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Optimizing Postpartum Contraception in Women With Preterm Births

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01864629
First Posted: May 29, 2013
Last Update Posted: February 6, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University of Utah
  Purpose

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.


Condition Intervention
Method of Contraception Preterm Birth Recurrence Behavioral: Focused contraception counseling

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Optimizing Postpartum Contraception in Women With Preterm Births

Resource links provided by NLM:


Further study details as provided by University of Utah:

Primary Outcome Measures:
  • Use of highly effective method [ Time Frame: Three months ]

Secondary Outcome Measures:
  • Pregnancy outcomes [ Time Frame: 12 months, 18 months, 24 months, 36 months ]
  • Use of highly effective method [ Time Frame: 12 months, 24 months, 36 months ]

Enrollment: 134
Study Start Date: April 2013
Study Completion Date: January 2016
Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years to 50 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01864629


Locations
United States, Utah
University of Utah Hospital
Salt Lake City, Utah, United States, 84132
Sponsors and Collaborators
University of Utah
Investigators
Principal Investigator: David K Turok, MD University of Utah
  More Information

Responsible Party: University of Utah
ClinicalTrials.gov Identifier: NCT01864629     History of Changes
Other Study ID Numbers: IRB_00061119
First Submitted: May 11, 2013
First Posted: May 29, 2013
Last Update Posted: February 6, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Premature Birth
Recurrence
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Disease Attributes
Pathologic Processes