Optimizing Postpartum Contraception in Women With Preterm Births

NCT01864629 | Completed

• 1 other identifier: IRB_00061119
• Study Type: interventional
• Target: 134
• Locations: 1 country
• Sites: 1

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.

Conditions

Method of Contraception; Preterm Birth Recurrence

Outcome Measures

Primary Outcomes (1)

• Use of highly effective method

  Three months

Secondary Outcomes (2)

• Pregnancy outcomes

  12 months, 18 months, 24 months, 36 months

• Use of highly effective method

  12 months, 24 months, 36 months

Study Arms (2)

Contraception after preterm birth

OTHER

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

Control Group

NO INTERVENTION

Participants will receive the standard postpartum contraception counseling that is received by all patients who deliver at our institution.

Interventions

Focused contraception counseling BEHAVIORAL

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.

Contraception after preterm birth

Eligibility Criteria

• Age: 14 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Women who have delivered via cesarean section and have also had a sterilization procedure at the time of the cesarean section.

Sponsors & Collaborators

• University of Utah: lead

Study Sites (1)

University of Utah Hospital

Salt Lake City, Utah, 84132, United States

Location

Study Officials

• David K Turok, MD

  University of Utah

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2013
• First Posted: May 29, 2013
• Study Start: April 1, 2013
• Primary Completion: October 1, 2014
• Study Completion: January 1, 2016
• Last Updated: October 26, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)