Optimizing Postpartum Contraception in Women With Preterm Births

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2013 by University of Utah
Sponsor:
Information provided by (Responsible Party):
University of Utah
ClinicalTrials.gov Identifier:
NCT01864629
First received: May 11, 2013
Last updated: May 24, 2013
Last verified: May 2013
  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: Open Label
Primary Purpose: Health Services Research

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pregnancy outcomes [ Time Frame: 12 months, 18 months, 24 months, 36 months ] [ Designated as safety issue: No ]
  • Use of highly effective method [ Time Frame: 12 months, 24 months, 36 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 362
Study Start Date: April 2013
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: April 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

Ages Eligible for Study:   14 Years to 50 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01864629

Contacts
Contact: Leah N Torres, MD 801-581-6170 leah.torres@hsc.utah.edu

Locations
United States, Utah
University of Utah Hospital Recruiting
Salt Lake City, Utah, United States, 84132
Contact: Leah Torres, MD    801-581-6170    leah.torres@hsc.utah.edu   
Principal Investigator: Leah Torres, MD         
Sponsors and Collaborators
University of Utah
  More Information

No publications provided

Responsible Party: University of Utah
ClinicalTrials.gov Identifier: NCT01864629     History of Changes
Other Study ID Numbers: IRB_00061119
Study First Received: May 11, 2013
Last Updated: May 24, 2013
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on August 21, 2014