Optimizing Postpartum Contraception in Women With Preterm Births

Method of Contraception Clinical Trial

Official title:

Optimizing Postpartum Contraception in Women With Preterm Births

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01864629
• Other study ID #: IRB_00061119
• Status: Completed
• Phase: N/A
• First received: May 11, 2013
• Last updated: October 24, 2017
• Start date: April 2013
• Est. completion date: January 2016

Study information

• Verified date: October 2017
• Source: University of Utah
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 134
• Est. completion date: January 2016
• Est. primary completion date: October 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 14 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Method of Contraception
• Premature Birth
• Preterm Birth Recurrence
• Recurrence

Intervention

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.

Locations

Country	Name	City	State
United States	University of Utah Hospital	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
University of Utah

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Use of highly effective method		Three months
Secondary	Pregnancy outcomes		12 months, 18 months, 24 months, 36 months
Secondary	Use of highly effective method		12 months, 24 months, 36 months