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Optimizing Postpartum Contraception in Women With Preterm Births

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ClinicalTrials.gov Identifier: NCT01864629
Recruitment Status : Completed
First Posted : May 29, 2013
Last Update Posted : October 26, 2017
Sponsor:
Information provided by (Responsible Party):

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.


Condition or disease Intervention/treatment
Method of Contraception Preterm Birth Recurrence Behavioral: Focused contraception counseling

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 134 participants
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
Study Start Date : April 2013
Primary Completion Date : October 2014
Study Completion Date : January 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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.


Outcome Measures

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

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

Eligibility Criteria

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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 Posted: May 29, 2013    Key Record Dates
Last Update Posted: October 26, 2017
Last Verified: October 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