 months, 24 months, 36 months
Title
Use of highly effective method
Time Frame
12 months, 24 months, 36 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David K Turok, MD
Organizational Affiliation
University of Utah
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Utah Hospital
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Optimizing Postpartum Contraception in Women With Preterm Births

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