Optimizing Postpartum Contraception in Women With Preterm Births

October 24, 2017 updated by: University of Utah

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

134

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Utah
      • Salt Lake City, Utah, United States, 84132
        • University of Utah Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 50 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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.
Behavioral: 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.
No Intervention: Control Group
Participants will receive the standard postpartum contraception counseling that is received by all patients who deliver at our institution.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Use of highly effective method
Time Frame: Three months
Three months

Secondary Outcome Measures

Outcome Measure
Time Frame
Pregnancy outcomes
Time Frame: 12 months, 18 months, 24 months, 36 months
12 months, 18 months, 24 months, 36 months
Use of highly effective method
Time Frame: 12 months, 24 months, 36 months
12 months, 24 months, 36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Utah

Investigators

  • Principal Investigator: David K Turok, MD, University of Utah

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2013

Primary Completion (Actual)

October 1, 2014

Study Completion (Actual)

January 1, 2016

Study Registration Dates

First Submitted

May 11, 2013

First Submitted That Met QC Criteria

May 24, 2013

First Posted (Estimate)

May 29, 2013

Study Record Updates

Last Update Posted (Actual)

October 26, 2017

Last Update Submitted That Met QC Criteria

October 24, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB_00061119

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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